Trial Outcomes & Findings for Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital (NCT NCT01014988)

NCT ID: NCT01014988

Last Updated: 2017-03-28

Results Overview

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. All AEs were assesed by the Investigateor as related or not related to the study treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 202 participants
• Primary outcome timeframe: Up to post-treatment (PT) + 23 days
• Results posted on: 2017-03-28

Participant Flow

Male or female participants who were >=6 months of age, hospitalized with laboratory-confirmed influenza, and able to receive study drug within 7 days of influenza symptom onset were enrolled in the study.

Participant milestones

Measure	Cohort 6: Adults (18 Years and Older) Participants \>=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Overall Study STARTED	130	7	11	12	27	14
Overall Study COMPLETED	107	7	9	12	26	11
Overall Study NOT COMPLETED	23	0	2	0	1	3

Reasons for withdrawal

Measure	Cohort 6: Adults (18 Years and Older) Participants \>=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Overall Study Adverse Event	20	0	1	0	1	3
Overall Study Lost to Follow-up	1	0	1	0	0	0
Overall Study Physician Decision	1	0	0	0	0	0
Overall Study Withdrawal by Subject	1	0	0	0	0	0

Baseline Characteristics

Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

Baseline characteristics by cohort

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Total n=201 Participants Total of all reporting groups
Age, Continuous	48.30 Years STANDARD_DEVIATION 16.19 • n=5 Participants	0.76 Years STANDARD_DEVIATION 0.127 • n=7 Participants	1.33 Years STANDARD_DEVIATION 0.220 • n=5 Participants	3.74 Years STANDARD_DEVIATION 1.201 • n=4 Participants	8.67 Years STANDARD_DEVIATION 1.861 • n=21 Participants	15.36 Years STANDARD_DEVIATION 1.151 • n=10 Participants	33.81 Years STANDARD_DEVIATION 23.796 • n=115 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants	6 Participants n=10 Participants	80 Participants n=115 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	18 Participants n=21 Participants	8 Participants n=10 Participants	121 Participants n=115 Participants
Race/Ethnicity, Customized African American/African Heritage	10 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants	3 participants n=10 Participants	23 participants n=115 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	4 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	4 participants n=115 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	10 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	10 participants n=115 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	3 participants n=115 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	6 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	8 participants n=115 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	97 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	18 participants n=21 Participants	11 participants n=10 Participants	145 participants n=115 Participants
Race/Ethnicity, Customized Unknown	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	3 participants n=115 Participants
Race/Ethnicity, Customized Mixed Race	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	0 participants n=10 Participants	3 participants n=115 Participants

PRIMARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: Safety Population: participants who received \>=1 dose of study medication.

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. All AEs were assesed by the Investigateor as related or not related to the study treatment.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment	28 Participants	5 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: Safety Population.

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With Any Severe or Grade 3/4 AEs	57 Participants	23 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: Safety Population.

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With Any Severe or Grade 3/4 Treatment-related AE	16 Participants	2 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 10 days

Population: Safety Population.

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE	17 Participants	2 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: Safety Population.

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants Who Were Permanently Discontinued From the Study Due to an AE	20 Participants	5 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Clinical chemistry parameters included alanine aminotransferase (ALT), direct bilirubin (DB), total bilirubin (TB), and creatinine. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated clinical chemistry parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N Creatinine, n=111, 46	46 Participants	34 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L Creatinine, n=111, 46	34 Participants	5 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H ALT, n=129, 71	48 Participants	21 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N ALT, n=129, 71	79 Participants	49 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L ALT, n=129, 71	1 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H ALT, n=102, 45	41 Participants	16 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N ALT, n=102, 45	60 Participants	27 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L ALT, n=102, 45	1 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H DB, n=83, 60	17 Participants	9 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N DB, n=83, 60	61 Participants	45 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L DB, n=83, 60	2 Participants	3 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H DB, n=70, 36	20 Participants	4 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N DB, n=70, 36	46 Participants	28 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L DB, n=70, 36	1 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H TB, n=128, 71	11 Participants	13 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H TB, n=102, 42	13 Participants	6 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N TB, n=128, 71	110 Participants	50 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L TB, n=128, 71	7 Participants	7 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N TB, n=102, 42	85 Participants	32 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L TB, n=102, 42	4 Participants	2 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H Creatinine, n=128, 71	27 Participants	6 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N Creatinine, n=128, 71	50 Participants	56 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L Creatinine, n=128, 71	51 Participants	9 Participants	—	—	—	—	—
Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H Creatinine, n=111, 46	31 Participants	7 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Hematology parameters included hemoglobin, total neutrophils (TN), and white blood cell (WBC) count. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated hematology parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H TN, n=123, 70	51 Participants	34 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H Hemoglobin, n=130, 71	0 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N Hemoglobin, n=130, 71	48 Participants	30 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L Hemoglobin, n=130, 71	82 Participants	40 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H Hemoglobin, n=114, 47	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N Hemoglobin, n=114, 47	25 Participants	16 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L Hemoglobin, n=114, 47	88 Participants	31 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N TN, n=123, 70	59 Participants	29 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L TN, n=123, 70	13 Participants	7 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H TN, n=106, 45	49 Participants	20 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N TN, n=106, 45	49 Participants	18 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L TN, n=106, 45	8 Participants	7 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, H WBC Count, n=130, 71	29 Participants	9 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, N WBC Count, n=130, 71	71 Participants	42 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 1, L WBC Count, n=130, 71	30 Participants	20 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, H WBC Count, n=114, 47	50 Participants	12 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, N WBC Count, n=114, 47	49 Participants	30 Participants	—	—	—	—	—
Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5 D 5, L WBC Count, n=114, 47	15 Participants	5 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: Safety Population

A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included ALT, TB, and creatinine. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities ALT, Grade 3, n=128, 69	10 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities ALT, Grade 4, n=128, 69	5 Participants	0 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities TB, Grade 3, n=127, 69	3 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities TB, Grade 4, n=127, 69	3 Participants	4 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities Creatinine, Grade 3, n=129, 69	6 Participants	3 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities Creatinine, Grade 4, n=129, 69	5 Participants	2 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: Safety Population

A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=71 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities Hemoglobin, Grade 3, n=129, 69	40 Participants	12 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities Hemoglobin, Grade 4, n=129, 69	9 Participants	2 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities TN, Grade 3, n=122, 68	0 Participants	3 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities TN, Grade 4, n=122, 68	1 Participants	2 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities WBC count, Grade 3, n=129, 69	2 Participants	1 Participants	—	—	—	—	—
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities WBC count, Grade 4, n=129, 69	2 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

Heart rate was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Heart rate was assessed once daily during inpatient or outpatient follow-up visits. Heart rate values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=87 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=43 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Heart Rate at Baseline (Day 1) and Day 5 Day 1, n=87, 43, 7, 11, 12, 27, 14	93.00 Beats per minute (bpm) Interval 58.0 to 143.0	95.00 Beats per minute (bpm) Interval 50.0 to 140.0	119.0 Beats per minute (bpm) Interval 95.0 to 156.0	144.0 Beats per minute (bpm) Interval 121.0 to 195.0	115.5 Beats per minute (bpm) Interval 92.0 to 160.0	112.0 Beats per minute (bpm) Interval 59.0 to 185.0	99.0 Beats per minute (bpm) Interval 74.0 to 134.0
Median Heart Rate at Baseline (Day 1) and Day 5 Day 5, n=73, 42, 7, 6, 9, 15, 10	87.00 Beats per minute (bpm) Interval 50.0 to 140.0	93.50 Beats per minute (bpm) Interval 60.0 to 134.0	127.0 Beats per minute (bpm) Interval 93.0 to 152.0	122.5 Beats per minute (bpm) Interval 98.0 to 146.0	112.0 Beats per minute (bpm) Interval 85.0 to 123.0	102.0 Beats per minute (bpm) Interval 67.0 to 128.0	79.5 Beats per minute (bpm) Interval 58.0 to 113.0

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

SBP and DBP were measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. SBP and DBP were assessed once daily during inpatient or outpatient follow-up visits. SBP and DBP values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=87 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=43 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5 SBP, Day 1, n=87, 43, 7, 11, 12, 27, 14	126.00 Millimeters of mercury (mmHg) Interval 70.0 to 175.0	118.00 Millimeters of mercury (mmHg) Interval 80.0 to 180.0	102.0 Millimeters of mercury (mmHg) Interval 83.0 to 116.0	100.0 Millimeters of mercury (mmHg) Interval 77.0 to 144.0	105.5 Millimeters of mercury (mmHg) Interval 82.0 to 124.0	108.0 Millimeters of mercury (mmHg) Interval 70.0 to 136.0	107.0 Millimeters of mercury (mmHg) Interval 95.0 to 137.0
Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5 SBP, Day 5, n=73, 43, 7, 5, 9, 15, 10	128.00 Millimeters of mercury (mmHg) Interval 51.0 to 182.0	132.00 Millimeters of mercury (mmHg) Interval 88.0 to 220.0	103.0 Millimeters of mercury (mmHg) Interval 86.0 to 130.0	98.0 Millimeters of mercury (mmHg) Interval 87.0 to 120.0	117.0 Millimeters of mercury (mmHg) Interval 83.0 to 140.0	110.0 Millimeters of mercury (mmHg) Interval 96.0 to 135.0	108.5 Millimeters of mercury (mmHg) Interval 95.0 to 121.0
Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5 DBP, Day 1, n=87, 43, 7, 11, 12, 27, 14	68.00 Millimeters of mercury (mmHg) Interval 32.0 to 96.0	63.00 Millimeters of mercury (mmHg) Interval 40.0 to 97.0	53.0 Millimeters of mercury (mmHg) Interval 42.0 to 64.0	60.0 Millimeters of mercury (mmHg) Interval 39.0 to 78.0	58.0 Millimeters of mercury (mmHg) Interval 37.0 to 86.0	57.0 Millimeters of mercury (mmHg) Interval 41.0 to 82.0	62.0 Millimeters of mercury (mmHg) Interval 36.0 to 74.0
Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5 DBP, Day 5, n=73, 43, 7, 5, 9, 15, 10	70.00 Millimeters of mercury (mmHg) Interval 29.0 to 106.0	66.00 Millimeters of mercury (mmHg) Interval 50.0 to 100.0	60.0 Millimeters of mercury (mmHg) Interval 42.0 to 83.0	60.0 Millimeters of mercury (mmHg) Interval 45.0 to 73.0	67.0 Millimeters of mercury (mmHg) Interval 43.0 to 89.0	68.0 Millimeters of mercury (mmHg) Interval 47.0 to 80.0	54.5 Millimeters of mercury (mmHg) Interval 35.0 to 72.0

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

TCPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. Because oxygen is carried to tissues by blood flow in the arteries, TCPO2 is an indirect measure of blood flow. The percent (%) oxygen saturation was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Oxygen saturation was assessed once daily during inpatient follow-up visits. The median oxygen saturation values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=87 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=43 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5 Day 1, n=87, 43, 7, 11, 12, 27, 14	97.00 Percentage of oxygen level in blood Interval 82.0 to 100.0	96.00 Percentage of oxygen level in blood Interval 70.0 to 100.0	98.0 Percentage of oxygen level in blood Interval 76.0 to 100.0	100.0 Percentage of oxygen level in blood Interval 93.0 to 100.0	98.0 Percentage of oxygen level in blood Interval 93.0 to 100.0	98.0 Percentage of oxygen level in blood Interval 91.0 to 100.0	97.5 Percentage of oxygen level in blood Interval 94.0 to 100.0
Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5 Day 5, n=70, 43, 7, 6, 9, 15, 9	97.00 Percentage of oxygen level in blood Interval 73.0 to 100.0	96.00 Percentage of oxygen level in blood Interval 45.0 to 100.0	100.0 Percentage of oxygen level in blood Interval 96.0 to 100.0	95.5 Percentage of oxygen level in blood Interval 85.0 to 100.0	97.0 Percentage of oxygen level in blood Interval 95.0 to 100.0	97.0 Percentage of oxygen level in blood Interval 50.0 to 100.0	96.0 Percentage of oxygen level in blood Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

Respiration rate was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Respiration rate was assessed once daily during inpatient or outpatient follow-up visits. The median respiration rate at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=87 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=43 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Respiration Rate at Baseline (Day 1) and Day 5 Day 1, n=87, 43, 7, 11, 12, 27, 14	23.00 Breaths per minute Interval 6.0 to 47.0	22.00 Breaths per minute Interval 10.0 to 40.0	32.0 Breaths per minute Interval 28.0 to 46.0	34.0 Breaths per minute Interval 20.0 to 40.0	29.5 Breaths per minute Interval 22.0 to 66.0	20.0 Breaths per minute Interval 4.0 to 49.0	21.0 Breaths per minute Interval 0.0 to 98.0
Median Respiration Rate at Baseline (Day 1) and Day 5 Day 5, n=67, 42, 7, 6, 9, 15, 10	20.00 Breaths per minute Interval 10.0 to 42.0	23.50 Breaths per minute Interval 8.0 to 41.0	40.0 Breaths per minute Interval 28.0 to 48.0	31.0 Breaths per minute Interval 10.0 to 50.0	30.0 Breaths per minute Interval 22.0 to 44.0	23.0 Breaths per minute Interval 8.0 to 48.0	19.0 Breaths per minute Interval 0.0 to 28.0

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

Body temperature was recorded at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Body temperature was recorded once daily during inpatient or outpatient follow-up visits. Median body temperature at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=87 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=43 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Body Temperature at Baseline (Day 1) and Day 5 Day 1, n=87, 43, 7, 11, 12, 27, 14	37.30 Degrees centigrade Interval 33.4 to 40.1	37.30 Degrees centigrade Interval 35.3 to 40.4	36.8 Degrees centigrade Interval 36.0 to 40.0	37.3 Degrees centigrade Interval 34.0 to 40.0	37.5 Degrees centigrade Interval 36.0 to 39.0	37.3 Degrees centigrade Interval 33.0 to 39.0	37.5 Degrees centigrade Interval 36.0 to 40.0
Median Body Temperature at Baseline (Day 1) and Day 5 Day 5, n=73, 42, 7, 6, 9, 15, 10	37.00 Degrees centigrade Interval 35.3 to 38.8	37.15 Degrees centigrade Interval 34.5 to 39.8	37.0 Degrees centigrade Interval 36.0 to 38.0	36.8 Degrees centigrade Interval 36.0 to 38.0	37.3 Degrees centigrade Interval 37.0 to 38.0	37.1 Degrees centigrade Interval 37.0 to 39.0	37.1 Degrees centigrade Interval 37.0 to 39.0

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Safety Population

The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) Normal, n=128, 7, 10, 12, 25, 13	68 Participants	5 Participants	7 Participants	8 Participants	20 Participants	8 Participants	—
Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) Abnormal NCS, n=128, 7, 10, 12, 25, 13	57 Participants	2 Participants	2 Participants	4 Participants	5 Participants	5 Participants	—
Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) Abnormal CS, n=128, 7, 10, 12, 25, 13	7 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 5

Population: Safety Population

Twelve-lead ECGs were recorded for the parameters of QTcF and QTcB. The first set of pre-dose ECG values at Baseline (Day 1) and the pre-dose ECG values at Day 5 are presented. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles). "NA" indicates that data are not available/analysis was not performed. Cohort 1 QTcF and QTcB minimum values of 0.0 were data entry errors that could not be addressed after Data Base Freeze.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=87 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=43 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 Participants Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5 QTcF, Baseline, n=87, 42, 6, 9, 11, 24, 13	400.6 Milliseconds Interval 204.0 to 584.0	413.5 Milliseconds Interval 285.0 to 502.0	356.00 Milliseconds Interval 0.0 to 465.0	362.00 Milliseconds Interval 331.0 to 426.0	365.00 Milliseconds Interval 297.0 to 483.0	387.50 Milliseconds Interval 267.0 to 544.0	387.00 Milliseconds Interval 271.0 to 424.0
Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5 QTcF, Day 5, n=68, 40, 0, 1, 3, 3, 5	406.6 Milliseconds Interval 298.0 to 610.0	405.5 Milliseconds Interval 339.0 to 555.0	NA Milliseconds "NA" indicates that data are not available/analysis was not performed.	373.00 Milliseconds Interval 373.0 to 373.0	394.00 Milliseconds Interval 291.0 to 411.0	353.00 Milliseconds Interval 310.0 to 392.0	389.00 Milliseconds Interval 179.0 to 409.0
Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5 QTcB, Baseline, n=87, 42, 6, 9, 11, 24, 13	424.0 Milliseconds Interval 231.0 to 642.0	432.0 Milliseconds Interval 310.0 to 514.0	412.00 Milliseconds Interval 0.0 to 443.0	422.00 Milliseconds Interval 389.0 to 502.0	410.00 Milliseconds Interval 330.0 to 493.0	422.50 Milliseconds Interval 264.0 to 497.0	415.00 Milliseconds Interval 316.0 to 467.0
Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5 QTcB, Day 5, n=68, 40, 0, 1, 3, 3, 5	422.0 Milliseconds Interval 325.0 to 649.0	434.0 Milliseconds Interval 334.0 to 535.0	NA Milliseconds "NA" indicates that data are not available/analysis was not performed.	416.00 Milliseconds Interval 416.0 to 416.0	444.00 Milliseconds Interval 321.0 to 475.0	380.00 Milliseconds Interval 350.0 to 410.0	399.00 Milliseconds Interval 189.0 to 422.0

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population consisted of all participants who receiveed at least one dose of IV zanamivir.

Time to virologic improvement is defined as a 2-log drop in viral load or undetectable viral ribonucleic acid (RNA) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples (PCR positive at Baseline). Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=76 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=5 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=9 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=13 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=7 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Time to Virologic Improvement	3.0 Days Interval 1.0 to 26.0	4.0 Days Interval 2.0 to 9.0	4.0 Days Interval 3.0 to 25.0	3.0 Days Interval 3.0 to 7.0	5.0 Days Interval 3.0 to 6.0	4.0 Days Interval 2.0 to 13.0	—

SECONDARY outcome

Timeframe: Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days

Population: ITT-E Population

Change from Baseline in viral load was measured from nasopharyngeal swab samples, as determined by RT-PCR (PCR positive at Baseline). Nasopharyngeal swab samples were collected at Baseline (Day 1); Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10; and, only if the participants had continued symptoms and were hospitalized, post-treatment (PT) samples were collected at +2 days, +5 days, +9 days, +16 days, and +23 days. 'PT +23 days' also comprises viral load values at early study withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). "NA" indicates that data are not available/analysis was not performed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points Day 2, n=89, 0, 0, 2, 3, 2	-0.92 Log10 copies per milliliter Interval -4.0 to 2.0	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-3.750 Log10 copies per milliliter Interval -3.87 to -3.63	-1.160 Log10 copies per milliliter Interval -1.87 to -0.5	-2.280 Log10 copies per milliliter Interval -2.55 to -2.01	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points Day 3, n=82, 4, 7, 10, 15, 7	-1.42 Log10 copies per milliliter Interval -3.38 to 1.08	-1.655 Log10 copies per milliliter Interval -3.15 to -0.94	-1.930 Log10 copies per milliliter Interval -4.36 to 0.55	-2.215 Log10 copies per milliliter Interval -6.16 to -0.49	-1.330 Log10 copies per milliliter Interval -5.19 to 0.62	-2.550 Log10 copies per milliliter Interval -4.01 to -0.29	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points Day 4, n=84, 0, 0, 2, 2, 1	-1.59 Log10 copies per milliliter Interval -5.4 to 1.38	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-4.895 Log10 copies per milliliter Interval -5.01 to -4.78	-2.060 Log10 copies per milliliter Interval -2.6 to -1.52	-2.550 Log10 copies per milliliter Interval -2.55 to -2.55	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points Day 5, n=75, 5, 4, 8, 12, 5	-1.57 Log10 copies per milliliter Interval -5.06 to 2.05	-2.720 Log10 copies per milliliter Interval -4.92 to -0.12	-3.705 Log10 copies per milliliter Interval -6.2 to 0.24	-3.285 Log10 copies per milliliter Interval -6.16 to -1.81	-2.930 Log10 copies per milliliter Interval -6.71 to -1.53	-2.550 Log10 copies per milliliter Interval -4.01 to -1.4	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points Day 7, n=23, 1, 1, 1, 3, 1	-1.58 Log10 copies per milliliter Interval -3.52 to 3.02	-1.820 Log10 copies per milliliter Interval -1.82 to -1.82	-6.200 Log10 copies per milliliter Interval -6.2 to -6.2	-3.030 Log10 copies per milliliter Interval -3.03 to -3.03	-3.040 Log10 copies per milliliter Interval -3.46 to -1.26	-1.610 Log10 copies per milliliter Interval -1.61 to -1.61	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points Day 10, n=19, 0, 2, 1, 4, 1	-1.75 Log10 copies per milliliter Interval -4.0 to 2.04	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-5.385 Log10 copies per milliliter Interval -6.2 to -4.57	-6.430 Log10 copies per milliliter Interval -6.43 to -6.43	-4.760 Log10 copies per milliliter Interval -5.42 to -2.48	-1.670 Log10 copies per milliliter Interval -1.67 to -1.67	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points PT +2 days, n=32, 0, 1, 2, 6, 3	-1.38 Log10 copies per milliliter Interval -4.86 to 0.46	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-6.200 Log10 copies per milliliter Interval -6.2 to -6.2	-2.495 Log10 copies per milliliter Interval -2.91 to -2.08	-3.825 Log10 copies per milliliter Interval -5.42 to -1.6	-3.060 Log10 copies per milliliter Interval -4.61 to -1.63	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points PT +5 days, n=26, 0, 2, 0, 5, 2	-1.84 Log10 copies per milliliter Interval -5.21 to -0.4	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-5.385 Log10 copies per milliliter Interval -6.2 to -4.57	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-4.190 Log10 copies per milliliter Interval -5.42 to -1.6	-3.275 Log10 copies per milliliter Interval -3.43 to -3.12	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points PT +9 days, n=27, 0, 1, 0, 3, 2	-2.58 Log10 copies per milliliter Interval -5.21 to -0.41	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-6.200 Log10 copies per milliliter Interval -6.2 to -6.2	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-4.190 Log10 copies per milliliter Interval -5.42 to -1.6	-3.865 Log10 copies per milliliter Interval -4.61 to -3.12	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points PT +16 days, n=21, 0, 1, 0, 4, 1	-2.48 Log10 copies per milliliter Interval -5.21 to -0.41	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-2.950 Log10 copies per milliliter Interval -2.95 to -2.95	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-3.825 Log10 copies per milliliter Interval -4.56 to -1.6	-4.610 Log10 copies per milliliter Interval -4.61 to -4.61	—
Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points PT +23 days, n=21, 2, 4, 0, 4, 0	-2.89 Log10 copies per milliliter Interval -5.21 to -0.46	-4.455 Log10 copies per milliliter Interval -4.92 to -3.99	-4.670 Log10 copies per milliliter Interval -6.2 to -2.95	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	-3.825 Log10 copies per milliliter Interval -4.56 to -1.6	NA Log10 copies per milliliter "NA" indicates that data are not available/analysis was not performed.	—

SECONDARY outcome

Timeframe: Baseline and up to post-treatment (PT) + 23 days

Population: ITT-E Population

Viral susceptibility to zanamivir at Baseline and at all post-Baseline visits collectively was assessed by neuraminidase (NA) enzyme inhibition assay. The mean IC50 data are summarized by subtype (A/H1N1, A/H3N2, B) and by visit. IC50 is defined as the concentration of zanamvir required to inhibit NA activity by 50%. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). "NA" indicates that data are not available/analysis was not performed. Please note: pediatric data are pending and will be updated when available.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively A/H1N1, Day 1, n=22, 2	0.2091 Nanomolar (nM) Standard Deviation 0.06886	—	—	—	—	—	—
Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively A/H1N1, All Post-Baseline, n=8, 1	0.1800 Nanomolar (nM) Standard Deviation 0.04000	—	—	—	—	—	—
Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively A/H3N2, Day 1, n=5, 16	0.2660 Nanomolar (nM) Standard Deviation 0.08385	—	—	—	—	—	—
Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively A/H3N2, All Post-Baseline, n=2, 3	0.2300 Nanomolar (nM) Standard Deviation 0.01414	—	—	—	—	—	—
Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively B, Day 1, n=2, 16	1.6100 Nanomolar (nM) Standard Deviation 0.35355	—	—	—	—	—	—
Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively B, All Post-Baseline, n=0, 10	NA Nanomolar (nM) Standard Deviation NA "NA" indicates that data are not available/analysis was not performed.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to post-treatment (PT) + 23 days

Population: ITT-E Population

Viral RNA isolated from participants at Baseline (Day 1) and post-Baseline visits were sequenced to determine the presence of TE neuraminidase (NA) and hemagglutinin (HA) mutations resulting from selective pressure. A mutation was considered to be TE if it was not present at Baseline and was present in the last post-Baseline sample analyzed.These mutations were classified as either known to confer zanamvir resistance or novel mutations with unknown clinical significance. Please note: pediatric data are pending and will be updated when available.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With Treatment-emergent (TE) Mutations Known Zanamivir-Resistant NA Mutations	0 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent (TE) Mutations Novel NA Mutations	5 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent (TE) Mutations Novel HA Mutations	4 Participants	—	—	—	—	—	—
Number of Participants With Treatment-emergent (TE) Mutations Resistant HA Mutations	2 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population

Times to return to afebrile status (normal body temperature), normal respiratory status, normal heart rate, and normal systolic blood pressure were assessed. Afebrile status is defined as a temperature <=36.6 axilla, <=37.2 oral, or <=37.7 rectal, core or typanic, degrees Centigrade. A return to normal respiratory status is defined as either: (a) return to pre-morbid oxygen requirement; or (b) return to no need for supplemental oxygen; or (c) respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute (without supplemental oxygen) for Cohorts 1-6 respectively . A normal HR is defined as <=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively, and a normal SBP is defined as >=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Time to Resolution of Individual Vital Signs Afebrile Status, n=120, 7, 11, 7, 24, 13	3.0 Days Interval 2.0 to 34.0	4.0 Days Interval 2.0 to 26.0	2.0 Days Interval 1.0 to 30.0	25.0 Days Interval 2.0 to 32.0	3.0 Days Interval 2.0 to 26.0	3.0 Days Interval 2.0 to 15.0	—
Median Time to Resolution of Individual Vital Signs Respiratory Status, n=89, 7, 10, 12, 23, 9	8.0 Days Interval 2.0 to 36.0	5.0 Days Interval 2.0 to 16.0	2.0 Days Interval 1.0 to 21.0	3.5 Days Interval 2.0 to 21.0	3.0 Days Interval 2.0 to 33.0	2.0 Days Interval 2.0 to 20.0	—
Median Time to Resolution of Individual Vital Signs HR, n=121, 7, 11, 12, 27, 13	2.0 Days Interval 2.0 to 22.0	2.0 Days Interval 2.0 to 2.0	2.0 Days Interval 1.0 to 25.0	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 31.0	2.0 Days Interval 2.0 to 5.0	—
Median Time to Resolution of Individual Vital Signs SBP, n=128, 7, 11, 12, 27, 14	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 2.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 24.0	2.0 Days Interval 2.0 to 3.0	—

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population

Ventilation status was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Ventilation status was assessed once daily during inpatient follow-up visits. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD) at "any time (AT) on study" and at Baseline (Day 1) are summarized.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation AT on Study, SOD	91 Participants	3 Participants	5 Participants	7 Participants	13 Participants	5 Participants	—
Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation AT on Study, Machine-Assisted: ECMO	4 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	—
Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation AT on Study, Machine-Assisted: Endotracheal	74 Participants	3 Participants	5 Participants	4 Participants	14 Participants	4 Participants	—
Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation Day 1, Machine-Assisted: ECMO	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	—
Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation Day 1, Machine-Assisted: Endotracheal	60 Participants	2 Participants	3 Participants	4 Participants	11 Participants	4 Participants	—
Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation Day 1, SOD	46 Participants	1 Participants	3 Participants	1 Participants	6 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Up to discharge from the hospital

Population: ITT-E Population

Due to the conditional nature of data collection post treatment, the duration of mechanical ventilation and supplemental oxygen use were not determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population

Time to return to pre-morbid functional status was assessed on a 3-point scale (bed rest, limited ambulation, or unrestricted). Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=76 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=9 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=22 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=9 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Time to Return to Pre-morbid Functional Status	10.0 Days Interval 2.0 to 48.0	8.0 Days Interval 2.0 to 27.0	3.0 Days Interval 2.0 to 27.0	5.0 Days Interval 2.0 to 28.0	5.5 Days Interval 2.0 to 34.0	4.0 Days Interval 2.0 to 8.0	—

SECONDARY outcome

Timeframe: Day 14 and Day 28

Population: ITT-E Population

The number of participants who died on or before Study Day 14 and Study Day 28 was summarized. Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With the Indicated Mortality Status at Day 14 and Day 28 Died on or before Study Day 28, No	108 Participants	7 Participants	10 Participants	12 Participants	26 Participants	11 Participants	—
Number of Participants With the Indicated Mortality Status at Day 14 and Day 28 Died on or before Study Day 14, No	113 Participants	7 Participants	11 Participants	12 Participants	26 Participants	12 Participants	—
Number of Participants With the Indicated Mortality Status at Day 14 and Day 28 Died on or before Study Day 14, Yes	17 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	—
Number of Participants With the Indicated Mortality Status at Day 14 and Day 28 Died on or before Study Day 28, Yes	22 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population

Sustained resolution of the following vital signs (composite) was assessed: afebrile status, normal oxygen saturation, normal respiratory status, normal HR, and normal BP. Clinical response is defined as the resolution of at least four of five vital signs within the following resolution criteria, maintained for 24 hours or hospital discharge, whichever occurred first: Temperature in degrees Centigrade (<=36.6 axilla, <=37.2 oral, <=37.7 rectal, core or tympanic); oxygen saturation (>=95%, without supplemental oxygen); respiratory status (return to pre-morbid oxygen requirement, or no need for supplemental oxygen, or respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute without supplemental oxygen for Cohorts 1-6 respectively); HR (<=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively); SBP (>=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively). Only those participants available at the specified time points were analyzed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=81 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=10 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=25 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=11 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)	9.0 Days Interval 2.0 to 32.0	7.0 Days Interval 2.0 to 23.0	3.5 Days Interval 1.0 to 21.0	6.5 Days Interval 2.0 to 37.0	4.0 Days Interval 1.0 to 42.0	5.0 Days Interval 2.0 to 32.0	—

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants With Any AE Categorized as an Influenza Complication	45 Participants	4 Participants	4 Participants	3 Participants	8 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Up to post-treatment (PT) + 23 days

Population: ITT-E Population

Concomitant medications (prescription and non-prescription) were permitted during the course of the study at the Investigator's discretion (except for prohibited medications: during the treatment period with IV zanamivir, other influenza antiviral drugs were not permitted). The number of participants who were treated with antibiotics for influenza complications was summarized.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza	63 Participants	5 Participants	7 Participants	7 Participants	12 Participants	6 Participants	—

SECONDARY outcome

Timeframe: Up to discharge from hospital

Population: ITT-E Population

The duration of hospitalization (H) reflects the number of hospitalization days between the date of the first dose of investigational product and the date of discharge. ICU stay includes total duration in ICU and may include days in ICU before entry into the study. For participants with a missing discharge date who were not discharged at the end of the study, the date of discharge was imputed to the last follow-up visit (post-treatment +23 days). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=11 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=27 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=14 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays Duration of H, n=130, 7, 11, 12, 27, 14	15.0 Days Interval 1.0 to 133.0	7.0 Days Interval 2.0 to 23.0	4.0 Days Interval 2.0 to 44.0	6.5 Days Interval 3.0 to 37.0	6.0 Days Interval 1.0 to 45.0	6.5 Days Interval 2.0 to 42.0	—
Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays Duration of H-ICU, n=108, 4, 6, 8, 19, 9	11.50 Days Interval 1.0 to 104.0	7.5 Days Interval 5.0 to 24.0	5.0 Days Interval 3.0 to 19.0	5.5 Days Interval 2.0 to 26.0	8.0 Days Interval 2.0 to 50.0	8.0 Days Interval 4.0 to 39.0	—

SECONDARY outcome

Timeframe: Day 1 and Days 3, 4, or 5

Population: PK Parameter Population: participants with one or more estimated zanamivir PK parameters

The Cmax of zanamivir was evaluated at the end of infusion. Serial blood samples for pharmacokinetic (PK) analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants who were neither on extracorporeal membrane oxygenation (ECMO) nor on continuous renal replacement therapy (CRRT), who were with CLcr >=80 mL/minutes (>=80mL/minute/1.73m^2 for cohorts 1-4) and who received an initial dose (ID) and a maintenance dose (MD) of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=6 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=15 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=13 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion ID, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 9, 3	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	44.16 Micrograms per mL Geometric Coefficient of Variation 47	4.99 Micrograms per mL Geometric Coefficient of Variation 3997	—
Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion ID, 14 mg/kg, CLcr>=80, n=0, 4, 5, 9, 0, 0	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	36.21 Micrograms per mL Geometric Coefficient of Variation 21	37.78 Micrograms per mL Geometric Coefficient of Variation 24	41.54 Micrograms per mL Geometric Coefficient of Variation 23	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion MD, 600 mg, CLcr>=80, n=72, 0, 0, 0, 0, 2	35.30 Micrograms per mL Geometric Coefficient of Variation 32	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	25.73 Micrograms per mL Geometric Coefficient of Variation 52	—
Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion MD, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 4, 0	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	45.18 Micrograms per mL Geometric Coefficient of Variation 48	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion ID, 600 mg, CLcr>=80, n=67, 0, 0, 0, 0, 6	32.77 Micrograms per mL Geometric Coefficient of Variation 34	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	34.47 Micrograms per mL Geometric Coefficient of Variation 27	—
Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion MD, 14 mg/kg, CLcr>=80, n=0, 0, 1, 4, 0, 0	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	38.01 Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	43.19 Micrograms per mL Geometric Coefficient of Variation 9	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms per mL Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—

SECONDARY outcome

Timeframe: Day 1 and Days 3, 4, or 5

Population: PK Parameter Population

The AUC(0-tau) during the repeat dose interval and AUC(0-inf) for the initial dose were evaluated. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=6 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=15 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=13 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir AUC(0-inf), ID, 600 mg, CLcr>=80, n=63,0,0,0,0,5	82.86 Micrograms*hour per milliliter Geometric Coefficient of Variation 36	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	91.07 Micrograms*hour per milliliter Geometric Coefficient of Variation 27	—
Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir AUC(0-inf), ID, 12 mg/kg, CLcr>=80, n=0,0,0,0,8,1	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	107.21 Micrograms*hour per milliliter Geometric Coefficient of Variation 41	135.22 Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir AUC(0-inf), ID, 14 mg/kg, CLcr>=80, n=0,3,4,9,0,0	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	75.31 Micrograms*hour per milliliter Geometric Coefficient of Variation 23	72.42 Micrograms*hour per milliliter Geometric Coefficient of Variation 14	80.28 Micrograms*hour per milliliter Geometric Coefficient of Variation 38	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir AUC(0-tau), MD, 600 mg, CLcr>=80, n=65,0,0, 0,0,2	90.33 Micrograms*hour per milliliter Geometric Coefficient of Variation 36	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	64.52 Micrograms*hour per milliliter Geometric Coefficient of Variation 30	—
Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir AUC(0-tau), MD, 12 mg/kg, CLcr>=80, n=0,0,0,0,4,0	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	90.33 Micrograms*hour per milliliter Geometric Coefficient of Variation 45	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir AUC(0-tau), MD, 14 mg/kg, CLcr>=80, n=0,0,1,4,0,0	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	68.20 Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	81.02 Micrograms*hour per milliliter Geometric Coefficient of Variation 28	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Micrograms*hour per milliliter Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—

SECONDARY outcome

Timeframe: Day 1 and Days 3, 4, or 5

Population: PK Parameter Population

The t1/2 of zanamivir was evaluated. Terminal half life is defined as the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Day 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr>=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=6 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=15 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=13 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Geometric Mean Terminal Half Life (t1/2) of Zanamivir ID, 600 mg, CLcr>=80, n=67, 0, 0, 0, 0, 5	2.39 Hours Geometric Coefficient of Variation 31	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	2.06 Hours Geometric Coefficient of Variation 47	—
Geometric Mean Terminal Half Life (t1/2) of Zanamivir ID, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 8, 1	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	2.57 Hours Geometric Coefficient of Variation 55	2.16 Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Terminal Half Life (t1/2) of Zanamivir ID, 14 mg/kg, CLcr>=80, n=0, 3, 5, 9, 0, 0	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	1.84 Hours Geometric Coefficient of Variation 19	2.49 Hours Geometric Coefficient of Variation 118	1.60 Hours Geometric Coefficient of Variation 34	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Terminal Half Life (t1/2) of Zanamivir MD, 600 mg, CLcr>=80, n=68, 0, 0, 0, 0, 2	2.56 Hours Geometric Coefficient of Variation 34	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	1.73 Hours Geometric Coefficient of Variation 21	—
Geometric Mean Terminal Half Life (t1/2) of Zanamivir MD, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 4, 0	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	1.81 Hours Geometric Coefficient of Variation 41	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Terminal Half Life (t1/2) of Zanamivir MD, 14 mg/kg, CLcr>=80, n=0, 0, 1, 4, 0, 0	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	1.68 Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	1.76 Hours Geometric Coefficient of Variation 20	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Hours Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—

SECONDARY outcome

Timeframe: Day 1 and Days 3, 4, or 5

Population: PK Parameter Population

The serum clearance of zanamivir was evaluated. Clearance is defined as the volume of zanamivir per unit time eliminated from serum. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=6 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=15 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=13 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Geometric Mean Serum Clearance of Zanamivir ID, 600 mg, CLcr>=80, n=63, 0, 0, 0, 0, 5	120.68 mL per minutes Geometric Coefficient of Variation 36	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	109.83 mL per minutes Geometric Coefficient of Variation 27	—
Geometric Mean Serum Clearance of Zanamivir ID, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 8, 1	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	46.70 mL per minutes Geometric Coefficient of Variation 47	53.70 mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Serum Clearance of Zanamivir ID, 14 mg/kg, CLcr>=80, n=0, 3, 4, 9, 0, 0	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	27.31 mL per minutes Geometric Coefficient of Variation 32	31.00 mL per minutes Geometric Coefficient of Variation 12	41.95 mL per minutes Geometric Coefficient of Variation 37	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Serum Clearance of Zanamivir MD, 600 mg, CLcr>=80, n=65, 0, 0, 0, 0, 0	110.71 mL per minutes Geometric Coefficient of Variation 36	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	155.03 mL per minutes Geometric Coefficient of Variation 30	—
Geometric Mean Serum Clearance of Zanamivir MD, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 4, 0	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	68.61 mL per minutes Geometric Coefficient of Variation 34	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Serum Clearance of Zanamivir MD, 14 mg/kg, CLcr>=80, n=0, 0, 1, 4, 0, 0	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	31.78 mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	40.35 mL per minutes Geometric Coefficient of Variation 35	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA mL per minutes Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—

SECONDARY outcome

Timeframe: Day 1 and Days 3, 4, or 5

Population: PK Parameter Population

The Vd of zanamivir was evaluated. Volume of distribution is defined as the apparent volume in which zanamivir is distributed. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >= 80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Outcome measures

Measure	Cohort 6: Adults (18 Years and Older) n=130 Participants Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years) n=7 Participants Participants 6 months to \<18 years of age received 14 mg/kg zanamivir (participants from 6 months to \<6 years of age) or 12 mg/kg zanamivir (participants from 6 years to \<18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=6 Participants Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=12 Participants Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=15 Participants Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=13 Participants Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Geometric Mean Volume of Distribution (Vd) of Zanamivir ID, 600 mg, CLcr>=80, n=63, 0, 0, 0, 0, 5	24.89 Liters (L) Geometric Coefficient of Variation 27	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	18.57 Liters (L) Geometric Coefficient of Variation 26	—
Geometric Mean Volume of Distribution (Vd) of Zanamivir ID, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 8, 1	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	9.21 Liters (L) Geometric Coefficient of Variation 48	10.09 Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Volume of Distribution (Vd) of Zanamivir ID, 14 mg/kg, CLcr>=80, n=0, 3, 4, 9, 0, 0	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	3.77 Liters (L) Geometric Coefficient of Variation 12	3.94 Liters (L) Geometric Coefficient of Variation 29	5.15 Liters (L) Geometric Coefficient of Variation 20	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Volume of Distribution (Vd) of Zanamivir MD, 600 mg, CLcr>=80, n=65, 0, 0, 0, 0, 0	24.61 Liters (L) Geometric Coefficient of Variation 32	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	23.20 Liters (L) Geometric Coefficient of Variation 25	—
Geometric Mean Volume of Distribution (Vd) of Zanamivir MD, 12 mg/kg, CLcr>=80, n=0, 0, 0, 0, 8, 0	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	9.82 Liters (L) Geometric Coefficient of Variation 8	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—
Geometric Mean Volume of Distribution (Vd) of Zanamivir MD, 14 mg/kg, CLcr>=80, n=0, 0, 1, 4, 0, 0	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	3.77 Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	5.23 Liters (L) Geometric Coefficient of Variation 32	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	NA Liters (L) Geometric Coefficient of Variation NA "NA" indicates that data are not available/analysis was not performed.	—

Adverse Events

Cohort 6: Adults (18 Years and Older)

Serious events: 44 serious events

Other events: 100 other events

Deaths: 0 deaths

Cohort 1: Infants (6 Months to <1 Year of Age)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2: Children (1 to <2 Years of Age)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 3: Children (2 to <6 Years of Age)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 4: Children (6 to <13 Years of Age)

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 5: Adolescents (13 to <18 Years of Age)

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 6: Adults (18 Years and Older) n=130 participants at risk Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 participants at risk Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 participants at risk Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 participants at risk Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 participants at risk Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 participants at risk Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Vascular disorders Deep vein thrombosis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Haemorrhage	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Hypertension	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Peripheral ischaemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Shock haemorrhagic	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Multi-organ failure	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Pyrexia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Depression	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood bilirubin increased	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Cardiac arrest	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Cardio-respiratory arrest	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Tachycardia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Atrioventricular block complete	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Cardiogenic shock	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Torsade de pointes	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Ventricular arrhythmia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Ventricular tachycardia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.4% 7/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Neutropenia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Encephalopathy	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Ischaemic stroke	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Status epilepticus	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Cyclic vomiting syndrome	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Renal failure	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Renal failure acute	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Hepatobiliary disorders Hepatocellular injury	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hyponatraemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia	5.4% 7/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Septic shock	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Bronchopulmonary aspergillosis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Sepsis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Bacteraemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Acinetobacter bacteraemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Cellulitis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Encephalitis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Endocarditis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Lung abscess	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pseudomonas infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Superinfection bacterial	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Viral pericarditis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.

Other adverse events

Measure	Cohort 6: Adults (18 Years and Older) n=130 participants at risk Participants \>=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 1: Infants (6 Months to <1 Year of Age) n=7 participants at risk Participants 6 months to \<1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 2: Children (1 to <2 Years of Age) n=11 participants at risk Participants 1 year to \<2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 3: Children (2 to <6 Years of Age) n=12 participants at risk Participants 2 years to \<6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 4: Children (6 to <13 Years of Age) n=27 participants at risk Participants 6 years to \<13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.	Cohort 5: Adolescents (13 to <18 Years of Age) n=14 participants at risk Participants 13 to \<18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Hypotension	11.5% 15/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.4% 2/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Hypertension	8.5% 11/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Deep vein thrombosis	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	16.7% 2/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Thrombophlebitis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Phlebitis	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Venous thrombosis	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Arterial thrombosis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Circulatory collapse	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Extremity necrosis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Haematoma	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Hypoperfusion	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Jugular vein thrombosis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Poor peripheral circulation	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Vascular disorders Venous thrombosis limb	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Pyrexia	10.8% 14/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.8% 4/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Oedema	5.4% 7/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Asthenia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Pain	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Drug withdrawal syndrome	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.4% 2/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Chest pain	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Generalised oedema	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Infusion site extravasation	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Catheter site haemorrhage	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Device occlusion	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Facial pain	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Hypothermia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Injection site reaction	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Multi-organ failure	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Oedema peripheral	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Thrombosis in device	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
General disorders Unintentional medical device removal	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Anxiety	9.2% 12/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Insomnia	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Mental status changes	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Agitation	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Delirium	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Conduct disorder	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Confusional state	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Drug dependence	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Psychiatric disorders Withdrawal syndrome	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Reproductive system and breast disorders Perineal rash	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Excoriation	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Contusion	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Overdose	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Injury, poisoning and procedural complications Procedural pain	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Alanine aminotransferase increased	8.5% 11/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Aspartate aminotransferase increased	3.8% 5/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood creatinine phosphokinase increased	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Hepatic enzyme increased	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Activated partial thromboplastin time prolonged	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood alkaline phosphatase increased	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood creatinine increased	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Electrocardiogram QT prolonged	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Oxygen saturation decreased	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Transaminases increased	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood glucose increased	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood pressure increased	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood sodium increased	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Blood triglycerides increased	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Chest X-ray abnormal	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Gamma-glutamyl transferase increased	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Gastric occult blood positive	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Haematrocrit decreased	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Haemoglobin decreased	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations International normalised ratio increased	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Liver function test abnormal	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Occult blood positive	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Prothrombin time prolonged	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Pseudomonas test positive	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Investigations Troponin I increased	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Atrial fibrillation	4.6% 6/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Tachycardia	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Arrhythmia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Bundle branch block right	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Aortic valve incompetence	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Bradycardia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Bundle branch block left	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Cardiac failure congestive	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Dilatation ventricular	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Left ventricular dysfunction	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Mitral valve incompetence	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Right atrial dilatation	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Cardiac disorders Ventricular arrhythmia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.6% 6/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	28.6% 2/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Cough	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Thoracic haemorrhage	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Anaemia	8.5% 11/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	11.1% 3/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Neutropenia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	18.2% 2/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Thrombocytopenia	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Leukocytosis	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Leukopenia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Thrombocytosis	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Coagulopathy	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Agranulocytosis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Bandaemia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Haemolytic anaemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Lymphpenia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Headache	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Critical illness polyneuropathy	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Dizziness	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Neuromyopathy	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Neuropathy peripheral	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Aphasia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Apraxia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Brain injury	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Brain oedema	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Dizziness exertional	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Epilepsy	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Migraine	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Polyneuropathy	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Psychomotor hyperactivity	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Nervous system disorders Tremor	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Eye disorders Conjunctival haemorrhage	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Eye disorders Conjunctival oedema	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Eye disorders Diplopia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Eye disorders Dry eye	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Eye disorders Keratopathy	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Eye disorders Pupillary disorder	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Constipation	7.7% 10/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	11.1% 3/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Diarrhoea	7.7% 10/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Vomiting	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.4% 2/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Nausea	4.6% 6/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Abdominal pain	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Dyspepsia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Abdominal distension	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Gastritis erosive	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Ileus	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Impaired gastic emptying	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Oral disorder	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Rectal haemorrhage	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Gastrointestinal disorders Volvulus	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Renal failure	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Renal failure acute	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Dysuria	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Glycosuria	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Polyuria	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Renal impairment	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Hepatobiliary disorders Hyperbilirubinaemia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Hepatobiliary disorders Hepatocellular injury	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Hepatobiliary disorders Cholestasis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Hepatobiliary disorders Cholelithiasis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Hepatobiliary disorders Hepatomegaly	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Rash	3.8% 5/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Decubitus ulcer	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.4% 2/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Skin disorder	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.4% 2/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	28.6% 2/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Drug eruption	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Blister	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Prurigo	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Rash erythematous	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Rash vesicular	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Skin discolouration	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Skin and subcutaneous tissue disorders Urticaria	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Back pain	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Muscle spasms	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Muscular weakness	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Myalgia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Myositis ossificans	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Neck pain	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Endocrine disorders Adrenal insufficiency	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Endocrine disorders Hyperparathyroidism secondary	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypokalaemia	12.3% 16/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypoalbuminaemia	5.4% 7/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypophosphataemia	4.6% 6/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hyperglycaemia	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypocalcaemia	4.6% 6/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hyperkalaemia	3.8% 5/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypernatraemia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Acidosis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypoglycaemia	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypomagnesaemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hyponatraemia	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Metabolic acidosis	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Metabolic alkalosis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Food intolerance	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.4% 2/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hyperphosphataemia	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Lactic acidosis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Fluid overload	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Fluid retention	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hyperchloraemia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	7.1% 1/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Hypophagia	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Malnutrition	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	28.6% 2/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Urinary tract infection	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Oral herpes	3.1% 4/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Bronchitis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Candida infection	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Oral candidiasis	2.3% 3/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Bronchopneumonia	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Fungal skin infection	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	18.2% 2/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Lung infection	1.5% 2/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia bacterial	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Sepsis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Sinusitis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Bacterial disease carrier	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Bronchiolitis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Clostridium difficile colitis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Clostridium difficile infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Croup infectious	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Device related infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Empyema	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Enterococcal infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Genital herpes	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Hordeolum	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Oesophageal candidiasis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Ophthalmic herpes simplex	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Otitis media	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	14.3% 1/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Otitis media acute	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Penile infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia haemophilus	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia necrotising	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	9.1% 1/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia staphylococcal	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pneumonia viral	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Pseudomonas bronchitis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Respiratory moniliasis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	3.7% 1/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Rhinitis	0.00% 0/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	8.3% 1/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Staphylococcal sepsis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Tracheitis	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Upper respiratory tract infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.
Infections and infestations Vulvovaginal mycotic infection	0.77% 1/130 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/7 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/11 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/12 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/27 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.	0.00% 0/14 • Non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 33 days). Serious adverse events (SAEs) assessed as related to study participation were recorded from time of consent until any follow up contact.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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