Trial Outcomes & Findings for A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia. (NCT NCT04806503)

NCT ID: NCT04806503

Last Updated: 2024-06-20

Results Overview

Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 234 participants
• Primary outcome timeframe: Baseline, Month 3
• Results posted on: 2024-06-20

Participant Flow

Participant milestones

Measure	UNR844 5 mg/mL UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution placebo ophthalmic solution; one drop twice-a-day for three months
Overall Study STARTED	48	48	44	48	46
Overall Study COMPLETED	46	47	42	46	45
Overall Study NOT COMPLETED	2	1	2	2	1

Reasons for withdrawal

Measure	UNR844 5 mg/mL UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution placebo ophthalmic solution; one drop twice-a-day for three months
Overall Study Lost to Follow-up	0	0	1	0	0
Overall Study Withdrawal by Subject	1	0	1	1	1
Overall Study Adverse Event	1	1	0	1	0

Baseline Characteristics

A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.

Baseline characteristics by cohort

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months	Total n=234 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 2.61 • n=5 Participants	50.9 years STANDARD_DEVIATION 2.80 • n=7 Participants	51.0 years STANDARD_DEVIATION 2.94 • n=5 Participants	50.5 years STANDARD_DEVIATION 2.66 • n=4 Participants	51.2 years STANDARD_DEVIATION 2.80 • n=21 Participants	50.9 years STANDARD_DEVIATION 2.75 • n=8 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	29 Participants n=4 Participants	23 Participants n=21 Participants	135 Participants n=8 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	23 Participants n=21 Participants	99 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 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=8 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	52 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	14 Participants n=8 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	34 Participants n=21 Participants	166 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 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=8 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set

Characterize dose response of UNR844 as measured by change from baseline at Month 3 in binocular DCNVA (without near correction) in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
Characterize Dose-response of UNR844 for Change From Baseline in Binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3	-0.106 logMAR Standard Error 0.0186	-0.110 logMAR Standard Error 0.0188	-0.136 logMAR Standard Error 0.0203	-0.101 logMAR Standard Error 0.0185	-0.112 logMAR Standard Error 0.0194

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set

Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (worse-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40 cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3	-0.125 logMAR Standard Error 0.0217	-0.121 logMAR Standard Error 0.0220	-0.143 logMAR Standard Error 0.0241	-0.112 logMAR Standard Error 0.0216	-0.146 logMAR Standard Error 0.0228

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set

Characterize dose response of UNR844 as measured by change from baseline at Month 3 in monocular (better-seeing eye) DCNVA in Logarithm of Minimum Angle of Resolution (logMAR), at 40cm. A low logMAR score represents good vision while a high logMAR score represents bad vision.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
Characterize Dose Response of UNR844 as Measured by Change From Baseline in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) at Month 3	-0.056 logMAR Standard Error 0.0194	-0.075 logMAR Standard Error 0.0198	-0.081 logMAR Standard Error 0.0210	-0.059 logMAR Standard Error 0.0194	-0.085 logMAR Standard Error 0.0206

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set

Percentage of participants gaining at least 0.3 logMAR in binocular DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.

Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
Percentage of Participants Gaining at Least 0.30 logMAR in Binocular Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3	4.4 Percentage of participants Interval 0.0 to 10.3	9.3 Percentage of participants Interval 0.78 to 17.9	14.9 Percentage of participants Interval 3.89 to 25.92	5.1 Percentage of participants Interval 0.0 to 11.7	4.6 Percentage of participants Interval 0.0 to 10.72

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set

Percentage of participants gaining at least 0.3 logMAR in monocular (worse-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.

Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Worse-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3	13.0 Percentage of participants Interval 3.32 to 22.62	9.0 Percentage of participants Interval 0.61 to 17.33	8.7 Percentage of participants Interval 0.0 to 17.82	10.0 Percentage of participants Interval 1.31 to 18.62	11.9 Percentage of participants Interval 2.16 to 21.71

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set

Percentage of participants gaining at least 0.3 logMAR in monocular (better-seeing eye) DCNVA compared to baseline at Month 3. DCNVA is measured in Logarithm of Minimum Angle of Resolution (logMAR) at 40 cm, with subjects corrected for any distance refraction error. A low logMAR score represents good vision while a high logMAR score represents bad vision.

Percentages were derived from Rubin's rule by integrating all results from multiple imputations. For subjects with missing DCNVA at Month 3, the value of DCNVA was imputed and dichotomized to derive the endpoint of gaining of 3 lines.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
Percentage of Participants Gaining at Least 0.30 logMAR in Monocular (Better-seeing Eye) Distance-corrected Near Visual Acuity (DCNVA) (Without Near Correction) From Baseline at Month 3	6.3 Percentage of participants Interval 0.0 to 13.2	9.4 Percentage of participants Interval 0.77 to 17.93	0.3 Percentage of participants Interval 0.0 to 2.5	2.8 Percentage of participants Interval 0.0 to 7.88	7.8 Percentage of participants Interval 0.0 to 16.13

POST_HOC outcome

Timeframe: On-treatment: up to 121 days, approx. 4 months. Off treatment: up to approx. 1 year and 1 month

Population: Safety Set

On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum timeframe of approx. 4 months.

Post-treatment deaths were collected from day 31 after last dose of study medication to end of study, up to approx. 1 year and 1 month.

All deaths refer to the sum of on-treatment and post-treatment deaths.

Outcome measures

Measure	UNR844 5 mg/mL n=48 Participants UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 Participants UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 Participants UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 Participants UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo Ophthalmic Solution n=46 Participants placebo ophthalmic solution; one drop twice-a-day for three months
All Collected Deaths Total Deaths	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
All Collected Deaths On-Treatment Deaths	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
All Collected Deaths Post-Treatment Deaths	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

UNR844 5 mg/mL

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

UNR844 13.3 mg/mL

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

UNR844 23 mg/mL

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

UNR844 30 mg/mL

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 21 other events

Deaths: 1 deaths

Total

Serious events: 5 serious events

Other events: 108 other events

Deaths: 1 deaths

Serious adverse events

Measure	UNR844 5 mg/mL n=48 participants at risk UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 participants at risk UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 participants at risk UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 participants at risk UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo n=46 participants at risk Placebo ophthalmic solution; one drop twice-a-day for three months	Total n=234 participants at risk Total
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cystadenoma	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Myelitis transverse	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Appendicitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.

Other adverse events

Measure	UNR844 5 mg/mL n=48 participants at risk UNR844 5 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 13.3 mg/mL n=48 participants at risk UNR844 13.3 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 23 mg/mL n=44 participants at risk UNR844 23 mg/mL ophthalmic solution; one drop twice-a-day for three months	UNR844 30 mg/mL n=48 participants at risk UNR844 30 mg/mL ophthalmic solution; one drop twice-a-day for three months	Placebo n=46 participants at risk Placebo ophthalmic solution; one drop twice-a-day for three months	Total n=234 participants at risk Total
Renal and urinary disorders Haematuria	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Reproductive system and breast disorders Abnormal uterine bleeding	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Reproductive system and breast disorders Heavy menstrual bleeding	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Cough	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.7% 4/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Dysgeusia	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	6.2% 3/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Headache	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	8.3% 4/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.5% 2/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	3.8% 9/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Migraine	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Spinal meningeal cyst	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Psychiatric disorders Anxiety	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Psychiatric disorders Depressed mood	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Psychiatric disorders Insomnia	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Psychiatric disorders Mood altered	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Blood and lymphatic system disorders Iron deficiency anaemia	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Cardiac disorders Palpitations	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Ear and labyrinth disorders Ear pain	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Ear and labyrinth disorders Hypoacusis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Ear and labyrinth disorders Tinnitus	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Asthenopia	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Blepharitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.3% 2/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 5/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Central serous chorioretinopathy	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Chalazion	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Conjunctival haemorrhage	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	6.8% 3/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.7% 4/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Conjunctival hyperaemia	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.3% 2/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Corneal epithelium defect	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Dry eye	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Episcleritis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Erythema of eyelid	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Eye irritation	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Eye pain	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Eye pruritus	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Eyelid cyst	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Eyelid rash	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Eyelid skin dryness	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Lacrimation increased	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Narrow anterior chamber angle	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Noninfective conjunctivitis	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Punctate keratitis	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Eye disorders Vision blurred	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Gastrointestinal disorders Dental cyst	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Gastrointestinal disorders Dyspepsia	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Gastrointestinal disorders Food poisoning	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Gastrointestinal disorders Large intestine polyp	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
General disorders Feeling hot	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
General disorders Influenza like illness	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
General disorders Injection site pain	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
General disorders Malaise	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
General disorders Pyrexia	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	3.0% 7/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
General disorders Sensation of foreign body	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Immune system disorders Drug hypersensitivity	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Immune system disorders Seasonal allergy	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.3% 2/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.7% 4/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations COVID-19	31.2% 15/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	20.8% 10/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	11.4% 5/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	16.7% 8/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	17.4% 8/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	19.7% 46/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Cystitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Diverticulitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Gastroenteritis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Gastroenteritis viral	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Gingivitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Hordeolum	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Infection	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Influenza	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Lower respiratory tract infection	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Nasopharyngitis	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	6.2% 3/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.5% 2/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.6% 6/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Oral herpes	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Otitis media	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Peritonsillitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Pharyngitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Pharyngitis streptococcal	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Rocky mountain spotted fever	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Sinusitis	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.5% 2/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.6% 6/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Upper respiratory tract infection	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Infections and infestations Urinary tract infection	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Animal bite	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	1.3% 3/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Injury, poisoning and procedural complications Wound complication	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Investigations Blood potassium decreased	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Investigations Blood testosterone decreased	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Investigations Hormone level abnormal	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Investigations Intraocular pressure increased	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Investigations Lipase increased	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	4.2% 2/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.85% 2/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blepharal papilloma	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteoma	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Bell's palsy	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Nervous system disorders Dizziness	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.2% 1/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Skin and subcutaneous tissue disorders Rash	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Social circumstances Menopause	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Vascular disorders Hot flush	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.1% 1/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Vascular disorders Hypertension	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.
Vascular disorders Thrombophlebitis	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	2.3% 1/44 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/48 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.00% 0/46 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.	0.43% 1/234 • Adverse events are reported from first dose of study treatment until end of study treatment (Max treatment exposure = 115 days) plus a maximum of 9 months post treatment, up to a maximum duration of approx. 1 year and 1 month.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER