Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease (NCT NCT04391894)

NCT ID: NCT04391894

Last Updated: 2025-01-28

Results Overview

The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 718 participants
• Primary outcome timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)
• Results posted on: 2025-01-28

Participant Flow

This study was conducted in 53 sites in the USA.

Approximately 800 subjects were planned to be screened in Part 1 to have approximately 680 subjects randomized into the 56-day treatment period. A total of 970 subjects were screened, of which 558 subjects received randomized treatment.

Participant milestones

Measure	ECF843 0.45 mg/mL TID (Part 1) ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Overall Study STARTED	111	112	112	109	114
Overall Study COMPLETED	107	111	108	107	111
Overall Study NOT COMPLETED	4	1	4	2	3

Reasons for withdrawal

Measure	ECF843 0.45 mg/mL TID (Part 1) ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Overall Study Adverse Event	1	1	1	1	1
Overall Study Lost to Follow-up	1	0	0	0	0
Overall Study Protocol Violation	0	0	0	1	0
Overall Study Withdrawal by Subject	2	0	3	0	1
Overall Study Unsatisfactory Therapeutic effect	0	0	0	0	1

Baseline Characteristics

A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

Baseline characteristics by cohort

Measure	ECF843 0.45 mg/mL TID (Part 1) n=111 Participants ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=112 Participants ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=112 Participants ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=109 Participants ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=114 Participants ECF843 vehicle bis in diem/twice a day (BID) (Part 1)	Total n=558 Participants Total of all reporting groups
Ethnicity (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
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	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	20 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	1 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	17 Participants n=7 Participants	24 Participants n=5 Participants	15 Participants n=4 Participants	12 Participants n=21 Participants	84 Participants n=8 Participants
Race (NIH/OMB) White	89 Participants n=5 Participants	88 Participants n=7 Participants	85 Participants n=5 Participants	90 Participants n=4 Participants	99 Participants n=21 Participants	451 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 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
Sjogren's Syndrome status Yes	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	19 Participants n=8 Participants
Age, Continuous	61.7 Years STANDARD_DEVIATION 13.68 • n=5 Participants	60.6 Years STANDARD_DEVIATION 13.64 • n=7 Participants	62.1 Years STANDARD_DEVIATION 12.89 • n=5 Participants	62.9 Years STANDARD_DEVIATION 13.51 • n=4 Participants	62.7 Years STANDARD_DEVIATION 13.04 • n=21 Participants	62.0 Years STANDARD_DEVIATION 13.33 • n=8 Participants
Age, Customized < 65 years	56 Participants n=5 Participants	60 Participants n=7 Participants	55 Participants n=5 Participants	49 Participants n=4 Participants	59 Participants n=21 Participants	279 Participants n=8 Participants
Age, Customized >= 65 years	55 Participants n=5 Participants	52 Participants n=7 Participants	57 Participants n=5 Participants	60 Participants n=4 Participants	55 Participants n=21 Participants	279 Participants n=8 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	89 Participants n=7 Participants	86 Participants n=5 Participants	82 Participants n=4 Participants	83 Participants n=21 Participants	423 Participants n=8 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	27 Participants n=4 Participants	31 Participants n=21 Participants	135 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	12 Participants n=4 Participants	19 Participants n=21 Participants	83 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants	92 Participants n=7 Participants	95 Participants n=5 Participants	97 Participants n=4 Participants	95 Participants n=21 Participants	475 Participants n=8 Participants
Sjogren's Syndrome status No	107 Participants n=5 Participants	108 Participants n=7 Participants	108 Participants n=5 Participants	107 Participants n=4 Participants	109 Participants n=21 Participants	539 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.

Outcome measures

Measure	ECF843 0.45 mg/mL TID (Part 1) n=111 Participants ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=112 Participants ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=112 Participants ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=109 Participants ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=114 Participants ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score	-6.0 Score on scale Standard Error 1.86	-8.1 Score on scale Standard Error 1.85	-4.9 Score on scale Standard Error 1.85	-1.8 Score on scale Standard Error 1.91	-6.1 Score on scale Standard Error 1.84

PRIMARY outcome

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.

Outcome measures

Measure	ECF843 0.45 mg/mL TID (Part 1) n=111 Participants ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=112 Participants ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=112 Participants ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=109 Participants ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=114 Participants ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score	-1.1 Score on scale Standard Error 0.30	-1.0 Score on scale Standard Error 0.30	-0.9 Score on scale Standard Error 0.30	-1.0 Score on scale Standard Error 0.31	-1.1 Score on scale Standard Error 0.30

SECONDARY outcome

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.

Outcome measures

Measure	ECF843 0.45 mg/mL TID (Part 1) n=107 Participants ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=111 Participants ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=110 Participants ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=108 Participants ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=110 Participants ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Part 1: Change From Baseline in Central Corneal Fluorescein Staining	-0.2 Score on scale Standard Deviation 0.80	-0.3 Score on scale Standard Deviation 0.78	-0.2 Score on scale Standard Deviation 0.83	-0.2 Score on scale Standard Deviation 0.65	-0.2 Score on scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.

Outcome measures

Measure	ECF843 0.45 mg/mL TID (Part 1) n=107 Participants ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=111 Participants ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=110 Participants ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=108 Participants ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=110 Participants ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining	-0.2 Score on scale Standard Deviation 0.75	-0.3 Score on scale Standard Deviation 0.85	-0.2 Score on scale Standard Deviation 0.89	-0.2 Score on scale Standard Deviation 0.98	-0.6 Score on scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Population: Safety Set 1

The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe.

Treatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term.

Outcome measures

Measure	ECF843 0.45 mg/mL TID (Part 1) n=111 Participants ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=112 Participants ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=112 Participants ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=109 Participants ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=114 Participants ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) Ocular treatment emergent adverse events · Mild	5 Participants	10 Participants	4 Participants	2 Participants	7 Participants
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) Ocular treatment emergent adverse events · Moderate	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) Ocular treatment emergent adverse events · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) Non-ocular treatment emergent adverse events · Mild	4 Participants	5 Participants	0 Participants	1 Participants	3 Participants
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) Non-ocular treatment emergent adverse events · Moderate	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) Non-ocular treatment emergent adverse events · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

ECF843 0.45 mg/mL TID (Part 1)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

ECF843 0.15 mg/mL TID (Part 1)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

ECF843 Vehicle TID (Part 1)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

ECF843 0.15 mg/mL BID (Part 1)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ECF843 Vehicle BID (Part 1)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	ECF843 0.45 mg/mL TID (Part 1) n=111 participants at risk ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=112 participants at risk ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=112 participants at risk ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=109 participants at risk ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=114 participants at risk ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
General disorders Pelvic mass	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Nervous system disorders Ischaemic stroke	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.

Other adverse events

Measure	ECF843 0.45 mg/mL TID (Part 1) n=111 participants at risk ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL TID (Part 1) n=112 participants at risk ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1)	ECF843 Vehicle TID (Part 1) n=112 participants at risk ECF843 vehicle ter in die/three times a day (TID) (Part 1)	ECF843 0.15 mg/mL BID (Part 1) n=109 participants at risk ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1)	ECF843 Vehicle BID (Part 1) n=114 participants at risk ECF843 vehicle bis in diem/twice a day (BID) (Part 1)
Cardiac disorders Tachycardia	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Blepharitis	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Chalazion	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	1.8% 2/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Conjunctival deposit	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Conjunctival hyperaemia	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	1.8% 2/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Corneal erosion	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Dry eye	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Eye irritation	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Eye pain	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	1.8% 2/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Eye pruritus	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	1.8% 2/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Eyelids pruritus	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.92% 1/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Foreign body sensation in eyes	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Glare	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Lacrimation increased	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Ocular hyperaemia	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Vision blurred	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Eye disorders Visual acuity reduced	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.92% 1/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Gastrointestinal disorders Nausea	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Gastrointestinal disorders Toothache	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
General disorders Chills	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
General disorders Instillation site pain	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
General disorders Pyrexia	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Bronchitis	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations COVID-19	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.92% 1/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Cellulitis	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Herpes zoster	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.92% 1/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Hordeolum	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Infected bite	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Pharyngitis streptococcal	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Sinusitis	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Infections and infestations Tooth abscess	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.92% 1/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	1.8% 2/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Injury, poisoning and procedural complications Fall	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.89% 1/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Injury, poisoning and procedural complications Muscle injury	0.90% 1/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.
Nervous system disorders Headache	0.00% 0/111 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	2.7% 3/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/112 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.00% 0/109 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.	0.88% 1/114 • Up to 28 days (Baseline (BL) to end of randomized treatment) All safety evaluations were carried out on the Safety Set 1 (SAF1). The SAF1 included all participants who received at least one dose of study treatment in Part 1. The analysis was done according to the study treatment received, where treatment received was defined as the actual randomized treatment if the subject took at least one dose of that treatment or the first treatment received if the randomized treatment was never received.

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