Trial Outcomes & Findings for A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT (NCT NCT02981446)

NCT ID: NCT02981446

Last Updated: 2024-03-15

Results Overview

The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 370 participants
• Primary outcome timeframe: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
• Results posted on: 2024-03-15

Participant Flow

Participant milestones

Measure	DE-117 Ophthalmic Solution DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Overall Study STARTED	185	185
Overall Study COMPLETED	170	177
Overall Study NOT COMPLETED	15	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

Baseline characteristics by cohort

Measure	DE-117 Ophthalmic Solution n=184 Participants DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% n=185 Participants Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Total n=369 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	137 Participants n=5 Participants	143 Participants n=7 Participants	280 Participants n=5 Participants
Age, Categorical >=65 years	47 Participants n=5 Participants	42 Participants n=7 Participants	89 Participants n=5 Participants
Age, Continuous	54.6 years STANDARD_DEVIATION 12.9 • n=5 Participants	52.6 years STANDARD_DEVIATION 13.1 • n=7 Participants	53.6 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	97 Participants n=7 Participants	175 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	88 Participants n=7 Participants	194 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	166 Participants n=5 Participants	173 Participants n=7 Participants	339 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	184 Participants n=5 Participants	185 Participants n=7 Participants	369 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment India	98 participants n=5 Participants	103 participants n=7 Participants	201 participants n=5 Participants
Region of Enrollment South Korea	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment Singapore	17 participants n=5 Participants	9 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment Taiwan	48 participants n=5 Participants	53 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)

Population: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.

The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Outcome measures

Measure	DE-117 Ophthalmic Solution n=184 Participants DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% n=185 Participants Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Mean Diurnal IOP at Month 3	17.5 mmHg Standard Error 0.25	16.8 mmHg Standard Error 0.25

SECONDARY outcome

Timeframe: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.

Population: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.

The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Outcome measures

Measure	DE-117 Ophthalmic Solution n=184 Participants DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% n=185 Participants Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Week 1 09:00	19.0 mmHg Standard Error 0.28	18.8 mmHg Standard Error 0.29
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Week 1 13:00	18.4 mmHg Standard Error 0.28	18.4 mmHg Standard Error 0.29
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Week 1 17:00	18.0 mmHg Standard Error 0.28	18.3 mmHg Standard Error 0.28
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Week 6 09:00	17.8 mmHg Standard Error 0.26	17.4 mmHg Standard Error 0.26
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Week 6 13:00	17.6 mmHg Standard Error 0.27	17.2 mmHg Standard Error 0.27
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Week 6 17:00	17.5 mmHg Standard Error 0.26	17.1 mmHg Standard Error 0.27
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Month 3 09:00	17.9 mmHg Standard Error 0.27	17.0 mmHg Standard Error 0.27
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Month 3 13:00	17.2 mmHg Standard Error 0.25	16.7 mmHg Standard Error 0.26
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) Month 3 17:00	17.2 mmHg Standard Error 0.26	16.7 mmHg Standard Error 0.27

SECONDARY outcome

Timeframe: Week 1

Population: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.

The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Outcome measures

Measure	DE-117 Ophthalmic Solution n=184 Participants DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% n=185 Participants Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)	18.5 mmHg Standard Error 0.26	18.5 mmHg Standard Error 0.27

Adverse Events

DE-117 Ophthalmic Solution

Serious events: 2 serious events

Other events: 74 other events

Deaths: 0 deaths

Latanoprost Ophthalmic Solution 0.005%

Serious events: 2 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	DE-117 Ophthalmic Solution n=185 participants at risk DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% n=185 participants at risk Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Ear and labyrinth disorders Tinnitus	0.54% 1/185 • Number of events 1 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Renal and urinary disorders Urinary retention	0.54% 1/185 • Number of events 1 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • Number of events 1 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Food poisoning	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • Number of events 1 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).

Other adverse events

Measure	DE-117 Ophthalmic Solution n=185 participants at risk DE-117: DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Latanoprost Ophthalmic Solution 0.005% n=185 participants at risk Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Renal and urinary disorders Urinary retention	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Renal and urinary disorders Dysuria	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Reproductive system and breast disorders Breast calcifications	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Skin and subcutaneous tissue disorders Pruritus	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Vascular disorders Hypertension	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Conjunctival hyperaemia	11.9% 22/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	5.4% 10/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Photophobia	5.4% 10/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Dry eye	4.9% 9/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	2.2% 4/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Corneal thickening	3.8% 7/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eye pain	2.7% 5/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	3.2% 6/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Ocular hyperaemia	2.2% 4/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	2.2% 4/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Vision blurred	2.2% 4/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Conjunctival irritation	1.6% 3/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Corneal deposits	1.6% 3/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eye irritation	1.6% 3/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Corneal pigmentation	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eye discharge	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eye pruritus	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	2.2% 4/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eyelid irritation	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eyelids pruritus	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Lacrimation increased	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Conjunctival follicles	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Corneal erosion	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Corneal opacity	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eyelid oedema	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Foreign body sensation in eyes	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.6% 3/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Iritis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Noninfective conjunctivitis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Ocular discomfort	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Punctate keratitis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Uveitis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Visual acuity reduced	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Visual impairment	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Blepharal pigmentation	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Cataract	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Conjunctival haemorrhage	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Eyelash thickening	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Growth of eyelashes	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Eye disorders Vitreous detachment	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Ear and labyrinth disorders Tinnitus	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Constipation	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Dental caries	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Diarrhoea	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Food poisoning	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Gastrointestinal disorders Gastroduodenitis	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
General disorders Pyrexia	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Immune system disorders Allergy to arthropod sting	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Conjunctivitis	1.6% 3/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	2.7% 5/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Nasopharyngitis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	2.2% 4/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Stoma site infection	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Urinary tract infection	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Vulvovaginal candidiasis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Hordeolum	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Otitis externa	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Infections and infestations Upper respiratory tract infection	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Injury, poisoning and procedural complications Foreign body in eye	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Investigations Intraocular pressure increased	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Investigations Optic nerve cup/disc ratio increased	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Investigations Vital dye staining cornea present	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Investigations Low density lipoprotein increased	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Myalgia	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Myositis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Polyarthritis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.6% 3/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Nervous system disorders Headache	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	1.1% 2/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Nervous system disorders Sciatica	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).
Renal and urinary disorders Hydronephrosis	0.54% 1/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).	0.00% 0/185 • An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization. Regardless of relationship to the investigational medicinal product, an AE is an unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 19.0).

Additional Information

Director of R&D Quality Management

Santen Inc

Phone: 15106851794

Email: evelyn.chikere@santen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place