Trial Outcomes & Findings for Study Assessing Double-masked Uveitis Treatment (NCT NCT01358266)

NCT ID: NCT01358266

Last Updated: 2019-07-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

592 participants

Primary outcome timeframe

Day1 (Baseline) and Month 5 (Day150)

Results posted on

2019-07-16

Participant Flow

Subjects who entered open-label period are defined as subjects who received at least one open-label injection during the open-label treatment period (Month 6 to Month 12, exclude Amendment 2 subjects), or those who had entered the open-label retreatment period (Month 12 to Month 24) with or without any PRN injections.

Participant milestones

Participant milestones
Measure	DE-109 44 μg SAKURA Study 1 \& Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 \& Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4	DE-109 440 μg SAKURA Study 1 \& Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 \& Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4	DE-109 880 μg SAKURA Study 1 \& Study 2 (Amendment #2) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4 Double-Masked PRN Treatment Period May receive up to 3 injections PRN from Month 6 through Month 10 SAKURA Study 1 \& Study 2 (Amendments #3 and #4) Injection on Day 1, Month 2, Month 4 Open-Label Treatment Period Injection on Month 6, Month 8, Month 10 Open-Label Re-Treatment Period May receive up to 6 injections PRN through Month 22 SAKURA Study 2 (Amendment #5) Double-Masked Treatment Period Injection on Day 1, Month 2, Month 4
Double-Masked Period STARTED	208	208	176
Double-Masked Period COMPLETED	175	162	137
Double-Masked Period NOT COMPLETED	33	46	39
Open-Label Period STARTED	119	102	114
Open-Label Period COMPLETED	63	58	44
Open-Label Period NOT COMPLETED	56	44	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Assessing Double-masked Uveitis Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DE-109 44 µg n=208 Participants Double Masked Phase Low Dose 44 µg Open Label Phase High Dose 880 µg	DE-109 440 µg n=208 Participants Double Masked Phase Medium Dose 440 µg Open Label Phase High Dose 880 µg	DE-109 880 µg n=176 Participants Double Masked Phase High Dose 880 µg Open Label Phase High Dose 880 µg	Total n=592 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	188 Participants n=5 Participants	191 Participants n=7 Participants	153 Participants n=5 Participants	532 Participants n=4 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	17 Participants n=7 Participants	23 Participants n=5 Participants	60 Participants n=4 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	117 Participants n=7 Participants	113 Participants n=5 Participants	343 Participants n=4 Participants
Sex: Female, Male Male	95 Participants n=5 Participants	91 Participants n=7 Participants	63 Participants n=5 Participants	249 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Asian	76 Participants n=5 Participants	77 Participants n=7 Participants	72 Participants n=5 Participants	225 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	42 Participants n=4 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	99 Participants n=7 Participants	79 Participants n=5 Participants	271 Participants n=4 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Region of Enrollment Colombia	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment Argentina	20 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment United States	70 Participants n=5 Participants	71 Participants n=7 Participants	45 Participants n=5 Participants	186 Participants n=4 Participants
Region of Enrollment Japan	4 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment India	69 Participants n=5 Participants	65 Participants n=7 Participants	65 Participants n=5 Participants	199 Participants n=4 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Austria	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Turkey	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Brazil	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment Poland	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Italy	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment Israel	7 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment Chile	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment France	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment Peru	6 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Region of Enrollment Germany	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day1 (Baseline) and Month 5 (Day150)

Outcome measures

Outcome measures
Measure	DE-109 44 µg n=208 Participants Low Dose DE-109 44 µg	DE-109 440 µg n=208 Participants Medium Dose DE-109 440 µg	DE-109 880 µg n=176 Participants High Dose DE-109 880 µg
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5	28 Participants	44 Participants	27 Participants

SECONDARY outcome

Timeframe: Day1/Baseline and Day150/Month 5

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible

Outcome measures

Outcome measures
Measure	DE-109 44 µg n=208 Participants Low Dose DE-109 44 µg	DE-109 440 µg n=208 Participants Medium Dose DE-109 440 µg	DE-109 880 µg n=176 Participants High Dose DE-109 880 µg
VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)	43 Participants	56 Participants	33 Participants

SECONDARY outcome

Timeframe: Day1/Baseline and Day150/Month 5

Outcome measures

Outcome measures
Measure	DE-109 44 µg n=208 Participants Low Dose DE-109 44 µg	DE-109 440 µg n=208 Participants Medium Dose DE-109 440 µg	DE-109 880 µg n=176 Participants High Dose DE-109 880 µg
VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)	84 Participants	104 Participants	70 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day1/Baseline and Day180/Month 6

Outcome measures

Outcome measures
Measure	DE-109 44 µg n=208 Participants Low Dose DE-109 44 µg	DE-109 440 µg n=208 Participants Medium Dose DE-109 440 µg	DE-109 880 µg n=176 Participants High Dose DE-109 880 µg
VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)	29 Participants	43 Participants	51 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day1/Baseline and Day180/Month 6

Outcome measures

Outcome measures
Measure	DE-109 44 µg n=208 Participants Low Dose DE-109 44 µg	DE-109 440 µg n=208 Participants Medium Dose DE-109 440 µg	DE-109 880 µg n=176 Participants High Dose DE-109 880 µg
VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)	42 Participants	52 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day1/Baseline and Day180/Month 6

Outcome measures

Outcome measures
Measure	DE-109 44 µg n=208 Participants Low Dose DE-109 44 µg	DE-109 440 µg n=208 Participants Medium Dose DE-109 440 µg	DE-109 880 µg n=176 Participants High Dose DE-109 880 µg
VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)	81 Participants	90 Participants	66 Participants

Adverse Events

DE-109 44 µg - Double Masked

Serious events: 41 serious events

Other events: 165 other events

Deaths: 1 deaths

DE-109 440 µg - Double Masked

Serious events: 45 serious events

Other events: 166 other events

Deaths: 0 deaths

DE-109 880 µg - Double Masked

Serious events: 38 serious events

Other events: 148 other events

Deaths: 0 deaths

DE-109 880 µg - Open-Label

Serious events: 59 serious events

Other events: 210 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Operations

Santen Inc.

Phone: +1-415-268-9100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	DE-109 44 µg - Double Masked n=207 participants at risk Double Masked Phase Low Dose 44 µg	DE-109 440 µg - Double Masked n=205 participants at risk Double Masked Phase Medium Dose 440 µg	DE-109 880 µg - Double Masked n=178 participants at risk Double Masked Phase High Dose 880 µg	DE-109 880 µg - Open-Label n=321 participants at risk Open-label Phase High Dose 880 µg
Nervous system disorders Cerebrovascular accident	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Uveitis	2.9% 6/207 • Number of events 7 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	4.9% 10/205 • Number of events 12 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.3% 13/178 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.6% 5/321 • Number of events 7 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Choroiditis	3.9% 8/207 • Number of events 8 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.0% 4/205 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.7% 3/178 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.9% 6/321 • Number of events 7 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Cataract	1.9% 4/207 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.98% 2/205 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.7% 3/178 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.2% 4/321 • Number of events 6 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Non-infectious endophthalmitis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	3.9% 7/178 • Number of events 7 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	3.4% 11/321 • Number of events 11 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Iridocyclitis	0.97% 2/207 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.98% 2/205 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.1% 2/178 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Retinal detachment	0.97% 2/207 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.98% 2/205 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.93% 3/321 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Visual acuity reduced	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.5% 3/205 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Vitritis	0.97% 2/207 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.98% 2/205 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.2% 4/321 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Cystoid macular oedema	0.97% 2/207 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Eye inflammation	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.1% 2/178 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Intermediate uveitis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.7% 3/178 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Macular oedema	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Optic atrophy	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.56% 1/178 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Optic neuropathy	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Vitreous haemorrhage	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Anterior chamber inflammation	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Choroidal neovascularisation	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Corneal deposits	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Corneal epithelium defect	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Corneal oedema	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.56% 1/178 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Eye haemorrhage	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Eye pain	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Iritis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Ocular hypertension	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.56% 1/178 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Ocular vasculitis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Open angle glaucoma	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.31% 1/321 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Retinal haemorrhage	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Retinal infiltrates	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Retinal oedema	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Retinal tear	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Endophthalmitis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.56% 1/178 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.2% 4/321 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Appendicitis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.62% 2/321 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Eye infection toxoplasmal	0.97% 2/207 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/205 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Pneumonia	0.48% 1/207 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Anal abscess	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Candidiasis	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Keratitis herpetic	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Infections and infestations Tooth infection	0.00% 0/207 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.49% 1/205 • Number of events 1 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/178 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.00% 0/321 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Investigations Intraocular pressure increased	1.4% 3/207 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.5% 3/205 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.7% 3/178 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.93% 3/321 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.

Other adverse events
Measure	DE-109 44 µg - Double Masked n=207 participants at risk Double Masked Phase Low Dose 44 µg	DE-109 440 µg - Double Masked n=205 participants at risk Double Masked Phase Medium Dose 440 µg	DE-109 880 µg - Double Masked n=178 participants at risk Double Masked Phase High Dose 880 µg	DE-109 880 µg - Open-Label n=321 participants at risk Open-label Phase High Dose 880 µg
Eye disorders Iridocyclitis	15.0% 31/207 • Number of events 41 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	15.6% 32/205 • Number of events 46 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	16.9% 30/178 • Number of events 51 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	9.7% 31/321 • Number of events 48 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Uveitis	9.2% 19/207 • Number of events 23 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.3% 15/205 • Number of events 18 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	16.3% 29/178 • Number of events 42 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	4.7% 15/321 • Number of events 16 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Conjunctival haemorrhage	10.6% 22/207 • Number of events 32 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	9.3% 19/205 • Number of events 22 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	14.6% 26/178 • Number of events 33 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.5% 24/321 • Number of events 33 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Eye pain	8.7% 18/207 • Number of events 20 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	10.7% 22/205 • Number of events 27 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	10.7% 19/178 • Number of events 22 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	4.4% 14/321 • Number of events 17 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Intermediate uveitis	7.7% 16/207 • Number of events 21 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.3% 15/205 • Number of events 21 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.9% 14/178 • Number of events 20 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.8% 9/321 • Number of events 14 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Cataract	5.3% 11/207 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	3.9% 8/205 • Number of events 9 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.3% 13/178 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	10.0% 32/321 • Number of events 33 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Cystoid macular oedema	5.8% 12/207 • Number of events 18 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	7.3% 15/205 • Number of events 17 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	6.2% 11/178 • Number of events 12 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.2% 7/321 • Number of events 7 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Choroiditis	5.3% 11/207 • Number of events 14 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.4% 11/205 • Number of events 15 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.8% 5/178 • Number of events 6 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.9% 6/321 • Number of events 8 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Cataract subcapsular	1.4% 3/207 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	4.9% 10/205 • Number of events 10 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	6.7% 12/178 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.3% 17/321 • Number of events 18 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Macular oedema	1.4% 3/207 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.4% 11/205 • Number of events 14 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.1% 9/178 • Number of events 11 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.5% 8/321 • Number of events 8 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Investigations Intraocular pressure increased	16.4% 34/207 • Number of events 50 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	16.6% 34/205 • Number of events 62 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	24.2% 43/178 • Number of events 64 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	13.7% 44/321 • Number of events 62 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Nervous system disorders Headache	3.4% 7/207 • Number of events 9 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.9% 12/205 • Number of events 14 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.2% 4/178 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.2% 7/321 • Number of events 8 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Conjunctival hyperaemia	5.3% 11/207 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.4% 11/205 • Number of events 12 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	3.4% 6/178 • Number of events 9 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	4.0% 13/321 • Number of events 14 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Vitreous opacities	2.4% 5/207 • Number of events 5 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.4% 5/205 • Number of events 8 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	5.1% 9/178 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.8% 9/321 • Number of events 12 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.
Eye disorders Dry eye	5.8% 12/207 • Number of events 13 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	2.0% 4/205 • Number of events 4 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	1.1% 2/178 • Number of events 2 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.	0.93% 3/321 • Number of events 3 • Adverse events - begin capturing once the first treatment is given. Per Schedule of Events through study completion, up to 24 months. Any subject with multiple AEs of one system organ class is counted only once for that class. Subjects are classified by actual treatment received. AEs summaries were done with the Safety Population (N=590) defined as all randomized subjects who received at least one study treatment.1 subject was randomized to the 44 μg dose group but received 880 μg at Month 2 1subject was randomized to the 44 μg dose group but received 880 μg at Month 4 both subjects are reflected in the 880/880 μg group.