Trial Outcomes & Findings for First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration (NCT NCT02076919)

Results Overview

A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

110 participants

Primary outcome timeframe

From time of consent until 30 days after stopping the trial/study drug

Results posted on

2016-04-01

Participant Flow

Subjects were recruited from a single investigational site located in the US.

Of the 110 enrolled, 30 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).

Participant milestones

Participant milestones
Measure	LHA510, Part 1 Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1	Vehicle, Part 1 Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1	LHA510, Part 2 Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2	Vehicle, Part 2 Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
Overall Study STARTED	24	8	36	12
Overall Study COMPLETED	24	8	36	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 Participants 1 drop instilled in the study eye as a single dose	LHA510 Lowest, Part 2 n=6 Participants 1 drop instilled in the study eye once daily for 7 days	LHA510 Next Lowest, Part 2 n=6 Participants 1 drop instilled in the study eye once daily for 7 days	LHA510 Next Highest, Part 2 n=6 Participants 1 drop instilled in the study eye once daily for 7 days	LHA510 Highest, Part 2 n=6 Participants 1 drop instilled in the study eye once daily for 7 days	LHA510 Highest BID, Part 2 n=6 Participants 1 drop instilled in the study eye twice daily for 7 days	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 Participants 1 drop instilled in the study eye once, twice, or three times daily for 7 days	Total n=80 Participants Total of all reporting groups
Age, Customized 55-64 years	2 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	1 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	14 participants n=36 Participants
Age, Customized ≥ 65 years	4 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	6 participants n=8 Participants	6 participants n=8 Participants	6 participants n=24 Participants	6 participants n=42 Participants	5 participants n=42 Participants	6 participants n=42 Participants	12 participants n=42 Participants	66 participants n=36 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	8 Participants n=42 Participants	41 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	39 Participants n=36 Participants

PRIMARY outcome

Timeframe: From time of consent until 30 days after stopping the trial/study drug

Population: This analysis population includes all enrolled subjects in Part 1.

A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1	0 participants	0 participants	0 participants	0 participants	0 participants	—	—

PRIMARY outcome

Timeframe: From time of consent until 30 days after stopping the trial/study drug

Population: This analysis population includes all enrolled subjects in Part 2.

A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 Participants 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From time of consent until 30 days after stopping the trial/study drug

Population: This analysis population includes all enrolled subjects in Part 1.

An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Number of Subjects Experiencing a Non-serious Adverse Event, Part I	2 participants	1 participants	0 participants	1 participants	1 participants	—	—

PRIMARY outcome

Timeframe: From time of consent until 30 days after stopping the trial/study drug

Population: This analysis population includes all enrolled subjects in Part 2.

An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 Participants 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Number of Subjects Experiencing a Non-serious Adverse Event, Part 2	3 participants	1 participants	1 participants	2 participants	2 participants	1 participants	3 participants

SECONDARY outcome

Timeframe: Up to Day 15

Population: This analysis population includes all enrolled subjects in Part 2.

Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2	NA ng/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	—

SECONDARY outcome

Timeframe: Up to Day 15

Population: This analysis population includes all enrolled subjects in Part 2.

Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2	NA hour Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	—

SECONDARY outcome

Timeframe: Up to Day 15

Population: This analysis population includes all enrolled subjects in Part 2.

Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2	NA ng*h/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng*h/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng*h/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng*h/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng*h/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	NA ng*h/mL Standard Deviation NA Statistical analysis was not conducted because the concentration was too low to allow reliable estimation.	—

SECONDARY outcome

Timeframe: Up to Day 15

Population: This analysis population includes all enrolled subjects in Part 2.

Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
The Terminal Elimination Half-life [Time] (T1/2), Part 2	NA hour Standard Deviation NA The analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA The analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA The analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA The analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA The analysis was not conducted because the concentration was too low to allow reliable estimation.	NA hour Standard Deviation NA The analysis was not conducted because the concentration was too low to allow reliable estimation.	—

SECONDARY outcome

Timeframe: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Population: This analysis population includes all enrolled subjects in Part 1.

Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 0.25 hours	5.2 mmHg Standard Error 3.19	-5.5 mmHg Standard Error 3.35	2.8 mmHg Standard Error 3.14	4.1 mmHg Standard Error 3.12	-5.2 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 0.50 hours	3.4 mmHg Standard Error 3.19	-0.2 mmHg Standard Error 3.35	5.6 mmHg Standard Error 3.14	7.6 mmHg Standard Error 3.12	2.1 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 1.00 hours	3.9 mmHg Standard Error 3.19	2.2 mmHg Standard Error 3.35	5.3 mmHg Standard Error 3.14	5.1 mmHg Standard Error 3.12	-1.4 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 2.00 hours	-3.8 mmHg Standard Error 3.19	-1.0 mmHg Standard Error 3.35	-1.6 mmHg Standard Error 3.14	-0.9 mmHg Standard Error 3.12	-6.5 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 4.00 hours	5.4 mmHg Standard Error 3.19	3.7 mmHg Standard Error 3.35	4.3 mmHg Standard Error 3.14	4.1 mmHg Standard Error 3.12	2.4 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 6.00 hours	-1.1 mmHg Standard Error 3.19	1.2 mmHg Standard Error 3.35	2.9 mmHg Standard Error 3.14	3.1 mmHg Standard Error 3.12	-6.1 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 8.00 hours	3.6 mmHg Standard Error 3.19	1.5 mmHg Standard Error 3.35	4.6 mmHg Standard Error 3.14	2.5 mmHg Standard Error 3.12	0.0 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 12.00 hours	3.7 mmHg Standard Error 3.19	1.7 mmHg Standard Error 3.35	4.1 mmHg Standard Error 3.14	-2.2 mmHg Standard Error 3.12	-3.9 mmHg Standard Error 2.70	—	—
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 24.00 hours	8.2 mmHg Standard Error 3.19	5.5 mmHg Standard Error 3.35	6.1 mmHg Standard Error 3.14	5.3 mmHg Standard Error 3.12	4.0 mmHg Standard Error 2.70	—	—

SECONDARY outcome

Timeframe: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Population: This analysis population includes all enrolled subjects in Part 1.

Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 1.00 hours	1.7 mmHg Standard Error 5.00	2.8 mmHg Standard Error 5.11	1.2 mmHg Standard Error 5.05	2.9 mmHg Standard Error 4.97	4.4 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 2.00 hours	-4.6 mmHg Standard Error 5.00	5.3 mmHg Standard Error 5.11	0.5 mmHg Standard Error 5.05	9.8 mmHg Standard Error 4.97	1.3 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 4.00 hours	-6.3 mmHg Standard Error 5.00	9.3 mmHg Standard Error 5.11	4.7 mmHg Standard Error 5.05	5.4 mmHg Standard Error 4.97	-0.9 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 6.00 hours	-2.0 mmHg Standard Error 5.00	10.5 mmHg Standard Error 5.11	0.7 mmHg Standard Error 5.05	4.9 mmHg Standard Error 4.97	-4.6 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 8.00 hours	4.0 mmHg Standard Error 5.00	4.3 mmHg Standard Error 5.11	2.2 mmHg Standard Error 5.05	14.1 mmHg Standard Error 4.97	-2.6 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 12.00 hours	3.9 mmHg Standard Error 5.00	11.8 mmHg Standard Error 5.11	-3.0 mmHg Standard Error 5.05	5.3 mmHg Standard Error 4.97	-1.9 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 0.25 hours	4.7 mmHg Standard Error 5.00	0.5 mmHg Standard Error 5.11	0.5 mmHg Standard Error 5.05	5.3 mmHg Standard Error 4.97	0.2 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 0.50 hours	-1.3 mmHg Standard Error 5.00	0.1 mmHg Standard Error 5.11	-0.3 mmHg Standard Error 5.05	6.9 mmHg Standard Error 4.97	4.9 mmHg Standard Error 4.32	—	—
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 24.00 hours	9.4 mmHg Standard Error 5.00	9.6 mmHg Standard Error 5.11	2.3 mmHg Standard Error 5.05	8.9 mmHg Standard Error 4.97	2.1 mmHg Standard Error 4.32	—	—

SECONDARY outcome

Timeframe: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Population: This analysis population includes all enrolled subjects in Part 1.

Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 0.25 hours	5.2 mmHg Standard Error 3.25	-4.4 mmHg Standard Error 3.52	2.4 mmHg Standard Error 3.31	4.7 mmHg Standard Error 3.26	-3.4 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 0.50 hours	2.0 mmHg Standard Error 3.25	-0.9 mmHg Standard Error 3.52	4.0 mmHg Standard Error 3.31	7.6 mmHg Standard Error 3.26	3.1 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 1.00 hours	3.3 mmHg Standard Error 3.25	1.5 mmHg Standard Error 3.52	4.3 mmHg Standard Error 3.31	4.6 mmHg Standard Error 3.26	0.6 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 2.00 hours	-3.9 mmHg Standard Error 3.25	0.3 mmHg Standard Error 3.52	-0.5 mmHg Standard Error 3.31	2.9 mmHg Standard Error 3.26	-3.9 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 4.00 hours	1.7 mmHg Standard Error 3.25	4.7 mmHg Standard Error 3.52	4.8 mmHg Standard Error 3.31	4.8 mmHg Standard Error 3.26	1.3 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 6.00 hours	-1.2 mmHg Standard Error 3.25	3.4 mmHg Standard Error 3.52	2.6 mmHg Standard Error 3.31	4.0 mmHg Standard Error 3.26	-5.6 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 8.00 hours	3.9 mmHg Standard Error 3.25	1.6 mmHg Standard Error 3.52	4.2 mmHg Standard Error 3.31	6.6 mmHg Standard Error 3.26	-0.8 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 12.00 hours	3.9 mmHg Standard Error 3.25	4.2 mmHg Standard Error 3.52	2.2 mmHg Standard Error 3.31	0.5 mmHg Standard Error 3.26	-3.2 mmHg Standard Error 2.81	—	—
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 Day 1, 24.00 hours	8.8 mmHg Standard Error 3.25	6.0 mmHg Standard Error 3.52	5.3 mmHg Standard Error 3.31	6.7 mmHg Standard Error 3.26	3.4 mmHg Standard Error 2.81	—	—

SECONDARY outcome

Timeframe: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Population: This analysis population includes all enrolled subjects in Part 2.

Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 Participants 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 2.00 Hours	-9.4 mmHg Standard Error 2.94	-6.5 mmHg Standard Error 2.96	1.2 mmHg Standard Error 2.95	-4.1 mmHg Standard Error 2.93	-4.2 mmHg Standard Error 2.93	-6.7 mmHg Standard Error 2.93	-4.9 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 0.25 Hours	-1.0 mmHg Standard Error 2.94	-4.4 mmHg Standard Error 2.96	-0.6 mmHg Standard Error 2.95	-2.9 mmHg Standard Error 2.93	2.5 mmHg Standard Error 2.93	0.6 mmHg Standard Error 2.93	-0.5 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 0.50 Hours	-1.7 mmHg Standard Error 2.94	-7.2 mmHg Standard Error 2.96	-4.5 mmHg Standard Error 2.95	-4.6 mmHg Standard Error 2.93	4.3 mmHg Standard Error 2.93	-2.2 mmHg Standard Error 2.93	2.4 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 1.00 Hours	4.3 mmHg Standard Error 2.94	-7.7 mmHg Standard Error 2.96	0.2 mmHg Standard Error 2.95	1.9 mmHg Standard Error 2.93	1.7 mmHg Standard Error 2.93	-5.4 mmHg Standard Error 2.93	0.3 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 4.00 Hours	1.8 mmHg Standard Error 2.94	-4.0 mmHg Standard Error 2.96	-5.5 mmHg Standard Error 2.95	0.9 mmHg Standard Error 2.93	-1.2 mmHg Standard Error 2.93	-2.4 mmHg Standard Error 2.93	-0.2 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 6.00 Hours	-4.9 mmHg Standard Error 2.94	-6.9 mmHg Standard Error 2.96	-3.3 mmHg Standard Error 2.95	-4.1 mmHg Standard Error 2.93	-2.2 mmHg Standard Error 2.93	-5.9 mmHg Standard Error 2.93	-5.3 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 8.00 Hours	3.1 mmHg Standard Error 2.94	2.1 mmHg Standard Error 2.96	-2.0 mmHg Standard Error 2.95	1.4 mmHg Standard Error 2.93	4.3 mmHg Standard Error 2.93	1.3 mmHg Standard Error 2.93	5.7 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 12.00 Hours	2.3 mmHg Standard Error 2.94	1.0 mmHg Standard Error 2.96	-1.3 mmHg Standard Error 2.95	-2.1 mmHg Standard Error 2.93	7.2 mmHg Standard Error 2.93	-0.4 mmHg Standard Error 2.93	0.4 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 24.00 Hours	3.8 mmHg Standard Error 2.94	-2.5 mmHg Standard Error 2.96	3.9 mmHg Standard Error 2.95	2.3 mmHg Standard Error 2.93	-2.7 mmHg Standard Error 2.93	-0.7 mmHg Standard Error 2.93	2.7 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 0.25 Hours	-3.4 mmHg Standard Error 2.94	-6.2 mmHg Standard Error 2.96	-3.3 mmHg Standard Error 2.95	-1.7 mmHg Standard Error 2.93	-2.8 mmHg Standard Error 2.93	-2.4 mmHg Standard Error 2.93	-3.6 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 0.50 Hours	-5.9 mmHg Standard Error 2.94	-5.7 mmHg Standard Error 2.96	-10.0 mmHg Standard Error 2.95	-2.1 mmHg Standard Error 2.93	-3.2 mmHg Standard Error 2.93	1.6 mmHg Standard Error 2.93	-2.8 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 1.00 Hours	-6.0 mmHg Standard Error 2.94	-4.9 mmHg Standard Error 2.96	-4.3 mmHg Standard Error 2.95	-3.1 mmHg Standard Error 2.93	-6.5 mmHg Standard Error 2.93	-2.2 mmHg Standard Error 2.93	-2.9 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 2.00 Hours	-4.2 mmHg Standard Error 2.94	-6.4 mmHg Standard Error 2.96	-8.3 mmHg Standard Error 2.95	-4.7 mmHg Standard Error 2.93	-0.7 mmHg Standard Error 2.93	-5.4 mmHg Standard Error 2.93	-9.6 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 4.00 Hours	-6.0 mmHg Standard Error 2.94	-6.7 mmHg Standard Error 2.96	-9.3 mmHg Standard Error 2.95	-3.6 mmHg Standard Error 2.93	-8.2 mmHg Standard Error 2.93	-2.4 mmHg Standard Error 2.93	-7.8 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 8.00 Hours	-0.7 mmHg Standard Error 2.94	1.0 mmHg Standard Error 2.96	-6.1 mmHg Standard Error 2.95	-2.7 mmHg Standard Error 2.93	-3.0 mmHg Standard Error 2.93	1.3 mmHg Standard Error 2.93	-2.4 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 12.00 Hours	-9.5 mmHg Standard Error 2.94	-1.0 mmHg Standard Error 2.96	-7.1 mmHg Standard Error 2.95	-3.7 mmHg Standard Error 2.93	-2.3 mmHg Standard Error 2.93	-2.7 mmHg Standard Error 2.93	-3.0 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 24.00 Hours	-4.2 mmHg Standard Error 2.94	-2.2 mmHg Standard Error 2.96	-7.5 mmHg Standard Error 2.95	-3.7 mmHg Standard Error 2.93	-1.2 mmHg Standard Error 2.93	-1.4 mmHg Standard Error 2.93	0.4 mmHg Standard Error 2.07
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 6.00 Hours	-4.4 mmHg Standard Error 2.94	0.3 mmHg Standard Error 2.96	-10.3 mmHg Standard Error 2.95	-5.6 mmHg Standard Error 2.93	-8.8 mmHg Standard Error 2.93	-6.4 mmHg Standard Error 2.93	-5.3 mmHg Standard Error 2.07

SECONDARY outcome

Timeframe: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Population: This analysis population includes all enrolled subjects in Part 2.

Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 Participants 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 0.25 Hours	12.5 mmHg Standard Error 5.70	-11.1 mmHg Standard Error 5.90	-4.1 mmHg Standard Error 5.70	-4.8 mmHg Standard Error 5.74	0.6 mmHg Standard Error 5.72	-4.1 mmHg Standard Error 5.69	1.0 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 0.50 Hours	-3.9 mmHg Standard Error 5.70	-12.7 mmHg Standard Error 5.90	-0.4 mmHg Standard Error 5.70	-11.4 mmHg Standard Error 5.74	-5.4 mmHg Standard Error 5.72	-5.8 mmHg Standard Error 5.69	0.8 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 1.00 Hours	7.1 mmHg Standard Error 5.70	-13.1 mmHg Standard Error 5.90	3.4 mmHg Standard Error 5.70	-8.9 mmHg Standard Error 5.74	-3.1 mmHg Standard Error 5.72	-8.9 mmHg Standard Error 5.69	0.8 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 2.00 Hours	-0.7 mmHg Standard Error 5.70	-3.9 mmHg Standard Error 5.90	-0.9 mmHg Standard Error 5.70	-6.4 mmHg Standard Error 5.74	-5.6 mmHg Standard Error 5.72	-10.6 mmHg Standard Error 5.69	-4.6 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 4.00 Hours	5.3 mmHg Standard Error 5.70	-5.4 mmHg Standard Error 5.90	-9.9 mmHg Standard Error 5.70	0.7 mmHg Standard Error 5.74	-3.4 mmHg Standard Error 5.72	-0.4 mmHg Standard Error 5.69	-0.4 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 6.00 Hours	-3.2 mmHg Standard Error 5.70	-15.6 mmHg Standard Error 5.90	-8.6 mmHg Standard Error 5.70	0.4 mmHg Standard Error 5.74	-2.2 mmHg Standard Error 5.72	-6.9 mmHg Standard Error 5.69	-10.1 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 8.00 Hours	5.5 mmHg Standard Error 5.70	11.1 mmHg Standard Error 5.90	-9.8 mmHg Standard Error 5.70	-1.4 mmHg Standard Error 5.74	-6.1 mmHg Standard Error 5.72	6.1 mmHg Standard Error 5.69	5.1 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 24.00 Hours	5.0 mmHg Standard Error 5.70	0.1 mmHg Standard Error 5.90	-2.6 mmHg Standard Error 5.70	7.7 mmHg Standard Error 5.74	-6.9 mmHg Standard Error 5.72	-6.8 mmHg Standard Error 5.69	2.6 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 0.25 Hours	-5.0 mmHg Standard Error 5.70	-7.6 mmHg Standard Error 5.90	-9.4 mmHg Standard Error 5.70	-2.3 mmHg Standard Error 5.74	-13.7 mmHg Standard Error 5.72	-11.3 mmHg Standard Error 5.69	-3.3 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 0.50 Hours	-5.7 mmHg Standard Error 5.70	-6.2 mmHg Standard Error 5.90	-14.9 mmHg Standard Error 5.70	-8.8 mmHg Standard Error 5.74	-9.9 mmHg Standard Error 5.72	-9.9 mmHg Standard Error 5.69	-6.4 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 1.00 Hours	-1.2 mmHg Standard Error 5.70	-9.4 mmHg Standard Error 5.90	-9.4 mmHg Standard Error 5.70	-4.6 mmHg Standard Error 5.74	-18.6 mmHg Standard Error 5.72	-6.1 mmHg Standard Error 5.69	-3.9 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 2.00 Hours	-5.4 mmHg Standard Error 5.70	-6.9 mmHg Standard Error 5.90	-9.8 mmHg Standard Error 5.70	-6.1 mmHg Standard Error 5.74	-14.7 mmHg Standard Error 5.72	-0.4 mmHg Standard Error 5.69	-12.3 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 8.00 Hours	0.1 mmHg Standard Error 5.70	15.6 mmHg Standard Error 5.90	-9.8 mmHg Standard Error 5.70	0.6 mmHg Standard Error 5.74	-10.9 mmHg Standard Error 5.72	0.1 mmHg Standard Error 5.69	-0.9 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 12.00 Hours	-4.5 mmHg Standard Error 5.70	8.4 mmHg Standard Error 5.90	-10.9 mmHg Standard Error 5.70	-9.6 mmHg Standard Error 5.74	-7.6 mmHg Standard Error 5.72	-4.9 mmHg Standard Error 5.69	-5.5 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 12.00 Hours	5.5 mmHg Standard Error 5.70	11.8 mmHg Standard Error 5.90	-8.8 mmHg Standard Error 5.70	-3.9 mmHg Standard Error 5.74	3.4 mmHg Standard Error 5.72	1.2 mmHg Standard Error 5.69	5.9 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 4.00 Hours	-4.2 mmHg Standard Error 5.70	-5.1 mmHg Standard Error 5.90	-12.4 mmHg Standard Error 5.70	-3.8 mmHg Standard Error 5.74	-9.4 mmHg Standard Error 5.72	-8.9 mmHg Standard Error 5.69	-17.4 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 6.00 Hours	-0.4 mmHg Standard Error 5.70	4.3 mmHg Standard Error 5.90	-18.8 mmHg Standard Error 5.70	-6.6 mmHg Standard Error 5.74	-7.7 mmHg Standard Error 5.72	-5.4 mmHg Standard Error 5.69	-3.3 mmHg Standard Error 4.03
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 24.00 Hours	-0.5 mmHg Standard Error 5.70	0.6 mmHg Standard Error 5.90	-23.1 mmHg Standard Error 5.70	-4.4 mmHg Standard Error 5.74	-4.4 mmHg Standard Error 5.72	0.6 mmHg Standard Error 5.69	7.3 mmHg Standard Error 4.03

SECONDARY outcome

Timeframe: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Population: This analysis population includes all enrolled subjects in Part 2.

Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.

Outcome measures

Outcome measures
Measure	LHA510 Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=6 Participants 1 drop instilled in the study eye as a single dose	LHA510 Highest TID, Part 2 n=6 Participants 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 Participants 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 0.25 Hours	3.5 mmHg Standard Error 3.34	-6.8 mmHg Standard Error 3.41	-1.7 mmHg Standard Error 3.35	-3.5 mmHg Standard Error 3.33	1.9 mmHg Standard Error 3.33	-1.0 mmHg Standard Error 3.33	-0.0 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 0.50 Hours	-2.4 mmHg Standard Error 3.34	-9.2 mmHg Standard Error 3.41	-3.1 mmHg Standard Error 3.35	-6.8 mmHg Standard Error 3.33	1.1 mmHg Standard Error 3.33	-3.4 mmHg Standard Error 3.33	1.8 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 1.00 Hours	5.3 mmHg Standard Error 3.34	-9.7 mmHg Standard Error 3.41	1.3 mmHg Standard Error 3.35	-1.6 mmHg Standard Error 3.33	0.1 mmHg Standard Error 3.33	-6.6 mmHg Standard Error 3.33	0.4 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 2.00 Hours	-6.4 mmHg Standard Error 3.34	-5.8 mmHg Standard Error 3.41	0.6 mmHg Standard Error 3.35	-4.8 mmHg Standard Error 3.33	-4.6 mmHg Standard Error 3.33	-8.1 mmHg Standard Error 3.33	-4.8 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 6.00 Hours	-4.3 mmHg Standard Error 3.34	-10.0 mmHg Standard Error 3.41	-5.0 mmHg Standard Error 3.35	-2.5 mmHg Standard Error 3.33	-2.1 mmHg Standard Error 3.33	-6.3 mmHg Standard Error 3.33	-6.9 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 24.00 Hours	4.2 mmHg Standard Error 3.34	-1.8 mmHg Standard Error 3.41	1.8 mmHg Standard Error 3.35	4.1 mmHg Standard Error 3.33	-4.0 mmHg Standard Error 3.33	-2.8 mmHg Standard Error 3.33	2.6 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 0.25 Hours	-3.9 mmHg Standard Error 3.34	-6.8 mmHg Standard Error 3.41	-5.3 mmHg Standard Error 3.35	-1.9 mmHg Standard Error 3.33	-6.4 mmHg Standard Error 3.33	-5.4 mmHg Standard Error 3.33	-3.5 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 0.50 Hours	-5.8 mmHg Standard Error 3.34	-6.1 mmHg Standard Error 3.41	-11.6 mmHg Standard Error 3.35	-4.3 mmHg Standard Error 3.33	-5.4 mmHg Standard Error 3.33	-2.3 mmHg Standard Error 3.33	-4.0 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 1.00 Hours	-4.4 mmHg Standard Error 3.34	-6.6 mmHg Standard Error 3.41	-5.9 mmHg Standard Error 3.35	-3.5 mmHg Standard Error 3.33	-10.5 mmHg Standard Error 3.33	-3.6 mmHg Standard Error 3.33	-3.3 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 4.00 Hours	-5.4 mmHg Standard Error 3.34	-6.3 mmHg Standard Error 3.41	-10.3 mmHg Standard Error 3.35	-3.6 mmHg Standard Error 3.33	-8.5 mmHg Standard Error 3.33	-4.6 mmHg Standard Error 3.33	-11.0 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 6.00 Hours	-3.0 mmHg Standard Error 3.34	1.4 mmHg Standard Error 3.41	-13.1 mmHg Standard Error 3.35	-5.9 mmHg Standard Error 3.33	-8.4 mmHg Standard Error 3.33	-6.1 mmHg Standard Error 3.33	-4.6 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 12.00 Hours	-7.8 mmHg Standard Error 3.34	1.9 mmHg Standard Error 3.41	-8.3 mmHg Standard Error 3.35	-5.6 mmHg Standard Error 3.33	-4.0 mmHg Standard Error 3.33	-3.5 mmHg Standard Error 3.33	-3.8 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 4.00 Hours	3.0 mmHg Standard Error 3.34	-4.7 mmHg Standard Error 3.41	-6.9 mmHg Standard Error 3.35	0.9 mmHg Standard Error 3.33	-1.9 mmHg Standard Error 3.33	-1.8 mmHg Standard Error 3.33	-0.3 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 8.00 Hours	4.0 mmHg Standard Error 3.34	4.9 mmHg Standard Error 3.41	-4.5 mmHg Standard Error 3.35	0.5 mmHg Standard Error 3.33	0.9 mmHg Standard Error 3.33	2.8 mmHg Standard Error 3.33	5.5 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 1, 12.00 Hours	3.4 mmHg Standard Error 3.34	4.4 mmHg Standard Error 3.41	-3.7 mmHg Standard Error 3.35	-2.6 mmHg Standard Error 3.33	6.0 mmHg Standard Error 3.33	0.1 mmHg Standard Error 3.33	2.2 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 2.00 Hours	-4.5 mmHg Standard Error 3.34	-6.7 mmHg Standard Error 3.41	-8.7 mmHg Standard Error 3.35	-5.1 mmHg Standard Error 3.33	-5.3 mmHg Standard Error 3.33	-3.8 mmHg Standard Error 3.33	-10.5 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 8.00 Hours	-0.4 mmHg Standard Error 3.34	5.7 mmHg Standard Error 3.41	-7.3 mmHg Standard Error 3.35	-1.6 mmHg Standard Error 3.33	-5.6 mmHg Standard Error 3.33	0.8 mmHg Standard Error 3.33	-1.9 mmHg Standard Error 2.35
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 Day 7, 24.00 Hours	-2.9 mmHg Standard Error 3.34	-1.5 mmHg Standard Error 3.41	-12.6 mmHg Standard Error 3.35	-3.9 mmHg Standard Error 3.33	-2.2 mmHg Standard Error 3.33	-0.8 mmHg Standard Error 3.33	2.7 mmHg Standard Error 2.35

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LHA510 Lowest, Part 1 n=6 participants at risk 1 drop instilled in the study eye as a single dose	LHA510 Next Lowest, Part 1 n=6 participants at risk 1 drop instilled in the study eye as a single dose	LHA510 Next Highest, Part 1 n=6 participants at risk 1 drop instilled in the study eye as a single dose	LHA510 Highest, Part 1 n=6 participants at risk 1 drop instilled in the study eye as a single dose	Vehicle, Part 1 n=8 participants at risk 1 drop instilled in the study eye as a single dose	LHA510 Lowest, Part 2 n=6 participants at risk 1 drop instilled in the study eye once daily for 7 days	LHA510 Next Lowest, Part 2 n=6 participants at risk 1 drop instilled in the study eye once daily for 7 days	LHA510 Next Highest, Part 2 n=6 participants at risk 1 drop instilled in the study eye once daily for 7 days	LHA510 Highest, Part 2 n=6 participants at risk 1 drop instilled in the study eye once daily for 7 days	LHA510 Highest BID, Part 2 n=6 participants at risk 1 drop instilled in the study eye twice daily for 7 days	LHA510 Highest TID, Part 2 n=6 participants at risk 1 drop instilled in the study eye three times daily for 7 days	Vehicle, Part 2 n=12 participants at risk 1 drop instilled in the study eye once, twice, or three times daily for 7 days
Gastrointestinal disorders Vomiting	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	33.3% 2/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 2/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	8.3% 1/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Nervous system disorders Headache	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Gastrointestinal disorders Nausea	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	33.3% 2/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	8.3% 1/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	8.3% 1/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	8.3% 1/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Eye disorders Eye Pain	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
General disorders Infusion Site Irritation	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Vascular disorders Phlebitis	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Nervous system disorders Sinus Headache	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	8.3% 1/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Vascular disorders Thrombophlebitis	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Infections and infestations Urinary Tract Infection	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Eye disorders Dry Eye	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	12.5% 1/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.
General disorders Vessel Puncture Site Swelling	16.7% 1/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/8 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/6 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.	0.00% 0/12 • AEs were collected for the duration of the study (Feb 2014 - Jun 2014). This analysis group includes all enrolled subjects. An AE is defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and observations by the study Investigator, as outlined in the study protocol.

Additional Information

Principal Clinical Scientist, CA CSI ID

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER