Trial Outcomes & Findings for A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat (NCT NCT02474589)

NCT ID: NCT02474589

Last Updated: 2017-11-28

Results Overview

To determine the safety and tolerability of oral tecovirimat

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 449 participants
• Primary outcome timeframe: 45 days
• Results posted on: 2017-11-28

Participant Flow

Participant milestones

Measure	Active 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule	Placebo matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply
Overall Study STARTED	359	90
Overall Study COMPLETED	334	85
Overall Study NOT COMPLETED	25	5

Reasons for withdrawal

Measure	Active 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule	Placebo matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply
Overall Study Adverse Event	6	2
Overall Study Lost to Follow-up	6	1
Overall Study Protocol Violation	4	1
Overall Study Withdrawal by Subject	4	0
Overall Study Inability to complete study procedures	5	1

Baseline Characteristics

A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat

Baseline characteristics by cohort

Measure	Active n=359 Participants 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule	Placebo n=90 Participants matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply	Total n=449 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 15.67 • n=5 Participants	41.9 years STANDARD_DEVIATION 15.85 • n=7 Participants	40.7 years STANDARD_DEVIATION 15.70 • n=5 Participants
Sex: Female, Male Female	211 Participants n=5 Participants	54 Participants n=7 Participants	265 Participants n=5 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	36 Participants n=7 Participants	184 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	5 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	315 Participants n=5 Participants	85 Participants n=7 Participants	400 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	101 Participants n=5 Participants	26 Participants n=7 Participants	127 Participants n=5 Participants
Race (NIH/OMB) White	249 Participants n=5 Participants	62 Participants n=7 Participants	311 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	359 participants n=5 Participants	90 participants n=7 Participants	449 participants n=5 Participants

PRIMARY outcome

Timeframe: 45 days

To determine the safety and tolerability of oral tecovirimat

Outcome measures

Measure	Active n=359 Participants 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule	Placebo n=90 Participants matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply
To Determine the Number of Participants With Adverse Events	134 Participants	30 Participants

Adverse Events

Active

Serious events: 1 serious events

Other events: 134 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active n=359 participants at risk 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule	Placebo n=90 participants at risk matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply
Respiratory, thoracic and mediastinal disorders Pulmonary embolus (pulmonary embolism)	0.28% 1/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.

Other adverse events

Measure	Active n=359 participants at risk 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects tecovirimat: Study is based on Animal Regulatory Rule	Placebo n=90 participants at risk matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects Placebo: Does not apply
Skin and subcutaneous tissue disorders Oropharyngeal pain	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	2.2% 2/90 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Disturbance in Attention	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Migraine	1.1% 4/359 • Number of events 4 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Dysgeusia	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Paraesthesia	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Syncope	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Abdominal Pain Upper	1.7% 6/359 • Number of events 7 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Dry Mouth	1.4% 5/359 • Number of events 5 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Dyspepsia	0.84% 3/359 • Number of events 3 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Abdominal Distention	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Headache	17.0% 61/359 • Number of events 104 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	14.4% 13/90 • Number of events 19 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Nausea	5.6% 20/359 • Number of events 29 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	5.6% 5/90 • Number of events 5 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Diarrhoea	3.1% 11/359 • Number of events 13 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	3.3% 3/90 • Number of events 4 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Dizziness	2.5% 9/359 • Number of events 9 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	3.3% 3/90 • Number of events 3 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Fatigue	1.4% 5/359 • Number of events 5 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	4.4% 4/90 • Number of events 4 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Vomiting	2.5% 9/359 • Number of events 10 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Constipation	1.4% 5/359 • Number of events 5 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	2.2% 2/90 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Nervous system disorders Somnolence	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	2.2% 2/90 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Back pain	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	2.2% 2/90 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Abdominal Pain	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Abdominal DIscomfort	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Abdominal Pain Lower	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Chapped Lips	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Dental Caries	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Epigastric Discomfort	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Eructation	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Food Poisoning	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Hypoaesthesia Oral	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Paraesthesia Oral	0.28% 1/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Toothache	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Gastrointestinal disorders Uvulitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Nasopharyngitis	1.7% 6/359 • Number of events 6 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Acute Sinusitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Bacterial Vaginosis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Bronchitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Conjunctivitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Fungal Infection	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Gastroenteritis Viral	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Influenza	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Kidney Infection	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Pharyngitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Sinusitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Tooth Abscess	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Upper Respiratory Tract Infection	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Urinary Tract Infection	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Viral Infection	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Folliculitis	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Infections and infestations Gastroenteritis	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Pyrexia	1.1% 4/359 • Number of events 4 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Pain	0.84% 3/359 • Number of events 3 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Chills	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Asthenia	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Malaise	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Oedema Peripheral	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Thirst	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
General disorders Peripheral Swelling	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Rash	0.84% 3/359 • Number of events 4 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Pruritis	0.56% 2/359 • Number of events 3 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Alopecia	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Erythema	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Palpable Purpura	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Pruritis Generalized	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Rash Pruritic	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Skin Hypertrophy	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Swelling Face	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Arthralgia	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Myalgia	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Muscle Tightness	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Neck Pain	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Pain in Jaw	0.28% 1/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Tendonitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Injury, poisoning and procedural complications Muscle Strain	1.1% 4/359 • Number of events 4 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Musculoskeletal and connective tissue disorders Ligament Sprain	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Injury, poisoning and procedural complications Head Injury	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Injury, poisoning and procedural complications Skin Abrasion	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Injury, poisoning and procedural complications Sunburn	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Injury, poisoning and procedural complications Upper Limb Fracture	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Injury, poisoning and procedural complications Fall	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Depression	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Nervousness	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Dysphoria	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Insomnia	0.28% 1/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Irritability	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Panic Attack	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Libido Increased	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Psychiatric disorders Nighmare	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	2.2% 2/90 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Pumonary Embolism	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Sputum Retention	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Vasomotor Rhinitis	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Wheezing	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Investigations Blood Pressure Systolic Increased	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Investigations Electroencephalogram Abnormal	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Investigations Haematocrit Decreased	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Investigations Haemoglobin Decreased	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Investigations Heart Rate Increased	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Ear and labyrinth disorders Ear Pain	0.56% 2/359 • Number of events 2 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Ear and labyrinth disorders Vertigo	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Ear and labyrinth disorders Hearing Impaired	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Ear and labyrinth disorders Tinnitus	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Blood and lymphatic system disorders Lymphadenopathy	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Cardiac disorders Ventricular Extrasystoles	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Eye disorders Eye Irritation	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Renal and urinary disorders Dysuria	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Reproductive system and breast disorders Menstruation Irregular	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Vascular disorders Peripheral Coldness	0.28% 1/359 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	0.00% 0/90 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.
Metabolism and nutrition disorders Dehydration	0.00% 0/359 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.	1.1% 1/90 • Number of events 1 • Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.

Additional Information

Dennis E Hruby, PhD, Chief Scientific Officer

SIGA Technologies

Phone: 541-753-2000

Email: dhruby@siga.com

Results disclosure agreements

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

Restriction type: LTE60