Trial Outcomes & Findings for An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study (NCT NCT05271370)

NCT ID: NCT05271370

Last Updated: 2025-10-30

Results Overview

The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table). Treatment-Emergent Serious Adverse Events (TESAEs) are defined as serious adverse events with an onset on or after the first treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 56 participants
• Primary outcome timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks
• Results posted on: 2025-10-30

Participant Flow

Participant milestones

Measure	PRO 140 350 mg PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Overall Study STARTED	8	18	30
Overall Study COMPLETED	0	2	1
Overall Study NOT COMPLETED	8	16	29

Reasons for withdrawal

Measure	PRO 140 350 mg PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Overall Study Study early termination	8	16	29

Baseline Characteristics

An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

Baseline characteristics by cohort

Measure	PRO 140 350 mg n=8 Participants PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=30 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants	52 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Age, Continuous	59.88 years STANDARD_DEVIATION 8.37 • n=5 Participants	47.17 years STANDARD_DEVIATION 11.94 • n=7 Participants	47.77 years STANDARD_DEVIATION 13.10 • n=5 Participants	49.30 years STANDARD_DEVIATION 12.90 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants	52 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants	47 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	18 participants n=7 Participants	30 participants n=5 Participants	56 participants n=4 Participants

PRIMARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The safety population is defined as all subjects who received at least one dose of PRO 140 within the PRO 140\_CD03 extension study.

The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:

• Grade 1 indicates a mild event
• Grade 2 indicates a moderate event
• Grade 3 indicates a severe event
• Grade 4 indicates a potentially life-threatening event
• Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table). Treatment-Emergent Serious Adverse Events (TESAEs) are defined as serious adverse events with an onset on or after the first treatment.

Outcome measures

Measure	PRO 140 350 mg n=8 Participants PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=30 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Long Term Clinical Safety of PRO 140 Monotherapy by Assessing the Number of Participants With Grade 2, 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale, and the Number of Participants With Treatment-emergent Serious Adverse Events. Participants with Grade 2, 3, or 4 AEs	5 participants	6 participants	6 participants
Long Term Clinical Safety of PRO 140 Monotherapy by Assessing the Number of Participants With Grade 2, 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale, and the Number of Participants With Treatment-emergent Serious Adverse Events. Participants with TESAEs	3 participants	5 participants	2 participants

PRIMARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The analysis population is defined as all subjects who enrolled in the study and received at least one dose of PRO 140.

Virological failure is defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group.

Outcome measures

Measure	PRO 140 350 mg n=8 Participants PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=30 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Proportion of Participants Experiencing Virologic Failure for All Subjects Within Each Treatment Group.	0 proportion of participants	0.17 proportion of participants	0.37 proportion of participants

SECONDARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The analysis population is defined as all subjects who enrolled in the study and received at least one dose of PRO 140.

Virological failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group. The date of VF event is defined as the date of the second assessment of the two (2) consecutive HIV-1 RNA levels of >= 200 copies/mL when virological failure is confirmed. Subjects who did not have VF, the last visit date will be used as the date of the event.

Outcome measures

Measure	PRO 140 350 mg n=8 Participants PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=30 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Time to Virologic Failure After Initiating PRO 140 Monotherapy for All Subjects Within Each Treatment Group.	1148.88 days Standard Deviation 457.15	735.67 days Standard Deviation 326.71	582.00 days Standard Deviation 407.71

SECONDARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The population includes all subjects who experienced virologic failure for each treatment group. No virologic failure was reported in the 350 mg treatment group.

Viral re-suppression is defined as having HIV-1 RNA levels of < 50 copies/mL after experiencing virologic failure within each treatment group.

Outcome measures

Measure	PRO 140 350 mg PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=3 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=11 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Proportion of Participants Achieving Viral Re-suppression After Experiencing Virologic Failure Within Each Treatment Group.	—	1 Portion of Participants	0.9 Portion of Participants

SECONDARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The population includes all subjects who experienced virologic failure and re-suppression for each treatment group. No virologic failure was reported in the 350 mg treatment group.

Viral re-suppression is defined as having HIV-1 RNA levels of < 50 copies/mL after experiencing virologic failure within each treatment group.

Outcome measures

Measure	PRO 140 350 mg PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=3 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=10 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Time to Achieving Viral Re-suppression After Experiencing Virologic Failure Within Each Treatment Group.	—	100.33 days Standard Deviation 33.48	136.71 days Standard Deviation 127.68

SECONDARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The population includes all subjects who experienced virologic failure and achieved viral re-suppression for each treatment group. No virologic failure was reported in the 350 mg treatment group.

Viral re-suppression is defined as having HIV-1 RNA levels of < 50 copies/mL after experiencing virologic failure within each treatment group. Subjects who experienced virologic failure during the treatment phase had an option to re-initiate their PRO 140 regimen to their previous baseline or dose escalate to the next dose level.

Outcome measures

Measure	PRO 140 350 mg PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=3 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=10 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Proportion of Virologic Failure Subjects Achieving Viral Re-suppression With Re-initiation of Previous Baseline Antiretroviral Regimen Within Each Treatment Group.	—	0.33 proportion of participants	0.78 proportion of participants

SECONDARY outcome

Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Population: The analysis population is defined as all subjects who enrolled in the study and received at least one dose of PRO 140. Subjects who had undefined change from baseline due to missing data were excluded from the analysis population.

The change from baseline in CD4 cell count was summarized for each visit during the treatment phase for each treatment group. The time-weighted mean of change of the post baseline (visit TE1) values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.

Outcome measures

Measure	PRO 140 350 mg n=8 Participants PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 Participants PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=27 Participants PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase for All Subjects Within Each Treatment Group	0.62 cells/uL Standard Deviation 2.60	-0.14 cells/uL Standard Deviation 2.59	0.58 cells/uL Standard Deviation 2.32

Adverse Events

PRO 140 350 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

PRO 140 525 mg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 1 deaths

PRO 140 700 mg

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	PRO 140 350 mg n=8 participants at risk PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 participants at risk PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=30 participants at risk PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Cardiac disorders Atrioventricular block complete	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations COVID-19	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Lacunar infarction	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Lower limb fracture	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Overdose	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Pancreatitis	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	11.1% 2/18 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Vascular disorders Peripheral ischaemia	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Cardiac disorders Pericarditis	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.

Other adverse events

Measure	PRO 140 350 mg n=8 participants at risk PRO 140 350mg weekly SQ injection. PRO 140 350: Pro140 SC injection 350 mg	PRO 140 525 mg n=18 participants at risk PRO 140 525mg weekly SQ injection. PRO 140 525: 525 mg	PRO 140 700 mg n=30 participants at risk PRO 140 700mg weekly SQ injection. PRO 140 700: 700 mg
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Abdominal pain lower	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Metabolism and nutrition disorders Abnormal loss of weight	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Abscess limb	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Acne	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Actinic keratosis	25.0% 2/8 • Number of events 5 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Anal chlamydia infection	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Arthropod bite	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Asthenia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Back pain	25.0% 2/8 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	25.0% 2/8 • Number of events 8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Eye disorders Blepharitis	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Bronchitis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Eye disorders Cataract	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Chlamydial infection	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Cluster headache	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations Colonoscopy	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations Computerised tomogram abdomen	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Conjunctivitis	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Dental caries	25.0% 2/8 • Number of events 4 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Depression	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Diarrhoea	37.5% 3/8 • Number of events 4 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	11.1% 2/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Diverticulum	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Eye disorders Dry eye	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Dry mouth	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Renal and urinary disorders Dysuria	25.0% 2/8 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Ear and labyrinth disorders Ear Discomfort	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Ear Infection	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 6 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations Endoscopy	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Eructation	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Essential tremor	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Fall	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Fatigue	25.0% 2/8 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Food poisoning	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Gastroenteritis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	6.7% 2/30 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Gastroenteritis viral	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Herpes zoster	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Hiatus hernia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Hordeolum	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Metabolism and nutrition disorders Hyperglycaemia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Hyperkeratosis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Vascular disorders Hypertension	25.0% 2/8 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Metabolism and nutrition disorders Hypoglycaemia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Vascular disorders Hypotension	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Influenza	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	10.0% 3/30 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Injection site haematoma	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Injection site pain	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Limb injury	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Social circumstances Menopause	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Mental status changes	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Nervous system disorders Migraine	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Cardiac disorders Mitral valve Prolapse	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Mucous stools	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Nasopharyngitis	37.5% 3/8 • Number of events 5 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	16.7% 3/18 • Number of events 5 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Nausea	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Renal and urinary disorders Nephrolithiasis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Eye disorders Ocular hypertension	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Oedema peripheral	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Renal and urinary disorders Oliguria	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Onychomycosis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Oral disorder	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Oral herpes	12.5% 1/8 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Oropharyngeal gonococcal infection	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Osteopenia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Osteoporosis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Panic attack	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Periodontal disease	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Pharyngitis streptococcal	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 3 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Blood and lymphatic system disorders Polycythaemia	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	25.0% 2/8 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
General disorders Pyrexia	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	11.1% 2/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Retching	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Eye disorders Retinal oedema	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	11.1% 2/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Sacroiliitis	12.5% 1/8 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Investigations SARS-CoV-2 test positive	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Immune system disorders Seasonal allergy	37.5% 3/8 • Number of events 4 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Sinus disorder	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Sinusitis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Skin bacterial infection	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Skin laceration	12.5% 1/8 • Number of events 4 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Skin and subcutaneous tissue disorders Skin lesion	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Psychiatric disorders Sleep disorder	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Musculoskeletal and connective tissue disorders Spinal pain	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Cardiac disorders Supraventricular tachycardia	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Syphilis	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	6.7% 2/30 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Tibia fracture	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Ear and labyrinth disorders Tinnitus	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Tooth abscess	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	11.1% 2/18 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Tooth disorder	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Injury, poisoning and procedural complications Tooth fracture	12.5% 1/8 • Number of events 2 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Toothache	0.00% 0/8 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	5.6% 1/18 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	3.3% 1/30 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Upper respiratory tract infection	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	22.2% 4/18 • Number of events 7 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	16.7% 5/30 • Number of events 7 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Urethritis chlamydial	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Renal and urinary disorders Urine flow decreased	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Metabolism and nutrition disorders Vitamin D deficiency	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/18 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.	0.00% 0/30 • Report initiation for all adverse events began at the time of the first treatment extension visit and continued up until the final study visit (up to approximately 197 weeks). AEs were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed clinically significant to the research subject and that occurred after initiation of the first study treatment were reported as AEs.

Additional Information

Vice President, Clinical Operations

CytoDyn

Phone: 3609808524

Email: jmeidling@cytodyn.com

Results disclosure agreements

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