Trial Outcomes & Findings for Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain. (NCT NCT02268812)

NCT ID: NCT02268812

Last Updated: 2018-10-25

Results Overview

VASPI is a worldwide validated measure of pain intensity. A Visual Analog Score (VAS) for pain is determined by using a horizontal line, 100-millimeter (mm) in length, anchored by word descriptors at each end; "no pain" (0 mm) on the left end and "worst imaginable pain" (100 mm) on the right end. The participant was asked to mark on the line the point that they feel represents their current state of pain. A VAS for least pain (over last two weeks), usual pain (over last two weeks), and pain today was determined and averaged to derive the total VAS score ranging from 0 (no pain) to 100 (worst pain imaginable). A last observation carried forward (LOCF) dataset was used to account for missing data where First Visit data could be carried forward.

• Recruitment status: COMPLETED
• Target enrollment: 219 participants
• Primary outcome timeframe: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)
• Results posted on: 2018-10-25

Participant Flow

Participant milestones

Measure	Ziconotide Monotherapy Participants who took ziconotide alone.	Ziconotide Combination Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy Participants who took an IT therapy other than ziconotide.	Other IT Combination Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Overall Study STARTED	77	72	30	40
Overall Study COMPLETED	61	40	21	26
Overall Study NOT COMPLETED	16	32	9	14

Reasons for withdrawal

Measure	Ziconotide Monotherapy Participants who took ziconotide alone.	Ziconotide Combination Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy Participants who took an IT therapy other than ziconotide.	Other IT Combination Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Overall Study Adverse Event	8	26	7	10
Overall Study Protocol deviation	0	0	1	0
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Physician Decision	3	1	0	1
Overall Study Other	5	4	1	3

Baseline Characteristics

Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.

Baseline characteristics by cohort

Measure	Ziconotide Monotherapy n=77 Participants Participants who took ziconotide alone.	Ziconotide Combination n=72 Participants Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=30 Participants Participants who took an IT therapy other than ziconotide.	Other IT Combination n=40 Participants Participants who took two (or more) IT therapies in conjunction other than ziconotide.	Total n=219 Participants Total of all reporting groups
Age, Continuous	53.2 Years STANDARD_DEVIATION 11.56 • n=5 Participants	55.9 Years STANDARD_DEVIATION 13.46 • n=7 Participants	56.7 Years STANDARD_DEVIATION 12.78 • n=5 Participants	54.4 Years STANDARD_DEVIATION 11.69 • n=4 Participants	54.8 Years STANDARD_DEVIATION 12.39 • n=21 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	28 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants	89 Participants n=21 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	44 Participants n=7 Participants	19 Participants n=5 Participants	22 Participants n=4 Participants	130 Participants n=21 Participants

PRIMARY outcome

Timeframe: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)

Population: Intent-to-Treat (ITT) (LOCF) population included all participants who had at least one dose of an IT therapy. Total number of participants for the outcome measures (335) does not match the total number enrolled (219) due to participants switching between treatment arms as allowed per protocol.

VASPI is a worldwide validated measure of pain intensity. A Visual Analog Score (VAS) for pain is determined by using a horizontal line, 100-millimeter (mm) in length, anchored by word descriptors at each end; "no pain" (0 mm) on the left end and "worst imaginable pain" (100 mm) on the right end. The participant was asked to mark on the line the point that they feel represents their current state of pain. A VAS for least pain (over last two weeks), usual pain (over last two weeks), and pain today was determined and averaged to derive the total VAS score ranging from 0 (no pain) to 100 (worst pain imaginable). A last observation carried forward (LOCF) dataset was used to account for missing data where First Visit data could be carried forward.

Outcome measures

Measure	Ziconotide Monotherapy n=83 Participants Participants who took ziconotide alone.	Ziconotide Combination n=114 Participants Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 Participants Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 Participants Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) Month 8 (Visit 4)	-3.23 Units on a scale Standard Deviation 23.160	-15.24 Units on a scale Standard Deviation 23.614	-1.50 Units on a scale Standard Deviation 20.736	-18.40 Units on a scale Standard Deviation 21.899
Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) Month 12 (Visit 5)	-3.78 Units on a scale Standard Deviation 23.424	-9.33 Units on a scale Standard Deviation 30.039	1.67 Units on a scale Standard Deviation 20.894	-14.33 Units on a scale Standard Deviation 29.800
Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) Termination Visit	-6.01 Units on a scale Standard Deviation 23.220	0.65 Units on a scale Standard Deviation 28.208	1.64 Units on a scale Standard Deviation 21.643	-14.27 Units on a scale Standard Deviation 34.620

SECONDARY outcome

Timeframe: Baseline (Visit 1) to Month 12 (Visit 5)

Population: ITT LOCF population

The Brief Pain Inventory-Short Form (BPI-SF) survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was "no pain" and 10 was "pain as bad as you can imagine" for each item listed. The pain interference survey scored each item on a scale, where 0 was "does not interfere" to 10 was "completely interferes". The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.

Outcome measures

Measure	Ziconotide Monotherapy n=83 Participants Participants who took ziconotide alone.	Ziconotide Combination n=114 Participants Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 Participants Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 Participants Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5) Pain severity	-0.41 Scores on a scale Standard Deviation 1.768	-0.77 Scores on a scale Standard Deviation 2.150	-0.09 Scores on a scale Standard Deviation 1.741	-0.99 Scores on a scale Standard Deviation 1.866
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5) Pain interference	-0.52 Scores on a scale Standard Deviation 1.645	-0.42 Scores on a scale Standard Deviation 2.445	-0.43 Scores on a scale Standard Deviation 2.248	-0.33 Scores on a scale Standard Deviation 2.039

SECONDARY outcome

Timeframe: Baseline (Visit 1) to Termination Visit (12 Months after last participant was enrolled)

Population: ITT LOCF population

The BPI-SF survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was "no pain" and 10 was "pain as bad as you can imagine" for each item listed. The pain interference survey scored each item on a scale, where 0 was "does not interfere" to 10 was "completely interferes". The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.

Outcome measures

Measure	Ziconotide Monotherapy n=83 Participants Participants who took ziconotide alone.	Ziconotide Combination n=114 Participants Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 Participants Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 Participants Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit Pain severity	-0.27 Scores on a scale Standard Deviation 2.219	-1.11 Scores on a scale Standard Deviation 2.127	-0.04 Scores on a scale Standard Deviation 1.957	-0.74 Scores on a scale Standard Deviation 2.321
Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit Pain interference	-0.77 Scores on a scale Standard Deviation 2.809	-1.05 Scores on a scale Standard Deviation 2.798	-0.73 Scores on a scale Standard Deviation 1.718	-0.72 Scores on a scale Standard Deviation 2.054

SECONDARY outcome

Timeframe: From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.

Population: Safety population included all participants who had at least one dose of an IT therapy.

Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), any therapeutic interventions including all drug therapies, vital signs, and creatine kinase (CK) if laboratory tests were taken by the physician as part of routine clinical practice. AEs were graded on a 3-point scale; 1) mild - discomfort noticed, but no disruption of normal daily activity, 2) moderate - discomfort sufficient to reduce or affect normal daily activity, 3) severe - incapacitating, with inability to work or to perform normal daily activity. A TEAE was defined as an adverse event (AE) with a start date on or after the date of the First Visit. Where a start date was missing, the AE was considered to be treatment-emergent.

Outcome measures

Measure	Ziconotide Monotherapy n=83 Participants Participants who took ziconotide alone.	Ziconotide Combination n=114 Participants Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 Participants Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 Participants Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) Any TEAEs	66 Participants	88 Participants	46 Participants	48 Participants
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) Drug-related TEAEs	56 Participants	54 Participants	26 Participants	28 Participants
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) SAEs	26 Participants	51 Participants	24 Participants	30 Participants
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) Drug-related SAEs	7 Participants	11 Participants	9 Participants	5 Participants
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) TEAEs leading to death	3 Participants	26 Participants	7 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months after the last patient was enrolled

Population: Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.

Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12 Visit, End of Study (Termination Visit)

Population: ITT population. Missing items/values used in calculating the partially complete Health Score were imputed using last observation carried forward (LOCF).

The EQ-5D is a standardized instrument used to measure quality of life. It classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain has three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state was defined by combining one level from each of the five dimensions. The response to the question of how good or bad the participant's health was today was given on a visual analogue scale of 0 to 100 millimeters (mm), where 0 meant the participant was in the worst imaginable health state today and 100 meant the participant was in the best imaginable health state today. The results for the Health Score were that of the calculated overall score of the five dimensions, where -0.594 is worst health and 1.00 is perfect health. Change is defined as change in actual from the First Visit.

Outcome measures

Measure	Ziconotide Monotherapy n=83 Participants Participants who took ziconotide alone.	Ziconotide Combination n=114 Participants Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 Participants Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 Participants Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Change in the Actual Overall EuroQoL (EQ-5D) Health Score From First Visit to Month 12 and End of Study Month 12	-0.01 Scores on a scale Standard Deviation 0.176	-0.06 Scores on a scale Standard Deviation 0.207	0.01 Scores on a scale Standard Deviation 0.217	-0.01 Scores on a scale Standard Deviation 0.136
Change in the Actual Overall EuroQoL (EQ-5D) Health Score From First Visit to Month 12 and End of Study End of Study	-0.00 Scores on a scale Standard Deviation 0.196	0.04 Scores on a scale Standard Deviation 0.180	-0.03 Scores on a scale Standard Deviation 0.193	-0.02 Scores on a scale Standard Deviation 0.145

Adverse Events

Ziconotide Monotherapy

Serious events: 26 serious events

Other events: 59 other events

Deaths: 3 deaths

Ziconotide Combination

Serious events: 51 serious events

Other events: 70 other events

Deaths: 26 deaths

Other IT Monotherapy

Serious events: 24 serious events

Other events: 34 other events

Deaths: 7 deaths

Other IT Combination

Serious events: 30 serious events

Other events: 43 other events

Deaths: 12 deaths

Serious adverse events

Measure	Ziconotide Monotherapy n=83 participants at risk Participants who took ziconotide alone.	Ziconotide Combination n=114 participants at risk Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 participants at risk Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 participants at risk Participants who took two (or more) IT therapies in conjunction other than ziconotide.
General disorders Death	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	6.1% 7/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	10.4% 7/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.5% 3/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.2% 3/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders General Physical Health Deterioration	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Catheter Related Complication	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.2% 3/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Pyrexia	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Chest Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Oedema Peripheral	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Catheter Site Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Disease Progression	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Drug Withdrawal Syndrome	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Extravasation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Face Oedema	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Fatigue	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Generalised Oedema	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Infusion Site Mass	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Oedema	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Pneumonia	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.6% 4/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Meningitis	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Urinary Tract Infection	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Catheter Related Infection	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Device Related Infection	2.4% 2/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Sepsis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Abscess	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Breast Cellulitis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Bronchitis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Cellulitis	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Escherichia Sepsis	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Gastroenteritis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Implant Site Infection	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Infection	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Lobar Pneumonia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Lower Respiratory Tract Infection	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Rectal Abscess	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Soft Tissue Infection	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Staphylococcal Infection	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Staphylococcal Skin Infection	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Infections and infestations Wound Infection	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small Cell Lung Cancer	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Sarcoma	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Metastatic	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Bone	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Central Nervous System	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Meninges	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Malignant Melanoma	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Uterine Cancer	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neoplasm	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer Metastatic	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Medical Device Complication	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Contusion	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Device Dislocation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Hip Fracture	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Excoriation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Fall	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Overdose	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Alcohol Poisoning	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Device Connection Issue	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Inadequate Analgesia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Poisoning	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Suture Related Complication	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Injury, poisoning and procedural complications Wound Secretion	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Confusional State	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Depression	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Anxiety	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Hallucination	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Mental Disorder	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Agitation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Anxiety Disorder	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Delirium	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Drug Abuse	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Hallucinations, Mixed	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Hostility	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Narcissistic Personality Disorder	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Psychotic Disorder	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Suicidal Ideation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Nausea	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Abdominal Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Constipation	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Diarrhoea	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Vomiting	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Colitis	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Gastritis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Haemorrhoids	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Melaena	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Oesophagitis	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Subileus	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.8% 2/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Arthralgia	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Foot Deformity	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Cerebral Haemorrhage	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Dysgeusia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Head Titubation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Hypersomnia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Ischaemic Stroke	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Neuralgia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Nystagmus	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Parosmia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Sciatica	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Somnolence	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Speech Disorder	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Spinal Cord Compression	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Stupor	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Syncope	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Tremor	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Trigeminal Neuralgia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Deep Vein Thrombosis	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Hypertension	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Shock Haemorrhagic	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Circulatory Collapse	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Peripheral Ischaemia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Thrombosis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Vascular disorders Venous Occlusion	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Bronchial Secretion Retention	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Obstructive Airways Disorder	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Cardiac disorders Cardiac Failure	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Cardiac disorders Atrial Fibrillation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Cardiac disorders Left Ventricular Dysfunction	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Cardiac disorders Left Ventricular Failure	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Metabolism and nutrition disorders Dehydration	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Metabolism and nutrition disorders Feeding Disorder	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Metabolism and nutrition disorders Hyperglycaemia	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Metabolism and nutrition disorders Malnutrition	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Renal and urinary disorders Renal Failure	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Renal and urinary disorders Renal Failure Acute	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Renal and urinary disorders Urinary Incontinence	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Surgical and medical procedures Central Venous Catheterisation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Surgical and medical procedures Drug Therapy	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Surgical and medical procedures Medical Device Removal	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Surgical and medical procedures Nerve Block	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Surgical and medical procedures Peripheral Nerve Decompression	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Surgical and medical procedures Spinal Nerve Stimulator Implantation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Reproductive system and breast disorders Pelvic Haemorrhage	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Reproductive system and breast disorders Prostatitis	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Eye disorders Cataract	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Eye disorders Diplopia	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Eye disorders Strabismus	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Investigations C-reactive Protein Increased	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Investigations International Normalised Ratio Increased	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Investigations Weight Decreased	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Blood and lymphatic system disorders Anaemia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Blood and lymphatic system disorders Neutropenia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Immune system disorders Behcet's Syndrome	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Immune system disorders Hypersensitivity	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Ear and labyrinth disorders Vertigo	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Hepatobiliary disorders Biliary Dilatation	0.00% 0/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Skin and subcutaneous tissue disorders Skin Erosion	1.2% 1/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.

Other adverse events

Measure	Ziconotide Monotherapy n=83 participants at risk Participants who took ziconotide alone.	Ziconotide Combination n=114 participants at risk Participants who took ziconotide in combination with another intrathecal (IT) therapy.	Other IT Monotherapy n=67 participants at risk Participants who took an IT therapy other than ziconotide.	Other IT Combination n=71 participants at risk Participants who took two (or more) IT therapies in conjunction other than ziconotide.
Nervous system disorders Dizziness	18.1% 15/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.3% 6/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	7.5% 5/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.2% 3/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Headache	13.3% 11/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.4% 5/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	7.5% 5/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	11.3% 8/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Memory Impairment	12.0% 10/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	7.0% 8/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Somnolence	3.6% 3/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.5% 3/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.6% 4/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Nervous system disorders Hypoaesthesia	4.8% 4/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	9.9% 7/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Nausea	18.1% 15/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.4% 5/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	14.9% 10/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	14.1% 10/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Constipation	7.2% 6/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	6.1% 7/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.6% 4/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Diarrhoea	8.4% 7/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.5% 3/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Dry Mouth	6.0% 5/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.2% 3/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Gastrointestinal disorders Vomiting	2.4% 2/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.5% 3/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.6% 4/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Oedema Peripheral	6.0% 5/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.4% 5/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	6.0% 4/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	8.5% 6/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
General disorders Fatigue	7.2% 6/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	9.0% 6/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	8.5% 6/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Arthralgia	9.6% 8/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	11.3% 8/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Muscular Weakness	6.0% 5/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	7.0% 5/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Back Pain	8.4% 7/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.5% 4/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.8% 2/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Musculoskeletal and connective tissue disorders Pain In Extremity	4.8% 4/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	2.6% 3/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	8.5% 6/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Confusional State	6.0% 5/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.3% 6/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	3.0% 2/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.4% 1/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Psychiatric disorders Insomnia	7.2% 6/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	1.5% 1/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.2% 3/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.8% 4/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.4% 5/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	13.4% 9/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	9.9% 7/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Investigations Weight Decreased	6.0% 5/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.88% 1/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	4.5% 3/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.6% 4/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.
Ear and labyrinth disorders Vertigo	3.6% 3/83 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.3% 6/114 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	0.00% 0/67 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.	5.6% 4/71 • For each participant, from the first dose till 30 days after the last dose or up to the termination visit (which was 12 months after the last subject had been enrolled), or approximately 4 years. The safety population included all participants who received at least one dose of an IT therapy. Treatment emergent adverse events (TEAEs) and serious adverse events were reported. Participants could switch IT therapies during the study, so AEs were assigned to the treatment taken at the time and date of the onset of the AE. This resulted in the possibility of a participant being counted in more than one therapy category.

Additional Information

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