Trial Outcomes & Findings for ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab (NCT NCT01663402)

NCT ID: NCT01663402

Last Updated: 2019-03-18

Results Overview

All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 18924 participants
• Primary outcome timeframe: From randomization up to 64 months
• Results posted on: 2019-03-18

Participant Flow

The study was conducted at 1387 sites in 57 countries. Of these, 1328 active sites randomized at least 1 participant. Overall, 35,437 participants were screened between 11 October 2012 and 17 Jan 2017; of whom 16,513 were screen failures. Screen failures were mainly due to exclusion criteria met.

Randomization was stratified according to country. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio (alirocumab: placebo), with permuted-block randomization.

Participant milestones

Measure	Placebo Placebo (for alirocumab) SC injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Overall Study STARTED	9462	9462
Overall Study Treated	9443	9451
Overall Study COMPLETED	7947	7378
Overall Study NOT COMPLETED	1515	2084

Reasons for withdrawal

Measure	Placebo Placebo (for alirocumab) SC injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Overall Study Randomized but not treated	19	11
Overall Study Adverse Event	347	362
Overall Study Two consecutive LDL-C <15 mg/dL	0	730
Overall Study Poor compliance to protocol	529	454
Overall Study Physician Decision	77	62
Overall Study Site terminated by sponsor	1	3
Overall Study Participant moved	139	104
Overall Study Withdrawal by Subject	118	91
Overall Study Related to study drug administration	96	105
Overall Study Lost to Follow-up	17	15
Overall Study Other than specified above	172	147

Baseline Characteristics

Here, 'number analyzed' signifies participants with available for specified measure.

Baseline characteristics by cohort

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).	Total n=18924 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 9.4 • n=9462 Participants	58.5 years STANDARD_DEVIATION 9.3 • n=9462 Participants	58.6 years STANDARD_DEVIATION 9.3 • n=18924 Participants
Sex: Female, Male Female	2372 Participants n=9462 Participants	2390 Participants n=9462 Participants	4762 Participants n=18924 Participants
Sex: Female, Male Male	7090 Participants n=9462 Participants	7072 Participants n=9462 Participants	14162 Participants n=18924 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1555 Participants n=9462 Participants	1581 Participants n=9462 Participants	3136 Participants n=18924 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7721 Participants n=9462 Participants	7700 Participants n=9462 Participants	15421 Participants n=18924 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	186 Participants n=9462 Participants	181 Participants n=9462 Participants	367 Participants n=18924 Participants
Race/Ethnicity, Customized White	7524 Participants n=9460 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	7500 Participants n=9461 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	15024 Participants n=18921 Participants • Here, 'number analyzed' signifies participants with available for specified measure.
Race/Ethnicity, Customized Black or African American	238 Participants n=9460 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	235 Participants n=9461 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	473 Participants n=18921 Participants • Here, 'number analyzed' signifies participants with available for specified measure.
Race/Ethnicity, Customized Asian	1247 Participants n=9460 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	1251 Participants n=9461 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	2498 Participants n=18921 Participants • Here, 'number analyzed' signifies participants with available for specified measure.
Race/Ethnicity, Customized Other	449 Participants n=9460 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	469 Participants n=9461 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	918 Participants n=18921 Participants • Here, 'number analyzed' signifies participants with available for specified measure.
Race/Ethnicity, Customized Unknown	2 Participants n=9460 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	6 Participants n=9461 Participants • Here, 'number analyzed' signifies participants with available for specified measure.	8 Participants n=18921 Participants • Here, 'number analyzed' signifies participants with available for specified measure.

PRIMARY outcome

Timeframe: From randomization up to 64 months

Population: Intent-to-treat (ITT) population included all randomized participants.

All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study	11.1 percentage of participants	9.5 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death, non-fatal non-fatal MI, UA requiring hospitalization, or ischemia-driven coronary revascularization procedure. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study	14.3 percentage of participants	12.7 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

All Major CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death and non-fatal MI. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any major CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study	9.5 percentage of participants	8.4 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

All CV events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of any non-fatal CHD event, any CV death and non-fatal IS. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CV event over time. Percentage of observed participants with outcome measure events during the study were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study	15.6 percentage of participants	13.7 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

All-cause mortality, non-fatal MI and non-fatal IS positively adjudicated by CEC in a blinded fashion, were used in the analysis of this endpoint. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of all-cause mortality, non-fatal MI and non-fatal IS over time. Percentage of observed participants with outcome measure events during the study were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study	11.9 percentage of participants	10.3 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CHD death over time. Percentage of observed participants with CHD death (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study	2.3 percentage of participants	2.2 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CV death over time. Percentage of observed participants with CV death (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study	2.9 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the all-cause death over time. Percentage of observed participants with all-cause death (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study	4.1 percentage of participants	3.5 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any non-fatal MI over time. Percentage of observed participants with any non-fatal MI (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study	7.6 percentage of participants	6.6 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of fatal or any non-fatal IS over time. Percentage of observed participants with fatal or any non-fatal IS (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study	1.6 percentage of participants	1.2 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any UA requiring hospitalization over time. Percentage of observed participants with any UA requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study	0.6 percentage of participants	0.4 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any ischemia-driven coronary revascularization procedure over time. Percentage of observed participants with any ischemia-driven coronary revascularization procedure (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study	8.8 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to 64 months

Population: ITT Population.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHF requiring hospitalization over time. Percentage of observed participants with any CHF requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study	1.9 percentage of participants	1.9 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Months 4, 12 and 48

Population: ITT Population. Here, 'number analyzed' corresponds to the number of participants with the parameter measured and baseline measure available for each time-point. A multiple approach was used to account for participants with missing data.

Adjusted means and standard errors at Month 4, 12 and 48 from multiple imputation approach (to account for missing data) followed by analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group and the continuous fixed covariate of baseline LDL-C value, including all available post-baseline data from Month 1 up to Month 48 regardless of status on- or off-treatment.

Outcome measures

Measure	Placebo n=9462 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9462 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis Month 4	4.4 Percent change Standard Error 0.3	-55.8 Percent change Standard Error 0.3
Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis Month 12	8.0 Percent change Standard Error 0.4	-45.7 Percent change Standard Error 0.4
Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis Month 48	16.4 Percent change Standard Error 1.8	-23.5 Percent change Standard Error 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Months 4, 12 and 48

Population: Randomized and treated population. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

Adjusted Least-squares (LS) means and standard errors at Month 4, 12 and 48 were obtained from a mixed-effect model with repeated measures (MMRM) including available post-baseline on-treatment data from Month 1 up to Month 48 (i.e. up to 21 days after last injection).

Outcome measures

Measure	Placebo n=9443 Participants Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab 75 mg Q2W/Up to 150 mg Q2W n=9451 Participants Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis Month 48	14.6 Percent change Standard Error 1.0	-40.1 Percent change Standard Error 1.0
Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis Month 4	4.4 Percent change Standard Error 0.3	-58.3 Percent change Standard Error 0.3
Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis Month 12	8.2 Percent change Standard Error 0.4	-52.8 Percent change Standard Error 0.4

Adverse Events

Placebo

Serious events: 2350 serious events

Other events: 2181 other events

Deaths: 278 deaths

Alirocumab

Serious events: 2202 serious events

Other events: 2203 other events

Deaths: 238 deaths

Serious adverse events

Measure	Placebo n=9443 participants at risk Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab n=9451 participants at risk Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
Gastrointestinal disorders Duodenal Vascular Ectasia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Duodenitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diverticulum Intestinal Haemorrhagic	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Duodenal Obstruction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Anaemia	0.16% 15/9443 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Anaemia Of Chronic Disease	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Anaemia Of Malignant Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Anaemia Vitamin B12 Deficiency	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Autoimmune Haemolytic Anaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Haemolytic Anaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.18% 17/9443 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.15% 14/9451 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Haemorrhagic Diathesis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Hypochromic Anaemia	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Leukopenia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Microcytic Anaemia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Nephrogenic Anaemia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Normochromic Normocytic Anaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Normocytic Anaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Thrombocytopenia	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Blood and lymphatic system disorders Thrombotic Thrombocytopenic Purpura	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Acute Coronary Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Acute Left Ventricular Failure	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Acute Myocardial Infarction	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Adams-Stokes Syndrome	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Angina Pectoris	1.4% 133/9443 • Number of events 148 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	1.2% 113/9451 • Number of events 136 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Angina Unstable	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Aortic Valve Disease Mixed	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Aortic Valve Incompetence	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Aortic Valve Sclerosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Aortic Valve Stenosis	0.18% 17/9443 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Arrhythmia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Arrhythmia Supraventricular	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Arteriosclerosis Coronary Artery	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Arteriospasm Coronary	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrial Fibrillation	1.0% 98/9443 • Number of events 110 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.87% 82/9451 • Number of events 103 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrial Flutter	0.11% 10/9443 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.15% 14/9451 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrial Tachycardia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrioventricular Block	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrioventricular Block Complete	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrioventricular Block First Degree	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Atrioventricular Block Second Degree	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Bradycardia	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Bundle Branch Block Left	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Bundle Branch Block Right	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Aneurysm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Arrest	0.10% 9/9443 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Discomfort	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Failure	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Failure Acute	0.03% 3/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Failure Chronic	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Failure Congestive	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Flutter	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Perforation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiac Tamponade	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardio-Respiratory Arrest	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiogenic Shock	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Cardiomyopathy	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Chordae Tendinae Rupture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Conduction Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Congestive Cardiomyopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Coronary Artery Disease	0.21% 20/9443 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.26% 25/9451 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Coronary Artery Dissection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Coronary Artery Occlusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Coronary Artery Stenosis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Diastolic Dysfunction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Extrasystoles	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Intracardiac Mass	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Intracardiac Thrombus	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ischaemic Cardiomyopathy	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ischaemic Mitral Regurgitation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Left Ventricular Dysfunction	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Low Cardiac Output Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Microvascular Coronary Artery Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Mitral Valve Incompetence	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Mitral Valve Prolapse	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Myocardial Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Myocardial Infarction	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Myocardial Ischaemia	0.14% 13/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Myocardial Rupture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Myocarditis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Nodal Arrhythmia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Nodal Rhythm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Palpitations	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Papillary Muscle Rupture	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Pericardial Effusion	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Pericardial Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Pericarditis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Pleuropericarditis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Prinzmetal Angina	0.01% 1/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Pulseless Electrical Activity	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Rhythm Idioventricular	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Sinus Arrest	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Sinus Arrhythmia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Sinus Bradycardia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Sinus Node Dysfunction	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Sinus Tachycardia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Stress Cardiomyopathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Supraventricular Tachycardia	0.13% 12/9443 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Systolic Dysfunction	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Tachyarrhythmia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Tachycardia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Tricuspid Valve Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ventricular Arrhythmia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ventricular Extrasystoles	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ventricular Fibrillation	0.18% 17/9443 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ventricular Hypokinesia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Cardiac disorders Ventricular Tachycardia	0.31% 29/9443 • Number of events 33 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.25% 24/9451 • Number of events 28 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Atrial Septal Defect	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Bicuspid Aortic Valve	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Bronchogenic Cyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Dermoid Cyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Gastrointestinal Arteriovenous Malformation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Haemorrhagic Arteriovenous Malformation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Hereditary Optic Atrophy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Spinocerebellar Ataxia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Thyroglossal Cyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Congenital, familial and genetic disorders Von Hippel-Lindau Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Acute Vestibular Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Deafness Neurosensory	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Hypoacusis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Sudden Hearing Loss	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Tinnitus	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Tympanic Membrane Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Tympanic Membrane Perforation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Vertigo	0.13% 12/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Vertigo Labyrinthine	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Ear and labyrinth disorders Vertigo Positional	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Adrenal Insufficiency	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Adrenocortical Insufficiency Acute	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Adrenocorticotropic Hormone Deficiency	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Autoimmune Hypothyroidism	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Basedow's Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Goitre	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Hyperthyroidism	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Hypothyroidism	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Inappropriate Antidiuretic Hormone Secretion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Pituitary Cyst	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Thyroid Mass	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Toxic Goitre	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Endocrine disorders Toxic Nodular Goitre	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Amaurosis Fugax	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Blepharochalasis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Cataract	0.14% 13/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Cataract Diabetic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Cataract Subcapsular	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Conjunctival Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Corneal Degeneration	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Diabetic Retinopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Eye Muscle Entrapment	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Glaucoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Macular Degeneration	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Ocular Myasthenia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Optic Ischaemic Neuropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Posterior Capsule Opacification	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Retinal Artery Embolism	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Retinal Artery Occlusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Retinal Detachment	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Retinal Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Retinal Vein Occlusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Ulcerative Keratitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Visual Acuity Reduced	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Vitreous Detachment	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Eye disorders Vitreous Haemorrhage	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Adhesions	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Distension	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Hernia	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Incarcerated Hernia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Pain	0.13% 12/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Pain Upper	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Strangulated Hernia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Abdominal Wall Haematoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Alcoholic Pancreatitis	0.03% 3/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Anal Fissure	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Anal Fistula	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Anal Incontinence	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Anal Polyp	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Aphthous Ulcer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Appendix Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Ascites	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Barrett's Oesophagus	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Bile Acid Malabsorption	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Breath Odour	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Chronic Gastritis	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Colitis	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Colitis Ischaemic	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Colitis Microscopic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Colitis Ulcerative	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Constipation	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Crohn's Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Dental Caries	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diabetic Gastroparesis	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diarrhoea	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diarrhoea Haemorrhagic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Dieulafoy's Vascular Malformation	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diverticular Perforation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diverticulum	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Diverticulum Intestinal	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Duodenal Ulcer	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.10% 9/9443 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Acute Hepatic Failure	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Ampulla Of Vater Stenosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Bile Duct Stenosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Bile Duct Stone	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Biliary Colic	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Biliary Dyskinesia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Biliary Tract Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholangitis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholangitis Acute	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholangitis Sclerosing	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholecystitis	0.15% 14/9443 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholecystitis Acute	0.15% 14/9443 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholecystitis Chronic	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholelithiasis	0.37% 35/9443 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.26% 25/9451 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cholestasis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Chronic Hepatitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Cirrhosis Alcoholic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Drug-Induced Liver Injury	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.16% 15/9451 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Gallbladder Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Gallbladder Necrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Gallbladder Perforation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Cirrhosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Congestion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Failure	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Function Abnormal	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Lesion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Necrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Steatosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatic Vein Dilatation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatitis Acute	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatitis Alcoholic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatitis Chronic Active	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatitis Toxic	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hepatocellular Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Hyperplastic Cholecystopathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Ischaemic Hepatitis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Jaundice Cholestatic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Liver Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Liver Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Hepatobiliary disorders Steatohepatitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Allergy To Arthropod Bite	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Allergy To Arthropod Sting	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Anaphylactic Reaction	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Anaphylactic Shock	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Contrast Media Allergy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Drug Hypersensitivity	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Hypersensitivity	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Immune system disorders Iodine Allergy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Abdominal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Abdominal Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Abdominal Sepsis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Abdominal Wall Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Abscess Limb	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Acute Endocarditis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Acute Hepatitis C	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Anal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Appendiceal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Appendicitis	0.11% 10/9443 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Appendicitis Perforated	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Arthritis Bacterial	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Atypical Pneumonia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bacteraemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bacterial Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bacterial Prostatitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bacterial Sepsis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Biliary Sepsis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bone Tuberculosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Borrelia Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Breast Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Breast Cellulitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bronchiolitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bronchitis	0.18% 17/9443 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.17% 16/9451 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bronchitis Bacterial	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bronchitis Viral	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Brucellosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Bursitis Infective	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Campylobacter Gastroenteritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Candida Sepsis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cellulitis	0.39% 37/9443 • Number of events 40 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.34% 32/9451 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cellulitis Of Male External Genital Organ	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cellulitis Staphylococcal	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cholangitis Infective	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cholecystitis Infective	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Chronic Sinusitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Citrobacter Sepsis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Clostridium Difficile Colitis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cutaneous Tuberculosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cystitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Cytomegalovirus Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Dengue Fever	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Dermo-Hypodermitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Device Related Infection	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Diabetic Foot Infection	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Diabetic Gangrene	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Diverticulitis	0.11% 10/9443 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Diverticulitis Intestinal Haemorrhagic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Encephalitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Endocarditis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Enterobacter Bacteraemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Enterococcal Bacteraemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Enterococcal Sepsis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Enterocolitis Bacterial	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Enterocolitis Infectious	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Epididymitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Erysipelas	0.08% 8/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Escherichia Pyelonephritis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Escherichia Sepsis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Escherichia Urinary Tract Infection	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations External Ear Cellulitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Extradural Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gallbladder Empyema	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gangrene	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gastric Ulcer Helicobacter	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gastritis Viral	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gastroenteritis	0.26% 25/9443 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.28% 26/9451 • Number of events 31 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gastroenteritis Bacterial	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gastroenteritis Salmonella	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Hantaviral Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Gastroenteritis Viral	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Graft Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Groin Abscess	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Haemophilus Sepsis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Helicobacter Gastritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Hepatic Amoebiasis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Hepatic Infection Bacterial	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Hepatitis C	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Herpes Virus Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Herpes Zoster	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Iatrogenic Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Implant Site Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infected Bite	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infected Cyst	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infected Skin Ulcer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infectious Colitis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infectious Pleural Effusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Infective Exacerbation Of Chronic Obstructive Airways Disease	0.07% 7/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Influenza	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Injection Site Cellulitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Klebsiella Bacteraemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Labyrinthitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Laryngitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Latent Tuberculosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Liver Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Localised Infection	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Lower Respiratory Tract Infection	0.11% 10/9443 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Ludwig Angina	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Lung Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Lung Infection	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Lyme Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Mastitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Mastoiditis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Mediastinitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Medical Device Site Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Meningitis Aseptic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Meningoencephalitis Bacterial	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Necrotising Fasciitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Neutropenic Sepsis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Ophthalmic Herpes Zoster	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Oral Herpes	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Orchitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Osteomyelitis	0.08% 8/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Osteomyelitis Acute	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Osteomyelitis Chronic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Otitis Externa	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Otitis Media	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Otitis Media Acute	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pancreas Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pelvic Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pelvic Inflammatory Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Perichondritis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Perihepatic Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Perineal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Periodontitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Periorbital Cellulitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Perirectal Abscess	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Peritoneal Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Peritonitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Peritonsillar Abscess	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pharyngitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pharyngolaryngeal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pilonidal Cyst	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pleurisy Viral	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia	1.1% 108/9443 • Number of events 123 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	1.0% 96/9451 • Number of events 98 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Bacterial	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Chlamydial	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Escherichia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Haemophilus	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Influenzal	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Klebsiella	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Legionella	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Mycoplasmal	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Pneumococcal	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Staphylococcal	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Streptococcal	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pneumonia Viral	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Post Procedural Cellulitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Post Procedural Infection	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Post Procedural Pneumonia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Post Procedural Sepsis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Post Viral Fatigue Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Postoperative Wound Infection	0.14% 13/9443 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Proctitis Bacterial	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pseudomembranous Colitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pseudomonal Bacteraemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pseudomonal Sepsis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Psoas Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pulmonary Sepsis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pulmonary Tuberculosis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Respiratory Syncytial Virus Infection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pyelonephritis	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pyelonephritis Acute	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Pyelonephritis Chronic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Renal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Respiratory Tract Infection	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Scrotal Abscess	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Scrub Typhus	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Sepsis	0.37% 35/9443 • Number of events 38 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.21% 20/9451 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Septic Shock	0.13% 12/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Sinusitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Sinusitis Bacterial	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Staphylococcal Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Staphylococcal Bacteraemia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Staphylococcal Osteomyelitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Staphylococcal Sepsis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Streptococcal Bacteraemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Streptococcal Endocarditis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Streptococcal Sepsis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Subcutaneous Abscess	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Systemic Infection	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Tonsillitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Tooth Abscess	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Toxic Shock Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Tracheitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Tracheobronchitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Tuberculosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Tuberculous Pleurisy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Upper Respiratory Tract Infection	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Urethritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Urinary Tract Infection	0.35% 33/9443 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.29% 27/9451 • Number of events 28 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Urinary Tract Infection Bacterial	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Urinary Tract Infection Enterococcal	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Urinary Tract Infection Staphylococcal	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Urosepsis	0.11% 10/9443 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.17% 16/9451 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Vestibular Neuronitis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Viral Cardiomyopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Viral Infection	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Viral Labyrinthitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Viral Myocarditis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Viral Pericarditis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Viral Upper Respiratory Tract Infection	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Visceral Leishmaniasis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Vulval Abscess	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Vulvovaginal Candidiasis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Wound Infection	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Wound Infection Staphylococcal	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Abdominal Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Accidental Overdose	0.10% 9/9443 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Acetabulum Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Alcohol Poisoning	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Allergic Transfusion Reaction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Anaemia Postoperative	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Anaesthetic Complication Neurological	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Anastomotic Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Ankle Fracture	0.08% 8/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Aortic Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Arterial Bypass Thrombosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Arterial Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Arthropod Sting	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Auricular Haematoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Blast Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Bone Contusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Brachial Plexus Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Brain Contusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Brain Herniation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Carbon Monoxide Poisoning	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Cardiac Contusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Cardiac Valve Replacement Complication	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Chemical Burn Of Gastrointestinal Tract	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Chest Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Clavicle Fracture	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Concussion	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Confusion Postoperative	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Contusion	0.04% 4/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Coronary Artery Restenosis	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Craniocerebral Injury	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Delayed Recovery From Anaesthesia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Electric Shock	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Extra-Axial Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Extradural Haematoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Eye Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Face Injury	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Facial Bones Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Fall	0.34% 32/9443 • Number of events 34 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.28% 26/9451 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Femur Fracture	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Fibula Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Foot Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Forearm Fracture	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Foreign Body In Urogenital Tract	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Fracture Displacement	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Fractured Skull Depressed	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Gastrointestinal Stoma Necrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Gun Shot Wound	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Hand Fracture	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Head Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Heat Stroke	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Hip Fracture	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Humerus Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Hyphaema	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Incision Site Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Incisional Hernia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Injury	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Intentional Overdose	0.08% 8/9443 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Jaw Fracture	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Joint Dislocation	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Joint Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Laceration	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Ligament Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Ligament Rupture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Ligament Sprain	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Limb Crushing Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Limb Injury	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Lip Injury	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Lower Limb Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Mallet Finger	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Meniscus Injury	0.03% 3/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Multiple Injuries	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Muscle Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Muscle Rupture	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Muscle Strain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Nerve Root Injury Lumbar	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Oesophageal Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Penetrating Abdominal Trauma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Periorbital Haematoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Periprosthetic Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Perirenal Haematoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Pneumothorax Traumatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Concussion Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Laminectomy Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Bile Leak	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Fistula	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Haematuria	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Inflammation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Pulmonary Embolism	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post Procedural Swelling	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Post-Traumatic Pain	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Postoperative Ileus	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Postoperative Renal Failure	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Postoperative Respiratory Failure	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Postoperative Thoracic Procedure Complication	0.04% 4/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Postoperative Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Postpericardiotomy Syndrome	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Procedural Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Procedural Hypertension	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Procedural Hypotension	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Procedural Intestinal Perforation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Procedural Pain	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Procedural Pneumothorax	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Pubis Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Pulmonary Contusion	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Radiation Associated Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Duodenitis Haemorrhagic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Dyspepsia	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Dysphagia	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Enteritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Enterocolitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Enterocolitis Haemorrhagic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Erosive Duodenitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Erosive Oesophagitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Faecaloma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Femoral Hernia, Obstructive	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Fistula Of Small Intestine	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Food Poisoning	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Functional Gastrointestinal Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastric Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastric Polyps	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastric Ulcer	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.12% 11/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.15% 14/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastric Ulcer, Obstructive	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastritis	0.18% 17/9443 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastritis Erosive	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastritis Haemorrhagic	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastroduodenitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastroduodenitis Haemorrhagic	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Angiectasia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Angiodysplasia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Angiodysplasia Haemorrhagic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.14% 13/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Inflammation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Mucosal Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Pain	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Polyp Haemorrhage	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Ulcer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrointestinal Ulcer Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.20% 19/9443 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.22% 21/9451 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Gingival Bleeding	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Haematemesis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Haematochezia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Haemorrhagic Erosive Gastritis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Haemorrhoids	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Hiatus Hernia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Hiatus Hernia Strangulated	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Ileal Perforation	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Ileus	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Ileus Paralytic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Incarcerated Hiatus Hernia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Incarcerated Inguinal Hernia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Incarcerated Umbilical Hernia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Inguinal Hernia	0.16% 15/9443 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.31% 29/9451 • Number of events 29 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Intestinal Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Intestinal Infarction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Intestinal Ischaemia	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Intestinal Obstruction	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Intestinal Perforation	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Irritable Bowel Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Large Intestinal Obstruction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Large Intestinal Ulcer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Large Intestine Perforation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Large Intestine Polyp	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Lumbar Hernia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Mallory-Weiss Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Megacolon	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Melaena	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Mesenteric Artery Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Mesenteric Panniculitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Nausea	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Obstruction Gastric	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Obstructive Pancreatitis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Odynophagia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oedematous Pancreatitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Achalasia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Rupture	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Spasm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Stenosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Ulcer Haemorrhage	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophageal Varices Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophagitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Oesophagitis Haemorrhagic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatic Failure	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatic Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatic Pseudocyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatitis	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatitis Acute	0.17% 16/9443 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.16% 15/9451 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatitis Chronic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Pancreatitis Necrotising	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Peptic Ulcer	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Peptic Ulcer Haemorrhage	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Periodontal Disease	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Peritoneal Cyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Peritoneal Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Rectal Haemorrhage	0.04% 4/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Rectal Prolapse	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Rectal Ulcer Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Retroperitoneal Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Salivary Duct Obstruction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Salivary Gland Calculus	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Small Intestinal Obstruction	0.04% 4/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Small Intestinal Perforation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Small Intestinal Ulcer Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Swollen Tongue	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Tongue Haematoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Toothache	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Umbilical Hernia	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Umbilical Hernia, Obstructive	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.07% 7/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Varices Oesophageal	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Gastrointestinal disorders Vomiting	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Asthenia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Chest Discomfort	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Chest Pain	0.31% 29/9443 • Number of events 32 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.26% 25/9451 • Number of events 27 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Death	0.35% 33/9443 • Number of events 33 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.26% 25/9451 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Device Related Thrombosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Exercise Tolerance Decreased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Facial Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Fatigue	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Gait Disturbance	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders General Physical Health Deterioration	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Granuloma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Impaired Healing	0.03% 3/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Implant Site Haematoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Implant Site Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Incarcerated Hernia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Influenza Like Illness	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Injection Site Reaction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Malaise	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Medical Device Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Medical Device Site Dermatitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Medical Device Site Joint Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Medical Device Site Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Multiple Organ Dysfunction Syndrome	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Non-Cardiac Chest Pain	2.4% 222/9443 • Number of events 256 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	2.3% 219/9451 • Number of events 264 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Oedema Peripheral	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Pacemaker Generated Arrhythmia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Pelvic Mass	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Peripheral Swelling	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Pyrexia	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Soft Tissue Inflammation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Strangulated Hernia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Sudden Cardiac Death	0.44% 42/9443 • Number of events 42 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.38% 36/9451 • Number of events 36 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Sudden Death	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.15% 14/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Systemic Inflammatory Response Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Vascular Stent Restenosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Vascular Stent Thrombosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Vessel Puncture Site Haematoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
General disorders Vessel Puncture Site Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Radiation Skin Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Radius Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Product Issues Device Malfunction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Rib Fracture	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Road Traffic Accident	0.20% 19/9443 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.15% 14/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Scapula Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Scrotal Haematoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Seroma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Silicosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Skin Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Skull Fracture	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Soft Tissue Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Spinal Cord Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Spinal Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Splenic Rupture	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Stab Wound	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Sternal Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Stoma Site Discharge	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Stomal Hernia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Subarachnoid Haemorrhage	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Subdural Haematoma	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Tendon Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Tendon Rupture	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Thermal Burn	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Tibia Fracture	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Tooth Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Tracheostomy Malfunction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Traumatic Haematoma	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Traumatic Haemothorax	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Traumatic Intracranial Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Traumatic Liver Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Traumatic Renal Injury	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Traumatic Ulcer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Ulna Fracture	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Upper Limb Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Urinary Retention Postoperative	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Vascular Access Site Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Vascular Access Site Pseudoaneurysm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Product Issues Device Occlusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm Ruptured	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Wound	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Wound Dehiscence	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Injury, poisoning and procedural complications Wrist Fracture	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Alanine Aminotransferase Increased	0.12% 11/9443 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Anticoagulation Drug Level Above Therapeutic	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Calcium Increased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Creatine Phosphokinase Mb Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Creatine Phosphokinase Increased	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Creatinine Increased	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Potassium Increased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Pressure Increased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Brain Natriuretic Peptide Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations C-Reactive Protein Increased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Cardiac Stress Test Abnormal	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Ejection Fraction Decreased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Electrocardiogram Qt Prolonged	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Exercise Electrocardiogram Abnormal	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Glomerular Filtration Rate Decreased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Hiv Test Positive	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Haematocrit Decreased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Haematocrit Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Haemoglobin Decreased	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Hepatic Enzyme Abnormal	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Hepatic Enzyme Increased	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Hepatitis C Virus Test Positive	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Human Papilloma Virus Test Positive	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Influenza A Virus Test Positive	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations International Normalised Ratio Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Liver Function Test Abnormal	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Liver Function Test Increased	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Mycobacterium Tuberculosis Complex Test Positive	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Scan Myocardial Perfusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Transaminases Increased	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Troponin Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Tumour Marker Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Weight Decreased	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations White Blood Cell Count Increased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Dehydration	0.14% 13/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Diabetes Mellitus	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.17% 16/9443 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.21% 20/9451 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Diabetic Complication	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.10% 9/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Diabetic Ketosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Fluid Overload	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Fluid Retention	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Gout	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypercalcaemia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyperglycaemia	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyperglycaemic Hyperosmolar Nonketotic Syndrome	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyperinsulinaemic Hypoglycaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyperkalaemia	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypoglycaemia	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypokalaemia	0.11% 10/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypomagnesaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hyponatraemia	0.08% 8/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Hypovolaemia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Lactic Acidosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Metabolic Acidosis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Metabolic Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Metabolic Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Obesity	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Type 1 Diabetes Mellitus	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.38% 36/9443 • Number of events 36 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.39% 37/9451 • Number of events 37 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Ankylosing Spondylitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Product Issues Lead Dislodgement	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Back Pain	0.11% 10/9443 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Bone Cyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Bursitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Costochondritis	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Femoroacetabular Impingement	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Product Issues Thrombosis In Device	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Foot Deformity	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.22% 21/9443 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.22% 21/9451 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Joint Instability	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Meniscal Degeneration	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Muscle Necrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.03% 3/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Muscle Tightness	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Acute Psychosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.37% 35/9443 • Number of events 44 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.25% 24/9451 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.04% 4/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Myalgia	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Myopathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Myositis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Neuropathic Arthropathy	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Osteitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.49% 46/9443 • Number of events 51 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.53% 50/9451 • Number of events 54 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Osteopenia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Osteoporotic Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Periarthritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Rheumatic Fever	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Delirium Tremens	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Spinal Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Spinal Ligament Ossification	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Spinal Pain	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Sympathetic Posterior Cervical Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Synovial Cyst	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Systemic Lupus Erythematosus	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Vertebral Foraminal Stenosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Lymphocytic Leukaemia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Gastric	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of Colon	0.15% 14/9443 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Adenoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Neoplasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Squamous Cell Carcinoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic Large Cell Lymphoma T- And Null-Cell Types	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Small Lymphocytic Lymphoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.15% 14/9443 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Ovarian Tumour	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Salivary Gland Neoplasm	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Stage Iv	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Papilloma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.10% 9/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Benign	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Stage I	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Stage Ii	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Stage Iii	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid Tumour Of The Appendix	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Adjustment Disorder With Mixed Disturbance Of Emotion And Conduct	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid Tumour Pulmonary	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac Myxoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac Valve Fibroelastoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebellar Tumour	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma Stage Ii	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myeloid Leukaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Affective Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myelomonocytic Leukaemia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear Cell Renal Cell Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Stage Iii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Adenocarcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Stage Iii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Agoraphobia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal Adenocarcinoma Of Pancreas	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Adenocarcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Stromal Tumour	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Tract Adenoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma Of Bone	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair Follicle Tumour Benign	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease Stage Iv	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Alcohol Abuse	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory Pseudotumour	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Proliferative Breast Lesion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Lobular Breast Carcinoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Cell Lung Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Cell Lung Cancer Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer Stage I	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Squamous Cell Carcinoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo Maligna	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Squamous Cell Carcinoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage I	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage Ii	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage I	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage Iii	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage Iv	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Stage I	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Stage Ii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Anorectal Neoplasm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Ascites	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Glioma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma In Situ	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma Stage I	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Alcoholic Psychosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma Stage Iv	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Palate Neoplasm	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Pleural Effusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Sweat Gland Neoplasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Bone	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Central Nervous System	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Alcoholism	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Liver	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lung	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lymph Nodes	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Peritoneum	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Spine	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Anger	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Bronchial Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Carcinoma Of The Bladder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Gastric Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Anxiety	0.05% 5/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Malignant Melanoma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Renal Cell Carcinoma	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Squamous Cell Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal Gammopathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucinous Cystadenocarcinoma Ovary	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Anxiety Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative Neoplasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal Cavity Cancer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour Of The Lung	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour Of The Lung Metastatic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Bipolar I Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma Recurrent	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Bipolar Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Borderline Personality Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Bradyphrenia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal Cancer Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal Squamous Cell Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neuroendocrine Tumour	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid Tumour Benign	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile Cancer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritoneal Mesothelioma Malignant	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Catatonia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Leukaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural Mesothelioma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia Vera	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.18% 17/9443 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.19% 18/9451 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Stage I	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Stage Ii	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Stage Iii	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Stage Iv	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic Adenoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Neoplasm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid Cancer Stage Ii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer Metastatic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma Stage I	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma Stage Ii	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma Stage Iii	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Oncocytoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Cancer Stage Iv	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic Keratosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal Papilloma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinus Cancer Metastatic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Completed Suicide	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Limited Stage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Lung	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Cervix	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Hypopharynx	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Tongue	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Confusional State	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Vulva	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Synovial Sarcoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Carcinoma Stage Iv	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Cancer Of Renal Pelvis And Ureter Metastatic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary Bladder Sarcoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Conversion Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vocal Cord Neoplasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval Cancer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Delirium	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval Cancer Metastatic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Alcoholic Seizure	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Amnesia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Amyotrophic Lateral Sclerosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Aphasia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Ataxia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Autonomic Nervous System Imbalance	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Axonal Neuropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Balance Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Brain Injury	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Brain Oedema	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carotid Arteriosclerosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carotid Artery Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carotid Artery Occlusion	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carotid Artery Stenosis	0.20% 19/9443 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.15% 14/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carotid Artery Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carotid Sinus Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Carpal Tunnel Syndrome	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cauda Equina Syndrome	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cerebral Atrophy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cerebral Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cerebral Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cerebral Ischaemia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cerebrospinal Fistula	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cerebrovascular Accident	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cervical Radiculopathy	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Chronic Inflammatory Demyelinating Polyradiculoneuropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cognitive Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Coma	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Coordination Abnormal	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Cubital Tunnel Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Dementia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Dementia Alzheimer's Type	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Demyelinating Polyneuropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Depressed Level Of Consciousness	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Diabetic Encephalopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Diabetic Neuropathy	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Dizziness	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Dizziness Exertional	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Dysarthria	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Encephalopathy	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Epilepsy	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Epileptic Encephalopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Essential Tremor	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Extrapyramidal Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Facial Paralysis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Focal Dyscognitive Seizures	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Generalised Tonic-Clonic Seizure	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Haemorrhage Intracranial	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Haemorrhagic Stroke	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Headache	0.07% 7/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hemianopia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hemiparesis	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hemiplegia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hyperaesthesia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hyperglycaemic Seizure	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hypoaesthesia	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hypoglycaemic Seizure	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hyponatraemic Seizure	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Intercostal Neuralgia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Intracranial Aneurysm	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Intracranial Mass	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Intracranial Venous Sinus Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Intraventricular Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Ischaemic Stroke	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Limbic Encephalitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Loss Of Consciousness	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Lumbar Radiculopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Lumbosacral Radiculopathy	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Memory Impairment	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Metabolic Encephalopathy	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Migraine	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Migraine With Aura	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Mixed Dementia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Monoparesis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Multiple Sclerosis Relapse	0.02% 2/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Myelopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Myoclonus	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Nerve Compression	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Neuralgia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Neuromuscular Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Neuropathy Peripheral	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Occipital Neuralgia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Paraesthesia	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Paralysis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Parkinson's Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Parkinsonism	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Partial Seizures With Secondary Generalisation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Peripheral Nerve Lesion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Petit Mal Epilepsy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Polyneuropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Posterior Reversible Encephalopathy Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Postictal Paralysis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Presyncope	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Pyramidal Tract Syndrome	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Radial Nerve Palsy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Radicular Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Radiculopathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Ruptured Cerebral Aneurysm	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Sciatica	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Seizure	0.07% 7/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Sensory Loss	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Spinal Cord Compression	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Spondylitic Myelopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Status Epilepticus	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Syncope	0.77% 73/9443 • Number of events 82 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.71% 67/9451 • Number of events 73 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Toxic Encephalopathy	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Transient Global Amnesia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Transient Ischaemic Attack	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Tremor	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Trigeminal Neuralgia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Ulnar Neuritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Ulnar Tunnel Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Vith Nerve Paralysis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Vith Nerve Paresis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Vascular Encephalopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Vertebral Artery Occlusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Vertebrobasilar Insufficiency	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Nervous system disorders Vertigo Cns Origin	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Product Issues Device Dislocation	0.01% 1/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Product Issues Device Lead Damage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.03% 3/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Choking	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.54% 51/9443 • Number of events 76 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.40% 38/9451 • Number of events 47 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Chronic Respiratory Failure	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Cough	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.13% 12/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.21% 20/9451 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.13% 12/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Idiopathic Pulmonary Fibrosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Laryngeal Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Laryngeal Oedema	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Nasal Mucosal Ulcer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Nasal Obstruction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Nasal Turbinate Hypertrophy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.08% 8/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Alveolar Haemorrhage	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Calcification	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.20% 19/9443 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.17% 16/9451 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Infarction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.05% 5/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.16% 15/9443 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Oedema	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Tonsillolith	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Vocal Cord Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Vocal Cord Polyp	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Wheezing	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Angioedema	0.07% 7/9443 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermal Cyst	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatitis Bullous	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatitis Exfoliative Generalised	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Dermatomyositis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Diabetic Foot	0.12% 11/9443 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Diabetic Neuropathic Ulcer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Diabetic Ulcer	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Drug Reaction With Eosinophilia And Systemic Symptoms	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Eczema Nummular	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Erythrodermic Psoriasis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Pruritus Allergic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Rash	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Scar Pain	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Skin Lesion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Skin Ulcer	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Swelling Face	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Urticaria	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Urticaria Chronic	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Skin and subcutaneous tissue disorders Vascular Purpura	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Social circumstances Physical Assault	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Accelerated Hypertension	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aortic Aneurysm	0.13% 12/9443 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aortic Aneurysm Rupture	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aortic Dissection	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aortic Intramural Haematoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aortic Stenosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aortic Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Aorto-Duodenal Fistula	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Arterial Insufficiency	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Arteriosclerosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Arteriovenous Fistula	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Blood Pressure Inadequately Controlled	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Circulatory Collapse	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Deep Vein Thrombosis	0.08% 8/9443 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.12% 11/9451 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Dry Gangrene	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Embolism	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Embolism Venous	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Essential Hypertension	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Extremity Necrosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Haematoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hot Flush	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hypertension	0.38% 36/9443 • Number of events 41 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.36% 34/9451 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hypertensive Crisis	0.18% 17/9443 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.22% 21/9451 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hypertensive Emergency	0.04% 4/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hypotension	0.18% 17/9443 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.17% 16/9451 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hypovolaemic Shock	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Iliac Artery Embolism	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Iliac Artery Occlusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Intermittent Claudication	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Ischaemic Limb Pain	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Leriche Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Lymphatic Fistula	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Lymphoedema	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Lymphorrhoea	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Malignant Hypertension	0.03% 3/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Orthostatic Hypotension	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Penetrating Aortic Ulcer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Arterial Occlusive Disease	0.50% 47/9443 • Number of events 49 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.29% 27/9451 • Number of events 29 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Artery Aneurysm	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Artery Dissection	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Artery Occlusion	0.14% 13/9443 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Artery Stenosis	0.08% 8/9443 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Artery Thrombosis	0.04% 4/9443 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Embolism	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Ischaemia	0.21% 20/9443 • Number of events 23 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Vascular Disorder	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Peripheral Venous Disease	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Phlebitis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Phlebitis Superficial	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Raynaud's Phenomenon	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Renovascular Hypertension	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Shock	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Shock Haemorrhagic	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Subclavian Artery Occlusion	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Subclavian Artery Stenosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Superior Vena Cava Occlusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Temporal Arteritis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Thrombophlebitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Thrombophlebitis Superficial	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Varicose Vein	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Venous Thrombosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Venous Thrombosis Limb	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Delusional Disorder, Unspecified Type	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Depression	0.26% 25/9443 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Depression Suicidal	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Drug Abuse	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Factitious Disorder	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Hallucination	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Homicidal Ideation	0.01% 1/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Insomnia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Major Depression	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Mental Status Changes	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Mood Disorder Due To A General Medical Condition	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Panic Attack	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Post-Traumatic Stress Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Sleep Disorder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Suicidal Behaviour	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Suicidal Ideation	0.08% 8/9443 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.07% 7/9451 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Suicide Attempt	0.15% 14/9443 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.05% 5/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Psychiatric disorders Transient Psychosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Acute Kidney Injury	0.66% 62/9443 • Number of events 74 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.60% 57/9451 • Number of events 59 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Acute Prerenal Failure	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Bladder Dilatation	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Bladder Outlet Obstruction	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Bladder Perforation	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Bladder Tamponade	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Calculus Bladder	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Calculus Urinary	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Chronic Kidney Disease	0.16% 15/9443 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.14% 13/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Cystitis Glandularis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Cystitis Interstitial	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Cystitis Noninfective	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Diabetic Cystopathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders End Stage Renal Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Glomerulonephritis Proliferative	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Glomerulonephropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Haematuria	0.14% 13/9443 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.10% 9/9451 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Hydronephrosis	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Hypertensive Nephropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Iga Nephropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Lower Urinary Tract Symptoms	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Nephrolithiasis	0.22% 21/9443 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.16% 15/9451 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Nephropathy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Nephropathy Toxic	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Nephrosclerosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Nephrotic Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Pelvi-Ureteric Obstruction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Postrenal Failure	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Artery Occlusion	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Artery Stenosis	0.04% 4/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Colic	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Cyst	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Cyst Haemorrhage	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Failure	0.06% 6/9443 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.08% 8/9451 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Haematoma	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Impairment	0.02% 2/9443 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Infarct	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Mass	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Pain	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Tubular Disorder	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Tubular Necrosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Renal Vein Thrombosis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Stress Urinary Incontinence	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Tubulointerstitial Nephritis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Ureteral Disorder	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Ureteric Stenosis	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Ureterolithiasis	0.16% 15/9443 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.13% 12/9451 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urethral Stenosis	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.04% 4/9451 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urinary Bladder Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urinary Bladder Rupture	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urinary Incontinence	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urinary Retention	0.03% 3/9443 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urinary Tract Obstruction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urinoma	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Renal and urinary disorders Urogenital Fistula	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Acquired Hydrocele	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Acquired Phimosis	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.14% 13/9443 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.17% 16/9451 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Breast Mass	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Breast Pain	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Dysfunctional Uterine Bleeding	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Endometrial Hyperplasia	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Erectile Dysfunction	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Menorrhagia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Ovarian Cyst	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Peyronie's Disease	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Prostatitis	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.03% 3/9451 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Rectocele	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Scrotal Ulcer	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Spermatocele	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Testicular Cyst	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Uterine Haemorrhage	0.02% 2/9443 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Uterine Polyp	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Uterine Prolapse	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Uterovaginal Prolapse	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Vaginal Dysplasia	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Vaginal Haemorrhage	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Vaginal Prolapse	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Varicocele	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Reproductive system and breast disorders Vulva Cyst	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Acquired Diaphragmatic Eventration	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.11% 10/9443 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.06% 6/9451 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.02% 2/9451 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.25% 24/9443 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.20% 19/9451 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Adenoidal Hypertrophy	0.01% 1/9443 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.00% 0/9451 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/9443 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.01% 1/9451 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 6/9443 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	0.11% 10/9451 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.

Other adverse events

Measure	Placebo n=9443 participants at risk Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.	Alirocumab n=9451 participants at risk Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).
General disorders Non-Cardiac Chest Pain	4.9% 462/9443 • Number of events 556 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	5.1% 481/9451 • Number of events 591 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Infections and infestations Nasopharyngitis	5.6% 532/9443 • Number of events 697 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	6.0% 567/9451 • Number of events 713 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Investigations Blood Creatine Phosphokinase Increased	5.2% 488/9443 • Number of events 560 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	4.8% 457/9451 • Number of events 521 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 496/9443 • Number of events 563 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	5.5% 522/9451 • Number of events 591 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
Vascular disorders Hypertension	6.1% 574/9443 • Number of events 678 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.	5.7% 542/9451 • Number of events 600 • All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized participants who actually received at least 1 dose or part of a dose of the double-blind IMP injection.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER