Trial Outcomes & Findings for A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor) (NCT NCT04435366)

NCT ID: NCT04435366

Last Updated: 2025-10-21

Results Overview

GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean \& SE were based on square-root transformation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 448 participants
• Primary outcome timeframe: Baseline to month 12
• Results posted on: 2025-10-21

Participant Flow

Participants ≥ 50 years of age diagnosed with geographic atrophy (GA) that was at least partly within 1.5 mm radius from the foveal center were enrolled in the study.

Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.

Participant milestones

Measure	Avacincaptad Pegol Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Avacincaptad Pegol and Sham Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT every other month (EOM) at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Year 1 (12 Months) STARTED	225	0	223
Year 1 (12 Months) Treated	225	0	222
Year 1 (12 Months) COMPLETED	200	0	205
Year 1 (12 Months) NOT COMPLETED	25	0	18
Year 2 (12 Months) STARTED	96	93	203
Year 2 (12 Months) COMPLETED	89	83	184
Year 2 (12 Months) NOT COMPLETED	7	10	19

Reasons for withdrawal

Measure	Avacincaptad Pegol Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Avacincaptad Pegol and Sham Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT every other month (EOM) at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Year 1 (12 Months) Adverse Event	3	0	2
Year 1 (12 Months) Death	2	0	1
Year 1 (12 Months) Lost to Follow-up	2	0	1
Year 1 (12 Months) Withdrawal by Subject	17	0	13
Year 1 (12 Months) Patient non-compliance	1	0	0
Year 1 (12 Months) Not treated	0	0	1
Year 2 (12 Months) Death	1	4	6
Year 2 (12 Months) Lost to Follow-up	0	2	0
Year 2 (12 Months) Withdrawal by Subject	4	3	7
Year 2 (12 Months) Adverse Event	2	1	6

Baseline Characteristics

A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

Baseline characteristics by cohort

Measure	Avacincaptad Pegol n=225 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly or ACP 2 mg/eye via IVT injections EOM at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Total n=447 Participants Total of all reporting groups
Age, Continuous	76.3 Years STANDARD_DEVIATION 8.6 • n=5 Participants	76.7 Years STANDARD_DEVIATION 8.8 • n=7 Participants	76.5 Years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	154 Participants n=5 Participants	156 Participants n=7 Participants	310 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	66 Participants n=7 Participants	137 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	178 Participants n=7 Participants	346 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	182 Participants n=5 Participants	186 Participants n=7 Participants	368 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	41 Participants n=5 Participants	34 Participants n=7 Participants	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to month 12

Population: ITT analysis set

GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean & SE were based on square-root transformation.

Outcome measures

Measure	Avacincaptad Pegol n=225 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12	0.336 millimeters (mm)/year Standard Error 0.032	0.392 millimeters (mm)/year Standard Error 0.033	—

PRIMARY outcome

Timeframe: Baseline to month 24

Population: Re-rand analysis set-The subset of the ITT analysis set who were re-randomized at Month 12 and who were on sham and completed the Month 12 visit.

GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean & SE were based on untransformed data.

Outcome measures

Measure	Avacincaptad Pegol n=96 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=93 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24	2.23 mm^2/year Standard Error 0.124	2.10 mm^2/year Standard Error 0.126	2.59 mm^2/year Standard Error 0.085

SECONDARY outcome

Timeframe: Baseline and month 24

Population: ITT analysis set

BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS Visual Acuity Score (VAS) is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

Outcome measures

Measure	Avacincaptad Pegol n=225 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months	-7.31 score on a scale Standard Error 1.07	-6.48 score on a scale Standard Error 1.05	—

SECONDARY outcome

Timeframe: Baseline and month 24

Population: ITT analysis set

BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. LL BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart.

Outcome measures

Measure	Avacincaptad Pegol n=225 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months	-10.58 score on a scale Standard Error 1.20	-9.1 score on a scale Standard Error 1.18	—

SECONDARY outcome

Timeframe: Baseline, months 6, 12, and 18

Population: ITT analysis set with available data was analyzed

The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.

Outcome measures

Measure	Avacincaptad Pegol n=206 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=215 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months Change at 6 months	-1.2 score on a scale Standard Deviation 10.56	-1.6 score on a scale Standard Deviation 9.98	—
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months Change at 12 months	-3.4 score on a scale Standard Deviation 11.05	-3.6 score on a scale Standard Deviation 11.01	—
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months Change at 18 months	-5.4 score on a scale Standard Deviation 12.80	-4.7 score on a scale Standard Deviation 11.53	—

SECONDARY outcome

Timeframe: Baseline and month 24

Population: ITT analysis

The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.

Outcome measures

Measure	Avacincaptad Pegol n=225 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months	-7.735 score on a scale Standard Error 0.950	-7.023 score on a scale Standard Error 0.931	—

SECONDARY outcome

Timeframe: Baseline up to month 24

Population: ITT analysis set with available data was analyzed

The National Eye Institute VFQ-25 measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively.Categorical one-level loss in each item was defined as decline of one or more levels at Month 24 on the original scale from Baseline (equivalently 20 points for general vision and 25 points for other vision items in a 0 to 100 scale).

Outcome measures

Measure	Avacincaptad Pegol n=175 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=182 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Color Vision	45 participants	35 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Distance Vision	56 participants	43 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Near Vision	61 participants	49 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Peripheral Vision	58 participants	65 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale General Vision	58 participants	58 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Dependency	55 participants	55 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Driving	27 participants	26 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale General Health	45 participants	67 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Mental Health	35 participants	42 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Ocular Pain	27 participants	20 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Role Difficulties	60 participants	59 participants	—
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale Social Function	52 participants	52 participants	—

SECONDARY outcome

Timeframe: Baseline up to month 24

Population: ITT analysis set

Vision loss event was defined as a loss of ≥ 15 letters (equivalent to a loss of 3 lines on the ETDRS chart) in BCVA from Baseline measured at any two or more consecutive visits up to Month 24. These parameters were chosen as a 3-line BCVA loss (equivalent to doubling of visual angle) is widely recognized as a significant deterioration in vision and a minimum of two consecutive visits was representative of persistent disease progression. BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS was defined as the number of letters read on the ETDRS chart. Min and max possible scores are 0-100. A higher score represents better visual functioning. Kaplan-Meier method was used for analysis. Participants with an event were reported and not the median time to event.

Outcome measures

Measure	Avacincaptad Pegol n=225 Participants Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.	Sham n=222 Participants Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Time to Persistent Vision Loss	17.02 months Interval 2.8 to 23.0	13.93 months Interval 1.3 to 23.2	—

Adverse Events

Avacincaptad Pegol Only (up to 12 Months)

Serious events: 31 serious events

Other events: 100 other events

Deaths: 4 deaths

Avacincaptad Pegol Only (12 to 24 Months)

Serious events: 18 serious events

Other events: 51 other events

Deaths: 1 deaths

Avacincaptad Pegol and Sham Only (12 to 24 Months)

Serious events: 16 serious events

Other events: 41 other events

Deaths: 4 deaths

Sham Only (up to 12 Months)

Serious events: 36 serious events

Other events: 83 other events

Deaths: 1 deaths

Sham Only (12 to 24 Months)

Serious events: 25 serious events

Other events: 77 other events

Deaths: 7 deaths

Serious adverse events

Measure	Avacincaptad Pegol Only (up to 12 Months) n=225 participants at risk Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1).	Avacincaptad Pegol Only (12 to 24 Months) n=96 participants at risk Participants were re-randomized at month 12 to receive ACP 2 mg/eye via IVT injections monthly from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Avacincaptad Pegol and Sham Only (12 to 24 Months) n=93 participants at risk Participants were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.	Sham Only (up to 12 Months) n=222 participants at risk Participants received sham injections through Month 11 (Year 1).	Sham Only (12 to 24 Months) n=203 participants at risk Participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Cardiac disorders Atrial fibrillation	0.89% 2/225 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Atrial flutter	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Atrial tachycardia	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Atrioventricular block second degree	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Cardiac failure	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Cardiac failure chronic	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Cardiac failure congestive	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Coronary artery disease	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Coronary artery insufficiency	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Intracardiac thrombus	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Mitral valve incompetence	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Myocardial infarction	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Myocardial ischaemia	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Sinus arrest	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Ventricular extrasystoles	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Congenital, familial and genetic disorders Mobile caecum syndrome	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Ear and labyrinth disorders Vertigo	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Choroidal neovascularisation	0.89% 2/225 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Retinal haemorrhage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Visual acuity reduced	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Visual acuity reduced transiently	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Inguinal hernia	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Large intestine polyp	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Pancreatitis chronic	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Gastrointestinal disorders Vomiting	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
General disorders Chest pain	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.2% 2/93 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Hepatobiliary disorders Biliary obstruction	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Hepatobiliary disorders Cholecystitis acute	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Hepatobiliary disorders Hepatic cirrhosis	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations COVID-19	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.90% 2/222 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations COVID-19 pneumonia	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Clostridium difficile colitis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Clostridium difficile infection	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Cystitis bacterial	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Diverticulitis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Endophthalmitis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Herpes zoster	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Listeria sepsis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Pneumonia	0.89% 2/225 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.90% 2/222 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Pneumonia bacterial	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Postoperative abscess	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Sepsis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Urosepsis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.90% 2/222 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Wound infection	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Exposure to toxic agent	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Fall	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Joint injury	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Multiple fractures	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Spinal compression fracture	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Wrist fracture	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IIIA	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Cerebral haemorrhage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Cerebral infarction	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Cerebrovascular accident	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.5% 3/203 • Number of events 3 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Intracranial aneurysm	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Metabolic encephalopathy	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Neuromyelitis optica spectrum disorder	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Nervous system disorders Transient ischaemic attack	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.90% 2/222 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Product Issues Device dislocation	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Product Issues Device lead damage	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Reproductive system and breast disorders Prostatitis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.89% 2/225 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Aortic aneurysm	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Aortic stenosis	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Circulatory collapse	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Hypertension	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.90% 2/222 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Hypertensive emergency	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Neurogenic shock	0.44% 1/225 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Vascular disorders Peripheral artery occlusion	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Acute myocardial infarction	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/222 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Cardiac disorders Angina pectoris	0.00% 0/225 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/96 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/93 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.45% 1/222 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.00% 0/203 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.

Other adverse events

Measure	Avacincaptad Pegol Only (up to 12 Months) n=225 participants at risk Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1).	Avacincaptad Pegol Only (12 to 24 Months) n=96 participants at risk Participants were re-randomized at month 12 to receive ACP 2 mg/eye via IVT injections monthly from month 12 through month 23 (Year 2). Participants were followed up until month 24.	Avacincaptad Pegol and Sham Only (12 to 24 Months) n=93 participants at risk Participants were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.	Sham Only (up to 12 Months) n=222 participants at risk Participants received sham injections through Month 11 (Year 1).	Sham Only (12 to 24 Months) n=203 participants at risk Participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.
Eye disorders Cataract	2.7% 6/225 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	7.3% 7/96 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	4.3% 4/93 • Number of events 5 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	4.1% 9/222 • Number of events 13 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	4.9% 10/203 • Number of events 13 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Choroidal neovascularisation	9.3% 21/225 • Number of events 21 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	11.5% 11/96 • Number of events 13 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	8.6% 8/93 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.0% 11/222 • Number of events 13 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	9.4% 19/203 • Number of events 21 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Conjunctival haemorrhage	13.8% 31/225 • Number of events 55 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	14.6% 14/96 • Number of events 22 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	9.7% 9/93 • Number of events 16 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	8.1% 18/222 • Number of events 32 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.5% 5/203 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Conjunctival hyperaemia	5.3% 12/225 • Number of events 34 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.0% 1/96 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.1% 1/93 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.9% 13/222 • Number of events 38 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.5% 5/203 • Number of events 6 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Punctate keratitis	6.2% 14/225 • Number of events 25 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.2% 5/96 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.4% 5/93 • Number of events 6 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	6.8% 15/222 • Number of events 32 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.5% 5/203 • Number of events 14 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Eye disorders Retinal haemorrhage	3.6% 8/225 • Number of events 9 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.1% 2/96 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.4% 5/93 • Number of events 6 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.3% 5/222 • Number of events 5 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.99% 2/203 • Number of events 3 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations COVID-19	3.1% 7/225 • Number of events 7 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	11.5% 11/96 • Number of events 11 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	15.1% 14/93 • Number of events 14 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	3.2% 7/222 • Number of events 7 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	12.8% 26/203 • Number of events 27 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Nasopharyngitis	1.8% 4/225 • Number of events 4 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	4.2% 4/96 • Number of events 6 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	6.5% 6/93 • Number of events 6 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.7% 6/222 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.5% 3/203 • Number of events 3 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Infections and infestations Urinary tract infection	6.2% 14/225 • Number of events 17 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	3.1% 3/96 • Number of events 3 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	2.2% 2/93 • Number of events 2 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.9% 13/222 • Number of events 13 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	8.9% 18/203 • Number of events 22 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Injury, poisoning and procedural complications Fall	6.2% 14/225 • Number of events 15 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	9.4% 9/96 • Number of events 9 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	8.6% 8/93 • Number of events 8 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	7.7% 17/222 • Number of events 18 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.9% 12/203 • Number of events 17 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.
Investigations Intraocular pressure increased	9.8% 22/225 • Number of events 43 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	9.4% 9/96 • Number of events 18 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	5.4% 5/93 • Number of events 7 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	1.8% 4/222 • Number of events 5 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.	0.49% 1/203 • Number of events 1 • All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months Participants in "ACP only" \& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group. ACM: All randomized participants. Serious \& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn't receive treatment \& was included in denominator for ACM only and not for other outcomes.

Additional Information

Clinical Transparency

Astellas Pharma Global Development, Inc

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Email: astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee No individual site or investigator may publish or present any results from the trial until a joint, multi-center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however approval will be at the sole discretion of the Sponsor.
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Restriction type: OTHER