Trial Outcomes & Findings for Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol (NCT NCT03400800)

NCT ID: NCT03400800

Last Updated: 2020-08-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1617 participants
• Primary outcome timeframe: Baseline, Day 510
• Results posted on: 2020-08-21

Participant Flow

Participant milestones

Measure	Inclisiran Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Overall Study STARTED	810	807
Overall Study COMPLETED	772	770
Overall Study NOT COMPLETED	38	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

Baseline characteristics by cohort

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo n=807 Participants Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).	Total n=1617 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	367 Participants n=93 Participants	366 Participants n=4 Participants	733 Participants n=27 Participants
Age, Categorical >=65 years	443 Participants n=93 Participants	441 Participants n=4 Participants	884 Participants n=27 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 8.29 • n=93 Participants	64.8 years STANDARD_DEVIATION 8.68 • n=4 Participants	64.8 years STANDARD_DEVIATION 8.48 • n=27 Participants
Sex: Female, Male Female	231 Participants n=93 Participants	226 Participants n=4 Participants	457 Participants n=27 Participants
Sex: Female, Male Male	579 Participants n=93 Participants	581 Participants n=4 Participants	1160 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	12 Participants n=93 Participants	8 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) White	791 Participants n=93 Participants	796 Participants n=4 Participants	1587 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Hungary	52 participants n=93 Participants	52 participants n=4 Participants	104 participants n=27 Participants
Region of Enrollment Czechia	10 participants n=93 Participants	11 participants n=4 Participants	21 participants n=27 Participants
Region of Enrollment Ukraine	55 participants n=93 Participants	54 participants n=4 Participants	109 participants n=27 Participants
Region of Enrollment Poland	360 participants n=93 Participants	357 participants n=4 Participants	717 participants n=27 Participants
Region of Enrollment South Africa	60 participants n=93 Participants	61 participants n=4 Participants	121 participants n=27 Participants
Region of Enrollment United Kingdom	231 participants n=93 Participants	231 participants n=4 Participants	462 participants n=27 Participants
Region of Enrollment Germany	42 participants n=93 Participants	41 participants n=4 Participants	83 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Day 510

Population: ITT population

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Percentage Change in LDL-C From Baseline to Day 510	-49.3 Percent change Interval -51.22 to -47.48	4.2 Percent change Interval 1.62 to 6.69

PRIMARY outcome

Timeframe: Baseline, Day 90 to Day 540

Population: ITT population

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540	-45.82 Percent change Interval -47.52 to -44.13	3.35 Percent change Interval 1.65 to 5.05

SECONDARY outcome

Timeframe: Baseline, Day 510

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Absolute Change In LDL-C From Baseline To Day 510	-50.91 mg/dL Interval -53.14 to -48.67	0.96 mg/dL Interval -1.26 to 3.18

SECONDARY outcome

Timeframe: Baseline, Day 90 to Day 540

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540	-48.63 mg/dL Interval -50.37 to -46.89	0.31 mg/dL Interval -1.42 to 2.04

SECONDARY outcome

Timeframe: Baseline, Day 510

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510	-63.64 Percent change Interval -65.55 to -61.74	15.62 Percent change Interval 13.72 to 17.53

SECONDARY outcome

Timeframe: Baseline, Day 510

Population: ITT Population

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Percentage Change in Total Cholesterol From Baseline to Day 510	-28.00 Percent change Interval -29.4 to -26.6	1.79 Percent change Interval 0.38 to 3.21

SECONDARY outcome

Timeframe: Baseline, Day 510

Population: ITT Population

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510	-38.15 Percent change Interval -39.76 to -36.54	0.79 Percent change Interval -0.82 to 2.41

SECONDARY outcome

Timeframe: Baseline, Day 510

Population: ITT Population

Outcome measures

Measure	Inclisiran n=810 Participants Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 millilitres (mL) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo n=807 Participants Placebo (1.5 mL) administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Percentage Change in Non-HDL-C From Baseline to Day 510	-41.16 Percent change Interval -43.09 to -39.24	2.15 Percent change Interval 0.22 to 4.09

Adverse Events

Inclisiran

Serious events: 181 serious events

Other events: 331 other events

Deaths: 14 deaths

Placebo

Serious events: 181 serious events

Other events: 319 other events

Deaths: 15 deaths

Serious adverse events

Measure	Inclisiran n=811 participants at risk Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo n=804 participants at risk Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Blood and lymphatic system disorders Anaemia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Acute coronary syndrome	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Acute myocardial infarction	0.62% 5/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	2.2% 18/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Angina pectoris	1.7% 14/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	1.6% 13/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Angina unstable	1.4% 11/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	1.4% 11/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Aortic valve stenosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Arrhythmia	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Atrial fibrillation	1.2% 10/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.75% 6/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Atrial flutter	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Atrioventricular block complete	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Atrioventricular block second degree	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Bradycardia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Cardiac arrest	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Cardiac failure	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.75% 6/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Cardiac failure chronic	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Cardiac failure congestive	0.62% 5/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Cardiomyopathy	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Coronary artery disease	0.99% 8/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	1.4% 11/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Coronary artery insufficiency	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Coronary artery occlusion	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Coronary artery stenosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Hypertensive heart disease	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Left ventricular dysfunction	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Left ventricular failure	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Mitral valve incompetence	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Myocardial infarction	0.62% 5/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.50% 4/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Myocardial ischaemia	0.49% 4/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.62% 5/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Palpitations	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Paroxysmal arrhythmia	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Pericardial effusion	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Silent myocardial infarction	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Supraventricular tachycardia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Ventricular fibrillation	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Cardiac disorders Ventricular tachycardia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Ear and labyrinth disorders Vertigo	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Endocrine disorders Hypopituitarism	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Eye disorders Cataract	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Eye disorders Retinal detachment	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Abdominal pain	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Abdominal pain upper	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Ascites	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Chronic gastritis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Constipation	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Diaphragmatic hernia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Diarrhoea	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Gastritis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Gastritis erosive	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Haemorrhoids	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Ileus paralytic	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Inguinal hernia	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Large intestine polyp	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Oesophageal spasm	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Pancreatitis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Pancreatitis necrotising	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Peptic ulcer	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Rectal haemorrhage	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Rectal prolapse	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Gastrointestinal disorders Volvulus	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Cardiac death	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Chest pain	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Death	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Exercise tolerance decreased	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Impaired healing	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Non-cardiac chest pain	0.49% 4/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	1.00% 8/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Sudden cardiac death	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Vascular stent occlusion	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
General disorders Vascular stent restenosis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Hepatobiliary disorders Biliary dilatation	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Hepatobiliary disorders Cholecystitis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Hepatobiliary disorders Cholecystitis acute	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Hepatobiliary disorders Cholelithiasis	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Immune system disorders Sarcoidosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Abscess limb	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Appendicitis	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Biliary sepsis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Bronchitis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Cellulitis	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Chest wall abscess	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Device related sepsis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Encephalitis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Erysipelas	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Gallbladder abscess	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Gallbladder empyema	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Gangrene	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Infectious pleural effusion	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Influenza	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Intervertebral discitis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Lower respiratory tract infection	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.37% 3/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Neuroborreliosis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Pathogen resistance	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Pneumonia	1.1% 9/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.87% 7/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Pneumonia pneumococcal	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Postoperative wound infection	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Sepsis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Septic shock	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Sialoadenitis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Staphylococcal sepsis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Urinary tract infection	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Wound infection	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Acetabulum fracture	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Arterial bypass occlusion	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Coronary vascular graft occlusion	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Fall	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Femoral neck fracture	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Head injury	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Incision site pain	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Joint injury	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Limb injury	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Peripheral arterial reocclusion	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Procedural hypotension	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Radius fracture	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Soft tissue injury	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Spinal fracture	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.37% 3/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Traumatic fracture	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Injury, poisoning and procedural complications Wound	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Investigations Liver function test increased	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Dehydration	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Diabetes mellitus	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Hyperglycaemia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Hypoglycaemia	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Hypovolaemia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Arthralgia	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Back pain	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Costochondritis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Inclusion body myositis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.37% 3/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Pain in extremity	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Periarthritis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Undifferentiated connective tissue disease	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the stomach	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer stage IV	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Linitis plastica	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral nerve sheath tumour malignant	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.75% 6/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tracheal neoplasm	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Brain injury	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Carotid artery stenosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Cerebral infarction	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Dementia Alzheimer's type	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Facial paralysis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Haemorrhagic stroke	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Intracranial venous sinus thrombosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Ischaemic stroke	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.37% 3/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Lacunar stroke	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Loss of consciousness	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Neuropathy peripheral	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Presyncope	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Sciatica	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Seizure	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Syncope	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Nervous system disorders Transient ischaemic attack	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Product Issues Device loosening	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Psychiatric disorders Depression	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Psychiatric disorders Suicide attempt	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Acute kidney injury	0.62% 5/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Calculus urinary	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Chronic kidney disease	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders End stage renal disease	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Glomerulonephritis membranous	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Haematuria	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Nephrolithiasis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Nephrotic syndrome	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Renal colic	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Renal and urinary disorders Urethral stenosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Reproductive system and breast disorders Vaginal prolapse	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Asthma	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.37% 3/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.37% 3/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Surgical and medical procedures Leg amputation	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Aortic aneurysm	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Aortic dissection	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Aortic stenosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Blood pressure inadequately controlled	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Circulatory collapse	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Deep vein thrombosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Extremity necrosis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Granulomatosis with polyangiitis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Hypertension	0.25% 2/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Hypotension	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Iliac artery embolism	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Orthostatic hypotension	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Peripheral arterial occlusive disease	0.86% 7/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	1.00% 8/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Peripheral artery occlusion	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Peripheral artery stenosis	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Peripheral ischaemia	0.00% 0/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.25% 2/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Peripheral vascular disorder	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.12% 1/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Thromboangiitis obliterans	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Vasculitis	0.12% 1/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	0.00% 0/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.

Other adverse events

Measure	Inclisiran n=811 participants at risk Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo n=804 participants at risk Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Infections and infestations Nasopharyngitis	11.2% 91/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	11.2% 90/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Infections and infestations Upper respiratory tract infection	6.4% 52/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	6.1% 49/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Metabolism and nutrition disorders Diabetes mellitus	10.9% 88/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	11.7% 94/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 47/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	4.0% 32/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.
Vascular disorders Hypertension	6.5% 53/811 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.	6.7% 54/804 • 17 months The Efficacy population was comprised of 807 (Placebo) and 810 (Inclisiran) for a toal of 1617 subjects. The Safety population consisted of 804 (Placebo) and 811 (Inclisiran). The reason for this discrepancy is because two randomized subjects (Placebo) were not dosed, so were randomized in error. In addition, a placebo subject received inclisiran at Day 450 so was reallocated into the inclisiran group for safety as per the definition.

Additional Information

Vice-President, Regulatory Operations

Novartis

Phone: 973-985-0597

Email: frank.bosley@novartis.com

Results disclosure agreements

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