A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Sponsor: CSL Behring

Protocol version: Amendment 1 
 
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CLINICAL STUDY PROTOCOL 
 
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-
group Study to Investigate the Efficacy and Safety of CSL112 
in Subjects with Acute Coronary Syndrome 
Study Number: 
CSL112_3001 
Study Product: 
CSL112 (apolipoprotein A-I [human]) 
Development Phase: 
Phase 3 
Sponsor: 
CSL Behring LLC (CSLB) 
1020 First Avenue 
King of Prussia 
PA 19406-0901 
Protocol Version: 
Amendment 1  
EudraCT Number: 
2017-000996-98 
IND Number: 
 
Protocol Date: 
10 September 2019 
Compliance: 
This study will be conducted in accordance with standards of 
Good Clinical Practice (as defined by the International Council 
for Harmonisation) and all applicable national and local 
regulations.  
 
 
 
 
 
 
CCI

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List of Personnel and Organizations Responsible for Conduct of the Study 
A list of personnel and organizations responsible for the conduct of the study will be supplied 
to study sites as part of the investigator’s Study File. This list will be updated by CSLB (or 
delegate) and provided to the study sites as needed. 
 
 

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Revision History 
Date 
Version  
Summary of Changes 
23 January 2018 
Original 
Not applicable 
10 September 2019 
Amendment 1  
• Modification of the primary endpoint to include all myocardial 
infarction (MI) events instead of only type 1 (spontaneous) MI events. 
• Modification of inclusion criterion 6 to limit to subjects that are at higher 
risk of an early recurrent cardiovascular event.  
• Inclusion of additional secondary and exploratory endpoints. 
• Specify that the 70% interim analysis will not be performed if the 
expected Independent Data Monitoring Committee (IDMC) review of 
the interim analysis is less than 2 months prior to the anticipated 
completion of enrollment.  
• Inclusion of the option to limit the number of subjects enrolled with a 
specific index MI type (ie, ST-segment elevation MI or non-ST-segment 
elevation MI). 
• Addition of recent nonclinical and clinical (ie, Study CSL112_1002) 
data. 
• Modification of wording associated with the following aspects of the 
study to provide clarification and improve protocol compliance: 
o 
Collection of concomitant medications related to acute coronary 
syndrome: timing during Follow-up Period. 
o 
Lipid panel tests: procedures to prevent unblinding. 
o 
Eligibility criteria: inclusion criteria 3, 5, and 7b and exclusion 
criteria 4 and 7c. 
o 
Angiography for treatment of the index MI: timing relative to 
randomization. 
o 
Stable renal function: inclusion of SI unit (µmol/L) values for 
serum creatinine. 
o 
Delayed infusions: study reference manual cited for additional 
guidance. 
o 
Measurement of creatinine: use of plasma or whole blood when 
serum creatinine testing is not available. 
o 
Suspected major adverse CV events reporting: events occurring 
before randomization not required to be reported for endpoint 
adjudication. 
o 
Potential hepatic injury: to be reported as an adverse event or 
serious adverse event as appropriate. 
o 
Acute kidney injury: laboratory abnormalities and associated 
conditions to be reported as an adverse event if deemed by the 
investigator as abnormal. 
• Minor corrections including changes for consistency, word 
modifications, and administrative changes. 
 
 
 

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Protocol Synopsis 
Title 
A Phase 3, Multicenter, Double-blind, Randomized, 
Placebo-controlled, Parallel-group Study to Investigate the Efficacy 
and Safety of CSL112 in Subjects with Acute Coronary Syndrome 
Study Number 
CSL112_3001 
Sponsor 
CSL Behring LLC 
Development Phase 
Phase 3 
Study Product 
CSL112 (apolipoprotein A-I [apoA-I]) 
Indication 
CSL112 is indicated to reduce the risk of cardiovascular (CV) death, 
myocardial infarction (MI), and stroke in acute coronary syndrome 
(ACS) patients diagnosed with either ST-segment elevation 
myocardial infarction (STEMI) or non-ST-segment elevation 
myocardial infarction (NSTEMI), and including those managed with 
percutaneous coronary intervention (PCI) or medically managed. 
Study Summary and 
Overview 
Acute coronary syndrome is a life-threatening condition, which most 
commonly occurs when an atherosclerotic plaque ruptures or erodes, 
leading to thrombus formation within a coronary artery. A thrombus 
within a coronary artery can result in unstable angina, MI, or sudden 
death. Even after recovery from an acute episode of ACS, patients 
continue to be at heightened risk. The risk of recurrent CV events is 
high despite advances in medical therapy and standard therapeutic 
regimens that have produced important improvements in the 
prognosis of patients with MI. 
CSL112 is a novel formulation of apoA-I, the major functional 
component of high-density lipoprotein. It is purified from human 
plasma, formulated to deliver exogenous apoA-I. Apolipoprotein A-I 
is formulated with phosphatidylcholine (PC) and stabilized with 
sucrose and cholate as excipients. CSL112 is being developed for use 
in patients with ACS (diagnosed with either STEMI or NSTEMI) to 
reduce the risk of CV death, MI, and stroke upon delivery of 
CSL112. Evidence from the Apo-I Event Reducing in Ischemic 
Syndromes-I (AEGIS-I) study has demonstrated that administration 
of apoA-I increases cholesterol efflux in MI patients. 
This is a phase 3, multicenter, double-blind, randomized, 
placebo-controlled, parallel-group study to evaluate the efficacy and 
safety of CSL112 on reducing the risk of major adverse CV events 

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Key Secondary 
Objective(s) 
1. To evaluate the efficacy of CSL112 on reducing the total number 
of hospitalizations for coronary, cerebral, or peripheral ischemia. 
2. To evaluate the efficacy of CSL112 on reducing the risk of 
MACE (CV death, MI, or stroke) through 180 and 365 days in 
subjects with ACS (diagnosed with STEMI or NSTEMI). 
Key Secondary 
Endpoint(s) 
1. Total number of hospitalizations for coronary, cerebral, or 
peripheral ischemia from the time of randomization through 
90 days. 
2. Time to first occurrence of CV death, MI, or stroke from the time 
of randomization through 180 days. 
3. Time to first occurrence of CV death, MI, or stroke from the time 
of randomization through 365 days. 
Other Secondary 
Objectives 
1. To further evaluate the efficacy of CSL112 on reducing the risk of 
MACE (CV death, MI, or stroke) and all-cause death in subjects 
with ACS (diagnosed with STEMI or NSTEMI). 
2. To evaluate the safety of CSL112 in subjects with ACS 
(diagnosed with STEMI or NSTEMI). 
Other Secondary 
Endpoints 
1. Time to first occurrence of each individual component of the 
composite primary efficacy endpoint from the time of 
randomization through 90 days: 
• CV death. 
• MI. 
• Stroke. 
2. Time to first occurrence of CV death, type 1 MI, or stroke from 
the time of randomization through 90, 180, and 365 days. 
3. Time to occurrence of all-cause death from the time of 
randomization through 365 days. 
Exploratory 
Objective(s) 
The exploratory objectives of this study are as follows: 
1. To evaluate the efficacy of CSL112 on reducing the rate of 
hospitalization for coronary, cerebral, or peripheral ischemia. 
2. To further explore the effect of CSL112 on the risk of MACE 
(CV death, MI, stroke), non-CV death, and severe coronary 
ischemia requiring urgent revascularization. 
3. To assess the impact of CSL112 on medical resource utilization 
and quality of life. 
4. To evaluate the pharmacokinetic / pharmacodynamic 
characteristics of CSL112.  

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Exploratory 
Endpoint(s) 
The endpoints for evaluation of the exploratory objectives are: 
1. Total number of hospitalizations for coronary, cerebral, or 
peripheral ischemia from the time of randomization through 
30 days. 
2. Time to first occurrence of CV death, MI, stroke, or severe 
coronary ischemia requiring urgent revascularization from the 
time of randomization through 90 days. 
3. Time to first occurrence of CV death, MI, or stroke from the time 
of randomization through 30 and 60 days. 
4. Time to first occurrence of MI by type, according to the universal 
definition, from the time of randomization through 90 days. 
5. Time to occurrence of CV death from the time of randomization 
through 365 days. 
6. Time to occurrence of non-CV death from the time of 
randomization through 365 days. 
7. Total occurrence of re-hospitalization for CV events and all-cause 
death from the time of randomization through 90 days. 
8. Total occurrence of CV death, MI, and stroke from the time of 
randomization through 90,180, and 365 days. 
9. Total occurrence of all-cause death, MI, and stroke from the time 
of randomization through 90, 180, and 365 days. 
10. Medical resource utilization from the time of randomization 
through 90 days: 
a. Number of total hospitalizations. 
b. Length of hospital stay. 
c. Number of critical care unit or intensive care unit days. 
d. Select procedures / surgeries related to hospitalization for 
coronary, cerebral, or peripheral ischemia. 
e. Discharge status to home with or without additional care, 
rehabilitation, and skilled nursing facilities following 
hospitalization for coronary, cerebral, or peripheral ischemia. 
11. Change in EQ-5D-3L data from baseline to Day 90. 
12. Pharmacokinetic endpoints will include the following: 
a. Baseline-corrected plasma apoA-I concentrations. 
b. Baseline-corrected plasma PC concentrations. 
c. Concentration in plasma at end of infusion for apoA-I and 
PC. 
d. Accumulation ratio for apoA-I and PC. 
13. Pharmacodynamic endpoints include the following: 
a. Total cholesterol efflux. 

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b. ABCA1-dependent efflux. 
c. ABCA1-independent efflux. 
Number of Subjects 
Approximately 17,400 subjects, with a maximum of 20,600 subjects, 
will be enrolled into this study.  
Study Duration 
The overall study duration (ie, first subject’s Screening Visit to last 
subject’s End of Study Visit) will be approximately 50 months. 
Study Population 
and Main Criteria 
for Eligibility 
1. Capable of providing written informed consent and willing and 
able to adhere to all protocol requirements. 
2. Male or female at least 18 years of age at the time of providing 
written informed consent. 
3. Evidence of myocardial necrosis in a clinical setting consistent 
with type 1 (spontaneous) MI (STEMI or NSTEMI) caused by 
atherothrombotic coronary artery disease (4th Universal 
Definition of MI [Thygesen et al, 2019]) as defined by the 
following: 
a. Detection of a rise and / or fall in cardiac troponin I or T with 
at least 1 value above the 99th percentile upper reference 
limitAND 
b. Any 1 or more of the following: 
i. Symptoms of acute myocardial ischemia (ie, resulting 
from a primary coronary artery event). 
ii. New (or presumably new) significant ST/T wave changes 
or left bundle branch block. 
iii. Development of pathological Q waves on 
electrocardiogram. 
iv. Imaging evidence of new loss of viable myocardium or 
regional wall motion abnormality in a pattern consistent 
with an ischemic etiology. 
v. Identification of intracoronary thrombus by angiography. 
Note: Electrocardiograms obtained as part of standard of care 
can be used to support or confirm the index MI. 
4. No suspicion of acute kidney injury at least 12 hours after IV 
contrast agent administration (subjects who have undergone 
angiography) or after first medical contact for the index MI 
(subjects who have not undergone angiography). There must be 
documented evidence of stable renal function defined as no more 
than an increase in serum creatinine < 0.3 mg/dL (27 µmol/L) 
from pre-contrast serum creatinine value. 
5. Evidence of multivessel coronary artery disease defined as 
meeting 1 or more of the following criteria: 

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Safety Assessments 
Adverse event monitoring will be conducted from the time the 
subject gives informed consent through Visit 8 (Day 90). In addition, 
adverse events considered to be related to investigational product will 
be monitored through the End of Study Visit (Day 365). All serious 
adverse events will be collected through the end of the study, 
regardless of relationship to investigational product, and will be 
followed until the event resolves, stabilizes, or the subject is lost to 
follow-up. Blood for clinical laboratory testing (biochemistry panel 
and hematology) will be collected, and vital sign measurements will 
be conducted according to the Schedule of Assessments. 
Pharmacokinetics 
Plasma concentrations of apoA-I and PC will be assayed from the 
blood samples drawn in the planned pharmacokinetic substudy. 
Accordingly, blood samples will be drawn before infusion 1, end of 
infusion 1, and end of infusion 4. 
Pharmacodynamics 
Blood samples for pharmacodynamic assessments will be drawn at 
the same as time points as pharmacokinetic draws. 
Other Assessments 
Not applicable. 
Statistical Analyses 
The study is designed as a superiority study. The sample size 
calculation is based upon the hypothesis that compared with placebo, 
CSL112 will have a 20% relative risk reduction (hazard ratio = 0.80) 
in the primary endpoint over 90 days of follow-up after 
randomization (ie, all subjects will be followed for a fixed duration of 
90 days after randomization). Assuming a 1-sided alpha of 0.025, not 
accounting for any dropouts from the study, and the specified interim 
analyses, 1004 confirmed MACE (CV death, MI, or stroke) will 
provide at least 90% power. A 1-sided hypothesis test is necessary to 
differentiate directionality for interim analyses of futility and 
efficacy. Based on an assumed 90-day placebo event rate of 6.4%, an 
estimated 17,400 subjects (8700 per group) will be required. 
The target number of events is also sufficient to achieve a 1-sided  
P value of 0.005 (approximate) with an observed hazard ratio of 0.85 
in the primary endpoint and will afford at least 69% power to detect 
the minimally clinically relevant hazard ratio of 0.85. 
The primary endpoint is defined as time to first occurrence of the 
composite MACE (ie, CV death, MI, or stroke), from the time of 
randomization through 90 days. The primary endpoint will include all 
MIs. 
The primary analysis of time to the 3-component MACE (CV death, 
MI, or stroke) will be based on a covariate-adjusted Cox regression 
model including fixed effects for treatment, region, index MI type, 

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index MI management, age (as a continuous variable), diabetes, 
peripheral artery disease, history of prior MI (excluding index MI) 
and a term for interaction between index MI type and index MI 
management will be fitted using the PHREG procedure in SAS. The 
1-sided Wald P value for hypothesis testing, the hazard ratio and its 
2-sided 95% confidence interval, will be estimated from the model. 
The primary statistical analysis will utilize the Intent-to-treat (ITT) 
Analysis Set. 
Additional sensitivity analyses of the primary endpoint will be 
performed to examine the robustness of the conclusion from the 
planned primary analysis to deviations from assumptions. 
Statistical analysis of key secondary endpoints will be based on the 
ITT Analysis Set utilizing an overall, 1-sided 0.025 significance 
level. The hypotheses associated with the key secondary endpoints 
will be formally tested and therefore adjusted for multiplicity. 
Interim Analyses 
The sample size calculation given above for number of required 
events and number of estimated subjects includes 3 formal interim 
analyses. The first 2 interim analyses will be conducted for futility 
only after observation of approximately 301 confirmed MACE (30% 
of the total target number of events) and 502 confirmed MACE (50% 
of the total target number of events). The third interim analysis will 
be conducted for efficacy only after observation of approximately 
703 confirmed MACE (70% of the total target number of events). 
Based on event accrual, if the expected timing of the Independent 
Data Monitoring Committee (IDMC) review of the 70% interim 
analysis is less than 2 months prior to the anticipated completion of 
study enrollment, the 70% interim analysis for efficacy will not be 
conducted. 

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ALT = alanine aminotransferase; central = central laboratory testing; EOI = end of infusion; EOS = End of Study; FBR = future biomedical research; HDL = High-density 
lipoprotein; IP = investigational product; IRT = interactive response technology; local = local laboratory testing; MACE = major adverse cardiovascular event; NA = not 
applicable; PD = pharmacodynamics; PK = pharmacokinetic; Ref. = reference; SOI = start of infusion. 
Notes to the schedule of assessments: 
A: A subject is considered eligible if they meet all inclusion criteria and none of the exclusion criteria. Screening and randomization may occur on the same day (Day 1) provided 
laboratory results are available for review by the investigator and eligibility criteria have been met for ALT, total bilirubin, and serum creatinine. Infusion 1 must be 
administered in the timeframe as detailed in Section 4.2.1. 
B: Visit 6 should occur approximately 7 (± 2) days after infusion 4 (or last infusion). Subjects who prematurely discontinue infusion(s) of investigational product are to have 
Visit 6 / Early Termination Visit assessments as soon as possible after discontinuation of investigational product. 
C: Visit 7 (Day 60) and Visit 10 (Day 270) assessments may be conducted either by telephone contact or face-to-face at the study site. 
D: If a subject refuses consent for FBR sampling, or there is a documented law or regulation prohibiting sample collection, or if the Institutional Review Board / Independent 
Ethics Committee does not approve collection of the sample for these purposes, then the sample will not be collected at that site. 
E: All concomitant treatments for ACS including the dose, route of administration, and frequency must be collected and monitored for change through to the EOS (Day 365).  
F: At the Screening Visit, randomization in IRT will occur after eligibility criteria are met. 
G: Only adverse events considered related to investigational product, leading to discontinuation of investigational product, and / or leading to withdrawal of consent during the 
study are to be collected at Visit 9 (Day 180), Visit 10 (Day 270), and EOS Visit (Day 365). Concomitant medications taken or administered for the treatment of such events 
are to be collected until resolution of the event. 
H: If a subject has a suspected or confirmed stroke, the modified Rankin score should be obtained at the time of occurrence. 
I: 
Only females of childbearing potential are to be tested; urine sample for local laboratory testing is the preferred method. If the urine test cannot be confirmed as negative, a 
serum pregnancy test will be required. 
J: 
An elevation in ALT > 3 × upper limit of normal with a concomitant increase in total bilirubin that is > 2 × upper limit of normal should be reported as a serious adverse event 
within 24 hours. 
K: Local laboratory values obtained as part of standard of care testing for the index acute myocardial infarction event and before obtaining written informed consent should be 
used to determine study entry and eligibility for infusion 1. However, if results (for ALT, total bilirubin and / or serum creatinine) are not available, then a blood sample must 
be obtained for the local laboratory testing. 
L: For subjects who received infusion 1 of investigational product > 12 hours and < 48 hours after IV contrast administration: local laboratory serum creatinine value 
must be obtained before the infusion for comparison with the local laboratory baseline value and reviewed by the investigator. A blood sample for local laboratory testing to 
assess dosing eligibility for infusion 2 should not occur earlier than 72 hours following the infusion 1. 
M: During study conduct, the Independent Data Monitoring Committee (IDMC) may make a recommendation to permit discontinuation of blood sampling at Visit 3 and Visit 4 
for local laboratory and / or central laboratory biochemistry testing. If the IDMC so recommends, study investigators will be notified by the Executive Committee chairperson 
that these routine laboratory assessments are no longer required and eligibility for all subsequent infusions is to be based on clinical assessment (ie, starting with 
infusion 2 / Visit 3). 
N: Blood sample is to be taken before the start of infusion. This blood sample must be sent to the central laboratory for study analysis purposes. 
O: Blood samples are to be collected from all subjects at baseline and Visit 6 (Day 29). Immunogenicity testing will be performed using samples from approximately the first 600 
subjects (approximately 300 CSL112 and 300 placebo) and oversight will be provided by the IDMC (Section 8.1.3.6). 
P: Blood samples are to be collected from all subjects at baseline and Visit 6 (Day 29). Nucleic acid testing and serology (parvovirus B19) will be performed using samples from 
approximately 300 randomly selected subjects (approximately 150 CSL112 and150 placebo). 
Q: Future biomedical research testing includes samples collected at baseline that are intended for storage and / or future analyses (eg, pharmacogenomics). 
Note: Assessments are to be conducted at all times and days that are marked with an X. The investigator and other blinded study staff must not review the results of a lipid 
panel test (specifically the HDL cholesterol level) during the Active Treatment Period as the results may unblind treatment assignment.

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Table of Contents 
List of Personnel and Organizations Responsible for Conduct of the Study ............................. 2 
Revision History ........................................................................................................................ 3 
Protocol Synopsis ...................................................................................................................... 4 
Schedule of Assessments ......................................................................................................... 12 
List of Tables............................................................................................................................ 19 
List of Figures .......................................................................................................................... 19 
List of Abbreviations ............................................................................................................... 20 
1 
Introduction .................................................................................................................. 22 
1.1 
Background ........................................................................................................... 22 
1.2 
Background Information on CSL112 ................................................................... 23 
1.2.1 
Overview ...................................................................................................... 23 
1.2.2 
Nonclinical Evaluation ................................................................................. 23 
1.2.3 
Clinical Experience ...................................................................................... 24 
1.3 
Study Overview .................................................................................................... 24 
1.4 
Potential Risks and Benefits ................................................................................. 25 
2 
Study Objectives and Endpoints .................................................................................. 27 
2.1 
Primary Objective and Endpoint .......................................................................... 27 
2.2 
Secondary Objectives and Endpoints ................................................................... 28 
2.2.1 
Key Secondary Objectives ........................................................................... 28 
2.2.2 
Key Secondary Endpoints ............................................................................ 28 
2.2.3 
Other Secondary Objectives ......................................................................... 28 
2.2.4 
Other Secondary Endpoints .......................................................................... 29 
2.3 
Exploratory Objectives and Endpoints ................................................................. 29 
2.3.1 
Exploratory Objectives ................................................................................. 29 
2.3.2 
Exploratory Endpoints .................................................................................. 30 
3 
Study Overview ........................................................................................................... 31 
3.1 
Study Design......................................................................................................... 31 
3.2 
Dose and Dosing Regimen ................................................................................... 34 
3.3 
Scientific Rationale ............................................................................................... 34 

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3.3.1 
Study Design Rationale ................................................................................ 34 
3.3.2 
Dose Rationale ............................................................................................. 35 
3.4 
Planned Study Duration ........................................................................................ 36 
3.5 
Planned Number of Subjects ................................................................................ 36 
3.6 
Definition of End of the Clinical Study ................................................................ 36 
3.7 
Study Oversight .................................................................................................... 37 
3.7.1 
Independent Data Monitoring Committee .................................................... 37 
3.7.2 
Executive Committee ................................................................................... 38 
3.7.3 
Steering Committee ...................................................................................... 38 
3.7.4 
Clinical Events Committee ........................................................................... 38 
3.8 
Study Stopping Criteria ........................................................................................ 39 
4 
Selection and Withdrawal of Subjects ......................................................................... 39 
4.1 
Eligibility Criteria ................................................................................................. 39 
4.1.1 
Inclusion Criteria .......................................................................................... 39 
4.1.2 
Exclusion Criteria ......................................................................................... 42 
4.2 
Dosing Eligibility ................................................................................................. 44 
4.2.1 
Infusion 1 ...................................................................................................... 44 
4.2.2 
Subsequent Infusions .................................................................................... 47 
4.2.3 
Infusion Delay .............................................................................................. 50 
4.3 
Discontinuation of Treatment and / or Subject Withdrawal from the Study ........ 50 
4.3.1 
Early Discontinuation of Investigational Product ........................................ 50 
4.3.2 
Possible Reasons for Discontinuation of Investigational Product ................ 51 
4.3.3 
Subject Withdrawal from the Study ............................................................. 52 
4.3.4 
Procedures for Subject Follow-up ................................................................ 53 
4.3.5 
Subjects Potentially Lost to Follow-up ........................................................ 54 
4.3.6 
Replacement Policy ...................................................................................... 54 
5 
Study Interventions ...................................................................................................... 54 
5.1 
Description of Investigational Product(s) ............................................................. 54 
5.1.1 
CSL112 ......................................................................................................... 54 
5.1.2 
Placebo ......................................................................................................... 55 
5.2 
Packaging, Labeling, Supply and Storage ............................................................ 55 
5.2.1 
Packaging and Labeling ............................................................................... 55 
5.2.2 
Supply and Storage ....................................................................................... 55 
5.3 
Accountability and Destruction ............................................................................ 56 

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5.4 
Other Intervention(s) ............................................................................................ 56 
5.5 
Dose Modification ................................................................................................ 56 
6 
Allocation, Dosing and Administration ....................................................................... 56 
6.1 
Allocation to Treatment ........................................................................................ 56 
6.1.1 
Subject Assignment ...................................................................................... 56 
6.1.2 
Randomization Procedures ........................................................................... 57 
6.1.3 
Blinding Procedures ..................................................................................... 57 
6.2 
Dosing and Administration ................................................................................... 58 
6.3 
Treatment Compliance .......................................................................................... 59 
7 
Contraindications, Permitted Therapies and Prohibited Therapies .............................. 59 
7.1 
Contraindications and Precautions to Further Dosing .......................................... 59 
7.2 
Permitted Therapies .............................................................................................. 60 
7.2.1 
Evidence-based Medical Therapy ................................................................ 60 
7.3 
Prohibited Therapies ............................................................................................. 61 
7.4 
Lifestyle Restrictions ............................................................................................ 61 
7.5 
Overdose ............................................................................................................... 62 
8 
Study Procedures and Visit Schedule .......................................................................... 62 
8.1 
Clinical Procedures ............................................................................................... 62 
8.1.1 
Demographics and Baseline Characteristic Assessments ............................. 62 
8.1.2 
Efficacy Assessments ................................................................................... 66 
8.1.3 
Safety Assessments ....................................................................................... 67 
8.1.4 
Other Assessments ........................................................................................ 74 
8.1.5 
Pharmacokinetic / Pharmacodynamics Assessments ................................... 74 
8.2 
Blood Samples ...................................................................................................... 75 
8.3 
Retention of Samples for Future Biomedical Research........................................ 75 
8.4 
Concomitant Therapies ......................................................................................... 75 
8.5 
Visit Schedule ....................................................................................................... 76 
8.5.1 
Visit 1 (Screening) ........................................................................................ 76 
8.5.2 
Active Treatment Period ............................................................................... 77 
8.5.3 
Visits 7, 8, 9, 10, and 11 (Follow-up Period) ................................................ 80 
8.5.4 
Early Termination Visit ................................................................................ 80 
9 
Adverse Events ............................................................................................................ 81 

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9.1 
Definitions ............................................................................................................ 81 
9.1.1 
Adverse Event .............................................................................................. 81 
9.1.2 
Adverse Events of Special Interest ............................................................... 82 
9.1.3 
Serious Adverse Event .................................................................................. 83 
9.2 
Severity of Adverse Events................................................................................... 84 
9.3 
Causality of Adverse Events ................................................................................. 84 
9.4 
Observation Period for Adverse Events ................................................................ 85 
9.5 
Follow-up of Adverse Events ............................................................................... 85 
9.6 
Adverse Event Reporting ...................................................................................... 86 
9.6.1 
Adverse Events ............................................................................................. 86 
9.6.2 
Adverse Events of Special Interest ............................................................... 86 
9.6.3 
Serious Adverse Event Reporting ................................................................. 87 
9.6.4 
Suspected MACE Reporting ........................................................................ 89 
9.6.5 
Negative Adjudication .................................................................................. 90 
9.6.6 
Overdose ....................................................................................................... 90 
9.6.7 
Pregnancy and Breastfeeding ....................................................................... 90 
9.7 
Institutional Review Board / Independent Ethics Committee Reporting 
Requirements ........................................................................................................ 91 
10 
Statistics ....................................................................................................................... 91 
10.1 
Sample Size .......................................................................................................... 91 
10.1.1 
Estimation ..................................................................................................... 91 
10.1.2 
Re-estimation ................................................................................................ 93 
10.2 
Description of Study Analysis Sets ...................................................................... 93 
10.2.1 
Screened Analysis Set .................................................................................. 93 
10.2.2 
Intent-to-Treat Analysis Set .......................................................................... 93 
10.2.3 
Modified Intent-to-Treat Analysis Set .......................................................... 93 
10.2.4 
Safety Analysis Set ....................................................................................... 94 
10.3 
Statistical Analyses and Methods ......................................................................... 94 
10.3.1 
Subject Disposition and Characteristics ....................................................... 94 
10.3.2 
Efficacy Analyses ......................................................................................... 94 
10.3.3 
Safety Analyses .......................................................................................... 103 
10.3.4 
Pharmacokinetic Analyses .......................................................................... 105 
10.3.5 
Pharmacodynamic Analyses ....................................................................... 105 
10.3.6 
Interim Analysis ......................................................................................... 106 

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11 
Quality Assurance ...................................................................................................... 111 
12 
Regulatory and Ethics Considerations ....................................................................... 111 
12.1 
Regulatory Considerations ................................................................................. 111 
12.2 
Institutional Review Board / Independent Ethics Committee ............................ 111 
12.3 
Subject Information and Informed Consent ....................................................... 111 
12.4 
Subject Confidentiality ....................................................................................... 112 
12.5 
Indemnity and Compensation ............................................................................. 112 
13 
Administrative Considerations .................................................................................. 113 
13.1 
Clinical Trial Research Agreement ..................................................................... 113 
13.2 
Clinical Study Registration and Results Disclosure ........................................... 113 
13.3 
Implementation of the Protocol / Protocol Amendment(s) ................................. 113 
13.4 
Protocol Deviations ............................................................................................ 113 
13.5 
Documentation and Record Keeping .................................................................. 114 
13.5.1 
Data Collection ........................................................................................... 114 
13.5.2 
Data Quality Assurance .............................................................................. 114 
13.5.3 
Record Retention ........................................................................................ 115 
13.6 
Study and Site Closure ....................................................................................... 115 
13.7 
Clinical Study Report ......................................................................................... 115 
13.8 
Use of Data and Publications.............................................................................. 116 
14 
References .................................................................................................................. 116 
15 
Appendices................................................................................................................. 120 
Appendix 1 
Signatures ................................................................................................... 121 
Appendix 2 
Modified Rankin Score .............................................................................. 123 
 
 
 

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List of Tables 
Table 1 
Investigational Product Dosing Characteristics ............................................... 59 
Table 2 
Study Procedures: Demographics and Baseline Characteristics...................... 63 
Table 3 
Safety Assessments .......................................................................................... 67 
Table 4 
Stopping Boundary Values ............................................................................. 108 
 
List of Figures 
Figure 1 
Study Schema .................................................................................................. 33 
 
 

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List of Abbreviations 
Abbreviation 
Term 
ACC / AHA / ESC 
American College of Cardiology / American Heart 
Association / European Society of Cardiology 
ACE 
Angiotensin-converting enzyme 
ACS 
Acute coronary syndrome 
AE 
Adverse event 
AESI 
Adverse event of special interest 
AKI 
Acute kidney injury 
ALT 
Alanine aminotransferase 
AMI 
Acute myocardial infarction 
apoA-I 
Apolipoprotein A-I 
ARB 
Angiotensin II receptor blocker 
AST 
Aspartate aminotransferase 
CCU 
Critical care unit 
CEC 
Clinical Events Committee 
CSLB 
CSL Behring 
CV 
Cardiovascular 
 
Dextrose 5% in water 
eCRF 
Electronic case report form 
eGFR 
Estimated glomerular filtration rate 
EOS 
End of Study 
FBR 
Future biomedical research 
FDA 
US Food and Drug Administration 
FMC 
First medical contact 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
HDL 
High-density lipoprotein 
HF 
Heart failure 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
ICU 
Intensive care unit 
IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committee 
IgA 
Immunoglobulin A 
CCI

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Abbreviation 
Term 
IMP 
Investigational Medicinal Product 
IRB 
Institutional Review Board 
IRT 
Interactive response technology 
ITT 
Intent-to-treat 
IV 
Intravenous 
KM 
Kaplan-Meier 
MACE 
Major adverse cardiovascular event(s) 
MedDRA  
Medical Dictionary for Regulatory Activities  
MI 
Myocardial infarction 
mITT 
Modified Intent-to-treat 
NA 
Not applicable 
NOAEL 
No observed adverse effect level 
NSTEMI 
Non-ST-segment elevation myocardial infarction 
PC 
Phosphatidylcholine 
PCI 
Percutaneous coronary intervention 
PD 
Pharmacodynamic(s) 
PK 
Pharmacokinetic(s) 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SMQ 
Standardized MedDRA Queries 
STEMI 
ST-segment elevation myocardial infarction 
ULN 
Upper limit of normal 
VAS 
Visual analog scale 
 
 
 

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1 
Introduction 
1.1 
Background 
Cardiovascular (CV) disease is the leading global cause of death, accounting for 17.3 million 
deaths per year, a number that is expected to grow to more than 23.6 million by 2030. There 
are more deaths annually from CV disease causes than all forms of cancer combined 
[Mozaffarian et al, 2016]. The disease process responsible for the majority of CV 
disease-related deaths is atherosclerosis, which can lead to a variety of acute presentations 
depending on the arterial bed affected and severity; the 2 most common are acute coronary 
syndrome (ACS) and ischemic stroke [Mahoney et al, 2008]. 
Acute coronary syndrome is a life-threatening condition, which most commonly occurs when 
an atherosclerotic plaque ruptures or erodes, leading to thrombus formation within a coronary 
artery. A thrombus within a coronary artery can result in unstable angina, a myocardial 
infarction (MI) (heart attack), or sudden death. Even after recovery from an acute episode of 
ACS, patients continue to be at heightened risk. The short-term morbidity and mortality 
associated with both the index coronary event and recurrent CV events can be as high as 20% 
per year [Morrow, 2010]. In the PLATO Study, which was conducted in ACS patients, 
approximately 50% of recurrent CV events (CV death, MI, or stroke) occurred within the 
first 30 days of a 1-year follow-up period in all ACS subgroups [NDA 22-433/S015 
Brilinta®, 2015]. 
Despite advances in therapeutic strategies for ACS, patients remain at heightened risk for 
recurrent ischemic events, particularly in the immediate weeks to months following the event. 
Consequently, effective and safe therapies that provide clinically relevant reductions in 
recurrent CV events beyond current secondary prophylaxis are needed for patients with ACS. 
High-density lipoprotein (HDL) exerts a protective effect in experimental models of 
atherosclerotic CV disease. While the proposed atheroprotective properties of HDL are 
multifaceted [Remaley et al, 2008; Tardif et al, 2009], HDL is believed to bring about 
beneficial effects mainly by reverse cholesterol transport, whereby excess cholesterol is 
removed from arteries containing atherosclerotic plaques and transported back to the liver for 
excretion. This removal of cholesterol is mediated by the dominant protein of HDL, 
apolipoprotein A-I (apoA-I) [Tall, 1998], and removal of cholesterol from the artery wall 
reduces the size of the plaque. Cholesterol efflux capacity, an ex vivo measure of HDL 
function, evaluates the ability of HDL to remove excess cholesterol from atherosclerotic 
plaque for transport to the liver. The measure is a correlate of major adverse CV events 

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(MACE) endpoints that is independent of HDL cholesterol [Khera et al, 2011; Rohatgi et al, 
2014; Saleheen et al, 2015; Liu et al, 2016; Zhang et al, 2016]. It has been suggested that 
pharmacotherapies that elevate cholesterol efflux capacity may be more likely to yield benefit 
to patients than those which raise HDL cholesterol [Siddiqi et al, 2015]. The central 
hypothesis of the program is that elevation of cholesterol efflux by infusion of CSL112 will 
reduce recurrent events in the period of high risk following an MI. 
1.2 
Background Information on CSL112 
1.2.1 
Overview 
CSL112 is a novel intravenous (IV) formulation of apoA-I purified from human plasma, 
formulated to deliver exogenous apoA-I. It is being developed for use in patients with ACS 
(diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-
segment elevation myocardial infarction (NSTEMI)  to reduce the risk of CV death, MI, and 
stroke upon delivery of exogenous apoA-I. The formulation of CSL112 includes apoA-I 
(active), phosphatidylcholine (PC), sodium cholate, and sucrose. 
A detailed description of the chemistry, pharmacology, efficacy, and safety of CSL112 is 
provided in the Investigator Brochure. 
1.2.2 
Nonclinical Evaluation 
CSL112 single and repeat dose nonclinical safety studies have been conducted. In single-dose 
studies (CSL112 administered as an IV infusion of 1-hour duration), a no observed adverse 
effect level (NOAEL) of 300 mg/kg was established in both rats and cynomolgus monkeys. 
In repeat-dose studies (CSL112 administered once every 3 days for 4 weeks by IV infusion), 
a NOAEL of 80 mg/kg was established in rats; however, a NOAEL was not established in the 
cynomolgus monkey because some adverse effects were observed at the lowest dose tested 
(80 mg/kg). In a 13-week repeat-dose toxicity study in rats (CSL112 administered by IV 
infusion over 2 hours, once every 3 days for 13 weeks), a NOAEL of 320 mg/kg was 
established. The higher NOAEL established in this longer term study, which indicates 
improved tolerability, reflects the transient nature of the effects observed with 4-week repeat 
dosing in rats. No treatment-related deaths occurred in any of the toxicity studies. 
After IV infusion of CSL112 to both rats and monkeys, the primary toxicological effects were 
hepatic and hematologic in nature. The effects were generally reversible, asymptomatic, and 
exhibited a moderate dose-response relationship. Some minor effects on renal parameters 

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were also observed; however, as there were no correlative histopathology findings in the 
kidney, the toxicological significance is unclear. 
The reproductive toxicity of CSL112 has been evaluated in embryo-fetal development  
studies in rats and rabbits; results from the embryo-fetal development study in rabbits 
indicate that CSL112 potentially represents a significant risk to the human fetus. Therefore, 
additional screening for pregnancy and highly effective contraception methods are necessary 
in clinical studies. No fertility studies have been conducted for CSL112; however, after repeat 
dosing, no treatment-related macroscopic or microscopic effects have been observed in 
reproductive organs of rats or cynomolgus monkeys. 
Further details on the hepatic and hematologic effects in the nonclinical studies, as well as 
other observations with CSL112, can be found in the Investigator Brochure for CSL112. 
1.2.3 
Clinical Experience 
In total, 1060 subjects have received at least 1 infusion of CSL112 in 7 completed clinical 
studies. Two phase 1 studies (Study CSLCT-HDL-09-63 and Study CSLCT-HDL-10-68), 
which were conducted in healthy adults, evaluated the safety, tolerability, and 
pharmacokinetics (PK) of escalating single or multiple doses of CSL112 [Gille et al, 2014]. A 
third phase 1 study (Study CSL112_1001) evaluated CSL112 in healthy adult subjects with 
normal renal function and adult subjects with moderate renal impairment. A fourth phase 1 
study (CSL112_1002) evaluated a single dose of CSL112 in healthy Japanese adults and 
weight-matched Caucasian adults. A phase 2a clinical study (Study CSLCT-HDL-10-70a) 
was conducted in subjects diagnosed with stable atherothrombotic disease, ie, the target 
population after initial acute presentation. A phase 2b study (Study CSLCT-HDL-12-77; 
AEGIS-I) [Gibson et al, 2016] evaluated CSL112 in MI subjects who were at high risk of 
subsequent CV events and had either normal renal function or mild renal impairment. The 
subjects enrolled in AEGIS-I were representative of the target phase 3 population in age, sex, 
concurrent medical conditions (eg, diabetes, hypertension), and chronic concomitant 
medications (eg, dual anti-platelet therapy, statins). A phase 2 study (Study CSL112_2001) 
was conducted in subjects with acute myocardial infarction (AMI) and moderate renal 
impairment. The safety profile, PK, and cholesterol efflux response were comparable to 
results demonstrated in the CSLCT-HDL-12-77 (AEGIS-I) clinical trial. 
1.3 
Study Overview 
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group 
study to evaluate the efficacy and safety of CSL112 on reducing the risk of MACE in 

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subjects with ACS, who are receiving evidence-based medical therapy. Subjects who present 
with STEMI or NSTEMI (managed with percutaneous coronary intervention [PCI] or 
medically managed), with documented evidence of multivessel coronary artery disease and  
other established risk factor(s) for recurrent CV events [Amsterdam et al, 2014; O’Gara et al, 
2013], were selected as the study population because they are all at high risk for recurrent 
MACE after experiencing an index event. The study will enroll approximately 17,400 
subjects with recent MI, up to approximately a maximum of 20,600 subjects, who will be 
randomized with equal allocation (1:1 ratio) to 1 of 2 treatment groups (CSL112 6 g or 
placebo). Randomization at baseline will be stratified by subject’s index MI type (STEMI vs 
NSTEMI), management of the index MI (PCI vs medically managed), and region (North 
America, Latin America, Western Europe, Central and Eastern Europe, or Asia Pacific). 
Investigational product will be administered by IV infusion once weekly for 4 consecutive 
weeks. The primary efficacy outcome will be the composite of CV death, MI, or stroke from 
the time of randomization through 90 days. Subjects will be followed for occurrence of 
MACE for 365 days from randomization. 
1.4 
Potential Risks and Benefits 
After an ACS event, patients are at risk of important additional clinical events such as death, 
MI, and stroke that could potentially be improved by treatment with CSL112. Six months 
after patients present with an index event of STEMI, approximately 15% will either have 
died or had another episode of myocardial ischemia, and a similar situation exists for 
NSTEMI / unstable angina patients [Yusuf et al, 2006]. Approximately half of these events 
will occur within the first 30 days after randomization [Wallentin et al, 2009]. It is 
hypothesized that infusion of CSL112 will provide therapeutic benefit to patients with recent 
MI who are at particularly high risk for early recurrent CV events. 
CSL112 contains sucrose as a stabilizer. Administration of sucrose by IV infusion has been 
associated with reports of acute kidney injury (AKI) attributed to osmotic nephrosis when 
immune globulin IV products formulated with sucrose were administered at high doses or at 
high rates of administration [Epstein and Zoon, 2000]. The dose of sucrose in a 6 g dose of 
CSL112 is approximately 2.5-fold less than the lowest single dose of sucrose that was 
associated with histopathologic changes in the kidney but without clinical evidence of 
nephrotoxicity. In addition, the maximum infusion rate for CSL112 of 6 g/2 hours 
(50 mg/min) ensures a sucrose infusion rate of < 1.7 mg sucrose/kg/min for an adult 
weighing 50 kg, which is well within the published guideline for safe administration of 
sucrose-containing immune globulin IV products [Epstein and Zoon, 2000]. In AEGIS-I, the 
co-primary endpoint of renal safety was demonstrated in subjects with an estimated 

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glomerular filtration rate (eGFR) ≥ 60 mL/min/m2 who received the first dose of CSL112 at 
least 12 hours but no later than 7 days after the index MI. Renal safety was demonstrated in 
subjects with moderate renal impairment eGFR < 60 and ≥ 30 mL/min/m2 in the 
CSL112_2001 study. 
CSL112 was formulated to contain lower PC and cholate levels than its predecessor 
formulation, CSL111. The intent of the reformulation was to mitigate the treatment-emergent, 
reversible, asymptomatic elevations in aminotransferases and unconjugated bilirubin that 
were noted with CSL111 in a phase 2a study conducted in MI subjects [Tardif et al, 2007]. In 
addition, the sucrose content was reduced in CSL112 to mitigate any potential renal safety 
issues. No renal or hepatic safety signals were identified with administration of CSL112 (2 g 
or 6 g) in the AEGIS-I study or in the phase 2 safety study in AMI with moderate renal 
impairment (6 g dose of CSL112). 
There is a potential for allergic reactions or hypersensitivity to CSL112 in certain individuals, 
given the constituents of the product. CSL112 consists of apoA-I purified from human 
plasma. To date, CSL112 has been evaluated in 1060 subjects who have been exposed to at 
least 1 dose of CSL112 without the occurrence of product-specific antibodies. CSL112 may 
contain immunoglobulin A (IgA) and also contains PC derived from soy beans. Therefore, 
subjects with a positive history of IgA deficiency, antibodies to IgA, or allergy to either soy 
bean or peanuts will be excluded from the study. In AEGIS-I, drug hypersensitivity reactions 
primarily consisting of rash were reported with similar frequency amongst treatment groups 
(all CSL112: 3.0%; placebo: 2.7%), and no anaphylaxis / anaphylactoid reactions were 
reported. 
The risk of viral and prion contamination is a feature common to all biologic agents in which 
the manufacture involves the use of materials of animal or human origin and CSL112, 
therefore, may carry a risk of transmitting infectious agents (eg, viruses and, theoretically, the 
Creutzfeldt-Jakob disease agent). However, the risk of infectious agent transmission has been 
reduced by screening plasma donors for prior exposure to certain viruses, testing for the 
presence of certain current virus infections, and including steps for virus inactivation, and 
sterility in the manufacturing process. In the development program, there was no evidence of 
exposure to viral contamination in subjects exposed to CSL112. 
Overall, the safety and tolerability profiles of CSL112 have been acceptable. 
A low dose of albumin will be used as the matching placebo. Albumin in therapeutic doses 
can be used as a volume expander in states of low intravascular volume and is 

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contraindicated in patients with cardiac failure. The use of 170 mL of a 4.4% albumin 
solution infused over 2 hours in hemodynamically stable, compensated ACS subjects is 
anticipated to have a negligible impact on plasma osmolality. The risk of anaphylaxis or other 
severe hypersensitivity reactions is anticipated to be very low based on post-marketing data 
and medical literature. All subjects will be monitored for the potential risk of 
hypersensitivity. Albumin in varying doses has been used as placebo in various non-CV 
disease states and was well tolerated [Chenevard et al, 2012; Relkin et al, 2017, Gelmont et 
al, 2016; Finfer, 2014]. Based on internal assessment and validation from external advisors 
such as the AEGIS-II Executive Committee and the Independent Data Monitoring Committee 
(IDMC), the use of albumin as placebo in a low concentration infused over a 2-hour period is 
anticipated to be well tolerated in compensated ACS subjects. 
Subjects in clinical studies generally cannot expect to receive direct benefit from treatments 
during participation as clinical studies are designed to provide information about safety and 
efficacy of a new investigational product. Additional details about CSL112 can be found in 
the current version of the Investigator Brochure for CSL112 which outlines the potential risks 
to subjects administered CSL112 and precautions for its use. 
Thus, given the potential benefit of CSL112 and the acceptable safety profile of CSL112 and 
low dose albumin (as placebo), justification is provided for the clinical trial, which will 
evaluate the use of CSL112 in the reduction of early MACE in a high-risk ACS population. 
2 
Study Objectives and Endpoints 
2.1 
Primary Objective and Endpoint 
The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk 
of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in 
subjects with ACS (diagnosed with STEMI or NSTEMI). 
Primary Efficacy Endpoint 
Summary Measures 
Time to first occurrence of any component of 
composite MACE, defined as CV death, MI, or 
stroke from the time of randomization through 
90 days. 
The primary endpoint will include all MIs. 
Event rate (%) at 90 days by treatment arm. 
Point estimate and 95% CI for hazard ratio 
(CSL112:Placebo). 
CV = cardiovascular; MACE = major adverse cardiovascular event; MI = myocardial infarction. 

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2.2 
Secondary Objectives and Endpoints 
2.2.1 
Key Secondary Objectives 
The secondary objectives of this study are as follows: 
1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for 
coronary, cerebral, or peripheral ischemia. 
2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or 
stroke) through 180 and 365 days in subjects with ACS (diagnosed with STEMI or 
NSTEMI). 
2.2.2 
Key Secondary Endpoints 
Key secondary efficacy endpoints are those for which the associated hypotheses will be 
formally tested and are therefore adjusted for multiplicity. 
Key 
Secondary 
Objective  
Key Secondary Endpoints 
Summary Measure(s) 
1 
Total number of hospitalizations for 
coronary, cerebral, or peripheral 
ischemia from the time of 
randomization through 90 days. 
• Mean hospitalization rate per 90 days by 
treatment arm. 
• Point estimate and 95% CI for Rate ratio 
(CSL112:Placebo). 
2 
Time to first occurrence of CV 
death, MI, or stroke from the time of 
randomization through 180 days. 
• Event rate (%) at 180 days by treatment 
arm. 
• Point estimate and 95% CI for hazard ratio 
(CSL112:Placebo). 
 
Time to first occurrence of CV 
death, MI, or stroke from the time of 
randomization through 365 days. 
Event rate (%) at 365 days by treatment arm 
• Point estimate and 95% CI for hazard ratio 
(CSL112:Placebo) 
CV = cardiovascular; MI = myocardial infarction. 
2.2.3 
Other Secondary Objectives 
Other secondary objectives of the study are as follows: 
1. To further evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, 
or stroke) and all-cause death in subjects with ACS (diagnosed with STEMI or NSTEMI). 
2. To evaluate the safety of CSL112 in subjects with ACS (diagnosed with STEMI or 
NSTEMI). 

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2.2.4 
Other Secondary Endpoints 
2.2.4.1 
Other Secondary Efficacy Endpoints 
Other Secondary Efficacy Endpoints 
Summary Measure(s) 
Time to first occurrence of each individual 
component of the composite primary efficacy 
endpoint from the time of randomization to 
90 days: 
• CV death. 
• MI. 
• Stroke. 
For each component: 
• Event rate (%) at 90 days by treatment arm. 
• Point estimate and 95% CI for hazard ratio 
(CSL112:Placebo). 
 
Time to first occurrence of CV death, type 1 
MI, or stroke from the time of randomization 
through 90, 180, and 365 days. 
• Event rate (%) at 90, 180, and 365 days by 
treatment arm. 
• Point estimate and 95% CI for hazard ratio 
(CSL112:Placebo). 
Time to occurrence of all-cause death from 
the time of randomization through 365 days. 
• Event rate (%) at 365 days by treatment arm. 
• Point estimate and 95% CI for hazard ratio 
(CSL112:Placebo). 
CV = cardiovascular; MI = myocardial infarction. 
2.2.4.2 
Other Secondary Safety Endpoints 
Other Secondary Safety Endpoints 
Summary Measure(s) 
Adverse Events. 
• 
Overall n (%) of subjects with adverse events 
through 90 days. 
• 
Overall n (%) of subjects with treatment-
related adverse events through End of Study 
(EOS). 
• 
Overall n (%) of subjects with SAEs through 
EOS. 
Changes in clinical laboratory assessments. 
• Descriptive statistics for actual value and 
change from baseline. 
• n (%) of subjects with a shift from baseline to 
worst post-treatment value according to normal 
range criteria (normal, high, or low). 
EOS = End of Study; SAE = serious adverse event. 
2.3 
Exploratory Objectives and Endpoints 
2.3.1 
Exploratory Objectives 
The exploratory objectives of this study are as follows: 
1. To evaluate the efficacy of CSL112 on reducing the rate of hospitalization for coronary, 
cerebral or peripheral ischemia. 

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2. To further explore the effect of CSL112 on the risk of MACE (CV death, MI, stroke), 
non-CV death, and severe coronary ischemia requiring urgent revascularization. 
3. To assess the impact of CSL112 on medical resource utilization and quality of life. 
4. To evaluate the PK / pharmacodynamic (PD) characteristics of CSL112. 
2.3.2 
Exploratory Endpoints 
The endpoints for evaluation of the exploratory objectives are: 
1. Total number of hospitalizations for coronary, cerebral, or peripheral ischemia from the 
time of randomization through 30 days. 
2. Time to first occurrence of CV death, MI, stroke, or severe coronary ischemia requiring 
urgent revascularization from the time of randomization through 90 days. 
3. Time to first occurrence of CV death, MI, or stroke from the time of randomization 
through 30 and 60 days. 
4. Time to first occurrence of MI by type, according to the universal definition, from the 
time of randomization through 90 days. 
5. Time to occurrence of CV death from the time of randomization through 365 days. 
6. Time to occurrence of non-CV death from the time of randomization through 365 days. 
7. Total occurrence of re-hospitalization for CV events and all-cause death from the time of 
randomization through 90 days. 
8. Total occurrence of CV death, MI, and stroke from the time of randomization through 90, 
180, and 365 days. 
9. Total occurrence of all-cause death, MI, and stroke from the time of randomization 
through 90, 180, and 365 days. 
10. Medical resource utilization from the time of randomization through 90 days: 
a. Number of total hospitalizations. 
b. Length of hospital stay. 
c. Number of critical care unit (CCU) or intensive care unit (ICU) days. 
d. Select procedures / surgeries related to hospitalization for coronary, cerebral, or 
peripheral ischemia. 

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e. Discharge status to home with or without additional care, rehabilitation, and skilled 
nursing facilities following hospitalization for coronary, cerebral, or peripheral 
ischemia. 
11. Change in EQ-5D-3L data from baseline to Day 90. 
12. Pharmacokinetic endpoints will include the following: 
a. Baseline-corrected plasma apoA-I concentrations. 
b. Baseline-corrected plasma PC concentrations. 
c. Concentration in plasma at end-of infusion for apoA-I and PC. 
d. Accumulation ratio for apoA-I and PC. 
13. Pharmacodynamic endpoints include the following: 
a. Total cholesterol efflux. 
b. ABCA1-dependent efflux. 
c. ABCA1-independent efflux. 
3 
Study Overview 
3.1 
Study Design 
This is a phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel-group 
study designed to evaluate the efficacy and safety of CSL112 on reducing the risk of MACE 
in subjects with ACS (diagnosed with STEMI or NSTEMI) who are receiving evidence-based 
medical therapy. 
Subjects will be screened and, if eligible, stratified at baseline by index MI type (STEMI vs 
NSTEMI), management of the index MI (PCI vs medically managed), and region (North 
America, Latin America, Western Europe, Central and Eastern Europe, or Asia Pacific). A 
balanced distribution of STEMI and NSTEMI is desired, and may require implementation of 
a limit on an index MI type during the conduct of the study. The study will enroll 
approximately 17,400 subjects with recent MI, up to a maximum of approximately 20,600 
subjects, who will be randomized with equal allocation (1:1 ratio) to 1 of 2 treatment groups 
(CSL112 6 g or placebo). 
The study is planned to be conducted at approximately 1000 sites. The estimated study 
duration is approximately 50 months. 

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The study will consist of a Screening Period, an Active Treatment Period, and a Follow-up 
Period (Figure 1).  
First medical contact (FMC) is defined as the documented time point (ie, clock start) when 
the subject arrives at the 1st treating hospital emergency department (ie, door time) or cardiac 
catheterization laboratory for evaluation and treatment of the index MI event. Eligible 
subjects meeting all inclusion criteria and none of the exclusion criteria (Section 4.1), and 
who meet dosing eligibility criteria (Section 4.2) will receive once weekly IV infusions of 
investigational product (CSL112 or placebo) for 4 consecutive weeks, with each infusion 
approximately 7 days apart (- 2 / + 1; ie, dosing between 5 to 8 days window) during the 
4-week Active Treatment Period. Each infusion of investigational product should be 
completed as close to the visit windows outlined in the Schedule of Assessments as possible. 
An infusion may be skipped (ie, ‘missed’) or delayed at the discretion of the investigator to 
evaluate and treat an adverse event (AE) before the next infusion. Therefore, the time 
window between each infusion may be extended as long as the last infusion of investigational 
product is given within 30 days of infusion 1, and the minimum window between infusions is 
at least 5 days. 
For all randomized subjects, before administration of infusion 1 of investigational product, 
each subject must be deemed clinically stable, must meet the renal and hepatic eligibility 
criteria, and be dosed within 5 days of FMC.  In addition: 
• For subjects treated medically with or without thrombolytic agents, infusion 1 of 
investigational product must occur no earlier than 12 hours after FMC. 
• For subjects undergoing angiography or PCI, with or without stent placement, infusion 1 
of investigational product must occur no earlier than 12 hours after IV contrast 
administration.  
Infusion 1 should occur before hospital discharge or on the day of discharge. If discharge 
occurs on a weekend, infusion 1 of investigational product can be administered on the next 
business day as long as timing is still within 5 days of FMC. All tests and procedures that are 
required to be performed to determine subject eligibility (ie, screening and randomization) 
must be performed with enough time to administer the investigational product within this 
timeframe. Screening and randomization may occur on the same day (Day 1) provided 
laboratory results are available for review by the investigator and all eligibility criteria have 
been met, including the requirements for alanine aminotransferase (ALT), total bilirubin, and 
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3.2 
Dose and Dosing Regimen 
CSL112 (6 g) or a matched volume of placebo will be administered as an IV infusion into a 
suitable vein (peripheral or central) once weekly for 4 consecutive weeks (4 infusions total) 
(Section 6.2). The placebo used in this study is a physical match to the investigational 
product, CSL112, (Section 5.1.2) after proper preparation. A 6 g dose of CSL112 was 
selected for this study based upon the safety and PK / PD data obtained in the AEGIS-I study 
in subjects with MI (Study CSLCT-HDL-12-77). 
Dosing eligibility criteria are presented in Section 4.2. 
3.3 
Scientific Rationale 
3.3.1 
Study Design Rationale 
Despite advances in therapeutic strategies for ACS, patients are at high risk for early 
recurrent events, particularly in the immediate weeks to months following the event. 
Consequently, effective and safe therapies that provide clinically relevant reductions in 
recurrent CV events beyond current secondary prevention are needed for patients with ACS. 
Subjects with a recent MI have been chosen as the study population to best study this unmet 
need in the immediate weeks to months following the event. In addition to the key inclusion 
criterion of evidence of multivessel coronary artery disease (see Section 4.1.1, Inclusion 
Criterion 5), subjects are required to have the presence of high cardiovascular risk, either the 
presence of diabetes mellitus requiring pharmacotherapy or at least 2 of the following risk 
factors: age of 65 years or older, prior history of MI, or peripheral arterial disease. This 
enrichment strategy selects subjects at highest risk for subsequent CV events after an MI and 
provides adequate representation of subgroups of interest. 
A double-blind design is being used to avoid potential bias during data collection and 
evaluation of clinical endpoints. A placebo-controlled design is being used because there is 
no approved active comparator for CSL112; therefore, CSL112 will be evaluated compared 
with placebo. All subjects randomized to treatment (CSL112 or placebo) in the study will 
receive background evidence-based medical therapy according to local standards of care and 
national practice guidelines (without a local standard, the current guideline from the 
American College of Cardiology / American Heart Association, European Society of 
Cardiology, etc. should be utilized), which will allow assessment of the incremental impact of 
CSL112 over currently approved treatments. 

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The definition of FMC has been selected to best represent the time the subject first presents 
for treatment for an acute ACS event and allows for targeted treatments to be provided. The 
goals of early treatment are immediate relief of ischemia, and prevention of complications 
arising from the MI and death. Thus, the time period of FMC is the start of the observation 
when acutely targeted therapies can be administered. This time period best allows for the 
identification of patients who have clinical instability and do not meet eligibility criteria. All 
patients who are deemed clinically stable during this period, have no suspicion of AKI after 
IV contrast agent administration (subjects who have undergone angiography) or after FMC 
for the index MI (subjects who have not undergone angiography), and meet all eligibility 
criteria should be considered for participation in the clinical trial. In contrast to acute ACS 
therapies, CSL112 is being developed for use in high-risk ACS patients to reduce the risk of 
CV death, MI, and stroke during the sub-acute period post MI when patients continue to be at 
increased risk for recurrent events. 
Because of the related pathophysiology of individual CV events such as death, MI, and stroke 
after the acute phase of ACS, composite MACE endpoints consisting of relevant and related 
components have become accepted as primary endpoints in the study of new agents in ACS 
studies [CPMP/EWP/570/98, 2016]. Cardiovascular death, MI, and stroke are the most 
clinically meaningful efficacy endpoints for CV clinical studies as they are distinct 
irreversible events. The treatment focus for CSL112 is the subacute (ie, short term) period 
when patients recovering from ACS are most vulnerable for recurrent events. Therefore, to 
assess clinical benefit of CSL112, the primary endpoint of MACE at Day 90 is an appropriate 
timepoint.  The durability of CSL112 will be assessed using the key secondary endpoints of 
MACE at Day 180 and extended follow-up at Day 365. 
3.3.2 
Dose Rationale 
A 6 g dose of CSL112 was selected for this study based upon results from a PK-PD model 
that was developed to assess the relationship between apoA-I exposure and cholesterol efflux 
capacity using data from the AEGIS-I study in subjects with MI: 
• The 6-g dose demonstrated an immediate 4-fold increase in cholesterol efflux capacity 
and 2-fold elevation in apoA-I compared with baseline. The 6-g dose can achieve the 
highest and most immediate elevation of cholesterol efflux capacity that can be 
practically obtained in MI subjects without compromising subject safety. 
• The interval between infusions was chosen to maximize continuous exposure to the drug 
substance, apoA-I, above baseline levels and to minimize net accumulation of either 
apoA-I or its phospholipid excipient. 

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• The choice of 4 infusions is based on the rapid decline in risk in the month after an MI, 
such that the potential value to the subject for subsequent infusions diminishes each week 
after MI as the potential risk also decreases. 
In AEGIS-I and CSL112_2001 studies, hepatic and renal safety were demonstrated in 
subjects with an eGFR ≥ 30 mL/min/m2 who received the first 6 g dose of CSL112 at least 12 
hours but no later than 7 days after an MI and 3 subsequent infusions at least 5 days apart. 
The type and frequency of AEs reported in AEGIS-I and CSL112_2001 are consistent with 
that reported in the early phase studies conducted in healthy adults, stable patients with 
atherothrombotic disease and stable patients with mild renal impairment. 
3.4 
Planned Study Duration 
The duration of the study for an individual subject is expected to be approximately 365 days 
(+ 14 days). This estimation is based on: 
• A Screening Period of up to 5 days from FMC. 
• An Active Treatment Period of 5 weeks (includes maximum window at each visit): 
4 infusions of investigational product administered approximately 7 days apart. 
• A Follow-up Period of approximately 11 months (ie, to Day 365). 
The overall study duration (ie, first subject’s Screening Visit to last subject’s EOS Visit) will 
be approximately 50 months. 
3.5 
Planned Number of Subjects 
An estimated 17,400 subjects will be enrolled. MACE rates will be monitored using blinded 
data on an ongoing basis during the enrollment phase of the study to determine the actual 
number of subjects to be enrolled. A sample size of up to approximately 20,600 subjects will 
be permitted without a protocol amendment (Section 10.1). 
3.6 
Definition of End of the Clinical Study 
The end of the clinical study (ie, completion of the study at all participating study sites) will 
be at least 365 days after the last subject is randomized (ie, all subjects have completed the 
EOS Visit). 

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If the study is to be terminated early for reason of futility or efficacy based on interim 
analysis results, the following definitions would apply to subject follow-up: 
• If the study is terminated early for futility, the end of the clinical study is defined as the 
latest date that a randomized subject has a study visit. 
• If the study is terminated early for efficacy, enrollment will cease upon the announcement 
of the decision to stop the study. In this case, the end of the clinical study is defined as the 
date the last subject randomized has completed the EOS Visit. 
Refer to Section 10.3.6 for details regarding the 3 planned interim analyses and Section 4.3.4 
for procedures for subject follow-up. 
3.7 
Study Oversight 
3.7.1 
Independent Data Monitoring Committee 
An unblinded IDMC will monitor the safe conduct of the study. An IDMC charter outlines 
the roles and responsibilities of the committee and guides its operations. The IDMC consists 
of qualified scientists who are not investigators in the study and not otherwise associated with 
CSLB. 
The responsibilities of the IDMC will include the following: 
• Review the safety data at planned intervals and identify if significant safety concerns 
arise during the study. 
• Provide recommendations to the Executive Committee chairperson and CSLB regarding 
study conduct matters that affect safety. 
• Request an interim safety review whenever it ascertains one is warranted. 
• If warranted due to safety concerns, recommend modifications to study conduct or early 
study termination. 
• Review efficacy and safety data as part of prespecified interim analyses for futility and 
efficacy, and make recommendations regarding study progression or termination 
(Section 10.3.6). 
• Monitor for the potential risk of an immune response to CSL112 and apoA-I and make 
recommendations regarding the number of samples to be assayed. 
Additionally during the course of study conduct, the IDMC will review unblinded laboratory 
data to assess safety with respect to hepatic and renal function when the first 20% of enrolled 

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subjects have completed Visit 6 (Day 29) (Section 10.3.6). In addition, the IDMC will review 
renal function for those subjects dosed within 12 to < 48 hours after contrast administration. 
The IDMC can determine whether the requirement for local and / or central laboratory 
assessments of hepatic and / or renal function before subsequent infusions can be 
discontinued (ie, blood sampling and review of results can stop (see Schedule of 
Assessment). If the IDMC so recommends, study investigators will be notified by the 
Executive Committee Chairperson as to which of these routine laboratory assessments are no 
longer required, and whether eligibility for all subsequent infusions may be based on clinical 
assessment (ie, starting with infusion 2 [Visit 3]). 
The IDMC will also monitor unblinded (ie, non-aggregated) suspected MACE endpoint 
events and other safety data to ensure the safety of subjects in the study. 
3.7.2 
Executive Committee 
A blinded Executive Committee will provide clinical guidance on study design, 
implementation, conduct, and interpretation of results. The Executive Committee will 
comprise designated representatives from among the principal investigators, other recognized 
thought leaders in the field of ACS, lipidology, and biostatistics, as well as sponsor 
representatives. The Executive Committee is described in further detail in its charter. 
A subgroup of the Executive Committee will provide academic leadership on study 
publications. The Publications Committee will be described in further detail in the Executive 
Committee charter. 
3.7.3 
Steering Committee 
A blinded Steering Committee will be formed consisting of members who are lead 
investigators from each country / region. The Steering Committee will advise and assist the 
Executive Committee with regard to the scientific and operational aspects of the study. 
Details of the composition, roles, and responsibilities of the Steering Committee are 
documented in its charter. 
3.7.4 
Clinical Events Committee 
An independent Clinical Events Committee (CEC) will review and adjudicate each suspected 
CV event endpoint while blinded to treatment assignments. Suspected CV event endpoints 
include all-cause mortality, CV death, all MI, all stroke, and hospitalizations for coronary, 
cerebral, or peripheral ischemia (including coronary revascularization). The CEC will also 
review and adjudicate the occurrence of potential hepatic injury, including results from 

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hepatic laboratory tests and hepatic injury assessments, and new or worsening heart failure 
(HF), in a blinded fashion. A common group of qualified scientists and physicians will 
prepare the definitions of endpoints and instructions for interpretation based on available 
guidance. The CEC is described in further detail in its charter. 
3.8 
Study Stopping Criteria 
At any time, the IDMC may recommend study termination due to safety concerns 
(Section 3.7.1). Three interim analyses are planned to evaluate the available efficacy data; the 
IDMC will review unblinded data from these planned interim analyses and may recommend 
study termination due to futility or strong evidence of efficacy (refer to Section 10.3.6). The 
IDMC recommendation will be relayed to the Executive Committee chairperson, and then 
communicated to the CSLB Head of Clinical Development. 
4 
Selection and Withdrawal of Subjects 
4.1 
Eligibility Criteria 
The study population will be selected on the basis of the inclusion and exclusion criteria 
described in the following sections. Each subject should meet all of the inclusion criteria and 
none of the exclusion criteria for this study. Subject eligibility should be reviewed and 
documented by a medically qualified member of the investigator’s study team before subjects 
are included in the study. Infusion 1 must be administered in the timeframe as detailed in 
Section 4.2.1.   
4.1.1 
Inclusion Criteria 
To be enrolled into the study, subjects must meet all of the following inclusion criteria: 
1. Capable of providing written informed consent and willing and able to adhere to all 
protocol requirements. 
2. Male or female at least 18 years of age at the time of providing written informed consent. 
3. Evidence of myocardial necrosis in a clinical setting consistent with type 1 (spontaneous) 
MI (STEMI or NSTEMI) caused by atherothrombotic coronary artery disease (4th 
Universal Definition of MI [Thygesen et al, 2019]) as defined by the following: 
a. Detection of a rise and / or fall in cardiac troponin I or T with at least 1 value above 
the 99th percentile upper reference limit. 
AND 

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b. Any 1 or more of the following: 
i. Symptoms of acute myocardial ischemia (ie, resulting from a primary coronary 
artery event). 
ii. New (or presumably new) significant ST/T wave changes or left bundle branch 
block. 
iii. Development of pathological Q waves on electrocardiogram. 
iv. Imaging evidence of new loss of viable myocardium or regional wall motion 
abnormality in a pattern consistent with an ischemic etiology. 
v. Identification of intracoronary thrombus by angiography. 
Note: Electrocardiograms obtained as part of standard of care can be used to support or 
confirm the index MI. 
4. No suspicion of AKI at least 12 hours after IV contrast agent administration (subjects 
who have undergone angiography) or after FMC for the index MI (subjects who have not 
undergone angiography). There must be documented evidence of stable renal function 
defined as no more than an increase in serum creatinine < 0.3 mg/dL (27 µmol/L) from 
pre-contrast serum creatinine value. 
5. Evidence of multivessel coronary artery disease defined as meeting 1 or more of the 
following criteria: 
a. At least 50% stenosis of the left main coronary artery or at least 2 epicardial coronary 
artery territories (left anterior descending, left circumflex, right coronary artery) on 
catheterization performed during the index hospitalization. 
b. Prior cardiac catheterization documenting at least 50% stenosis of the left main 
coronary artery or at least 2 epicardial coronary artery territories (left anterior 
descending, left circumflex, right coronary artery). 
c. Prior PCI and evidence of at least 50% stenosis of at least 1 epicardial coronary artery 
territory different from prior revascularized artery territory. 
d. Prior multivessel coronary artery bypass grafting. 
6. Presence of established cardiovascular risk factor(s), defined as: 
a. Diabetes mellitus on pharmacotherapy. 
OR  
b. 2 or more of the following: 

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i. Age ≥ 65 years. 
ii. Prior history of MI. 
iii. Peripheral arterial disease defined as meeting at least 1 of the following criteria: 
1. Current intermittent claudication or resting limb ischemia AND an ankle 
brachial index ≤ 0.90. 
2. History of peripheral revascularization (surgical or percutaneous). 
3. History of limb amputation due to peripheral arterial disease. 
4. Angiographic evidence (using computed tomographic angiography, magnetic 
resonance angiography, or invasive angiography) of a peripheral artery 
stenosis ≥ 50%. 
7. Female subjects must be postmenopausal or with a negative urine pregnancy test prior to 
randomization. If the urine test cannot be confirmed as negative, a serum pregnancy test 
will be required. This pregnancy test must be negative for the subject to be eligible. 
a. Postmenopausal status is defined as subjects over the age of 60 years, subjects 
aged 45 to 60 years (inclusive) with amenorrhea for at least 1 year with 
documented evidence of follicle-stimulating hormone level > 30 IU/L, or 
subjects who are surgically sterile for at least 3 months before randomization. 
If the follicle-stimulating hormone value is not available prior to 
randomization, a urine pregnancy test is required. 
b. Females of childbearing potential must be willing to use an acceptable method 
of contraception to avoid pregnancy while receiving treatment with CSL112 
(ie, during the Active Treatment Period) and for 30 days after receipt of the 
last dose of investigational product; and, if currently breastfeeding a child, 
willing to cease breastfeeding. 
NOTE: Acceptable methods of contraception are:  
i. Abstinence, where abstinence is the preferred and usual lifestyle of the 
subject, including refraining from heterosexual intercourse during the 
entire period of risk associated with the study treatments. Periodic 
abstinence (calendar, symptothermal, postovulation methods), 
withdrawal (coitus interruptus), spermicides only, and lactational 
amenorrhoea method are not acceptable definitions of abstinence. 
ii. Surgical sterilization (more than 3 months before randomization) of 
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iii. Use of intrauterine device (placed more than 3 months before 
randomization). 
iv. Injectable combined hormonal or contraceptive medication implant 
alone.  
v. Injectable single hormone, oral hormonal contraceptive (eg, combined 
or progesterone only), contraceptive medication patch, or 
estrogen/progestin vaginal ring plus an acceptable barrier method as 
outlined below. 
Acceptable barrier methods include: female or male condoms, with spermicidal 
foam or spermicidal jelly, or diaphragm, with spermicidal foam or spermicidal 
jelly, all of which must be used with an additional method of contraception 
outlined above. Female condom and male condom should not be used together. 
8. Investigator believes that the subject is willing and able to adhere to all protocol 
requirements. 
9. Willing to not participate in another investigational study until completion of their final 
study visit. 
4.1.2 
Exclusion Criteria 
Subjects must not be enrolled into the study if they meet any of the following exclusion 
criteria: 
1. Ongoing hemodynamic instability defined as any of the following: 
a. A history of New York Heart Association Class III or IV HF within the last year. 
b. Killip Class III or IV. 
c. Sustained and / or symptomatic hypotension (systolic blood pressure < 90 mmHg). 
d. Known left ventricular ejection fraction < 30%. 
2. Evidence of hepatobiliary disease as indicated by any 1 or more of the following at 
screening: 
a. Current active hepatic dysfunction or active biliary obstruction. 
b. Chronic or prior history of cirrhosis or of infectious / inflammatory hepatitis. 

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Note: If a subject has a medical history of recovered hepatitis A, B, or C without 
evidence of cirrhosis, he / she could be considered for inclusion if there is 
documented evidence that there is no active infection (ie, antigen negative). 
c. ALT > 3 × upper limit of normal (ULN) or total bilirubin > 2 × ULN at time of 
randomization. Subjects with a known or suspected history of Gilbert's syndrome are 
not eligible for study participation if their direct bilirubin is > 2 × ULN. 
3. Evidence of severe chronic kidney disease with an estimated glomerular filtration rate of 
< 30 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology 
Collaboration equation) [Levey et al, 2009; Stevens et al, 2010] or if subject is receiving 
dialysis. 
4. Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index 
MI. 
5. Body weight < 50 kg. 
6. Known history of allergies, hypersensitivity, or deficiencies as follows: 
a. Allergy to soy bean or peanuts (Section 7.1) 
b. Known or suspected hypersensitivity to the investigational product, or to any 
excipients of the investigational product or placebo (albumin) (Section 5.1.1 and 
Section 5.1.2, respectively). 
c. A known history of IgA deficiency or antibodies to IgA. 
7. Other severe comorbid condition, concurrent medication, or other issue that renders the 
subject unsuitable for participation in the study, including but not limited to: 
a. A comorbid condition with an estimated life expectancy of ≤ 6 months at the time of 
consent. 
b. Women who are pregnant or breastfeeding at the time of randomization. 
c. Participated in another interventional clinical study within 30 days of consent or has 
plans to participate in another interventional clinical study at the time of consent. 
d.  Known alcohol, drug, or medication abuse within 1 year before consent to this study. 
e. Treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, 
targeted therapy, or gene therapy) within 3 months before the first administration of 
investigational product or at any time during the study. Recovery from associated 
toxicities (eg, hematologic) must be documented in the source document. 

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NOTE: Use of low-dose chemotherapy for treatment of a condition other than cancer 
(eg, rheumatic disease) is permissible. Hormonal therapy or anti-hormonal therapy is 
also allowed; however, a subject’s life expectancy must be > 24 months at the time of 
consent. 
f. Previously randomized or participated in this study or previously exposed to CSL112. 
g. Mental condition rendering the subject (or the subject's legally acceptable 
representative[s]) unable to understand the nature, scope, and possible consequences 
of the study. 
h. Subjects who are incarcerated, including prisoners or subjects compulsorily detained 
for treatment of either a psychiatric or physical (eg, infectious disease) illness. 
i. Inability or unwillingness to comply with all follow-up through end of the study, 
and / or unwilling to allow review of medical records in accordance with local 
regulatory requirements at time of consent. 
j. Investigator determines that the subject is not suitable for study participation for any 
other reason. 
8. Involved in the planning and / or conduct of the study (applies to CSLB staff, staff at the 
study site, and third-party vendors). 
4.2 
Dosing Eligibility 
4.2.1 
Infusion 1 
For all randomized subjects, before administration of infusion 1 of investigational product, 
each subject must be deemed clinically stable, must meet the renal and hepatic eligibility 
criteria, and be dosed within 5 days of FMC.  In addition: 
• For subjects treated medically with or without thrombolytic agents, infusion 1 of 
investigational product must occur no earlier than 12 hours after FMC. 
• For subjects undergoing angiography or PCI, with or without stent placement, infusion 1 
of investigational product must occur no earlier than 12 hours after IV contrast 
administration.  
The first infusion should occur before hospital discharge or on the day of discharge. If 
discharge occurs on a weekend, infusion 1 of investigational product can be administered on 
the next business day as long as timing is still within 5 days of FMC. 

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All tests and procedures that are required to determine subject eligibility (ie, screening and 
randomization) must be performed with enough time to administer the investigational 
product within the specified timeframe. If angiography is planned for treatment of the index 
MI, randomization must occur after the procedure has been performed and stability of serum 
creatinine confirmed at least 12 hours after IV contrast administration. Screening and 
randomization may occur on the same day (Day 1) provided laboratory results are available 
for review by the investigator and eligibility criteria have been met for ALT, total bilirubin, 
and serum creatinine. 
Hepatic function (ALT and total bilirubin) must be within acceptable limits and stability of 
renal function (serum creatinine) must be confirmed by the investigator before administration 
of infusion 1 of investigational product (Sections 4.2.1.1 and 4.2.1.2, respectively). 
According to the following criteria, local laboratory values at screening (Visit 1) will be used 
to determine eligibility for inclusion into the study and eligibility for infusion 1 of 
investigational product. These local laboratory values will also be considered “baseline” for 
determining subsequent dosing eligibility. 
Local laboratory values obtained as part of standard of care testing for the index AMI event 
and before obtaining written informed consent may be used to determine study entry and 
infusion 1 eligibility. However, if results (for ALT, total bilirubin, and / or serum creatinine) 
are not available, then a blood sample must be obtained for the local laboratory testing. A 
single blood draw may be performed to collect samples for local and central laboratory 
testing; a blood sample must be sent to the central laboratory at baseline for study analysis 
purposes. 
4.2.1.1 
Key Hepatic Laboratory Requirements before Infusion 1 
For the assessment of hepatic function before infusion 1, the following criteria must be met: 
• If the screening ALT value (absolute level) is ≤ 3 x ULN and total bilirubin value is 
≤ 2 x ULN, then the subject is eligible for dosing. 
• If the subject has a known or suspected history of Gilbert’s syndrome, a direct bilirubin 
value must be obtained for the assessment. If the screening direct bilirubin value is 
≤ 2 x ULN, then the subject is eligible for dosing. The condition is to be recorded in the 
targeted medical history electronic case report form (eCRF). 
If multiple local laboratory tests are obtained, the ALT or total bilirubin value closest in time 
before the planned randomization should be used to determine hepatic function eligibility. 

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4.2.1.2 
Key Renal Laboratory Requirements before Infusion 1 
There should be no evidence of severe chronic kidney disease; the eGFR must be 
≥ 30 mL/min/1.73 m2 (as calculated by the CKD epidemiology collaboration (CKD-EPI] 
equation) [Levey et al, 2009; Stevens et al, 2010] and the result is to be reviewed by the 
investigator before infusion 1 (exclusion criterion 3). 
For subjects who have not undergone angiography, a serum creatinine value obtained 
(collected as part of standard of care or for study purposes by local laboratory) at least 
12 hours after FMC for the index event must be reviewed by the investigator to assess renal 
function. The subject must be considered clinically stable and have hemodynamic stability 
after the index event for study and dosing eligibility. 
For subjects who have undergone angiography and, therefore, have received IV contrast 
agent, the values for serum creatinine should be obtained before and at least 12 hours after IV 
contrast administration (ie, screening value). There must be documented evidence of stable 
renal function defined as an increase in serum creatinine < 0.3 mg/dL (27 µmol/L) from 
pre-contrast serum creatinine value, and there must be no suspicion of AKI. If multiple local 
laboratory tests are obtained before the administration of contrast agent, the serum creatinine 
value closest in time prior to IV contrast administration should be used as reference to assess 
stable renal function. If a pre-contrast serum creatinine value is not available, historical 
documentation of serum creatinine within ≤ 6 months from screening is acceptable for use as 
a reference.  
• If the screening serum creatinine value meets the criteria indicated above, then the subject 
is eligible for dosing. 
• If the screening serum creatinine value is increased ≥ 0.3 mg/dL (27 µmol/L) from pre-
contrast serum creatinine value, then eligibility for the study and infusion 1 must be 
delayed. 
o A repeat assessment by local laboratory is to be performed once at least 24 hours later 
to assess renal stability for study and dosing eligibility. 
• If the repeat serum creatinine value is increased < 0.3 mg/dL (27 µmol/L) from the pre-
contrast serum creatinine value and there is no suspicion of AKI, then the subject is 
eligible for dosing. 
• If the repeat serum creatinine value is increased ≥ 0.3 mg/dL (27 µmol/L) from the pre-
contrast serum creatinine value, then the subject is not eligible for dosing (ie, screen 
failure). 

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4.2.2 
Subsequent Infusions 
Eligibility for the subsequent infusions of investigational product will be determined by the 
investigator based on clinical assessment (eg, assessments of hemodynamic status, directed 
physical examination if clinically indicated, and AE assessment) and review of local and / or 
central laboratory values according to the following criteria (Sections 4.2.2.1 and 4.2.2.2). In 
addition, the investigator should review the results of any available local and central 
laboratory ALT, total bilirubin and serum creatinine results from specimens drawn before or 
after the previous infusion before administering a subsequent infusion of the investigational 
product. 
Note: During the course of study conduct, the IDMC will determine whether the requirement 
for local and / or central laboratory assessments of hepatic and / or renal function before 
subsequent infusions may be discontinued (ie, blood sampling and review of results can 
stop). In that case, all subsequent infusions are to be based on clinical assessment (ie, starting 
with infusion 2 [Visit 3]). 
Each infusion of investigational product should be completed as close to the visit windows 
outlined in the Schedule of Assessments as possible. An infusion may be skipped (ie, 
‘missed’) or delayed at the discretion of the investigator to evaluate and treat an AE before 
the next infusion. The time window between each infusion may be extended as long as the 
last infusion of investigational product is given within 30 days of infusion 1 and the 
minimum window between infusions is at least 5 days. 
4.2.2.1 
Key Hepatic Laboratory Requirements before Subsequent 
Infusions 
For assessment of hepatic function before infusion 2, 3, or 4, the following criteria must be 
met by investigator review of central laboratory values obtained from the previous visits: 
• ALT value must be ≤ 3 x ULN and total bilirubin value must be ≤ 2 x ULN for dosing 
eligibility. 
• If the ALT value is > 3 x ULN and total bilirubin value is > 2 x ULN, or if the ALT value 
is > 5 x ULN then infusion must be delayed. 
o A repeat assessment by local laboratory should be performed once at least 24 hours 
later to assess hepatic stability and dosing eligibility. Additionally, a blood sample 
must be sent to the central laboratory for study analysis purposes. 

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• If the ALT value is > 3 x ULN and ≤ 5 x ULN, or the total bilirubin value is > 2 x ULN, 
the investigator should perform a clinical assessment using all available data (including 
assessment of symptoms consistent with liver dysfunction, including right upper quadrant 
abdominal pain, anorexia, etc.), which may include a repeat laboratory assessment. 
o If the elevation in ALT or total bilirubin is not related to the investigational product 
and an alternate nonserious etiology is known, the infusion may be administered at 
the discretion of the investigator. 
o If the repeat ALT value is > 3 x ULN and total bilirubin value is > 2 x ULN, or if the 
repeat ALT value is > 5 x ULN, then subject should be discontinued from further 
dosing. 
If clinically significant abnormal laboratory test results are identified after investigational 
product infusion, the test(s) should be repeated until laboratory values return to normal 
and / or baseline for hepatic function, as per Section 8.1.3.1.1.2, and are reported as AEs as 
per Section 9. 
4.2.2.2 
Key Renal Laboratory Requirements before Subsequent 
Infusions 
Before infusion 2, for subjects who received infusion 1 of investigational product > 12 hours 
and < 48 hours after IV contrast administration, a local laboratory serum creatinine value 
should be obtained before the infusion for comparison with the local laboratory baseline 
value and reviewed by the investigator. A blood sample for local laboratory testing to assess 
dosing eligibility for infusion 2 should not occur earlier than 72 hours following infusion 1. 
• If the serum creatinine value is increased < 0.3 mg/dL (27 µmol/L) from the baseline 
serum creatinine value, then the subject is eligible for dosing. 
• If the serum creatinine value is increased between 0.3 and 0.5 mg/dL (27 µmol/L and 
44 µmol/L) from the baseline serum creatinine value and it may be attributable to changes 
in concomitant medications with potential renal effect or other clinical factors (eg, IV 
fluid discontinued), or falls within range of variability previously observed for the subject 
as per investigator’s discretion and there is no suspicion of AKI, then the subject is 
eligible for dosing. A repeat creatinine assessment should be performed prior to the next 
infusion / visit. If variation cannot be attributable to clinical factors as listed above, the 
infusion should be delayed and repeat assessment of serum creatinine is performed.  
• If the serum creatinine value is increased > 0.5 mg/dL (44 µmol/L) from the baseline 
serum creatinine value, then dosing of infusion 2 must be delayed. 

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o A repeat assessment by local laboratory should be performed once at least 24 hours 
later to assess renal stability for study and dosing eligibility. Additionally, a blood 
sample must be sent to the central laboratory for study analysis purposes. 
• If the repeat serum creatinine value is increased > 0.5 mg/dL (44 µmol/L) from the 
baseline serum creatinine value (ie, the elevation is confirmed), then the infusion and 
subsequent infusions must be discontinued. 
If clinically significant abnormal laboratory test results are identified after investigational 
product infusion, the test(s) should be repeated until laboratory values return to normal 
and / or baseline for renal function, and are reported as AEs per Section 9. 
Before infusion 2, for subjects who received infusion 1 of investigational product ≥ 48 hours 
after FMC or IV contrast administration, eligibility for dosing will be determined by the 
investigator based on clinical assessment (eg, assessments of hemodynamic status, directed 
physical exam if clinically indicated, and AE assessment) with support of local and central 
laboratory serum creatinine values at baseline. 
Before infusions 3 and 4, all subjects must meet the following criteria based on a review of 
central laboratory values from the previous visits (infusions 2 and 3, respectively) compared 
with the central laboratory baseline value: 
• If the serum creatinine value is increased < 0.3 mg/dL (27 µmol/L) from the baseline 
serum creatinine value, then the subject is eligible for dosing. 
• If the serum creatinine value is increased between 0.3 and 0.5 mg/dL (27 µmol/L and 
44 µmol/L) from the baseline serum creatinine value and it may be attributable to changes 
in concomitant medications with potential renal effect or other clinical factors (eg, IV 
fluid discontinued), or falls within range of variability previously observed for the subject 
as per investigator’s discretion and there is no suspicion of AKI, then the subject is 
eligible for dosing. A repeat creatinine assessment should be performed prior to the next 
infusion / visit. If variation cannot be attributable to clinical factors as listed above, the 
infusion should be delayed and repeat assessment of serum creatinine should be 
performed. 
• If the serum creatinine value is increased > 0.5 mg/dL (44 µmol/L) from the baseline 
serum creatinine value, then dosing of the infusion must be delayed. 
o A repeat assessment by local laboratory must be performed once at least 24 hours 
later to assess renal stability for study and dosing eligibility. Additionally, a blood 
sample must be sent to the central laboratory for study analysis purposes. 

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• If the repeat serum creatinine value is increased > 0.5 mg/dL (44 µmol/L) from the 
baseline serum creatinine value, then the infusion and all subsequent infusions should be 
discontinued. 
If clinically significant abnormal laboratory test results are identified after investigational 
product infusion, the test(s) should be repeated until laboratory values return to normal 
and / or baseline for renal function, and are reported as AEs as per Section 9. 
4.2.3 
Infusion Delay 
Each infusion of investigational product should be completed as close to the visit windows 
outlined in the Schedule of Assessments as possible. An infusion may be skipped 
(ie, ‘missed’) or delayed at the discretion of the investigator to evaluate and treat an AE 
before the next infusion. The time window between each infusion may be extended as long as 
the last infusion of investigational product is given within 30 days of infusion 1 and the 
minimum window between infusions is at least 5 days. 
Refer to the study reference manuals for detailed instructions for how to address study 
procedures performed in the Active Treatment Period and for detailed instructions for skipped 
(ie, ‘missed’) or delayed infusion.  
4.3 
Discontinuation of Treatment and / or Subject Withdrawal 
from the Study 
Subjects may withdraw from treatment at any time but will continue in follow-up: every 
subject, including those who prematurely stop taking investigational product, will be 
followed for vital status and MACE endpoint assessments and complete study procedures as 
specified in the protocol unless they explicitly withdraw consent from follow-up 
(Section 4.3.3). The requirements for handling early discontinuations from investigational 
product are described below. Details of the requirements for subject follow-up are provided 
in Section 4.3.4. All efforts should be made to confirm vital status for all subjects up to the 
end of his / her follow-up. 
4.3.1 
Early Discontinuation of Investigational Product 
Subjects may request at any time that further investigational product administration be 
discontinued, or it may be discontinued at any time at the discretion of the investigator or 
CSLB for safety, behavioral, or administrative reasons (eg, due to an AE, protocol deviation, 
or study termination). In accordance with International Council for Harmonisation (ICH) 

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principles of Good Clinical Practice (GCP), the investigator always has the option to advise a 
subject to stop further administration of investigational product if the subject's safety or 
well-being is compromised by the continued administration of investigational product. 
Concern for the interests of the subject must always prevail over the interests of the study. 
If a subject permanently discontinues treatment with investigational product (regardless of 
the reason) before the end of the planned Active Treatment Period, the subject will undergo 
an investigational product Early Termination Visit (Visit 6) and continue safety and MACE 
endpoint follow-up according to the Schedule of Assessments and Section 4.3.4. If the 
discontinuation occurs at a scheduled visit, the assessments and procedures for the 
investigational product Early Termination Visit (Visit 6, Schedule of Assessments) should be 
completed instead of that visit. 
If a subject discontinues investigational product (regardless of the reason) between scheduled 
visits, the subject should be brought into the clinic as soon as possible to complete the 
investigational product Early Termination Visit / Visit 6 assessments. All subjects should 
continue follow-up visits for MACE endpoint assessment (Section 4.3.4). 
In all cases, reasons for discontinuation of investigational product and the date of last dose 
will be recorded. 
4.3.2 
Possible Reasons for Discontinuation of Investigational 
Product 
Possible reasons for subject discontinuation from investigational product include, but are not 
limited to, the following: 
• Adverse event resulting in discontinuation. 
• Subject becomes pregnant during the study. 
• Need for chronic use of a prohibited concomitant medication, ie, chemotherapy or other 
investigational product (Section 7.3). 
• Decision by subject or proxy. 
• Sponsor terminated study. 
• Investigative site closed and subject was unable to transfer to another investigative site. 

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4.3.3 
Subject Withdrawal from the Study 
Subjects who no longer wish to attend study visits in person will be asked to be contacted for 
follow-up by telephone or other methods identified below to assess MACE endpoints and 
vital status. Similarly, subjects who withdraw consent will be asked if they can be contacted 
at the end of the study to determine vital status, at a minimum. This change to follow-up from 
in-clinic visits to by telephone or other methods does not constitute subject withdrawal from 
the study. 
Subject withdrawal from the study is defined as the subject’s withdrawal of consent from 
further participation in the study, including any contact by the study site personnel to 
determine the MACE endpoints and vital status of the subject. Subjects may withdraw from 
the study at any time at their own request, or they may be withdrawn at any time at the 
discretion of the investigator or CSLB for safety, behavioral, or administrative reasons 
(eg, due to an AE, protocol violation, subject noncompliance, and study termination). In 
accordance with ICH principles of GCP, the investigator always has the option to advise a 
subject to withdraw from the study if the subject's safety or well-being is compromised by his 
or her further participation in the study. Concern for the interests of the subject must always 
prevail over the interests of the study. If a subject is withdrawn from the study by the 
investigator or further participation is declined by the subject, they will continue to have 
access to medical care and will be treated as per routine medical practice. 
When a subject is contemplating withdrawal from the study, the investigator (in addition to 
the coordinator) should discuss with the subject the importance of further follow-up and how 
further follow-up information can be obtained through telephone contact, registered mail 
contact, contact through referring physician(s), family or friends, or utilization of publically 
available information. This latter source is the only available option for subjects who 
withdraw consent. All efforts should be made to confirm vital status at minimum. 
Information regarding study outcomes or vital status will be collected if it is available in the 
public domain, and if it is permitted by local and national law, according to the specific 
provision included in the signed informed consent. Alternative permitted options to obtain 
study outcomes and vital status (eg, healthcare providers and / or relatives) will be 
summarized on a checklist to be provided to all sites participating in the study separate from 
the protocol; these permitted options are also subject to local and national law. For any 
subject who withdraws consent for contact by the study site personnel, the reason for 
withdrawal of consent will be recorded in the eCRF; the investigator will document / sign the 

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checklist, and describe the discussion with the subject regarding each of the contact methods 
that were offered. The discussion must be documented. 
Withdrawal from the study as a result of an AE and any therapeutic measures that are taken 
shall be at the discretion of the investigator. If a subject withdraws from the study for any 
reason, any ongoing AEs will be followed until resolution, until deemed stable by the 
investigator, or until the subject is deemed by the investigator to be lost to follow-up. 
If the subject withdraws from the study, CSLB will retain and continue to use any data 
collected before such withdrawal of consent, in accordance with prevailing regulatory 
guidance. 
4.3.4 
Procedures for Subject Follow-up 
Every effort should be made to educate the subjects on the importance of remaining in the 
study and attending scheduled study visits up to the end of clinical study, including those 
required after early discontinuation of investigational product. 
All subjects who either complete the Active Treatment Period or who prematurely 
discontinue investigational product are required to undergo the Visit 6 / Early Termination 
(Day 29 clinical assessments according to the Schedule of Assessments). 
If a subject prematurely discontinues investigational product and is unwilling or unable to 
attend visits during the Active Treatment Period in-person according to the visit schedule, 
he / she will be contacted by telephone or other methods to assess study outcomes and vital 
status. The only exception to this requisite is for subjects who withdraw consent for any form 
of contact (Section 4.3.3). 
Refer to Section 10.3.6 for early study termination rules for futility and efficacy based on the 
3 planned interim analyses, respectively. If the study is terminated early for futility, subjects 
still in the Active Treatment Period should not receive further investigational product and 
should return to the site for the Early Termination Visit (Visit 6 [Day 29]); subjects in the 
Follow-up Period should return for their EOS Visit as defined in Section 3.6. If the study is 
terminated early for efficacy, enrollment will cease upon the announcement of the decision to 
stop the study. 
Other subject follow-up options to collect MACE endpoints and vital status should be 
pursued according to local laws and regulations. If 1 of these alternate methods to collect 

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MACE endpoints and vital status is acceptable to the subject, then the subject will be deemed 
not to have withdrawn consent for follow-up. 
Study completion is defined in Section 3.6. 
4.3.5 
Subjects Potentially Lost to Follow-up 
Investigators should make every effort to contact subjects who are potentially lost to follow-
up, including pursuing any alternative contact methods permitted by local regulations or 
agreed upon by the subject. As permitted by local regulations, a third party may be used to 
locate alternative subject contact information in the public domain that will be provided to 
the investigator. The following procedures should be performed before a subject will be 
deemed lost to follow-up at the end of the study: 
1. At least 3 documented subject contact attempts should be made (eg, in-person visit, 
phone, mail, email). 
2. If the subject cannot be directly contacted, utilize all contact information provided when 
the subject signed consent (next of kin, “referring (non-study) physician”, etc.). 
3. If all contact attempts are unsuccessful, available sources such as electronic medical 
records and death registries should be reviewed on an ongoing basis until EOS to attempt 
to locate the subject, as permitted according to local and national laws. 
4. A patient locator service should be utilized (as allowed by local laws). 
5. These subject contact procedures should be followed by the sites, who will be encouraged 
to continue their attempts to locate the subject or next of kin up until the database lock 
before designating a subject lost to follow-up. 
4.3.6 
Replacement Policy 
Subjects withdrawn from the study will not be replaced. 
5 
Study Interventions 
5.1 
Description of Investigational Product(s) 
5.1.1 
CSL112 
The study product, CSL112, will be manufactured by CSLB in accordance with Good 
Manufacturing Practice (GMP) guidelines and local regulatory requirements. 

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The active component of CSL112 is apoA-I, which is purified from human plasma. 
Apolipoprotein A-I is formulated with PC and stabilized with sucrose and cholate as 
excipients. CSL112 will be provided to the site as a sterile, slightly yellow, lyophilized 
powder containing 2 g total protein in a 100-mL glass bottle with a rubber stopper and an 
aluminum cap. Before use, each bottle of CSL112 is reconstituted with 50 mL of water for 
injection, yielding approximately 57 mL of ready-for-use product. For the 6 g CSL112 dose 
to be used in this study, 3 bottles will be reconstituted for an approximate total of 170 mL of 
product. Once reconstituted, CSL112 is a pale yellow solution with foaming characteristics. 
Further details regarding preparation of CSL112 are specified in the Investigator Brochure 
and site investigational medicinal product manual (ie, Site IMP Manual). 
5.1.2 
Placebo 
The placebo product will be manufactured by CSLB in accordance with Good Manufacturing 
Practice guidelines and local regulatory requirements. 
The placebo product will be 
 in water (
 for IV 
infusion. An equivalent amount of placebo (approximately 170 mL) to CSL112 will be 
intravenously infused in a vein (peripheral or central) over 2 hours. Placebo product will be 
provided to the site as 50 mL vial of a registered 25% albumin solution. The placebo solution 
will comprise 
 
 to yield a 4.4% 
albumin solution. Further details regarding the preparation of the placebo are specified in the 
Site IMP Manual. 
5.2 
Packaging, Labeling, Supply and Storage 
5.2.1 
Packaging and Labeling 
CSL112 and placebo product will be packaged and labeled according to current ICH GMP 
and GCP guidelines, and national legal requirements. 
Commercially-available, sterile, water for injection and 
 will be purchased by the study 
sites for use in the preparation of CSL112 and placebo, respectively. 
5.2.2 
Supply and Storage 
CSL112 and placebo will be supplied to the study sites by CSLB or delegates. 
CSL112 must be stored under temperature-monitored conditions (+2°C to +30°C, inclusive) 
in a secure storage area. 
CCI
CCI
CCI
CCI
CCI

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Placebo (albumin) must be stored under temperature-monitored conditions (+2 to +8°C, 
inclusive) in a secured storage area. 
CSL112 and placebo MUST NOT BE FROZEN, as this may disrupt the protein structure of 
each product. 
CSL112 and placebo must be protected from light during storage. The individual packaging 
holding the CSL112 and placebo bottles is sufficient for light protection. 
Further details regarding specific storage conditions of CSL112 and placebo are specified in 
the Site IMP Manual. 
5.3 
Accountability and Destruction 
All supplies of investigational product(s) must be accounted for throughout the study. 
Records for the delivery of investigational product to the study site, the inventory at the study 
site, the use by each subject, and the destruction or return of investigational product to CSLB 
must be maintained by the investigator (or delegate). The records will include dates, 
quantities, and unique code numbers assigned to investigational product and unique code 
numbers assigned to the subjects. 
Information on the destruction of CSL112 or placebo is provided in the Site IMP Manual. 
5.4 
Other Intervention(s) 
Not applicable. 
5.5 
Dose Modification 
Not applicable. 
6 
Allocation, Dosing and Administration 
6.1 
Allocation to Treatment 
6.1.1 
Subject Assignment 
After providing written informed consent, the subject will be issued a study-level unique 
subject identification number via an interactive response technology (IRT) system. The 
subject identification number will be used to identify the subject for the duration of the study. 
Subject identification numbers will not be reassigned or reused. 

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6.1.2 
Randomization Procedures 
Eligible subjects will be randomized in a 1:1 ratio to receive CSL112 or placebo by means of 
the IRT. A centralized randomization schedule will be used. The randomization schedule will 
be stratified by subject’s index MI type (STEMI vs NSTEMI), whether they are managed 
with PCI or medically managed for the index MI, and region (North America, Latin America, 
Western Europe, Central and Eastern Europe, or Asia Pacific). A balanced distribution of 
STEMI and NSTEMI is desired, and may require implementation of a limit on an index MI 
type during the conduct of the study. To ensure the study blind is maintained, the IRT external 
service provider will prepare the study randomization code according to the specifications 
provided by the CSLB statistician. The external service provider will keep the randomization 
code on file. 
6.1.3 
Blinding Procedures 
6.1.3.1 
Blinding Method 
This study is a double-blind study and, therefore the reference placebo product matches the 
physical characteristics of the investigational product after preparation. Once prepared 
according to the instructions given in the Site IMP Manual and transferred to IV infusion 
bags, CSL112 and placebo match in color and foaming characteristics. 
Investigational site staff, including the investigator, will be blinded to treatment allocation. 
Subjects and CSLB staff participating in the conduct of the study will also be blinded to 
treatment allocation (double-blind). Study site personnel delegated by the investigator will 
administer the investigational product by IV infusion in a suitable peripheral or central vein. 
Unblinded study site personnel delegated by the investigator will prepare the investigational 
product and the IV infusion bag and infusion set for administration. The unblinded study site 
personnel will also ensure the contents remain blinded to the subject and the blinded study 
site personnel who will be conducting safety assessments. Unblinded study site personnel are 
not to administer the investigational product and will not be involved in conducting or 
recording any study assessment procedures (ie, in the care of the subject). 
Adequate procedures will be in place to ensure the integrity of the blinded data within CSLB 
and the study sites. The investigator and other blinded study staff must not review the 
results of a lipid panel test (specifically the HDL cholesterol level) during the Active 
Treatment Period as the results may unblind treatment assignment.  

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6.1.3.2 
Breaking the Blind for an Emergency 
The randomization code for individual subjects may be unblinded to a site during the study in 
emergency situations for reasons of subject safety, if knowing treatment assignment will 
change subject management. In case of an emergency situation for the reason of subject 
safety, the investigator should use IRT to identify the treatment allocation for a subject. 
Whenever possible, the investigator should consult with the study hotline before unblinding 
the randomization code. The reason for unblinding the randomization code must be fully 
recorded in the subject’s source documents, and the investigator must follow the defined 
procedures provided in the study reference manuals. The subject’s treatment allocation 
should not be recorded in the subject’s source document. 
6.1.3.3 
Planned Unblinding Procedures 
Three unblinded interim analyses and periodic unblinded safety reviews are planned for this 
study for the purposes of safety monitoring activities and efficacy assessment by the IDMC 
(Section 10.3.6). With authorization by CSLB, the IRT external service provider will provide 
the randomization code to the unblinded statistician (external service provider) performing 
analyses for the IDMC. At the end of the study, CSLB will authorize that the study be 
unblinded after database lock. The randomization codes will be provided to the study 
statistician / delegate. 
CSLB Global Clinical Safety and Pharmacovigilance personnel may unblind the 
randomization code from the IRT to facilitate assessment of suspected unexpected serious 
adverse reactions (SUSAR) experienced by any subject for expedited reporting to regulatory 
authorities. MACE are exempt from suspected unexpected serious adverse reactions 
reporting (see Section 9.6.4). 
6.2 
Dosing and Administration 
The investigator (or delegate) will administer the investigational product only to subjects who 
provide written consent, meet the inclusion criteria and none of the exclusion criteria 
(Section 4.1) and have confirmed infusion eligibility (Section 4.2), and will follow the 
administration parameters outlined in Table 1 as well as the procedures described below. 
Infusion 1 must be administered in the timeframe as detailed in Section 4.2.1. Infusions 2, 3, 
and 4 may be administered in the hospital or an outpatient setting at least 5 days apart (see 
Schedule of Assessments). 

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Table 1 
Investigational Product Dosing Characteristics 
Administration parameter 
CSL112 6 g 
Placebo 
Route 
Intravenous 
Intravenous 
Anatomical location 
Vein (peripheral or central) 
Vein (peripheral or central) 
Infusion rate 
approximately 170 mL over 
2 hours  
approximately 170 mL over 
2 hours 
The blinding procedures are described in Section 6.1.3. After preparation, CSL112 and 
placebo will be identical in physical appearance at administration. Administration of the 
investigational product should be completed within 6 hours of preparation of the solution. A 
dedicated IV line should be used for administration of investigational product. Patency of the 
IV line should be ensured before the start of the infusion. Subjects should be advised to sit 
down or lie in a semi-supine position while receiving the infusion. Subjects randomized to 
the placebo group will receive a volume of placebo matched to the corresponding CSL112 
infusion volume. 
After completion of the infusion, the IV line should be flushed with saline. The end of 
the saline flush defines the end of infusion. 
Study site personnel who are medically qualified to recognize and treat drug hypersensitivity 
reactions must be available together with medications and equipment to treat such reactions. 
All possible drug hypersensitivity reactions require follow-up until resolution 
(Section 9.1.2.1). 
6.3 
Treatment Compliance 
All doses of investigational product will be administered by IV infusion. Each subject will be 
considered to have received a complete dose of investigational product if they receive at least 
80% of investigational product per infusion. 
7 
Contraindications, Permitted Therapies and Prohibited 
Therapies 
7.1 
Contraindications and Precautions to Further Dosing 
CSL112 has previously been administered to humans. Potential risks and guidance to the 
investigator for use of CSL112 are provided in the current version of the Investigator’s 
Brochure. The administration of CSL112 to any subject not meeting the eligibility criteria for 
this study, or to any subject not enrolled in this study, is prohibited. 

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There is potential for allergic reactions or hypersensitivity to CSL112 in certain individuals, 
given the constituents of the product. CSL112 consists of apoA-I purified from human 
plasma that may contain IgA and PC derived from soy beans. Therefore, investigators should 
ensure that subjects do not have a positive history of IgA deficiency or antibodies to IgA and 
that the subjects are not allergic to either soy bean or peanuts (there is a documented risk of 
cross reactions to soy in known peanut allergy sufferers). 
Regarding placebo, the albumin prescribing information contains warnings for allergic and 
anaphylactic like reactions and notes hypersensitivity reactions under adverse reactions. The 
reported rate of anaphylaxis cases is very low. In addition, there has been no correlation 
between increasing strength and anaphylactic reaction. Due to limited data available for 
dosage, no trend of the association between dose and anaphylactic reaction can be made. 
In the event that a subject experiences signs or symptoms of a hypersensitivity reaction 
requiring hospitalization or urgent intervention, or there is suspected angioedema during 
infusion of investigational product, the current infusion and all subsequent infusions must be 
immediately discontinued. The subject must receive immediate medical assessment and 
indicated supportive management per the institutional standard of care (Section 9.1.2.1). 
If a subject experiences a serious adverse event (SAE) of hypersensitivity reaction within 72 
h of administration of a dose of investigational product, or there is suspected angioedema 
during infusion of investigational product, additional doses of investigational product should 
not be administered. 
7.2 
Permitted Therapies 
Concomitant medication typical of those taken by the intended target population (ie, 
ACS-related treatments) is permitted throughout the study unless prohibited as described in 
Section 7.3 and must be recorded as outlined in Section 8.1.1.3. 
7.2.1 
Evidence-based Medical Therapy 
All randomized subjects should receive evidence-based post-MI care according to local 
standards of care and national practice guidelines (without a local standard, the current 
guideline from the American College of Cardiology / American Heart Association / European 
Society of Cardiology [ACC / AHA / ESC] etc. should be utilized). Close adherence to 
professional society evidence-based medical therapy in ACS will be emphasized during study 
conduct, including use of appropriate revascularization (PCI) and pharmacological 
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inhibitor, or aspirin in combination with another anti-platelet agent), angiotensin-converting 
enzyme (ACE) inhibitors (or angiotensin II receptor blockers [ARBs] for patients intolerant 
to ACE inhibitors), beta-blockers, statin and other lipid lowering medications. 
All concomitant treatment for ACS including the dose, route of administration, and frequency 
must be documented in the eCRF, including variance from evidence-based medical therapy 
(eg, aspirin, adenosine diphosphate receptor inhibitors, and statins) (Section 8.1.1.3). 
7.3 
Prohibited Therapies 
The following therapies are NOT PERMITTED during the study: 
• Treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted 
therapy, or gene therapy) at any time during the study. 
NOTE: Use of low dose chemotherapy for treatment of a condition other than cancer 
(eg, rheumatic disease) is permissible (see Section 4.1.2). 
• Administration of any other investigational agent within 3 months before the first 
administration of investigational product or at any time before the subject’s completion of 
the study. 
Subjects are not to be enrolled into the study if they received any prohibited therapy within 3 
months of screening. If administration of any prohibited therapy becomes necessary during 
the study for medical reasons, the subject may be discontinued from receiving further 
infusions of investigational product. The requirements for handling early discontinuations 
from investigational product are described in Section 4.3.1. 
7.4 
Lifestyle Restrictions 
There are no study-specific dietary or lifestyle restrictions for subjects who participate in the 
study. 
All randomized subjects should receive evidence-based post-MI care according to local 
standards of care and national practice guidelines (without a local standard, the current 
guideline from the ACC / AHA / ESC etc. should be utilized). Close adherence to these 
guidelines for ACS regarding diet and lifestyle restrictions, physical activity and / or cardiac 
rehabilitation, and tobacco smoking cessation is to be emphasized during study conduct as 
per site’s standard practice and will be assessed at Days 90, 180 and 365. 

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7.5 
Overdose 
For this study, overdose is defined as any single dose 50% greater than the total volume of 
investigational product (Section 5.1.1) or an infusion rate that exceeds 3 mg/kg/min of 
sucrose. The effects of any potential overdose with CSL112 have not been studied, and 
therefore infusion rate for the investigational product should be maintained as per Table 1 
(Section 6.2). Total duration of the infusion should not be less than 1 hour. Any suspected 
overdose resulting in an AE that is considered by the investigator to be medically significant 
must be reported as a SAE (see Section 9.6.3).  See Section 9.6.6 for overdose reporting 
requirements. 
8 
Study Procedures and Visit Schedule 
8.1 
Clinical Procedures 
The clinical procedures will be performed at time points as detailed in the Schedule of 
Assessments, and the basics of these procedures are described in the following sections. 
Refer to the study reference manuals for detailed instructions on how the assessments should 
be performed. 
8.1.1 
Demographics and Baseline Characteristic Assessments 
The clinical procedures to be conducted during this study related to the evaluation of 
population demographics and baseline characteristics are provided in Table 2. These 
assessments are to be performed at time points (including time windows) as detailed in the 
Schedule of Assessments. 

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Table 2 
Study Procedures: Demographics and Baseline Characteristics 
Assessment / Section 
Reference 
Description 
Demographics  
Year of birth, years of age, sex, race, ethnicity (where permitted). 
Medical history and 
index MI (see 
Section 8.1.1.1 for 
additional details)  
Targeted medical history including but not limited to: 
• Known coronary artery disease (including previous MI, 
coronary artery bypass surgery and / or PCI) 
• Diabetes mellitus. 
• Peripheral artery disease. 
• Heart failure. 
• Moderate to severe valvular heart disease. 
• Hypertension. 
• Cerebrovascular disease. 
• History of angina pectoris. 
• Number of angina events in the prior 24 hours to FMC. 
• Time from symptom onset to FMC. 
• Tobacco and / or e-cigarette use. 
• Gilbert’s syndrome. 
Physical examination 
(Section 8.1.1.2) 
• Directed physical examination per the site’s standard practice. 
• Body weight and height. 
Prior / concomitant 
therapies 
(Section 8.1.1.3) 
• Selective medications (ACS-related) taken prior to the index MI 
and those used in the treatment of the index MI prior to 
enrollment will be collected in a targeted fashion by drug 
and / or class.  
• All concomitant treatments for ACS including the dose, route of 
administration, and frequency must be collected and monitored 
for change through to the EOS as per Section 7.2.1. 
• All other concomitant medications will be collected through 
Day 90. 
• Medications contributing to or used in the treatment of an SAE 
will be collected through to the EOS. 
ACS = acute Coronary Syndrome; EOS = End of Study; MI = myocardial infarction; FMC = first medical 
contact; PCI = percutaneous coronary intervention; SAE = serious adverse event. 
8.1.1.1 
Medical and Surgical History 
A review of targeted medical and surgical history will be conducted and should include, but 
not be limited to, history of prior MI, history of diabetes mellitus, and all additional medical 
history with implications for health (note that severe chronic kidney disease and evidence of 

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hepatobiliary disease are reasons for exclusion; Section 4.1.2). Historical documentation of 
Gilbert’s syndrome should be recorded in the eCRF. 
Other types of information collected may include: FMC at the first presenting hospital, MI 
diagnosis, index MI hospitalization dates, details on any IV contrast administration received 
during angiography, location of occlusion, and interventions received for the index event 
including revascularizations or medications used. 
Targeted medical history events that occur before the initial Screening Visit will be recorded 
in the targeted medical history section of the eCRF and will only be reported as an AE if 
there is an increase in the frequency or severity of the condition during the study. If, during 
the study period, a subject presents with an SAE, only relevant preexisting conditions that 
support the narrative of the event should be retrospectively recorded in the medical history 
section of the SAE page of the eCRF. 
8.1.1.2 
Directed Physical Examination, Body Weight, and Height 
A brief directed physical examination, which focuses on pulmonary and CV examination, 
should be performed at screening and must be performed by the investigator or a medically 
qualified delegate. Height may be obtained at any time during hospitalization for the index 
MI. Body weight should be obtained as the Screening Visit, Visit 6 (Day 29), Visit 8 
(Day 90), Visit 9 (Day 180), and Visit 11 (Day 365). Height and body weight measurements 
will be used to calculate body mass index.  
Any clinically significant changes occurring between screening and Visit 8 (Day 90) will be 
documented in the eCRF as an AE. Physical examination should also include hypersensitivity 
findings, if relevant (Section 9.1.2.1) 
8.1.1.3 
Prior and Concomitant Medication 
Selective medications (ie, ACS-related medications) taken by subjects in the 4 weeks before 
screening, including those administered for the index MI, and taken or administered at any 
time during the study will be collected through the EOS. All other concomitant medications 
taken or administered during the study will be collected through the Visit 8 (Day 90), or 
beyond in the event of an SAE, or AEs considered related to investigational product, leading 
to discontinuation of investigational product, and / or leading to withdrawal of consent during 
the study. The identity (ie, generic name), dose, route of administration, frequency, dates 
started and stopped (or notation of “ongoing”), and reason for use should be recorded. 
Exceptions to recording medications / therapies are outlined below. 

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Concomitant medication typical of those taken by the intended target population is permitted 
throughout the study unless prohibited as described in Section 7.3. Evidence-based medical 
therapy (eg, dual anti-platelet therapy, adenosine diphosphate receptor inhibitors, ACE 
inhibitors [or ARBs for patients intolerant to ACE inhibitors], beta-blockers, and statin and 
other lipid-lowering medications) should be administered as described in Section 7.2.1. 
Reasons for variance from use of evidence-based medical therapy (eg, aspirin, adenosine 
diphosphate receptor inhibitors, and statins) should be noted in the eCRF. 
If the use of any concomitant treatment (whether medication or non-pharmacologic 
treatment) becomes necessary for treatment of an AE, the treatment and administration 
details must be recorded in the eCRF.  
All concomitant medications taken or administered resulting in or for the treatment of an 
SAE, or AEs considered related to investigational product, leading to discontinuation of 
investigational product and / or leading to withdrawal of consent during the study, will be 
collected through the end of the study. These details should include (as appropriate) the 
reason for treatment, name of the treatment, dose, and unit and route of administration. 
Exceptions to Concomitant Medications Reporting 
It is not required to record information on the following medications / therapies unless they 
are deemed to the cause of or contributor to the occurrence of an AE / SAE: 
• Intravenous fluid. 
• Electrolyte or nutritional replacement. 
• Anesthetic medications that are inhaled or topical. 
• Medications / therapies that are not directly administered to the subject, such as 
cardioplegic solution or antithrombin used in conjunction with the cardiopulmonary 
bypass pump. 
• Nonsystemic bowel preparation (eg, enema). 
• Topical treatments intended for therapy of dermatologic conditions. 
• “As needed” (PRN) medications / therapies (eg, sedatives, bowel preparation) (except for 
antacids, proton-pump inhibitors, and H2-receptor antagonists – typically taken by the 
intended target population). 
• Medications for surgical or nonsurgical procedures (eg, anesthetic, sedative). 
• Vaccines. 

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8.1.2 
Efficacy Assessments 
MACE is a composite of endpoints as presented in Sections 2.1, 2.2.2, 2.2.4.1, and 2.3.2. An 
assessment for MACE should be performed at all visits as outlined in the Schedule of 
Assessments. All untoward medical occurrences that are potential MACE will be reported as 
endpoints for adjudication (including all-cause death). The event is to be reported in the 
appropriate eCRF within 24 hours of the investigator becoming aware of the event. Details of 
the events will be systematically collected on the eCRF, including event-specific details 
(Section 9.6.4). The CEC will adjudicate each event according to definitions specified in a 
separate charter. If multiple suspected MACE occurs in the same subject, each event should 
be entered separately in the appropriate module(s) of the eCRF. Thus, if a subject has an MI 
and subsequently dies, the appropriate information would be entered in the separate MI and 
death modules of the eCRF. 
Note: MACE that occur after informed consent but prior to randomization do not need to be 
adjudicated as endpoints and should be reported as AEs or SAEs as appropriate. 
Should an investigator report an SAE during the study that is considered by CSLB to be 
potentially consistent with a study endpoint, CSLB or delegate will request confirmation 
from the investigator that this event is indeed an SAE and not an endpoint. The investigator 
should respond immediately (within 24 hours) to these requests in order to minimize the risk 
that such an event may require expedited safety reporting. Following the request for review 
of the reported SAE, and should the investigator consider it as a suspected MACE instead, 
the event must be reported on the endpoint and / or procedure eCRF (eg, revascularization) 
for adjudication. 
Events following adjudication that are deemed not to be endpoints for this study will be 
classified as AE / SAEs as soon as the adjudication process has been completed, following 
standard reporting guidelines. In this instance, the start date for SAE reporting purposes will 
be the day that the CEC determines that the event is negatively adjudicated. The CEC will 
notify CSLB within 24 hours of determination of a negatively adjudicated event. 
Further details to AE, SAE and MACE endpoint reporting are provided in Sections 9.6.1, 
9.6.3, and 9.6.4, respectively. 
The modified Rankin score should be obtained if a subject has a suspected or confirmed 
stroke at the time of occurrence. Scoring of the modified Rankin score is defined 
in Appendix 2.  

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If a subject experiences a PCI-related MI (Type 4a), the event will be classified by the CEC 
based on the baseline status of the subject (ie, before PCI). Baseline status will be determined 
based on a combination of CV-biomarker samples (eg, troponin or CK-MB; obtained via 
standard of care practice) as well as ischemic symptoms and ECG changes. In the event of a 
PCI-related MI, at least 2 pre-PCI CV-biomarker values obtained within 72 hours before PCI 
are to be recorded in the source. For subjects with NSTEMI, at least 1 of the CV biomarker 
values recorded in the source should be at least 6 hours before the PCI. At least 3 
CV-biomarker values taken after the PCI are to be recorded in the source. 
8.1.3 
Safety Assessments 
Safety assessments are provided in Table 3. Timing of safety assessments will be performed 
as detailed in the Schedule of Assessments. More frequent evaluations may be performed in 
the case of an AE, if clinically indicated, at the discretion of the investigator. Clinical 
laboratory test results that are outside the normal reference range and are deemed clinically 
significant by the investigator are to be recorded as AEs or SAEs. If clinically significant 
abnormal laboratory test results are identified after investigational product infusion, the 
test(s) will be repeated until the values return to normal and / or baseline values. 
Table 3 
Safety Assessments 
Assessment / 
Section Reference 
Description 
Adverse events 
(Sections 9.6.1 and 
9.6.3, respectively) 
• All AEs will be collected through Visit 8 (Day 90). The following 
types of AE will be collected through the End of Study (ie, Day 365): 
o AEs considered related to investigational product.  
o AEs leading to discontinuation of investigational product. 
o AEs leading to withdrawal of consent during the study.  
• All SAEs will be collected through the end of the study, regardless of 
relationship to investigational product. 
Vital signs 
(Section 8.1.3.4) 
• Blood pressure (systolic and diastolic) in mmHg. 
• Pulse rate (beats per minute).  
ALT, total bilirubin, 
creatinine 
(Section 8.1.3.2.1) 
Local laboratory values obtained as part of standard of care testing for the 
index MI event will be used for assessment of subject eligibility and 
infusion 1 eligibility. 
Hematology 
(Section 8.1.3.2.2) 
Blood samples will be collected for analysis by the central laboratory: 
• Hemoglobin 
• Hematocrit 
• WBC counts 
• Total platelet count 
• CBC with differential 

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Assessment / 
Section Reference 
Description 
Serum 
Biochemistry 
(Section 8.1.3.2.2) 
Blood samples will be collected for analysis by the central laboratory: 
 
• Alkaline 
phosphatase 
• ALT 
• AST 
 
• Total bilirubin 
• Direct bilirubin 
• BUN 
 
• Cholesterola 
• LDL cholesterola 
• HDL cholesterola 
 
• Creatinine 
• eGFR (calculated) 
• Triglyceridesa 
Pregnancy test 
(Section 8.1.3.3) 
Blood or urine test for beta-human chorionic gonadotropin, as indicated 
for women of childbearing potential. 
Documented contraception method (if relevant). 
Parvovirus testing 
(Section 8.1.3.5) 
Nucleic acid testing and serology (parvovirus B19) will be performed for 
a subset of subjects. 
Immunogenicity 
testing 
(Section 8.1.3.6) 
Immunogenicity testing will be performed using samples from 
approximately the first 600 subjects (approximately 300 CSL112 and 300 
placebo) and results will provided to the IDMC for review.  
AE = adverse event; ALT = alanine aminotransferase; apoA-I = apolipoprotein A-I; AST = aspartate 
aminotransferase; BUN = blood urea nitrogen; CBC = complete blood count; eGFR = estimated glomerular 
filtration rate; HDL = high density lipoprotein; IDMC = Independent Data Monitoring Committee; 
LDL = low density lipoprotein; MI = myocardial Infarction; SAE = serious adverse event; ULN = upper 
limit of normal; WBC = white blood cell. 
a All lipid panel analytes must be blinded. 
8.1.3.1 
Adverse Events Monitoring 
Incidence, severity, and causality of AEs, including SAEs, will be evaluated according to the 
criteria specified in Section 9. The period of observation of AEs extends from the time the 
subject provides signed informed consent through Visit 8 (Day 90) and, for an individual 
subject, is to be extended to the EOS Visit (Day 365) for the following instances (see 
Section 9.4): 
• AEs considered related to investigational product. 
• AEs leading to discontinuation of investigational product. 
• AEs leading to withdrawal of consent during the study. 
The period of observation of SAEs for an individual subject extends from the time the subject 
provides signed informed consent through the EOS Visit (Day 365), regardless of the 
relationship to investigational product, as specified in Section 9.4. Before and at the end of 
each infusion conducted at the study site, the investigator or a medically qualified delegate 

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will specifically inquire (via non-leading questioning) about any AEs that might have 
occurred since the last infusion conducted at the study site. All AEs (and SAEs and AEs of 
special interest) will be recorded on the AE page of the eCRF page. 
Procedures for reporting AEs, adverse events of special interest (AESIs), and SAEs are 
specified in Section 9.6.1, Section 9.6.2 and Section 9.6.3, respectively. 
8.1.3.1.1 
Adverse Events of Special Interest 
8.1.3.1.1.1 
Hypersensitivity 
In the event that a subject experiences an SAE of hypersensitivity, or there is suspected 
angioedema during infusion of investigational product (as defined in Section 9.1.2), the 
current infusion and all subsequent infusions must be immediately discontinued. The subject 
must receive immediate medical assessment and indicated supportive management per the 
institutional standard of care. 
•
Additional assessments are to be performed as outlined below. A follow-up is required
until resolution of the event. The following assessments should be performed: Collect
blood samples for complete blood count with differential (Table 3), levels of quantitative
immunoglobulins (immunoglobulins G, M, E, and A), and presence of anti-IgA
antibodies.
•
A blood sample for immunogenicity testing will be taken as close as possible to the event
and tested for anti-CSL112 and anti-apoA-I antibodies.
•
The subject should be re-queried to confirm the absence of a history of allergy to soy or
peanuts.
•
Pertinent positives and negatives should also be assessed and documented in the source
document and eCRF including but not limited to: rash, swelling, hives, itching, shortness
of breath, wheezing, stridor, and involvement of the mucous membranes.
•
Relevant physical examination findings should also be documented (eg, maculopapular
rash, swelling of the face or oropharynx, wheezing, etc.).
Any hypersensitivity reaction should be recorded as an AE (Section 9.6.1). 

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8.1.3.1.1.2 
Potential Hepatic Injury 
If a subject has elevation in ALT > 3 × ULN with a concomitant increase in total bilirubin 
> 2 × ULN OR an elevation in ALT > 5 × ULN, blood samples should be obtained and sent to 
the central laboratory within 48 to 72 hours in order to perform the following assessments: 
• ALT, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, alkaline 
phosphatase, gamma glutamyl transferase, amylase, and lipase. 
• Complete blood count with differential. 
• C-reactive protein. 
• Prothrombin time / international normalized ratio. 
• Serology for Hepatitis A, B, C, D, E. 
• Cytomegalovirus titers (Immunoglobulin M, Immunoglobulin G). 
• Epstein–Barr virus titers (Immunoglobulin M, Immunoglobulin G). 
• Quantitative immunoglobulins (Immunoglobulins G, M, E, and A). 
• Anti-nuclear antibodies. 
If there is suspicion for autoimmune mediated hepatitis, blood samples should be obtained 
and sent to the central laboratory for: 
• Double-stranded DNA. 
• Anti-smooth muscle antibodies. 
• Anti-mitochondrial antibodies. 
• Cytoplasmic autoantibodies. 
• Perinuclear anti-neutrophil cytoplasmic antibodies. 
A hepatic injury assessment should include a clinical assessment of symptoms consistent with 
liver dysfunction, including right upper quadrant abdominal pain, anorexia, etc. Diagnostic 
imaging of the liver, such as liver ultrasound, should be performed if clinically indicated and 
should be reported in the eCRF if performed. 
Further repeat testing for ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, and 
gamma glutamyl transferase should occur as clinically indicated but at least every 48 to 
72 hours until abnormalities improve or stabilize. 
Retesting may decrease to once a week or less if abnormalities stabilize, the investigational 
product has been discontinued, and subject is asymptomatic to resolution. Retesting of other 

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relevant parameters may be performed as clinically indicated. Local laboratory assessments 
may be used for this repeat testing. Consultation with a specialist should be considered if 
indicated. 
The condition resulting in elevations in AST or ALT > 3 × ULN with concomitant elevation 
in total bilirubin > 2 × ULN, or an elevation in ALT > 5 × ULN should be reported as an AE 
or SAE as appropriate as per Section 9.6.2.2. 
8.1.3.1.1.3 
Acute Kidney Injury 
If there is an increase from baseline in serum creatinine ≥ 0.3 mg/dL (27 µmol/L), the 
subject’s serum creatinine value must be retested. 
8.1.3.2 
Clinical Laboratory Testing 
During the course of study conduct, the IDMC may recommend whether the requirement for 
local and / or central laboratory assessments of hepatic and / or renal function before 
subsequent infusions can be discontinued (ie, blood sampling and review of results can stop). 
In that case, all subsequent infusions are to be based on clinical assessment (see 
Sections 3.7.1 and 4.2). The investigator should review the results of any available local and 
central laboratory ALT, total bilirubin, and serum creatinine results from specimens drawn 
prior to or subsequent to the previous infusion before administering the investigational 
product. 
During the course of study conduct, the investigator may obtain local laboratory values as 
part of standard of care testing; however, the investigator and other blinded study staff 
must not review the results of a lipid panel test (specifically the HDL cholesterol level) 
during the Active Treatment Period as the results may unblind treatment assignment. 
8.1.3.2.1 
Local Laboratory Testing 
Local laboratory values obtained as part of standard of care testing for the index MI event 
and before obtaining written informed consent may be used to determine hepatic (ALT and 
total bilirubin) and renal (serum creatinine) function stability for study entry and dosing 
eligibility of investigational product as per Section 4.2. The use of plasma or whole blood 
creatinine (instead of serum creatinine) when performed by a certified laboratory using an 

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approved methodology will be deemed an acceptable alternative to serum creatinine, if serum 
creatinine testing is not available. If multiple local laboratory tests are obtained: 
•
The ALT or total bilirubin value closest in time prior to the planned randomization should
be used to determine hepatic function eligibility.
•
A serum creatinine value obtained at least 12 hours after FMC for the index event to
assess clinical stability and determine eligibility for subjects who have not undergone
angiography.
•
A serum creatinine value closest in time prior to IV contrast administration should be
used as reference to assess stable renal function for subjects who have undergone
angiography and received IV contrast agent. If a pre-contrast serum creatinine value is
not available, historical documentation of serum creatinine within ≤ 6 months from
screening is acceptable for use as a reference. The serum creatinine value obtained closest
in time to the planned randomization should be used to determine eligibility by
comparing it to this historical reference serum creatinine value.
If laboratory testing values from standard of care practices are not available to assess hepatic 
and renal function eligibility, then a blood sample must be obtained for local laboratory 
testing. The laboratory values must be confirmed by the investigator for eligibility before 
administration investigational product. A single blood draw may be performed to collect 
samples for local and central laboratory testing; a blood sample must be sent to the central 
laboratory at baseline for study analysis purposes (Section 8.1.3.2.2). 
8.1.3.2.2 
Central Laboratory Testing 
Blood for the clinical laboratory tests presented in Table 3 is to be obtained from the subject 
as outlined in the Schedule of Assessments. Before infusion 2, 3, and 4, the ALT, total 
bilirubin and serum creatinine criteria must be met by review of central laboratory (obtained 
from the previous visits) by the investigator as indicated in Sections 4.2.2.1 and 4.2.2.2. Any 
additional testing is considered part of standard of care and / or unscheduled visit at the 
discretion of the investigator to assess subject safety. 
Clinical laboratory test results (serum biochemistry and hematology) from the central and / or 
local laboratory that are outside the normal reference range and are deemed clinically 
significant by the investigator are to be recorded as AEs (Section 9.6) or SAEs 
(Section 9.6.3). Refer to Table 3 for specific serum biochemistry and hematology parameters 
for testing. If clinically significant abnormal laboratory test results are identified after 

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investigational product infusion, the test(s) will be repeated until the values return to normal 
and / or baseline. Safety parameters should be repeated if the specimen is hemolyzed. 
Investigators must review all laboratory results to assess for clinical significance and to 
determine if values meet criteria for AEs (Section 9.1.1). 
Refer to the Laboratory Manual for details about the collection, storage, handling, and 
transportation of biological specimens. 
8.1.3.3 
Pregnancy Test 
All female subjects of child-bearing potential will be tested using a urine pregnancy test for 
beta-human chorionic gonadotropin. Country-specific mandates may require additional 
pregnancy testing prior to each infusion. 
All female subjects of child-bearing potential must have a negative urine pregnancy test. If 
the urine test cannot be confirmed as negative, a serum pregnancy test will be required. This 
pregnancy test must be negative for the subject to be eligible (Section 4.1.1). 
8.1.3.4 
Vital Signs 
Vital signs measurement will include blood pressure (systolic and diastolic) and pulse rate 
according to site’s standard practices. Blood pressure and pulse rate will be measured after 
the subject has rested. Pulse rate will be counted and adjusted per minute or measured with 
an automatic blood pressure monitor. 
8.1.3.5 
Parvovirus Testing 
Samples will be collected from all randomized subjects at Visit 2 (Day 1; before infusion 1) 
and Visit 6 (Day 29), and will be stored for up to 1 year after completion of the clinical study 
report or for the duration permitted by national or local regulations for routine testing or 
safety surveillance. Nucleic acid testing and serology (parvovirus B19) will be performed 
using complete samples (at all timepoints indicated in Schedule of Assessments) from 
approximately 300 randomly selected subjects (approximately 150 CSL112 and 150 placebo) 
to evaluate changes from baseline (ie, evidence of seroconversion or infection) for parvovirus 
B19. 
8.1.3.6 
Immunogenicity Testing 
Immunogenicity testing will be performed using blood samples from approximately the first 
600 subjects (approximately 300 CSL112 and 300 placebo), and results will provided to the 

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IDMC for review (Section 3.7.1). If no immunogenicity signal is observed in the CSL112-
treated subjects, the IDMC can recommend that no further samples be assayed for 
immunogenicity. Samples will continue to be collected from all randomized subjects and will 
be stored for up to 1 year after completion of the clinical study report or for the duration 
permitted by national or local regulations for routine testing or surveillance as 
immunogenicity testing is part of evaluation for a serious hypersensitivity reaction. 
In the event that a subject experiences an SAE of hypersensitivity, or there is suspected 
angioedema during infusion of investigational product, the subject’s blood samples taken at 
baseline and at the time of the serious hypersensitivity reaction will be analyzed for the 
presence of binding antibodies specific to CSL112 and apoA-I. 
8.1.4 
Other Assessments 
8.1.4.1 
Quality of Life Questionnaire 
The EQ-5D-3L is a standardized measure of health status that provides a simple, generic 
measure of health for clinical and economic appraisal. The questionnaire, which is designed 
for self-completion by respondents, is applicable to a wide range of health conditions and 
treatments [EuroQol Group, 1990]. The questionnaire is to be completed at Visits 1 and 8. 
The EQ-5D-3L consists of 2 parts: 
• A descriptive profile, comprising the following 5 dimensions: mobility, self-care, usual 
activities, pain / discomfort, and anxiety / depression. Subjects rate each dimension based 
on 3 levels of severity (ie, no problems, some problems, extreme problems). 
• A vertical, visual analog scale (VAS), on which the subject rates their overall health from 
‘Best imaginable health state’ to ‘Worst imaginable health state’. 
8.1.4.2 
Lifestyle Adherence Assessment 
Adherence to guidelines regarding diet and lifestyle restrictions, physical activity and / or 
cardiac rehabilitation, and tobacco smoking cessation will be assessed at Visit 8 (Day 90), 
Visit 9 (Day 180), and the EOS Visit (Day 365) (see Section 7.4). 
8.1.5 
Pharmacokinetic / Pharmacodynamics Assessments 
Blood samples from randomized subjects at selected sites, who provide signed informed 
consent for PK and PD blood sample collection, will be collected at time points listed in the 
Schedule of Assessments for determination of the PK parameters of CSL112 through analysis 
of apoA-I and PC plasma concentrations and PD analyses of lipid biomarkers (cholesterol 

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efflux), respectively. Sample analysis will be conducted as detailed in the study reference 
manuals. 
8.2 
Blood Samples 
Detailed information on the estimated volume of blood to be sampled for each assessment 
and / or by visits will be available in the informed consent form (ICF) and study reference 
manuals. Repeat or unscheduled blood samples may be taken for safety reasons or for 
technical issues with the samples. Refer to the study reference manuals for details about the 
collection, storage, handling, and processing of blood samples. 
8.3 
Retention of Samples for Future Biomedical Research 
Retention samples including whole blood will be obtained at time point(s) specified in the 
Schedule of Assessments for future biomedical research (FBR), including for genomic use, 
from consenting subjects. Retention samples will be stored and will be destroyed within 10 
years after completion of the clinical study report, or for the duration permitted by national or 
local regulations. Refer to the study reference manuals for further details about the storage 
and destruction of retention samples. 
Research for biomedical testing is to address emergent questions not described elsewhere in 
the protocol and will only be conducted on a subset of appropriately consented subjects. 
Research may be done to explore and identify biomarkers that inform the scientific 
understanding of the disease and / or therapeutic treatment. The overarching goal is to use the 
information to understand the risk and progression of the disease of interest, and to develop 
safer, more effective drugs and / or to ensure the correct dose of drug at the correct time. 
Future biomedical research testing including samples intended for storage and / or future 
analyses (eg, archival blood sample) will be collected at time point(s) specified in the 
Schedule of Assessments. 
The decision to assess additional biomarkers from an archival blood may be made by the 
Executive Committee with input from the Steering Committee, and based on the latest 
available information on the utility of such measurements. These analyses, including 
genotypic analysis, may be used for future planning and / or exploratory analyses. 
8.4 
Concomitant Therapies 
All drugs and / or procedures currently being administered to a subject at the time of signing 
informed consent, and which continue to be taken in addition to investigational product 

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during the study, are regarded as concomitant therapies and must be documented as such in 
the eCRF. Refer to Sections 7.2 and 8.1.1.3 for detailed instructions. 
8.5 
Visit Schedule 
The timing and frequency of the study visits, including assessment time windows, are 
presented in the Schedule of Assessments. 
8.5.1 
Visit 1 (Screening) 
All subjects must provide written informed consent before any study-specific assessments or 
procedures are performed. Written informed consent is not required for assessments or 
procedures performed according to standard of care (eg, for diagnosis or treatment); results 
from such assessments may be used in the determination of study eligibility. 
Subjects will be assessed for eligibility at screening (Visit 1). Screening / eligibility 
assessment should occur before or on the day of hospital discharge. Before infusion 1 of 
investigational product is administered, the subject must be clinically stable and meet all of 
the inclusion and none of the exclusion criteria (Section 4.1). Hepatic and renal eligibility 
must be confirmed by the investigator and there must be no suspicion of AKI (Section 4.2.1). 
Subjects who complete all of these assessments and who fulfill all eligibility criteria 
(ie, eligible subjects) will be enrolled into the study. If the subject is not eligible for the study, 
the subject information and primary reason for screen failure must be entered in the IRT. 
Screening and randomization of subjects may occur on the same day (Day 1 of the Active 
Treatment Period) provided that the minimum time window after FMC for the index event is 
met. All tests and procedures that are required to be performed to determine subject eligibility 
(ie, screening and randomization) must be performed with enough time to administer the 
investigational product within this timeframe. If angiography is planned for treatment of the 
index MI, randomization must occur after the procedure has been performed and stability of 
serum creatinine confirmed at least 12 hours after IV contrast administration.   
The following procedures will be conducted and documented at the Screening Visit: 
• Informed consent. 
o All subjects must provide written informed consent before any study-specific 
assessments or procedures are performed. Written informed consent is not required 
for assessments or procedures performed according to standard of care (eg, for 

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diagnosis or treatment); results from such assessments may be used in the 
determination of study eligibility. 
• Informed consent for FBR (optional). 
• Medical and surgical history. 
• Prior / concomitant medication review. 
• Review of inclusion and exclusion criteria. 
• IRT subject registration and randomization (if eligible). 
o If the subject is not eligible for the study, the primary reason for screen failure must 
be entered in the IRT system. 
• Pregnancy test (if applicable). 
• Demography (year of birth, years of age, sex, race, and ethnicity). 
• Height. 
• Vital signs. 
• Directed physical examination. 
• Body weight. 
• Blood sample for local laboratory testing (ALT, total bilirubin, and serum creatinine to 
confirm infusion eligibility), unless already collected as part of standard of care. 
• AE / SAE monitoring. 
• EQ-5D-3L questionnaire. 
8.5.2 
Active Treatment Period 
8.5.2.1 
Visit 2 (Infusion 1) 
Infusion 1 must be administered in the timeframe as detailed in Section 4.2.1. 
Before infusion 1 of investigational product, hepatic and renal eligibility based on test results 
from the local laboratory must be confirmed by the investigator, and there must be no 
suspicion of AKI (Sections 4.2.1 and 8.5.1). 
Before the start of infusion, perform the following assessments: 
• Prior / concomitant medication review. 
• Vital signs. 
• Blood sample for central laboratory testing (biochemistry panel and hematology). 

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• Blood sample for immunogenicity testing (to be retained in the case of a subject 
experiencing serious hypersensitivity or suspected angioedema during infusion of 
investigational product infusion). 
• Blood sample for parvovirus testing. 
• Blood sample for FBR (if subject consented). 
• Blood sample for PK / PD assessment (at selected sites). 
• AE / SAE monitoring. 
Administer the first IV infusion of investigational product (placebo or CSL112) (Section 6.2). 
At the end of the infusion, perform the following assessments: 
• AE / SAE monitoring. 
• MACE endpoint assessment. 
• Blood sample for PK / PD assessment (at selected sites) 
8.5.2.2 
Visits 3, 4, and 5 (Infusions 2, 3, and 4) 
Each infusion of investigational product should be completed as close to the visit windows 
outlined in the Schedule of Assessments as possible. An infusion may be skipped 
(ie, ‘missed’) or delayed at the discretion of the investigator to evaluate and treat an AE 
before the next infusion. The time window between each infusion may be extended as long as 
the last infusion of investigational product is given within 30 days of infusion 1 and the 
minimum window between infusions is at least 5 days. 
Refer to the study reference manuals for detailed instructions for how to address study 
procedures performed in the Active Treatment Period and for detailed instructions for skipped 
(ie, ‘missed’) or delayed infusion.  
Before infusion 2, dosing eligibility depends on timing of infusion 1 relative to IV contrast 
administration in the subsets of subjects as follows: 
• For subjects who received infusion 1 of investigational product > 12 hours and < 48 hours 
after IV contrast administration, a local laboratory serum creatinine value must be 
obtained before the infusion for comparison with the local laboratory baseline value and 
reviewed by the investigator. A blood sample for local laboratory testing to assess dosing 
eligibility for infusion 2 should not occur earlier than 72 hours following infusion 1 (refer 
to Section 4.2.2.2 for dosing eligibility). 

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• For subjects who received infusion 1 of investigational product ≥ 48 hours after FMC or 
IV contrast administration, eligibility for dosing will be determined by the investigator 
based on clinical assessment (eg, assessments of hemodynamic status, directed physical 
exam if clinically indicated, and AE assessment) with support of local and central 
laboratory serum creatinine values at baseline (refer to Section 4.2.2.2 for dosing 
eligibility). 
Before infusions 3 and 4, eligibility for dosing will be determined by the investigator based 
on clinical assessment (eg, assessments of hemodynamic status, directed physical exam if 
clinically indicated, and AE assessment) with support of available local and central 
laboratory serum creatinine values at baseline and follow up (refer to Section 4.2.2.2 for 
dosing eligibility). 
Before the start of infusions 2, 3, and 4, perform the following assessments: 
• Prior / concomitant medication review. 
• Prior laboratory value review (see footnote M in the Schedule of Assessments). 
• Vital signs. 
• Infusions 2 and 3 only: blood sample for central laboratory testing (biochemistry panel). 
• AE / SAE monitoring. 
• MACE endpoint assessment. 
Administer the IV infusions 2, 3, and 4 of investigational product (placebo or CSL112) 
(Section 6.2). 
At the end of the infusion, perform the following assessments: 
• AE / SAE monitoring. 
• MACE endpoint assessment. 
• Infusion 4 only: blood sample for PK / PD assessment (at selected sites). 
8.5.2.3 
Visit 6 (End of Active Treatment Period) 
• Visit 6 (Day 29) is the end of the Active Treatment Period and should occur 
approximately 7 (± 2) days after infusion 4 (or last infusion) of investigational product. 
• Prior / concomitant medication review. 
• Vital signs. 
• Body weight.  

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•
Directed physical examination.
•
Pregnancy test (if applicable).
•
Blood sample for central laboratory testing (biochemistry panel and hematology,
immunogenicity, and parvovirus testing).
•
AE / SAE monitoring.
•
MACE endpoint assessment.
•
Blood sample for FBR (if subject consented).
8.5.3 
Visits 7, 8, 9, 10, and 11 (Follow-up Period) 
Visit 7 and Visit 10 assessments may be conducted either by telephone contact or face-to-face 
at the study site. Visit 8, 9, and 11 assessments should be conducted face-to-face at the study 
site.  
•
Concomitant medication review of all treatments for ACS including the dose, route of
administration, and frequency must be collected and monitored for change through to the
EOS (Day 365). Note: All other concomitant medications taken or administered during
the study will be collected through Visit 8 (Day 90), or beyond in the event of an SAE, or
AEs considered related to investigational product, leading to discontinuation of
investigational product, and / or leading to withdrawal of consent during the study.
•
MACE endpoint assessment (all visits).
•
Body weight (Visits 8, 9, and 11).
•
Lifestyle adherence assessment (Visits 8, 9, and 11).
•
AE monitoring (Visits 7 and 8). Note: AEs considered related to investigational product,
leading to discontinuation of investigational product, and / or leading to withdrawal of
consent during the study are also to be collected at Visits 9, 10, and EOS.
•
AEs related to investigational product / SAE monitoring (all visits).
•
EQ-5D-3L assessment (Visit 8).
8.5.4 
Early Termination Visit 
Subjects who prematurely discontinue infusion(s) of investigational product are to be 
assessed at Visit 6 / Early Termination Visit as soon as possible after discontinuation of 
investigational product. Refer to Sections 4.3.1 and 4.3.3 for definition of discontinuation of 
treatment and / or subject withdrawal from study, respectively, and Sections 4.3.4 and 4.3.5 
for follow-up procedures. 

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9 
Adverse Events 
9.1 
Definitions 
9.1.1 
Adverse Event 
As per the ICH guidelines, an AE is any untoward medical occurrence in a patient or clinical 
investigation subject administered a pharmaceutical product and which does not necessarily 
have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and 
unintended sign (including an abnormal, clinically significant laboratory finding), symptom, 
or disease temporally associated with the use of a medicinal (investigational) product, 
whether or not considered related to the medicinal (investigational) product. 
Adverse events may include: 
• Exacerbation (ie, an increase in the frequency or severity) of a preexisting condition. 
• A clinical event occurring after consent but before investigational product administration. 
• Intercurrent illnesses with an onset after administration of investigational product. 
Adverse events do not include: 
• Events identified at screening that meet exclusion criteria. 
• Medical or surgical procedures (the condition that leads to the procedure is the AE). 
• Situations where an untoward medical occurrence has not taken place. For example: 
o Planned hospitalizations due to preexisting conditions, which have not worsened. 
o Hospitalizations that occur for procedures not due to an AE (eg, cosmetic surgery). 
o Hospitalizations for a diagnostic procedure where the hospital stay is less than 
24 hours in duration or for normal management procedures (eg, low dose 
chemotherapy for a rheumatologic disorder). 
o Overdose of investigational product or any concomitant therapy that does not result in 
any AE signs or symptoms. 
For laboratory safety parameters, any instances of absolute values being outside the reference 
range or changes at any visit after study start that are considered by the investigator as 
clinically significant must be recorded in the eCRF as AEs. In addition, at the investigator’s 
discretion, any changes or trends over time in laboratory parameters can be recorded in the 
eCRF as AEs if such changes or trends are considered to be clinically relevant, even if the 
absolute values are within the reference range. 

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Laboratory findings do not need to be reported as AEs in the following cases: 
• Laboratory parameters already beyond the reference range at screening, unless a further 
increase / decrease can be considered an exacerbation of a preexisting condition. 
• Abnormal laboratory parameters caused by mechanical or physical influences on the 
blood sample (eg, in vitro hemolysis) and flagged as such by the laboratory in the 
laboratory report. 
• Abnormal parameters that are obviously biologically implausible (eg, values that are 
incompatible with life or outside the measuring range). 
• An abnormal laboratory value that cannot be confirmed after repeat analysis, preferably 
in the same laboratory (ie, the previous result could be marked as not valid and should not 
necessarily be reported as an AE). 
9.1.2 
Adverse Events of Special Interest 
Adverse events of special interest will include hypersensitivity, potential hepatic injury, AKI, 
and new or worsening of pre-existing HF. Potential hepatic injury and new or worsening of 
pre-existing HF will be adjudicated by the CEC (Section 3.7.4). At each scheduled study 
assessment, the investigator or a medically qualified delegate will specifically inquire about 
any AEs that might have occurred since the last infusion. All AEs will be recorded on the AE 
page of the eCRF page. 
The reporting requirements for AEs of Special Interest are detailed in Section 9.6.2. 
9.1.2.1 
Hypersensitivity 
Hypersensitivity findings may include allergic reactions, bronchospasm / wheezing, 
generalized rash, swelling, hives, involvement of the mucous membranes, anaphylaxis, etc. 
Study site personnel who are medically qualified to recognize and treat hypersensitivity 
reactions must be available together with medications and equipment to treat such reactions. 
In the event that a subject experiences signs or symptoms of a hypersensitivity reaction 
requiring hospitalization or urgent intervention, or there is suspected angioedema during (or 
within 6 hours following) an infusion of investigational product, the current infusion and all 
subsequent infusions must be immediately discontinued. The subject must receive immediate 
medical assessment and indicated supportive management per the institutional standard of 
care. In the event that a subject experiences an SAE of hypersensitivity, or there is suspected 
angioedema during infusion of investigational product, assessments should be performed as 
detailed in Section 8.1.3.1.1.1. 

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9.1.2.2 
Potential Hepatic Injury 
Hy’s Law is by definition an elevation in ALT or AST > 3 × ULN with a concomitant 
increase in total bilirubin that is > 2 × ULN without initial findings of cholestasis (elevated 
alkaline phosphatase > 2 × ULN), and with no other reason found to explain the combination 
of these increased ALT / AST and total bilirubin findings [FDA Guidance for Industry, 2009]. 
For the purpose of this study, potential Hy’s law cases are defined as an elevation in ALT 
> 3 × ULN with a concomitant increase in total bilirubin that is > 2 × ULN that is confirmed 
by repeat assessment, without initial findings of cholestasis (ie, without elevated alkaline 
phosphatase) and with no other reason to explain the combination of these increased ALT and 
total bilirubin findings. Note that elevated AST is not being used in the definition for this 
study because there may be increases in AST that are due to the index MI event. If any 
subject has elevation in ALT > 3 × ULN with a concomitant elevation in total bilirubin 
> 2 × ULN OR an elevation in ALT > 5 × ULN, blood samples should be obtained and sent to 
the central laboratory within 48 to 72 hours in order to perform the assessments detailed in 
Section 8.1.3.1.1.2. All potential hepatic injury AEs and laboratory values meeting these 
criteria will be sent to the CEC for adjudication (Section 3.7.4). 
9.1.2.3 
Acute Kidney Injury 
Acute Kidney Injury for this study purpose is defined as any increase from the baseline in 
serum creatinine of ≥ 0.3 mg/dL (27 μmol/L) during the Active Treatment Period. 
Further guidance to reporting AKI as an AE is in Section 9.6.2.3. 
9.1.2.4 
New or Worsening Heart Failure 
New or worsening HF is defined as an event requiring an urgent, unscheduled medical 
attention, with a primary diagnosis of HF, where the patient exhibits new or worsening 
symptoms of HF on presentation, has objective evidence of new or worsening HF, and 
receives initiation or intensification of treatment specifically for HF. Any suspected new or 
worsening of HF events will be sent to the CEC for adjudication (Section 3.7.4). 
9.1.3 
Serious Adverse Event 
A SAE is defined as any untoward medical occurrence that at any dose: 
• Results in death – The event must be the cause of death for the SAE to meet this serious 
criterion. 

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• Is life-threatening – The term “life-threatening” refers to an event in which the subject 
was at risk of death at the time of the event; it does not refer to an event that 
hypothetically might have caused death if it had been more severe. 
• Requires in-patient hospitalization or prolongation of existing hospitalization – 
CSLB considers “hospitalization or prolongation of existing hospitalization” for at least 
24 hours as the defining criterion for an SAE. Hospital admissions for planned surgery or 
for normal disease management procedures (eg, chemotherapy) are not considered as 
defining criteria for SAEs. 
• Results in persistent or significant disability or incapacity. 
• Is a congenital anomaly or birth defect. 
• Is medically significant – A medically significant event is defined as an event that does 
not necessarily meet any of the SAE criteria, but which is judged by a physician to 
potentially jeopardize the subject or require medical or surgical intervention to prevent 
1 of the above outcomes listed as an SAE criterion. 
Adverse events that do not fall into the above categories are defined as nonserious AEs. 
9.2 
Severity of Adverse Events 
The severity of each AE (ie, nonserious and serious AEs) is to be assessed by the investigator 
as follows: 
Severity 
Definition 
Mild 
A type of AE that is usually transient and may require only minimal 
treatment or therapeutic intervention. The event does not generally interfere 
with usual activities of daily living. 
Moderate 
A type of AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, 
causing discomfort but poses no significant or permanent risk of harm to the 
subject. 
Severe 
A type of AE that interrupts usual activities of daily living, or significantly 
affects clinical status, or may require intensive therapeutic intervention. 
AE = adverse event. 
Note: Definitions are based on the Clinical Data Interchange Standards Consortium Study Data Tabulation 
Model Severity Intensity Scale for AE Terminology. 
9.3 
Causality of Adverse Events 
The causal relationship of an AE to investigational product must always be assessed by the 
investigator. All AEs will be classified as either related or not related to investigational 

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product. If a causality assessment is not provided for an AE (including an SAE), that AE will 
be considered related to investigational product. 
The degree of certainty with which an AE is attributed to investigational product or an 
alternative cause (eg, natural history of the underlying disease, concomitant therapy) will be 
determined by how well the event can be understood in terms of: 
• Known pharmacology of investigational product. 
• Clinically and / or pathophysiologically plausible context. 
• Reaction of a similar nature previously observed with similar products, or reported in the 
literature for similar products as being product related (eg, headache, facial flushing, 
pallor). 
• Plausibility supported by the temporal relationship (eg, the event being related by time to 
administration or termination of treatment with investigational product, drug withdrawal 
or reproduced on rechallenge). 
• Evidence from the literature. 
9.4 
Observation Period for Adverse Events 
The observation period for AE reporting for an individual subject will start at the time of 
giving written informed consent for participation in the current study and through Visit 8 
(Day 90) and, for an individual subject, is to be extended to the EOS Visit (Day 365) in the 
following instances: AEs considered related to investigational product, AEs leading to 
discontinuation of investigational product and AEs leading to withdrawal of consent. The 
observation period for SAE reporting for an individual subject will start at the time of giving 
written informed consent and continue through to the EOS. 
If an SAE occurs at any time during the study (including after the observation period has 
finished and there is at least a possible causal relationship to investigational product), the 
event must be reported to CSLB (see Section 9.6.3). 
9.5 
Follow-up of Adverse Events 
Every effort should be made to follow AEs until resolution or stabilization. Ongoing, 
nonserious AEs that have not resolved or stabilized will be followed until the subject 
completes the study. SAEs will be followed until the AE resolves, stabilizes, or the subject is 
lost to follow-up. 

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All follow-up information (and attempted follow-up contacts) should be documented in the 
subject’s medical records. Details of the subject’s progression to the SAE should also be 
submitted to CSLB Global Clinical Safety and Pharmacovigilance. 
9.6 
Adverse Event Reporting 
9.6.1 
Adverse Events 
The investigator (or delegate) will determine whether any AEs have occurred throughout the 
study as per Section 9.4. AEs will be recorded in the AE module of the eCRF. If known, the 
medical diagnosis of an AE should be recorded in preference to the listing of individual signs 
and symptoms. 
The investigator must follow-up on the course of an AE until resolution or stabilization. If an 
AE is ongoing after the subject’s EOS Visit, the AE will continue to be followed until 
resolution, stabilization, a new baseline is achieved, or the subject is lost to follow-up, 
whichever is sooner, or to the end of the study. 
If during the study period a subject presents with an SAE, only relevant preexisting condition 
to support the narrative of the event should be retrospectively recorded. For AE reporting, the 
study period is defined as that time period from the signature of the ICF through 
Visit 8 (Day 90) and is to be extended to the end of study for specific instances as outlined in 
Section 9.4. 
9.6.2 
Adverse Events of Special Interest 
If an AESI is considered serious, the event must be reported to CSLB as described in 
Section 9.6.3 (Serious Adverse Event Reporting). 
9.6.2.1 
Hypersensitivity 
In the event that a subject experiences signs or symptoms of a hypersensitivity reaction 
requiring hospitalization or urgent intervention, or there is suspected angioedema during 
infusion of investigational product, the current infusion and all subsequent infusions must be 
immediately discontinued. In the event that a subject experiences an SAE of hypersensitivity, 
or there is suspected angioedema during infusion of investigational product, the event should 
be reported as an SAE within 24 hours of the investigator awareness of the event as described 
in Section 9.6.1. Assessments for serious hypersensitivity reactions or suspected angioedema 
during infusion of investigational product should be performed as described in 
Section 8.1.3.1.1.1. 

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9.6.2.2 
Potential Hepatic Injury 
An elevation in ALT > 3 × ULN with a concomitant increase in total bilirubin that is 
> 2 × ULN should be reported as an SAE within 24 hours of the investigator awareness of the 
event as described in Section 9.6.3. An elevation in ALT that is 5 × ULN should be reported as 
an AESI but is only to be reported as an SAE if it meets SAE criteria (Section 9.1.3). 
Additional assessments in the event of either laboratory criterion should be performed as 
described in Section 8.1.3.1.1.2. All potential hepatic injury AEs and laboratory assessments 
for values meeting these criteria will also be sent to the CEC for adjudication (Section 3.7.4). 
9.6.2.3 
Acute Kidney Injury 
Acute kidney injury for this study purpose is defined as any increase from baseline in serum 
creatinine value of ≥ 0.3 mg/dL (27 μmol/L) during the Active Treatment Period. In such 
instances, the serum creatinine value must be retested. As described in Section 9.6.1 the 
laboratory abnormality or associated condition should be reported as an AE if it is deemed by 
the investigator as an abnormal, clinically significant finding. 
9.6.2.4 
New or Worsening Heart Failure 
Any suspected new or worsening of HF events will be sent to the CEC for adjudication 
(Section 3.7.4). This event is considered exempt from SAE reporting as per Section 9.6.4 and 
is to be reported in the appropriate endpoint eCRF. 
9.6.3 
Serious Adverse Event Reporting 
This study will comply with all applicable regulatory requirements and adhere to the full 
requirements of ICH Topic E2A (Clinical Safety Data Management: Definitions and 
Standards for Expedited Reporting). 
For SAEs occurring during the study, the investigator or delegate will enter all relevant 
information in the eCRF. If an electronic document is not able to be generated (eg, internet 
access problem), a handwritten paper SAE report must be completed, which must be signed 
and dated by the investigator. 
All SAEs that occur during the course of the study, whether or not causally related to 
investigational product, must be entered into the eCRF immediately (within 24 hours of 
the investigator becoming aware of the event). 

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Adverse events occurring in the period between the time the subject gave written informed 
consent and the first exposure to investigational product that meet 1 or more of the 
seriousness criteria for AEs must be entered into the eCRF in the same manner as other SAEs 
and will be included in the clinical study database and reported to CSLB. 
Any SAE that occurs after the EOS Visit through study database lock as specified in 
Section 3.6 that is considered to be causally related to investigational product must be 
reported immediately (ie, within 24 hours of the investigator becoming aware of the 
event) to CSLB. 
The minimum reporting requirements for reporting of SAEs include: 
• Subject identification number. 
• Suspected medicinal product and / or procedure. 
• Event term. 
• Reporting source identification. 
If the minimum requirements for reporting are fulfilled, the investigator should not wait to 
receive additional information to fully document the event. 
In addition, the investigator must: 
• Report all SAEs to the relevant Institutional Review Board (IRB) / Independent Ethics 
Committee (IEC) as required within the timeframe specified by the IRB / IEC. 
• Enter follow-up information in the eCRF until the SAE has resolved, or, in the case of 
permanent impairment, until stabilized. 
• Ensure that the causality assessment for all SAEs is entered in the eCRF. 
When submitting SAE reports and any other related reports (eg, discharge summaries) to 
CSLB, subjects should be identified only by their subject number and study number. The 
investigator should not include the subject’s name, date of birth, or address. 
In the case of negative adjudication of an event by CEC, the start date for safety reporting 
purposes begins when the event has been negatively adjudicated (see Section 9.6.5). The 
CEC will notify CSLB Safety within 24 hours of a negative adjudication. 
The procedure to be followed if an ongoing AE becomes an SAE after the end of the 
observation period for AEs is described in Section 9.5. Contact details and guidance for 
reporting SAEs will be provided to study sites before the study starts. 

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9.6.4 
Suspected MACE Reporting 
MACE is a composite of the study efficacy endpoints as presented in Sections 2.1, 2.2.2, 
2.2.4.1, and 2.3.2, with further description in Section 8.1.2. All untoward medical 
occurrences that are suspected MACE will be reported as endpoints for CEC adjudication. 
All suspected MACE will be entered by sites on the AE / SAE eCRF. Sites will also complete 
the details needed for adjudication on the endpoint eCRF. 
Note: MACE that occur after informed consent but prior to randomization do not need to be 
adjudicated as endpoints and should be reported as AEs or SAEs as appropriate. 
Suspected MACE events entered on the SAE / AE eCRF page will not be subject to 
expedited safety reporting by CSLB unless the event is determined by the CEC to not meet 
study endpoint criteria as defined in the CEC charter (ie, negative adjudication of the 
potential endpoint; see Section 9.6.5).The suspected MACE are as follows: 
• CV death. 
• MI. 
• Stroke. 
• Hospitalizations for coronary, cerebral or peripheral ischemia. 
ALL deaths should be reported as an endpoint for adjudication. Non-CV death will be 
adjudicated by the CEC and should undergo standard SAE reporting in parallel with the CEC 
adjudication. In cases of death (CV or non-CV), the investigator should supply the CEC and 
the IEC / IRB (as applicable) with any additional information as it becomes available (eg, 
autopsy reports and detailed medical reports). IEC / IRB notification of suspected MACE 
may be required; therefore sites should follow local ethic guidance for reporting of these 
events. 
New or worsening HF is considered an AESI that will also be adjudicated by the CEC for 
safety. A serious event of this condition is exempted from expedited safety reporting by 
CSLB unless it is negatively adjudicated by the CEC (Section 9.6.5). 
Potential hepatic injury (defined in Section 9.1.2.2) is considered an AESI that will also be 
adjudicated by the CEC for safety. Potential hepatic injury events will undergo standard SAE 
reporting in parallel with the CEC adjudication. 
Suspected MACE and new or worsening HF events will be centrally adjudicated by a blinded 
CEC according to the guidelines specified in a separate charter. All MACE, new or 

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worsening HF events, or triggered requests for additional information will be reviewed and 
adjudicated by the CEC without unblinding treatment. 
9.6.5 
Negative Adjudication 
Suspected MACE and new or worsening HF will be evaluated by the CEC. If the reported 
event is determined to not meet study endpoint criteria as defined in the CEC charter (ie, 
negative adjudication of the event) and meets serious criteria, or if CV death is adjudicated 
by the CEC as non-CV death, then the event is to be classified as an SAE by CSLB. 
In the case of negative adjudication of an event by the CEC, the start date for safety reporting 
purposes by CSLB begins when the event has been negatively adjudicated. The CEC will 
notify CSLB within 24 hours of a negative adjudication. 
It is important to note that ALL deaths must be reported as an endpoint and sent for 
adjudication. Only those suspected MACE of CV death that the CEC deems to be of non-CV 
cause will be classified by CSLB as an SAE for expedited reporting. CSLB will be notified 
by the CEC of these non-CV deaths. 
9.6.6 
Overdose 
Any overdose of investigational product that occurs in association with an adverse sign or 
symptom must be entered into the eCRF as an AE; if the AE meets any seriousness criteria, 
the event must be reported as an SAE (see Section 9.6.3). An overdose that does not result in 
any adverse signs or symptoms should not be considered an AE (see Section 9.1.1). 
Details (ie, volume, location of infusions) of overdose of investigational product (defined in 
Section 7.5) must be recorded in the study treatment administration eCRF. Details of 
overdose of any concomitant therapy should be recorded in the concomitant medication 
eCRF. 
9.6.7 
Pregnancy and Breastfeeding 
A female subject or female partner of a male subject who becomes pregnant while 
participating in the study up to and including Visit 7 (Day 60), must notify the investigator 
immediately. CSLB must be notified within 5 days of the investigator becoming aware of the 
pregnancy. 
If a female subject becomes pregnant, she must discontinue treatment with investigational 
product, but may continue other study procedures at the discretion of the investigator. The 

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procedure for discontinuation of a subject will be followed, as described in Section 4.3. 
Every effort will be made to ensure that the relevant safety assessments for Early Termination 
Visit 6 are completed (telephone documentation is allowed). 
A pregnancy in a subject or in a female partner of a male subject exposed to investigational 
product should be followed to term to assess any potential occurrence of congenital 
anomalies or birth defects. Any follow-up information, including premature termination and 
the status of the mother and child after delivery, should be reported by the investigator to 
CSLB using a Pregnancy Reporting / Outcome Form. 
All abnormal pregnancies and neonatal outcomes (eg, spontaneous abortion, stillbirth, 
neonatal death or congenital anomaly) will meet the criteria for SAE classification. The 
investigator should follow the procedure for reporting these events as SAEs (Section 9.6.3). 
9.7 
Institutional Review Board / Independent Ethics Committee 
Reporting Requirements 
The time frame within which an IRB / IEC must be notified of deaths and investigational 
product-related unexpected SAEs is stipulated by each IRB / IEC. It is the investigator’s 
responsibility to comply with the requirements for IRB / IEC notification. CSLB will provide 
investigators with all details of all SAEs reported to regulatory authorities. 
10 
Statistics 
10.1 Sample Size 
10.1.1 
Estimation 
The study is designed as a superiority study. The sample size calculation is based upon the 
hypothesis that compared with placebo, CSL112 will have a 20% relative risk reduction 
(hazard ratio = 0.80) in the primary endpoint over 90 days of follow-up after randomization 
(ie, all subjects will be followed for a fixed duration of 90 days after randomization). 
Assuming a 1-sided alpha of 0.025, not accounting for any dropouts from the study, and the 
interim analyses specified below, 1004 confirmed MACE (CV death, MI, or stroke) will 
provide at least 90% power. A 1-sided hypothesis test is necessary to differentiate 
directionality for interim analyses of futility and efficacy. Based on an assumed 90-day 
placebo event rate of 6.4%, an estimated 17,400 subjects (8700 per group) will be required. 

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The target number of events is also sufficient to achieve a 1-sided P value of 0.005 
(approximate) with an observed hazard ratio of 0.85 in the primary endpoint and will afford 
at least 69% power to detect the minimally clinically relevant hazard ratio of 0.85. 
The sample size calculation given above for number of required events and number of 
estimated subjects includes 3 formal interim analyses. The first 2 interim analyses will be 
conducted for futility only after observation of approximately 301 confirmed MACE (30% of 
the total target number of events) and 502 confirmed MACE (50% of the total target number 
of events). The third interim analysis will be conducted for efficacy only after observation of 
approximately 703 confirmed MACE (70% of the total target number of events).  
The definition of futility boundary value is based on a 2-sided 95% confidence interval for 
the interim hazard ratio and a conclusion of no true underlying treatment difference will be 
reached if the confidence interval excludes a hazard ratio of 0.8 which is the hypothesized 
treatment effect. Specifically, the stopping boundary (non-binding) for futility will be crossed 
at the first interim analysis if the observed hazard ratio is ≥ 1.003 (1-sided P value ≥ 0.51), 
assuming the analysis is performed with 301 events. At the second interim analysis for 
futility, the stopping boundary on the hazard ratio scale is defined to be 0.953 (1-sided 
P value ≥ 0.295) assuming the number of events is exactly 50% of the target (502 events). 
The cumulative probabilities of meeting the futility thresholds at the first or second interim 
analyses if there is no true underlying treatment difference (ie, a true hazard ratio of 1) are 
0.49 and 0.735, respectively. 
Alpha-spending function from the Rho family [Kim and DeMets, 1987] with a parameter 
value of 16 will be utilized for the assessment of efficacy. At 70% of the planned event target 
(703 events), the stopping boundary for efficacy requires an approximate point estimate for 
the hazard ratio of < 0.753 or a 1-sided P value < 0.000083 assuming the interim analysis is 
conducted with exactly 703 events. Such a finding would provide robust and compelling 
evidence of treatment effect attributable to CSL112. The stopping boundary will be 
recomputed at the time of analysis using the actual number of events included in the interim 
analysis, and the specified spending function. Based on event accrual, if the expected timing 
of the IDMC review of the 70% interim analysis is less than 2 months prior to the anticipated 
completion of study enrollment, the 70% interim analysis for efficacy will not be conducted.  
The sample size calculation was performed using East 6.4. 

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10.1.2 
Re-estimation 
MACE rates will be monitored using blinded data to reach a decision on the final sample size 
prior to completion of the enrollment phase. The observed blinded event rate will be based on 
a 90-day Kaplan-Meier (KM) estimate using a time-to-event approach with appropriate 
censoring to account for unobserved data.  If the observed blinded event rate is higher than 
expected, then fewer subjects than 17,400 may be enrolled, with a minimum of 
approximately 15,000 subjects, corresponding to a placebo 90-day event rate of 7.4%. 
Conversely, if the observed, blinded event rate is less than expected, more subjects may be 
enrolled, but the increase would be capped at approximately 20,600 subjects, corresponding 
to a placebo 90-day event rate of 5.4%. The decision regarding sample size adjustment will 
be made when approximately 75% of subjects have been enrolled or approximately 75% of 
events have been accrued, whichever occurs first, with communication to sites occurring 
approximately 3 months prior to close of enrollment. The actual number of subjects to be 
enrolled, within the pre-specified sample size range (15,000 to 20,600), will be determined 
by the Executive Committee and CSLB and chosen to provide a total of approximately 1004 
events for the primary outcome. At final reporting of study data, subgroup analysis to assess 
the consistency of primary MACE results for cohorts enrolled before and after the initial 
communication on sample size re-estimation will be performed. 
10.2 
Description of Study Analysis Sets 
10.2.1 
Screened Analysis Set 
The Screened Analysis Set comprises all subjects who provide written informed consent. 
10.2.2 
Intent-to-Treat Analysis Set 
The Intent-to-treat (ITT) Analysis Set comprises all subjects in the Screened Analysis Set 
who were randomized. The ITT Analysis Set will be analyzed using the treatment to which 
the subject was randomized, regardless of the treatment actually received. 
Any subject who receives a treatment randomization number will be considered to have been 
randomized. 
10.2.3 
Modified Intent-to-Treat Analysis Set 
The modified Intent-to-treat (mITT) Analysis Set comprises all subjects in the ITT Analysis 
Set who receive any amount of investigational product. The mITT Analysis Set will be 

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analyzed using the treatment to which the subject was randomized, regardless of the 
treatment actually received. 
10.2.4 
Safety Analysis Set 
The Safety Analysis Set comprises all subjects in the ITT Analysis Set who receive any 
amount of the investigational product, and will be based on the actual treatment received. The 
safety set will be the primary analysis population for safety data. 
10.3 
Statistical Analyses and Methods 
A complete description of the statistical analyses and methods will be available in the 
Statistical Analysis Plan (SAP), which will be finalized before the database is locked. 
10.3.1 
Subject Disposition and Characteristics 
10.3.1.1 
Subject Disposition 
The total number of subjects who were screened, randomized, completed the study, 
discontinued investigational product (including the reason), and withdrew consent from the 
study (including the reason) will be summarized. Screen failure rates will be presented by 
reason. The number of infusions received by each subject will be summarized. The data will 
be presented in summary tables by treatment group. The reason for discontinuing 
investigational product or withdrawing of consent from the study will be listed by subject. 
The duration of follow-up will be descriptively summarized across all subjects. 
10.3.1.2 
Subject Characteristics 
All demographic and baseline characteristics summaries will be based on the ITT Analysis 
Set. They will be presented in summary tables by treatment group. Continuous data will be 
summarized by descriptive statistics, and categorical data will be summarized by frequency 
distributions. By-subject listings will be provided for demographic and baseline characteristic 
data. 
10.3.2 
Efficacy Analyses 
The ITT Analysis Set will be the primary population for analysis of efficacy data. 

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10.3.2.1 
Study Hypotheses 
The study is designed with the objective of testing the null and the alternative hypotheses for 
the hazard ratio as defined below: 
H0: Hazard ratio (λT / λC) ≥ 1.0 
H1: Hazard ratio (λT / λC) < 1.0 
Where: λT = hazard rate of MACE on the CSL112 group and λC = hazard rate of MACE on 
the placebo group. Under the null hypothesis, the assumption is that no beneficial effect is 
afforded by CSL112 while the alternative hypothesis states that CSL112 is effective in 
reducing the hazard rate of MACE relative to the placebo group. 
10.3.2.2 
Primary Efficacy Endpoint 
The primary endpoint is defined as: 
• Time to first occurrence of any component of the composite MACE, ie, CV death, MI, or 
stroke, from the time of randomization through 90 days. 
All positively adjudicated MIs from randomization through 90 days will be included in the 
analysis of the primary endpoint. For each subject, time to event is defined as the time from 
randomization to the first occurrence of CV death, MI, or stroke based on CEC adjudicated 
and confirmed events. For subjects who do not have an event and do not complete the 90-day 
Follow-up Period, the censoring time is defined as the time from randomization to the last 
assessment at which it is confirmed that no event has occurred. For subjects who do not have 
an event or censoring time within the first 90 days after randomization, an administrative 
censoring will be applied at 90 days. 
10.3.2.2.1 
Primary Efficacy Analysis 
The primary analysis of time to the 3-component MACE (CV death, MI, or stroke) will be 
based on a covariate-adjusted Cox regression model including fixed effects for treatment, 
region, index MI type, index MI management, age (as a continuous variable), diabetes, 
peripheral artery disease, history of prior MI (excluding index MI) and a term for interaction 
between index MI type and index MI management will be fitted using the PHREG procedure 
in SAS. The 1-sided Wald P value for hypothesis testing, the hazard ratio and its 2-sided 95% 
confidence interval, will be estimated from the model. The primary statistical analysis will 
utilize the ITT Analysis Set. Statistical significance will be assessed using a 1-sided 0.000083 
alpha level at the efficacy interim look and 0.024999 at the final analysis (if the primary null 

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hypothesis is not rejected at the 70% interim analysis) assuming the number of events 
accrued is exactly the same as the target, ie, 703 and 1004 at the interim and final analyses, 
respectively. The actual significance level will be recomputed using an alpha spending 
function at the time of analysis if the observed number of events is different from that 
expected. Cumulative event rates will be calculated using the KM method. The effect over 
time will be illustrated with a plot of the complement (1 – KM) of KM estimates. Event 
counts and percentages will be summarized. Analysis under the ITT Analysis Set will utilize 
the strata to which subjects were randomized regardless of any errors in the randomization 
process. 
10.3.2.2.2 
Sensitivity Analyses of the Primary Endpoint 
Additional sensitivity analyses of the primary endpoint will be performed to examine the 
robustness of the conclusion from the planned primary analysis to deviations from 
assumptions. Consistency of findings from the primary and sensitivity analyses will be 
investigated and clinical plausibility of findings examined. Sensitivity analyses will address 
the following categories of data: 
• Informative censoring – Sensitivity to censored-at-random assumption will be examined 
to determine the impact of missing outcome data on the study conclusion in those 
subjects discontinuing the study prior to completing the 90-day duration of follow-up. 
The tipping point analysis for time to event endpoints as outlined in Lipkovich et al, 2016 
will be used to investigate the departures from the censored-at-random assumption 
utilized in the primary analysis. For non-administratively censored observations, missing 
event times in the placebo arm will be imputed from completers in the same arm using a 
censored at random assumption whereas missing event times in the CSL112 arm will be 
imputed under increasingly higher hazards of MACE until the conclusion from the 
primary analysis is nullified. The clinical plausibility of the MACE hazard necessary to 
overturn the conclusion from the primary analysis will be examined. 
• Reduced statistical model – this sensitivity analysis will be conducted without the 
prognostic variables which are included in the primary model (ie, age ≥ 65 years, 
diabetes, peripheral artery disease, or history of prior MI [excluding index MI]).The 
statistical analysis will be based on a covariate-adjusted Cox proportional hazards 
regression model including fixed effects for treatment, region, index MI type, index MI 
management, and a term for interaction between index MI type and index MI 
management. Thus, this model adjusts only for stratification factors and not for 
prognostic factors. 

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• Unadjusted statistical model – in this sensitivity analysis, the primary efficacy endpoint 
will be analyzed based on a Cox regression model including a covariate for treatment 
only. 
• Receipt of investigational product – Sensitivity of results to whether the subject received 
any amount of the investigational product will be examined by repeating the primary 
analysis in the mITT Analysis Set. 
10.3.2.3 
Secondary Efficacy Endpoints 
10.3.2.3.1 
Key Secondary Efficacy Endpoints 
The following key secondary efficacy endpoints are defined in the study and will be based on 
adjudication by the CEC: 
• Total number of hospitalizations for coronary, cerebral, or peripheral ischemia from the 
time of randomization through 90 days. 
• Time to first occurrence of CV death, MI, or stroke from the time of randomization 
through 180 days. 
• Time to first occurrence of CV death, MI, or stroke from the time of randomization 
through 365 days. 
10.3.2.3.1.1 
Key Secondary Efficacy Analyses 
Statistical analysis of key secondary endpoints will be based on the ITT Analysis Set utilizing 
an overall, 1-sided 0.025 significance level. The hypotheses associated with the key 
secondary endpoints will be formally tested and therefore adjusted for multiplicity as 
described in Section 10.3.2.5. 
Total number of hospitalizations for coronary, cerebral, or peripheral ischemia from the 
time of randomization through 90 days: 
A negative binomial regression model will be fitted to the count data arising from the number 
of hospitalizations. The model will include fixed effects for treatment, region, index MI type, 
index MI management, age (as a continuous variable), diabetes, peripheral artery disease, 
history of prior MI (excluding index MI) and a term for interaction between index MI type 
and index MI management. The log link function will be used and the log-transformed 
duration of follow-up within 90 days will be included in the model in order to account for the 
variable duration of follow-up across subjects. The mean rate of hospitalization per 90 days 
will be presented by treatment group. A 1-sided P value for treatment comparison, the rate 

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ratio (CSL112: Placebo) and its 2-sided 95% confidence interval will be estimated from the 
model. A cumulative plot of recurrent hospitalization events will be generated. 
A sensitivity analysis of the hospitalization data will be performed to explicitly incorporate 
death into the outcome using the Win Ratio [Pocock et al, 2012] method. This approach 
recognizes clinical hierarchies within composite outcomes. With the planned endpoint, death 
will be weighted more heavily relative to the total number of CV hospitalizations during 
90 days from the time of randomization. The unmatched win ratio (CSL112: Placebo) will be 
calculated along with associated 2-sided 95% CI and a 1-sided P value. A complete 
description of the analytical approach will be provided in the SAP. 
In addition, hospitalizations per thousand subject-years will be summarized by treatment 
group for descriptive purposes. 
Time to first occurrence of CV death, MI, or stroke from the time of randomization 
through 180 and 365 days: 
Treatment comparison will be based on a covariate-adjusted Cox regression model which 
will be used to estimate the 1-sided Wald P value, the hazard ratio and its 95% confidence 
interval. The model will included fixed effects for treatment, region, index MI type, index MI 
management, age (as a continuous variable), diabetes, peripheral artery disease, history of 
prior MI (excluding index MI) and a term for interaction between index MI type and index 
MI management. The effect over time will be illustrated with a plot of the complement 
(1 - KM) of KM estimates. Event counts and percentages through 180 days will be presented 
by treatment group. 
10.3.2.3.2 
Other Secondary Efficacy Endpoints 
The set of other secondary efficacy endpoints comprises: 
• Time to first occurrence of each individual component of the composite primary efficacy 
endpoint from the time of randomization through 90 days (CV death, MI, Stroke). 
• Time to first occurrence of CV death, type 1 MI, or stroke from the time of randomization 
through 90, 180, and 365 days. 
• Time to occurrence of all-cause death from the time of randomization through 365 days.  
The intent of analyzing the components of the composite primary endpoint is to provide 
information regarding the contribution of each component. The endpoints described in this 
section are not included in the formal hypothesis-testing framework described in 
Section 10.3.2.5 and therefore are not adjusted for multiplicity. 

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10.3.2.3.2.1 
Other Secondary Efficacy Analyses 
The other secondary efficacy endpoints will be analyzed similarly to the primary efficacy 
endpoint (ie, as time to event variables). With respect to the components of the primary 
composite, time to occurrence of each individual component will be analyzed and reported 
separately. Treatment comparison will be based on a covariate-adjusted Cox regression model 
for estimating the 1-sided Wald P value, the hazard ratio and its 95% confidence interval. The 
P values are intended to be descriptive. Event rates and percentages will be presented. The 
effect over time will be illustrated with the complement (1 – KM) of KM estimates. 
10.3.2.4 
Exploratory Efficacy Endpoints 
The exploratory endpoints are defined as: 
1. Total number of hospitalizations for coronary, cerebral, or peripheral ischemia from the 
time of randomization through 30 days. 
2. Time to first occurrence of CV death, MI, stroke, or severe coronary ischemia requiring 
urgent revascularization from the time of randomization through 90 days. 
3. Time to first occurrence of CV death, MI, or stroke from the time of randomization 
through 30 and 60 days. 
4. Time to first occurrence of MI by type, according to the universal definition, from the 
time of randomization through 90 days. 
5. Time to occurrence of CV death from the time of randomization through 365 days. 
6. Time to occurrence of non-CV death from the time of randomization through 365 days. 
7. Total occurrence of re-hospitalization for CV events and all-cause death from the time of 
randomization through 90 days. 
8. Total occurrence of CV death, MI, and stroke from the time of randomization through 90, 
180, and 365 days. 
9. Total occurrence of all-cause death, MI, and stroke from the time of randomization 
through 90, 180, and 365 days. 
10. Medical resource utilization from the time of randomization through 90 days: 
a. Number of total hospitalizations. 
b. Length of hospital stay. 
c. Number of CCU or ICU days. 

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d. Select procedures / surgeries related to hospitalization related to coronary, cerebral, or 
peripheral ischemia. 
e. Discharge to home with additional care, home without additional care, rehabilitation, 
and skilled nursing facilities following hospitalization for coronary, cerebral, or 
peripheral ischemia. 
11. Change in EQ-5D-3L data from baseline to Day 90. 
10.3.2.4.1 
Exploratory Efficacy Analyses 
The analyses of the exploratory efficacy endpoints will be based on the ITT Analysis Set. 
The total number of hospitalizations from the time of randomization through 30 days will be 
analyzed using a negative binomial regression model in a similar manner as described in 
Section 10.3.2.3.1.1 for the number of hospitalizations through 90 days. 
The exploratory time to event efficacy endpoints listed in 2 to 6 above, will be analyzed in a 
manner similar to that of the primary endpoint (see Section 10.3.2.2.1). Treatment 
comparison will be based on a covariate-adjusted Cox regression model for estimating the 
1-sided Wald P value, the hazard ratio and its 2-sided 95% confidence interval. The effect 
over time will be illustrated with a plot of the complement (1 – KM) KM estimates. Event 
counts and percentages will be presented. 
The analysis of the endpoint, total occurrence of rehospitalizations for CV events and 
all-cause death from the time of randomization through 90 days, will be based on the 
unmatched Win Ratio [Pocock et al, 2012], as described in Section 10.3.2.3.1. 
The exploratory endpoints including total occurrence of CV death, MI, and stroke from the 
time of randomization through 90, 180, and 365 days and total occurrence of all-cause death, 
MI, and stroke from the time of randomization through 90, 180, and 365 days will be 
analyzed using a negative binomial regression model in a similar manner as described in 
Section 10.3.2.3.1.1 for the number of hospitalizations through 90 days. 
The relationship between medical resource utilization and treatment with CSL112 will be 
explored and characterized using descriptive statistics. For the purpose of data analysis, the 
medical resource utilization endpoints including number of hospitalizations, length of stay 
and days in ICU or CCU will be treated as count data. For each subject, the following results 
will be derived across all hospitalizations occurring during the 90 days from randomization: 
total number of hospitalizations, total number of days hospitalized and the total number of 

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days spent in ICU or CCU. The analysis of these endpoints will be performed using a 
negative binomial regression model in a similar approach to that described for CV 
hospitalizations. Treatment comparisons will be based on the resulting incidence ratio, 95% 
confidence interval, and 1-sided P value obtained from the model. 
Following hospitalizations related to coronary, cerebral, or peripheral ischemia, counts of 
occurrences of discharge by category (to home with additional care, home without additional 
care, rehab, and skilled nursing facilities) will be summarized. 
The EQ-5D-3L is a patient self-assessment of 5 dimensions of health-related quality of life: 
mobility, self-care, usual activities, pain or discomfort and anxiety or depression. Each 
dimension is measured on a 3-point scale where a higher score corresponds to a worse health 
state. Scores from the individual dimensions will be utilized to calculate an overall utility 
score for each patient using the algorithm specified by the developers of the instrument 
[EuroQol Group, 1990]. The EQ VAS is a continuous 100-point integer scale from 0 (the 
worst health you can imagine) to 100 (the best health you can imagine). 
Response to each of the 5 dimensions will be descriptively summarized. For each treatment, 
shift tables will be employed indicating the number of subjects whose response falls into a 
grid defined by the baseline value on 1 axis and the post-treatment value on the other axis. To 
compare treatments on each dimension, the number (%) of subjects with improvement, no 
change, or worsening from baseline to the post-treatment value will be analyzed using a chi-
square test for a 2 x 3 contingency table with ordered categories of response. 
Both the utility score and the EQ VAS are continuous response variables describing the 
patient’s self-assessment of their health status at baseline and post-treatment. Descriptive 
statistics including the mean, median, SD, minimum and maximum will be provided at 
baseline, post-treatment and for the change from baseline. The change from baseline will be 
compared between treatments employing an analysis of variance model including terms for 
treatment, index MI type, index MI management, region, an interaction term for index MI 
type by index MI management, age (as a continuous variable), diabetes, peripheral artery 
disease, and history of prior MI (excluding index MI). 
10.3.2.5 
Multiplicity 
Issues related to multiplicity arising from testing the primary endpoint and key secondary 
endpoints will be addressed using the serial gatekeeping procedure [Dmitrienko et al, 2013] 
to control the overall experiment-wise error rate at a 1-sided 0.025 level. Three families of 
null hypotheses will be defined with family 1 consisting of the primary endpoint (ie, H01), 

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family 2 consisting of the 2 key secondary endpoints (H02 and H03), and family 3 consisting 
of the third key secondary endpoint (H04). The null hypothesis associated with each of these 
endpoints is given below: 
• H01: Hazard ratio (CSL112:Placebo) for time to first CV death, MI, or stroke from the 
time of randomization through 90 days ≥ 1.0. 
• H02: The risk ratio (CSL112:Placebo) of hospitalizations for coronary, cerebral, or 
peripheral ischemia from the time of randomization through 90 days ≥ 1.0. 
• H03: Hazard ratio (CSL112:Placebo) for time to first occurrence of CV death, MI, or 
stroke from the time of randomization through 180 days ≥ 1.0. 
• H04: Hazard ratio (CSL112:Placebo) for time to first occurrence of CV death, MI, or 
stroke from the time of randomization through 365 days ≥ 1.0. 
If H01 is rejected at the interim analysis (ie, 1-sided P < 0.000083), then the hypothesis tests 
associated with the second family will be performed using the Hochberg procedure at 1-
sided, 0.025 type I error level. The testing will proceed from the largest to smallest raw 
P value. Of the 2 P values, the larger will be compared with a 0.025 significance level; if 
significant (P < 0.025) then the remaining null hypothesis will also be rejected; otherwise, the 
smaller P value will be compared with a 1-sided significance level of 0.0125. Testing will 
proceed to family 3 (H04) at a 1-sided 0.025 level only if both family 2 null hypotheses, H02 
and H03, are rejected. 
If the formal testing process stops with family 1 or family 2 because of failure to achieve 
statistical significance, the remaining secondary outcomes will be considered as exploratory 
outcomes. 
If the observed, 1-sided P value exceeds or is equal to the significance level at the efficacy 
interim analysis then the study will continue until 100% of events have been accrued. In this 
situation, testing of key secondary endpoints will be undertaken only at the final analysis 
using a 1-sided type I error of 0.025. 
10.3.2.6 
Subgroup Analysis 
Internal consistency of observed treatment effect across major subgroups will be investigated 
as part of exploratory analyses. Subgroups may include, but are not limited to, groupings 
based on age, sex, region, ACS type (STEMI vs NSTEMI), whether managed with PCI or 
medically managed, subjects meeting modified enrichment criteria or not (diabetes mellitus 
on pharmacotherapy or at least 2 risk factors [age ≥ 65 years, prior history of MI, or 

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peripheral arterial disease]), prior PCI, renal function, and enrollment cohort relative to the 
communication date of sample size re-estimation to investigators (before or after). Further 
details will be provided in the SAP. 
10.3.3 
Safety Analyses 
10.3.3.1 
Extent of Exposure 
The following data will be summarized by treatment group to describe the extent of exposure 
to investigational product. 
An overall summary of the number of infusions administered and completed will be 
provided. Furthermore, each individual infusion will be described by providing the number of 
subjects starting an infusion, place and total volume (mL) of infusion administration, number 
of infusion interruptions, and total duration across all interruptions. 
10.3.3.2 
Adverse Events 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities and 
summarized by system organ class and preferred term. Separate tables for AEs and SAEs, by 
severity (defined as mild, moderate, or severe) will be provided. In addition, AEs leading to 
discontinuation of investigational product, AEs leading to withdrawal of consent, or AEs 
leading to dose interruptions will be summarized. 
A summary of AEs meeting any of the pre-specified criteria as described below will be 
generated: 
• AEs that begin within 24 hours of the start of an infusion regardless of investigator 
causality assessment, 
• All AEs that begin later than 24 hours of the start of an infusion and are considered to be 
at least possibly causally related to investigational product by the investigator or the 
Sponsor, 
• AEs for which the investigator causality assessment is missing or indeterminate. 
• AEs, for which the exposure-adjusted incidence rate in the CSL112 arm exceeds the 
exposure-adjusted incidence rate in the placebo arm by 30% or more on a relative basis, 
provided the difference in incidence rates is 1% or more. 

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10.3.3.3 
Adverse events of special interest: 
The following types of AEs are of special interest: 
• Hypersensitivity: Standardized MedDRA Queries (SMQ) for hypersensitivity will be 
used to identify relevant preferred terms. The number (%) of subjects with SAEs and non-
SAEs will be summarized. 
• Acute kidney injury:  
o This AESI is defined based on laboratory values.  Any increase in serum creatinine 
value of ≥ 0.3 mg/dL (27 μmol/L) from the baseline serum creatinine during the 
Active Treatment Period will be considered an event. 
o Any increase in serum creatinine value of ≥ 0.3mg/dL (27 μmol/L) from the baseline 
serum creatinine on 2 consecutive occasions during the Active Treatment Period will 
also be summarized. 
o Relevant preferred terms will be identified using the SMQ Acute Renal Failure, 
narrow and will be summarized as an additional analysis of kidney safety / injury. 
• Potential hepatic injury: 
o This AESI is defined based on laboratory values. Any occurrence of either 
concomitant elevations of ALT > 3 x ULN with total bilirubin > 2 x ULN, or ALT 
> 5 x ULN will be considered an event. The number (%) of subjects with an event 
will be summarized. 
o In addition, potential drug-induced liver injury will be adjudicated by the CEC. The 
number (%) of subjects with a positively adjudicated event will be summarized. 
• New or worsening HF – will be adjudicated by the CEC. The number (%) of subjects 
with positively adjudicated events will be reported. 
10.3.3.4 
Other Safety 
Post-treatment changes in serum creatinine relative to baseline will be assessed to support the 
AKI AESI. Change from baseline will be categorized as ≤ baseline value, > 0 to < 0.3, ≥ 0.3 
to < 0.5, and ≥ 0.5 mg/dL (44 µmol/L). The number (%) of subjects who achieve the 
threshold of rise in serum creatinine corresponding to ≥ 0.3 mg/dL (27 µmol/L)  on 1 or more 
occasions as well as on 2 or more consecutive occasions will be presented. Increase relative 
to baseline will be categorized as ≥ 1.5 x baseline value, ≥ 2.0 x baseline value, 
≥ 3.0 x baseline value. The number (%) of subjects with raw serum creatinine value 
≥ 4.0 mg/dL (353.6 μmol/L) will be presented. The number (%) of subjects in each category 
and for each outcome will be presented by treatment arm. 

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Renal function will be further analyzed in subgroups defined on the basis of renal function 
categories and by time delay between contrast administration and investigational product 
administration, both alone and in combination. The 3 renal function subgroups are defined as 
normal (eGFR ≥ 90 mL/min/1.73 m2), or mild renal impairment (eGFR ≥ 60 to 
< 90 mL/min/1.73 m2), and moderate renal impairment (eGFR ≥ 30 to 
< 60 mL/min/1.73 m2). The 3 subgroups for time delay between administration of contrast 
and investigational product are defined as < 24 hours, 24 to < 48 hours, and ≥ 48 hours. 
Of the subjects with blood samples assayed for anti-drug antibodies (ADA), the number (%) 
of subjects who are positive for binding antibodies to CSL112 and apoA-I will be 
summarized. Immunogenicity results for routine samples will be separately summarized from 
those samples taken to assess hypersensitivity reactions. 
All other clinical laboratory assessments and vital sign measurements will be summarized 
using descriptive statistics. Actual value and change from baseline will be summarized by 
treatment arm. Further details will be provided in the SAP. 
10.3.4 
Pharmacokinetic Analyses 
The following PK endpoints are planned as part of the exploratory objective: 
• Baseline-corrected plasma apoA-I concentrations. 
• Baseline-corrected plasma PC concentrations. 
• Concentration in plasma at end-of infusion for apoA-I and PC. 
• Accumulation ratio for apoA-I and PC. 
Plasma concentrations of apoA-I and PC will be assayed from the blood samples drawn in 
the planned PK substudy. Accordingly, blood samples will be drawn before infusion 1, end of 
infusion 1, and end of infusion 4.Plasma concentrations will be descriptively summarized by 
treatment and nominal sampling time points. In addition, a population PK analysis will be 
conducted to further characterize the relationship between the plasma concentrations of 
apoA-I and PC and demographic and baseline characteristics, that will be reported separately. 
10.3.5 
Pharmacodynamic Analyses 
The following pharmacodynamic endpoints are included to support the exploratory objective: 
• Total cholesterol efflux. 
• ABCA1-dependent efflux. 
• ABCA1-independent efflux. 

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Blood samples for pharmacodynamic assessments will be drawn at the same as time points as 
PK blood draws. For each of these the above 3 endpoints, the change from baseline will be 
derived for each parameter and a 2 sample t-test will be used to compare the 2 treatment 
arms. 
10.3.6 
Interim Analysis 
An IDMC will be convened to review accumulating efficacy and safety data. The statistical 
analysis and generation of relevant output will be performed by an external statistical data 
analysis center using the master randomization schedule provided by the IRT service 
provider. To preserve the integrity of the study blind, the results of the interim analyses will 
only be known to the IDMC. Any recommendation by the IDMC to terminate the study 
would not be based solely on statistical grounds. For either futility or efficacy interim 
assessments, a number of factors must be considered as part of the decision including 
exploring internal consistency across key subgroups, consistency across primary and key 
secondary endpoints, possible differences in prognostic factors between treatment groups and 
taking external information into account [Ellenberg et al, 2002]. The process for 
communicating the recommendations to the sponsor and the Executive Committee will be 
outlined in the charter. The key results of interim analyses will be summarized in the final 
clinical study report. 
10.3.6.1 
Interim Analysis of Futility and Efficacy Data 
The IDMC will review efficacy data at 3 planned interim analyses and may recommend early 
termination of the study under the following conditions: 
• There is strong evidence that CSL112 will fail to show superiority with respect to the 
primary MACE endpoint if the study is allowed to run to its planned completion (futility), 
given that the 2-sided 95% CI for the interim hazard ratio excludes 0.8, the hypothesized 
treatment benefit. 
• There is strong evidence that CSL112 is superior to placebo with respect to the primary 
MACE endpoint (efficacy), based on crossing a threshold defined by the Rho alpha 
spending function with parameter of 16. 
Of the 3 planned interim analyses, the first 2 interim analyses will be conducted after 
observation of approximately 301 confirmed MACE (30% of the total target number of 
events) and 502 confirmed MACE (50% of the total target number of events) and will be for 
futility only. The third interim analysis will be conducted after observation of approximately 
703 confirmed MACE (70% of the total target) and will be for efficacy only. Events to be 

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counted toward the interim analysis targets will be adjudicated events from patients with at 
least 90 days of follow-up to ensure there is adequate representation across the full 90-day 
time period in the primary endpoint. Based on event accrual, if the expected timing of the 
IDMC review of the 70% interim analysis is less than 2 months prior to the anticipated 
completion of study enrollment, the 70% interim analysis for efficacy will not be 
conducted.  If the 70% interim analysis is not conducted, an alpha adjustment will be applied 
as if it were conducted (ie, the alpha level for the final analysis will be 0.024999). 
The decision rule for evaluating whether to stop the study due to futility (ie, no true 
underlying difference between treatments) will be based on the 2-sided 95% confidence 
limits for the observed hazard ratio at the interim look; futility will be concluded if the lower 
limit of the CI exceeds a hazard ratio of 0.8, the hypothesized treatment benefit. Assuming 
the futility looks are taken with exactly 301 (30% of the total target number of events) and 
502 (50% of the total target) events, this futility rule corresponds to boundary values of 
≥ 1.003 and ≥ 0.953 on the hazard ratio scale, respectively. These parameter values result in 
cumulative boundary-crossing probabilities of 0.49 and 0.735 for early stopping due to 
futility at the first or the second interim analysis, respectively, if there is no true underlying 
treatment difference. Equivalently, the futility boundary values on the 1-sided P-value scale 
correspond to ≥ 0.51 and ≥ 0.295 at the first and second interim looks for futility, 
respectively. The futility boundary does not represent a binding decision to stop the study 
should this boundary be crossed at either interim look. 
For the purpose of evaluating whether to stop the study for efficacy, the Rho spending 
function with a parameter value of 16 represents a robust and compelling treatment difference 
as the observed hazard ratio at the efficacy interim look has to be approximately < 0.753, 
depending on the number of events included in the analysis. 
For all interim analyses including futility (30% and 50%) and efficacy (70%), the assessment 
regarding whether the boundary is met will be based on an analysis using only subjects 
enrolled at least 90 days prior to the data cutoff date. The IDMC will also consider analyses 
including all subjects and events through 90 days, regardless of enrollment time. In addition 
to the analyses using adjudicated events, analyses based on investigator-events and ‘best 
available’ data will be reviewed. Best available MACE data includes the combination of 
MACE events that have been adjudicated and investigator-reported events that have not yet 
been through the adjudication process. 
The stopping boundary values on the hazard ratio and P value scales given in Table 4 
correspond to the number of confirmed events targeted at the interim and final analyses. The 

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efficacy boundary value may be recalculated using the rho alpha spending function at the 
time of analysis if the number of events accrued is different from that expected. The futility 
evaluation will be based on the confidence interval for the observed hazard ratio computed at 
the time of interim analysis. 
Table 4 
Stopping Boundary Values 
Analysis 
IF 
Events 
 
Cumulative
α Spent 
Boundary Values 
Hazard Ratio Scale 
1-Sided P-Value Scale 
Efficacy 
Futility 
Efficacy 
Futility 
1 
0.3 
301 
0 
NA 
≥ 1.003 
NA 
≥ 0.51 
2 
0.5 
502 
0 
NA 
≥ 0.953 
NA 
≥ 0.295 
3 
0.7 
703 
0.000083 
< 0.753 
NA 
< 0.000083 
NA 
4 
1.0 
1004 
0.025 
< 0.884 
≥ 0.884 
< 0.024999 
≥ 0.024999 
IF = information fraction; NA = not applicable. 
The boundaries are defined in East 6.4 to preserve 1-sided type I error at 2.5% under the 
assumption of a nonbinding futility rule. 
In the event the efficacy stopping boundary is met at the third interim analysis, the IDMC 
will review key secondary endpoints, components (CV Death, spontaneous MI and stroke), 
and subgroups of the primary endpoint. Prior to recommending early termination of the study 
due to efficacy, the IDMC will ensure the presence of positive trends for key secondary 
endpoints and components of the primary MACE endpoint, as well as consistency across 
subgroups for the primary MACE endpoint. In addition to meeting the efficacy stopping 
boundary for the primary MACE endpoint, there will be a criterion for benefit in CV death or 
all-cause mortality, with details to be specified in the IDMC charter. In considering both 
efficacy data and safety data, an extremely compelling benefit / risk must be observed in 
order to recommend early stopping for efficacy. 
If the study is terminated early for efficacy, a final analysis will be performed to account for 
data that have accrued during the conduct of the interim analysis and to test the key 
secondary endpoints. The results from the interim analysis where the efficacy threshold was 
met, as well as the final analysis, will be presented in the final clinical study report. 
10.3.6.2 
Analysis of Safety Data 
The IDMC will evaluate the potential impact of CSL112 on hepatic and renal function and 
examine immunogenicity data for safety signals. 

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Central laboratory data for ALT and serum creatinine will be evaluated to assess the non-
inferiority of CSL112 relative to placebo when approximately 20% of subjects have 
completed Visit 6 (Day 29). 
Hepatic evaluation will be based on unconfirmed elevations in ALT (> 3 x ULN) at any time 
up to Day 29. The treatment difference in the incidence rates along with 2-sided 95% 
confidence interval for the treatment difference will be estimated. If the upper limit of the 
confidence interval is lower than the pre-specified non-inferiority margin of 3%, the hepatic 
effect of CSL112 will be considered to be non-inferior to placebo. In addition to evaluation of 
the non-inferiority analysis, the IDMC will review AEs that may be related to hepatic 
dysfunction (ie, right upper quadrant pain, anorexia, generalized pruritus, jaundice, and 
encephalopathy). The IDMC, using their clinical judgment and the outcome of non-inferiority 
evaluation, may recommend that central laboratory samples prior to infusions 2 and 3 be 
discontinued in the remaining subjects. 
Renal evaluation will be based on the percentage of subjects with a change from baseline 
(before infusion 1) in serum creatinine ≥ 0.3 mg/dL (27 µmol/L) at any time up to Day 29. 
The treatment difference in the incidence rates along with a 2-sided 95% confidence interval 
for the treatment difference will be estimated. If the upper limit of the confidence interval is 
lower than the pre-specified non-inferiority margin of 5%, the renal impact of CSL112 will 
be considered to be non-inferior to placebo. The IDMC has the discretion to recommend that 
laboratory samples in remaining subjects be discontinued. 
In addition to the non-inferiority assessment detailed above, the IDMC will conduct subgroup 
analyses by renal function categories and by time delay between contrast and investigational 
product administration, both alone and in combination. The renal function subgroups will be 
based on the following 3 eGFR categories: normal renal function (eGFR ≥ 90 mL/min/1.73 
m2), mild renal impairment (eGFR ≥ 60 to < 90 mL/min/1.73 m2), and moderate renal 
impairment (eGFR ≥ 30 to < 60 mL/min/1.73 m2). Within the moderate renal impairment 
subgroup, additional analyses will be performed by degree of CKD Stage 3 (ie, CKD 3a 
(eGFR ≥ 45 to < 60 mL/min/1.73 m2) versus CKD 3b (eGFR ≥ 30 to < 45 mL/min/1.73 m2). 
The 3 subgroups for time delay between contrast and investigational product administration 
will be: < 24 hours, 24 to < 48 hours, ≥ 48 hours). Within each of the 9 subgroups defined 
above, the IDMC will review the following summary statistics: event rates by treatment, the 
treatment difference in event rates, and the 95% CI for the treatment difference in event rates. 
The summary statistics for each of the component subgroups will be reviewed as well: 
3 subgroups based on renal function and 3 subgroups based on time delay between contrast 

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administration and investigational product administration. Summaries of increases occurring 
on 1 or more occasions as well as on 2 or more consecutive occasions will be presented. For 
the subgroup with moderate renal impairment and a time delay between administration of 
contrast and investigational product that is < 24 hours, the IDMC will review data after each 
20 subjects are enrolled in this subgroup and reach Day 29 in order to assess for any possible 
effect of the investigational product on renal function. The reviews of this individual 
subgroup will continue until the IDMC determine they are no longer necessary.   
The non-inferiority assessment will serve as a minimum criterion for a potential IDMC 
decision to discontinue routine assessments of renal function prior to infusions 2 and 3. Prior 
to a decision to discontinue routine assessments of renal function at infusions 2 and 3, the 
IDMC will also utilize clinical judgment, considering the summary of results for the 
subgroups outlined above. The IDMC will also use clinical criteria and will review AEs that 
are related to AKI, defined as AEs with a MedDRA Preferred Term included in the Acute 
Renal Failure narrow SMQ. Before any decision, the IDMC will also apply medical 
judgment to assess severity, reversibility and a change to the benefit-risk balance. After this 
planned interim renal evaluation, the IDMC will have the option to recommend discontinuing 
or continuing renal assessments prior to infusions 2 and 3 in the overall study population or 
in certain subgroups of either renal function (such as moderate renal impairment), or time 
interval between contrast administration and administration of investigational product. For 
example, if data are insufficient in a certain subgroup, the recommendation can be 
appropriately tailored to ensure adequate safety monitoring in all subgroups of subjects. 
Blood samples drawn from approximately the first 600 subjects (approximately 300 CSL112 
and 300 placebo) or in the event of a serious hypersensitivity reaction will be assayed to 
detect the presence of binding antibodies to CSL112 and apoA-I. Samples from 300 subjects 
who receive CSL112 will provide a 95% probability of observing at least 1 positive result if 
the underlying rate is 1/100 (ie, 1%). If no immunogenicity signal is observed in CSL112-
treated subjects, the IDMC chair may recommend that no further samples be assayed 
although samples will be collected from all enrolled subjects at baseline and Visit 6 and 
stored. The IDMC may also recommend continued assay of immunogenicity samples in an 
additional subset of subjects based on other safety concerns whether or not immunogenicity 
signal is observed. The number (%) of subjects with positive results for binding antibodies 
will be presented. 

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11 
 Quality Assurance 
The study may be subject to an audit by CSLB, an authorized representative(s) of CSLB 
and / or inspections by an authorized regulatory authority (eg, US Food and Drug 
Administration [FDA]). Regulatory authorities may request access to all study 
documentation, including source documents for inspection and copying, in keeping with local 
regulations. CSLB will notify the investigator of any upcoming audit / inspection. 
In the event of an audit, all pertinent study-related documentation must be made available to 
the auditor(s). If an audit or inspection occurs, the investigator at each study site will permit 
the auditor / inspector direct access to all relevant documents and allocate their time as well 
as the time of relevant staff to discuss the findings and any relevant issues. 
12 
 Regulatory and Ethics Considerations 
12.1 
Regulatory Considerations 
CSLB or its agents will submit the appropriate documents to the local regulatory agencies 
before study start. 
This study will be conducted under an appropriate regulatory submission and documented in 
accordance with the applicable regulatory guidelines and requirements. 
The procedures set out in this study protocol are designed to ensure that CSLB and the 
investigator abide by the principles of the current ICH GCP guideline on the conduct, 
evaluation and documentation of this study, as described in ICH Topic E6 R2 (Guideline for 
GCP). The study will also be carried out according to all applicable international and national 
regulatory requirements. 
12.2 
 Institutional Review Board / Independent Ethics Committee 
The investigator must submit the protocol and ICFs for review by an authorized and properly 
constituted (according to local guidelines) IRB / IEC. Written approval must be received 
from the IRB / IEC before commencement of the study. 
12.3 
Subject Information and Informed Consent 
Informed consent of study subjects according to the standards of GCP must be implemented 
in this clinical study before protocol-specified procedures are carried out. Information should 
be given in both oral and written form and should be deemed appropriate and approved by 

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the IRB / IEC. Subjects (or if necessary, legally acceptable representatives) must be given 
ample opportunity to inquire about details of the study. 
The subject (or if necessary, legally acceptable representatives) must be provided with a copy 
of the signed ICF. 
Should there be any amendments to the protocol that would directly affect the subject’s 
participation in the study (eg, a change in any procedure), the ICF must be amended to 
incorporate this modification. Subjects must be informed of the change and they must sign 
the amended ICF indicating that they re-consent to participate in the study. 
12.4 
 Subject Confidentiality 
All subject names and contact details will be kept confidential. Subjects will be identified 
throughout documentation and evaluation by the number allotted to them during the study. 
Each subject will be told that all study findings will be handled in the strictest confidence. 
The investigator at the study site will be responsible for retaining sufficient information about 
each subject (eg, name, address, phone number and identity in the study) so that regulatory 
agencies or CSLB may access this information should the need arise. These records should be 
retained in a confidential manner as long as legally mandated according to local 
requirements. 
Subject medical records pertaining to the study may be inspected / audited at any time by 
CSLB employees or their duly authorized representatives, a regulatory authority or the 
IRB / IEC. All records accessed will be strictly confidential. Consent to participate in the 
study includes consent to these inspections / audits. 
12.5 
Indemnity and Compensation 
CSLB has taken out insurance to cover its obligations under both the Indemnity and the 
Compensation guidelines for injury to subjects involved in the study. 
Other details regarding compensation and the obligations of the investigator / CSLB are 
provided in the Clinical Trial Research Agreement for the study (see Section 13.1). 

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13 
 Administrative Considerations 
13.1 
Clinical Trial Research Agreement 
This study will be conducted under a Clinical Trial Agreement between CSLB (“Sponsor”) 
and the institution(s) representing the investigational study site(s) (“Authority”). Financial 
support to the investigational site(s) will be detailed in the Clinical Trial Agreement. The 
Clinical Trial Agreement must be signed before the commencement of the study and will 
clearly delineate the responsibilities and obligations of investigator and CSLB, and will form 
the contractual basis under which the clinical study will be conducted. 
13.2 
Clinical Study Registration and Results Disclosure 
CSLB will provide the relevant study protocol information in public database(s) before or at 
commencement of the study. CSLB may also provide study information for inclusion in 
national registries according to local regulatory requirements. 
Results of this study will be disclosed according to the relevant regulatory requirements. All 
publications in peer-reviewed medical journals resulting from this study will be listed in the 
original study protocol registration record. 
13.3 
 Implementation of the Protocol / Protocol Amendment(s) 
With the exception of medical emergencies, no changes or deviations in the conduct of the 
signed protocol will be permitted without documented approval of the CSLB Medical 
Monitor or designee and the IRB / IEC. In the event of a medical emergency, the investigator 
at the study site will institute any medical procedures deemed appropriate. However, all such 
procedures must be promptly reported to the CSLB and the IRB / IEC. 
Modifications to the protocol that may affect subject safety or the way the study is to be 
conducted will be documented in a protocol amendment, which must be approved by the 
IRB / IEC. 
Administrative changes to the protocol, defined as minor corrections and / or clarifications 
that have no effect on the way the study is to be conducted, will not require IRB / IEC 
approval, but will be submitted to the IRB / IEC for their information. 
13.4 
 Protocol Deviations 
All instances where the critical requirements of the study protocol were not complied with 
will be tracked. Corresponding subjects may be withdrawn from the study at the discretion of 

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the investigator and / or CSLB. Study protocol deviations arise when either subjects who 
have been entered in the study and / or the study sites deviate from the IEC / IRB-approved 
study protocol. 
A major protocol deviation is any significant divergence from the protocol that could have a 
significant effect on the subject’s safety, rights, or welfare and / or on the integrity of the 
study data (ie, nonadherence on the part of the subject, the investigator, or the sponsor to 
protocol-specific inclusion / exclusion criteria, and / or GCP guidelines). If a major protocol 
deviation occurs, the investigator must notify CSLB designee and the appropriate IRB / IEC 
as soon as possible or as per local regulation. Major protocol deviations will be tracked. 
13.5 
 Documentation and Record Keeping 
13.5.1 
 Data Collection 
The investigator (or delegate) will maintain individual records for each subject. These records 
should include dates when a subject visited the study site, records of vital signs, medical 
history, or physical examinations, administration of investigational product or concomitant 
therapy, any AEs experienced, and other notes as appropriate. These records (electronic or 
paper) constitute source data. 
Electronic CRF entries will be considered source data if the eCRF is the site of the original 
recordings (ie, there is no other written or electronic record of the data). 
An eCRF will be provided by CSLB (or delegate) for each subject enrolled into the study. 
The investigator is responsible for ensuring accurate and proper completion of the eCRF in a 
timely manner so that it always reflects the latest observations on the subjects enrolled in the 
study. All entries on the eCRF must be backed up by source data unless the eCRF is 
considered source data. All source data will be kept according to all applicable regulatory 
requirements. Source data must be completed legibly for each subject enrolled into the study 
and signed by the investigator (or delegate). 
13.5.2 
 Data Quality Assurance 
Data generated throughout the study will be monitored and the eCRFs checked against the 
subject records for completeness and accuracy. The investigator must provide direct access to 
source data documents. CSLB’s study monitor or delegate will perform this function. 
Following completion of eCRF pages and entry of the data into a database, the data will be 
checked electronically for consistency and plausibility. Queries will be generated for 

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questionable data and clarification sought from the investigator. These data queries must be 
resolved in a timely manner by the investigator (or delegate). 
13.5.3 
Record Retention 
The investigator must follow the principles for record retention outlined in the Clinical Trial 
Research Agreement. An investigator study file prepared by CSLB (or delegate), containing 
all applicable documents for use at the study site, will be made available to the investigator 
before the start of the study. All study documentation and materials maintained in the 
investigator study file must be kept in conformance with applicable national laws and 
regulations. 
All study documentation and materials maintained in the investigator study file at the study 
site must be available for inspection by CSLB’s study monitor (or delegate) to determine that 
all required documentation is present and correct. 
The study may be audited or inspected by qualified delegates from CSLB or a competent 
regulatory authority. 
Following completion of the study, the investigator is responsible for archiving the 
investigator’s study file, the subject’s records and the source data according to applicable 
regulatory requirements. 
13.6 
Study and Site Closure 
CSLB reserves the right to prematurely discontinue or suspend the study either at a particular 
site or at all study sites at any time and for any reason. If such action is taken, the CSLB 
Study Monitor (or delegate) will discuss this with the investigator at each study site at that 
time and notify the investigators in writing. If the study is suspended or terminated for safety 
reasons, all investigators and the relevant regulatory agencies will be immediately notified of 
the action as well as the reason for the suspension / termination. The investigator at each 
study site will advise their IRB / IEC overseeing the study of the suspension / termination. 
13.7 
Clinical Study Report 
A clinical study report will be written after the completion of the study. CSLB or its agent 
will write the report in consultation with the investigator or, if applicable, a nominated 
coordinating investigator (or delegate). It is required by CSLB that the coordinating 
investigator will sign the clinical study report. 

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Progress reports may be provided to the relevant regulatory bodies in accordance with their 
requirements. 
13.8 
 Use of Data and Publications 
The rights and obligations of investigators and CSLB concerning any formal presentation or 
publication of data collected as a direct or indirect result of this study will be addressed 
specifically in the Clinical Trial Agreement for the study. 
14 
References 
Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, et al. 
2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute 
coronary syndromes: a report of the American College of Cardiology/American Heart 
Association Task Force on practice guidelines. J Am Coll Cardiol. 2014;64(24):e139-228. 
Center for Drug Evaluation and Research, Approval Package for Application Number: NDA 
22-433/S015. Brilinta® (ticagrelor). AstraZeneca Pharmaceuticals LP 9/03/2015. 
Chenevard R, Hürlimann D, Spieker L, Béchir M, Enseleit F, Hermann M, et al. 
Reconstituted HDL in acute coronary syndromes. Cardiovascular therapeutics 2012;30e51-7. 
CPMP/EWP/570/98. Guideline on clinical investigation of new medicinal products for the 
treatment of acute coronary syndrome (CPMP/EWP/570/98). 2016. Available from: 
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/04/WC5
00205365.pdf. 
Dmitrienko A, Ralph, B, D’Agostino, Huque MF. Key multiplicity issues in clinical drug 
development. Statist Med. 2013;32(7):1079-111. 
Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials: a 
practical perspective. John Wiley & Sons, Ltd. Chichester, UK:2002. 
Epstein JS, Zoon KC. Important drug warning: immune globulin intravenous (human) (IGIV) 
products. Neonatal Netw. 2000;19(2):60-2. 
Finfer, S. Clinical controversies in the management of critically ill patients with severe 
sepsis: resuscitation fluids and glucose control. Virulence. 2014;5(1):200-5. 

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Gelmont D, Thomas RG, Britt J, Dyck-Jones JA, Doralt J, Fritsch S, et al. Demonstration of 
safety of intravenous immunoglobulin in geriatric patients in a long-term, placebo-controlled 
study of Alzheimer’s disease. Alzheimer's and dementia: Translational research and clinical 
interventions. 2016;2(2):131-9. 
Gibson CM, Korjian S, Tricoci P, Daaboul Y, Yee M, Jain P, et al. Safety and Tolerability of 
CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute 
Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes 
I). Circulation. 2016;134(24):1918-30. 
Gille A, Easton R, D’Andrea D, Wright SD, Shear CL. CSL112 enhances biomarkers of 
reverse cholesterol transport after single and multiple infusions in healthy subjects. 
Arterioscler Thromb Vasc Biol. 2014;34(9):2106-14. 
FDA. Guidance for Industry: Drug-induced liver injury: premarketing clinical evaluation. 
July 2009. 
Khera AV, Cuchel M, de la Llera-Moya M, Rodrigues A, Burke MF, Jafri K, et al. Cholesterol 
efflux capacity, high-density lipoprotein function, and atherosclerosis. N Engl J Med. 
2011;364:127-35. 
Kim K, DeMets DL. Design and analysis of group sequential tests based on the type I error 
spending rate function. Biometrika. 1987;74(1):149-54. 
Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al. A new 
equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604-12. 
Lipkovich I, Ratitch B, and O’Kelly M. Sensitivity to censored-at-random assumption in the 
analysis of time-to-event endpoints. Pharmaceut. Statist. 2016,15:216-29. 
Liu C, Zhang Y, Ding D, Li X, Yang Y, Li Q, et al. Cholesterol efflux capacity is an 
independent predictor of all-cause and cardiovascular mortality in patients with coronary 
artery disease: A prospective cohort study. Atherosclerosis. 2016;249:116-24. 
Mahoney EM, Wang K, Cohen DJ, Hirsch AT, Alberts MJ, Eagle K, et al. One-year costs in 
patients with a history of or at risk for atherothrombosis in the United States. Circ Cardiovasc 
Qual Outcomes. 2008;1(1):38-45. 
Morrow DA. Cardiovascular risk prediction in patients with stable and unstable coronary 
heart disease. Circulation. 2010;121(24):2681-91. 

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Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Heart disease 
and stroke statistics – 2016 update: a report from the American Heart Association. 
Circulation. 2016;133(4):447-54. 
O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, et al. 2013 
ACCF/AHA guideline for the management of ST-elevation myocardial infarction:: a report of 
the American College of Cardiology Foundation/American Heart Association Task Force on 
practice guidelines. CF/AHA Task Force. Circulation. 2013;127(4):529-55. 
Pocock SJ,Ariti, CA Collier TJ, Wang D. The Win Ratio: a new approach to the analysis of 
composite endpoints in clinical trials based on clinical priorities. European Heart Journal. 
2012;33,176-82. 
Relkin, NR, Thomas, RG, Rissman, RA, Brewer, JB, Rafii, MS, van Dyck, CH, et al. A phase 
3 trial of IV immunoglobulin for Alzheimer disease. Neurology. 2017;88(18):1768-75. 
Remaley AT, Amar M, Sviridov D. HDL-replacement therapy: mechanism of action, types of 
agents and potential clinical indications. Expert Rev Cardiovasc Ther. 2008;6(9):1203-15. 
Rohatgi A, Khera A, Berry JD, Givens EG, Ayers CR, Wedin KE, et al. HDL cholesterol 
efflux capacity and incident cardiovascular events. N Engl J Med. 2014;371(25):2383-93. 
Saleheen D, Scott R, Javad S, Zhao W, Rodrigues A, Picataggi A, et al. Association of HDL 
cholesterol efflux capacity with incident coronary heart disease events: a prospective 
case-control study. Lancet Diabetes Endocrinol. 2015;3(7):507-13. 
Siddiqi HK, Kiss D, Rader D. HDL-cholesterol and cardiovascular disease: rethinking our 
approach. Curr Opin Cardiol. 2015;30(5):536-42. 
Stevens LA, Schmid CH, Greene T, Zhang YL, Beck GJ, Froissart M, et al. Comparative 
performance of the CKD epidemiology collaboration (CKD-EPI) and the modification of diet 
in renal disease (MDRD) study equations for estimating GFR levels above 
60 mL/minute/1.73 m2. Am J Kidney Dis. 2010;56(3):486-95. 
Tall AR. An overview of reverse cholesterol transport. Eur Heart J. 1998;19(Suppl A):A31-5. 
Tardif JC, Gregoire J, L’Allier PL, Ibrahim R, Lesperance J, Heinonen TM, et al. Effects of 
reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized 
controlled trial. JAMA. 2007;297(15):1675-82. 

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Tardif JC, Heinonen T, Noble S. High-density lipoprotein/apolipoprotein A-I infusion 
therapy. Curr Atheroscler Rep. 2009;11(1):58-63. 
The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related 
quality of life. Health Policy. 16(3):199-208. 
Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD, Mickley H, 
Crea F, Van de Werf F, Bucciarelli-Ducci C. Fourth universal definition of myocardial 
infarction (2018). European heart journal. 2019 Jan 1;40(3):237-69. 
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, et al. Ticagrelor 
versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 
2009;361(11):1045-57. 
Yusuf S, Phil D, Mehta SR, Chrolavicius S, Afzal R, Pogue J, , et al. Fifth organization to 
assess strategies in acute ischemic syndromes investigators. Comparison of fondaparinux and 
enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354(14):1464-76. 
Zhang J, Xu J, Wang J, Wu C, Xu Y, Wang Y, et al. Prognostic Usefulness of Serum 
Cholesterol Efflux Capacity in Patients With Coronary Artery Disease. Am J Cardiol. 
2016;117:508-14. 
 
 

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15 
Appendices 
 
 

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Signature of Principal Investigator 
 
Study Title: 
A phase 3, multicenter, double-blind, randomized, placebo-controlled, 
parallel-group study to investigate the efficacy and safety of CSL112 
in subjects with acute coronary syndrome. 
Protocol 
Number: 
CSL112_3001 
Site Number: 
 
I have read the Clinical Study Protocol titled “A phase 3, multicenter, double-blind, 
randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of 
CSL112 in subjects with acute coronary syndrome”. 
By signing this Clinical Study Protocol, I agree to conduct the clinical study, after approval 
by an Institutional Review Board or Independent Ethics Committee (as appropriate), in 
accordance with the Clinical Study Protocol, the standards of Good Clinical Practice (as 
defined by the International Council for Harmonisation) and applicable regulatory 
requirements. 
Changes to the Clinical Study Protocol will only be implemented after written approval is 
received from CSL Behring (CSLB) and the Institutional Review Board or Independent 
Ethics Committee (as appropriate) with the exception of medical emergencies. 
I will ensure that study staff fully understand and follow the Clinical Study Protocol. 
 
 
 
(Signature) 
 
 
Date (DD MMM YYYY) 
(Printed name) 
 
 
 
(Title) 
 
 

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Appendix 2 
Modified Rankin Score 
The modified Rankin score should be assessed at the time of stroke occurrence for subjects 
with a suspected or confirmed stroke.  
Score 
Description 
0 
No symptoms at all 
1 
No significant disability despite symptoms; able to carry out all usual duties 
and activities 
2 
Slight disability; unable to carry out all previous activities, but able to look 
after own affairs without assistance 
3 
Moderate disability; requiring some help, but able to walk without 
assistance 
4 
Moderately severe disability; unable to walk without assistance and unable 
to attend to own bodily needs without assistance 
5 
Severe disability; bedridden, incontinent, and requiring constant nursing 
care and attention 
6 
Dead 
 
References: 
Rankin J. Cerebral vascular accidents in patients over the age of 60. Scott Med J. 
1957;2:200-15. 
Bonita R. and Beaglehole R. Modification of Rankin Scale: Recovery of motor function after 
stroke. Stroke. Dec. 1988;19(12):1497-1500. 
Van Swieten JC, Koudstaal PJ, Visser, MC, et al. Interobserver agreement for the assessment 
of handicap in stroke patients. Stroke. 1988;19(5):604-7. 

Version: 2.0
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CSL112_3001 - Protocol Amendment - 1 - 10Sep2019
Signed By
Date (GMT)
Approved-
 Approval
11-Sep-2019 15:06:38
Approved-
 Approval
11-Sep-2019 15:42:20
Approved-
 Approval
11-Sep-2019 16:00:13
PPD
PPD
PPD
PPD
PPD
PPD