Conditions: Benign Prostatic Hyperplasia Overactive Bladder
Keywords: Myrbetriq Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Overactive Bladder Betmiga Mirabegron Tamsulosin Hydrochloride
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 715
Healthy volunteers: no

Brief summary:
The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

Detailed description:
At Screening (Visit 1), participants entered into a 4-week open label tamsulosin hydrochloride 0.4 mg QD run-in period prior to being randomized into the 12-week double-blind treatment period (Visit 2). At conclusion of the 4-week tamsulosin hydrochloride run-in period, participants completed a 3-day diary just prior to Baseline (Visit 2). Approximately 7 days prior to Visit 2 participants received a phone call reminding them about the diary and to answer any questions.

If participants met all entry criteria at the end of the tamsulosin hydrochloride run-in period, participants were randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks of treatment in addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those participants randomized to Mirabegron started at 25 mg and increased to 50 mg after 4 weeks. Those participants randomized to placebo started blinded product matched to the mirabegron 25 mg tablet and increased to blinded product matched to 50 mirabegron after 4 weeks. Once a participant increased dose, the participant remained on that dose for the remainder of the study unless for safety reasons was required to discontinue study drug.

A training diary was completed in the first 2 weeks of the tamsulosin hydrochloride run-in period. During this evaluation period at least one telephone contact took place with the participant. Diaries were completed at home, using the electronic patient-reported outcome (ePRO) device, for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). Site staff contacted the participant approximately 7 days prior to the scheduled visit to remind the participant to complete the electronic diary, review completion instruction and review changes to concomitant medications and adverse events (if applicable).

Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), participants completed a 3-day diary, using the ePRO device in which the participant recorded micturition frequency, urgency (PPIUS), incontinence and volume voided. In addition, the diary captured morning and evening blood pressure and pulse rate measurements via Home Blood Pressure Monitoring (HBPM). At Visit 1, International Prostate Symptom Score (IPSS) was completed. At Visits 2, 3, 4, and 5, participants completed the IPSS, EQ-5D-5L, OAB-q, PPBC, and TS-VAS. Maximum urinary flow (Qmax) was measured at Visit 1 (Screening/tamsulosin hydrochloride run-in) and Visit 5 (Week 12/End of Treatment). Post-void residual volume (PVR) was assessed at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2) and at Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). A follow-up phone call (Visit 6) was conducted 4-weeks after End of Treatment (Visit 5). Total study participation was approximately 20 weeks.

Arms:
arm 1: Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study. arm 2: Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.

Interventions: intervention 1: Mirabegron intervention 2: Placebo intervention 3: Tamsulosin Hydrochloride
Intervention descriptions: intervention 1: Participants received initial dose of 25 mg of mirabegron (oral tablet) which was increased to 50 mg after 4 weeks. intervention 2: Participants received initial dose of 25 mg of matching placebo (oral tablet) which was increased to 50 mg after 4 weeks. intervention 3: Participants received once daily treatment with tamsulosin hydrochloride 0.4 mg (oral tablet) throughout the study.

Protocol document:
Prot_000.pdf: 
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
Center Study to Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Men with Overactive Bladder (OAB) Symptoms
While Taking the Alpha Blocker Tamsulosin Hydrochloride for 
Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH)
PLUS
ISN/Protocol 178-MA-1008
ClinicalTrials.gov Identifier: NCT02757768
Date of Protocol Version 5.2: 22 Jan 2018
Sponsor: Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062, USA


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 1 of 87
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
Center Study to Evaluate the Efficacy, Safety, and Tolerability 
of Mirabegron in Men with Overactive Bladder (OAB) Symptoms 
While Taking the Alpha Blocker Tamsulosin Hydrochloride
for Lower Urinary Tract Symptoms (LUTS) due to 
Benign Prostatic Hyperplasia (BPH)
PLUS
ISN/Protocol 178-MA-1008
Version 5.2
Incorporating Substantial Amendment 4 [See Attachment 1]
22 January 2018
IND 69,416
EudraCT 2015-004036-36
Sponsor:
Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062
Investigator information is on file at Astellas.  
--------------------------------------------------------------------------------------------------------------------------------------
This confidential document is the property of the Sponsor.  No unpublished information contained in this 
document may be disclosed without prior written approval of the Sponsor.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 2 of 87
Table of Contents
I.
SIGNATURES ······················································································ 8
II.
CONTACT DETAILS OF KEY SPONSOR’S PERSONNEL····························10
III.
LIST OF ABBREVIATIONS AND DEFINITION OF KEY TERMS ··················12
IV.
SYNOPSIS··························································································17
V.
FLOW CHART AND SCHEDULE OF ASSESSMENTS·································24
1
INTRODUCTION·················································································28
1.1
Background ····················································································28
1.2
Summary of Non-clinical and Clinical Data···············································29
1.2.1
Mirabegron (YM178) ···································································29
1.2.1.1
Summary of Non-clinical Studies of Mirabegron······························29
1.2.1.2
Summary of the Pharmacokinetics of Mirabegron ····························30
1.2.1.3
Summary of Clinical Data with Mirabegron ···································30
1.2.2
Tamsulosin Hydrochloride ·····························································32
1.2.2.1
Summary of Non-clinical Studies of Tamsulosin Hydrochloride············32
1.2.2.2
Summary of the Pharmacokinetics of Tamsulosin Hydrochloride···········33
1.2.2.3
Summary of Clinical Data with Tamsulosin Hydrochloride··················33
1.3
Summary of Key Safety Information for Study Drugs ···································34
1.3.1
Summary of Key Safety Information for Mirabegron ······························34
1.3.2
Summary of Key Safety Information for Tamsulosin Hydrochloride·············35
1.3.3
Summary of Key Safety Information for Combination of Mirabegron and 
Tamsulosin Hydrochloride ·····························································35
1.4
Risk-Benefit Assessment·····································································36
2
STUDY OBJECTIVE(S), DESIGN, AND ENDPOINTS ··································36
2.1
Study Objectives ··············································································36
2.2
Study Design and Dose Rationale···························································37
2.2.1
Study Design·············································································37
2.2.2
Dose Rationale···········································································38
2.3
Endpoints·······················································································38
2.3.1
Primary Endpoints·······································································38
2.3.2
Secondary Endpoints····································································38
2.3.3
Exploratory Endpoint ···································································39
2.3.4
Safety Variables ·········································································39


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 3 of 87
3
STUDY POPULATION··········································································39
3.1
Selection of Study Population ·······························································39
3.2
Inclusion Criteria··············································································39
3.3
Exclusion Criteria ·············································································40
4
TREATMENT(S)··················································································42
4.1
Identification of Investigational Product(s) ················································42
4.1.1
Test Drug(s)··············································································42
4.1.2
Concomitant Medication ·······························································43
4.1.3
Placebo····················································································43
4.2
Packaging and Labeling ······································································43
4.3
Study Drug Handling ·········································································43
4.4
Blinding ························································································44
4.4.1
Blinding Method·········································································44
4.4.2
Confirmation of the Indistinguishability of the Study Drugs ······················44
4.4.3
Retention of the Assignment Schedule and Procedures for Treatment Code 
Breaking ··················································································45
4.4.4
Breaking the Treatment Code for Emergency ·······································45
4.4.5
Breaking the Treatment Code by the Sponsor ·······································45
4.5
Assignment and Allocation ··································································45
5
TREATMENTS AND EVALUATION························································46
5.1
Dosing and Administration of Study Drug(s) and Other Medication(s)················46
5.1.1
Dose/Dose Regimen and Administration Period ····································46
5.1.2
Increase or Reduction in Dose of the Study Drug(s)································46
5.1.3
Previous and Concomitant Treatment (Medication and Non-Medication 
Therapy) ··················································································46
5.1.3.1
Previous Medication (Drugs and Therapies) ···································46
5.1.3.2
Concomitant Medication (Drugs and Therapies) ······························47
5.1.4
Treatment Compliance··································································47
5.2
Demographics and Baseline Characteristics ···············································48
5.2.1
Demographics············································································48
5.2.2
Medical History··········································································48
5.2.3
Diagnosis of the Target Disease, Severity, and Duration of Disease··············48
5.3
Efficacy Assessment··········································································48
5.3.1
Patient Diary – Micturition and Incontinence········································48


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 4 of 87
5.3.2
Patient Perception of Intensity of Urgency Scale (PPIUS)·························49
5.3.3
Total Urgency and Frequency Score (TUFS) ········································50
5.3.4
International Prostate Symptom Score (IPSS) ·······································50
5.3.5
OAB Symptoms, Quality of Life, Bladder Health and Treatment Benefit ·······50
5.3.5.1
Overactive Bladder-questionnaire (OAB-q)····································50
5.3.5.2
Patient Perception of Bladder Condition (PPBC)······························51
5.3.5.3
EQ-5D-5L ··········································································51
5.3.5.4
Treatment Satisfaction – Visual Analog Scale (TS-VAS) ····················51
5.4
Safety Assessment ············································································51
5.4.1
Vital Signs················································································51
5.4.2
Patient Diary – Subject Measurement Vital Signs···································52
5.4.3
Adverse Events ··········································································53
5.4.3.1
Adverse Events of Possible Hepatic Origin ····································53
1.1.1.1
Adverse Events of Special Interest ··············································53
5.4.4
Laboratory Assessments································································53
5.4.5
Physical Examination···································································55
5.4.6
Electrocardiogram (ECG) ······························································55
5.4.7
Post-Void Residual Volume (PVR) ···················································56
5.4.8
Uroflowmetry············································································56
5.4.9
Follow-up Phone Call to Patients······················································56
5.5
Adverse Events and Other Safety Aspects ·················································56
5.5.1
Definition of Adverse Events (AEs) ··················································56
5.5.2
Definition of Serious Adverse Events (SAEs) ·······································57
5.5.3
Criteria for Causal Relationship to the Study Drug ·································58
5.5.4
Criteria for Defining the Severity of an Adverse Event ····························58
5.5.5
Reporting of Serious Adverse Events (SAEs) ·······································58
5.5.6
Follow-up of Adverse Events··························································60
5.5.7
Monitoring of Common Serious Adverse Events ···································60
5.5.8
Procedure in Case of Pregnancy·······················································60
5.5.9
Emergency Procedures and Management of Overdose ·····························60
5.5.10
Supply of New Information Affecting the Conduct of the Study··················60
5.6
Test Drug Concentration ·····································································60
5.7
Other Measurements, Assessments or Methods ···········································60
5.8
Total Amount of Blood·······································································61
6
DISCONTINUATION············································································61


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 5 of 87
6.1
Discontinuation of Individual Subject(s)···················································61
6.2
Discontinuation of the Site···································································61
6.3
Discontinuation of the Study·································································62
7
STATISTICAL METHODOLOGY ···························································62
7.1
Sample Size····················································································63
7.2
Analysis Set····················································································63
7.2.1
Full Analysis Set ········································································63
7.2.2
Full Analysis Set - Incontinence (FAS-I)·············································63
7.2.3
Safety Analysis Set (SAF)······························································63
7.3
Demographics and Other Baseline Characteristics········································64
7.4
Analysis of Efficacy ··········································································64
7.4.1
Analysis of Primary Endpoint ·························································64
7.4.1.1
Primary Analysis···································································64
7.4.1.2
Secondary Analysis································································64
7.4.1.3
Subgroup Analysis·································································65
7.4.2
Analysis of Secondary Endpoints ·····················································65
7.4.3
Analysis of Exploratory Endpoints····················································65
7.5
Analysis of Safety·············································································66
7.5.1
Adverse Events ··········································································66
7.5.2
Laboratory Assessments································································66
7.5.3
Vital Signs················································································66
7.5.4
Physical Examination ···································································67
7.5.5
ECGs······················································································67
7.5.6
PVR ·······················································································67
7.5.7
Qmax ·······················································································67
7.6
Analysis of Pharmacokinetics ·······························································67
7.7
Analysis of Pharmacodynamics ·····························································67
7.8
Protocol Deviations and Other Analyses···················································68
7.9
Interim Analysis (and Early Discontinuation of the Clinical Study)····················68
7.10
Handling of Missing Data, Outliers, Visit Windows, and Other Information ·········68
8
OPERATIONAL AND ADMINISTRATIVE CONSIDERATIONS ····················68
8.1
Procedure for Clinical Study Quality Control ·············································68
8.1.1
Data Collection ··········································································68


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 6 of 87
8.1.2
Specification of Source Documents···················································69
8.1.3
Clinical Study Monitoring······························································69
8.1.4
Direct Access to Source Data/Documents············································70
8.1.5
Data Management ·······································································70
8.1.6
Protocol Deviations ·····································································70
8.1.7
End of Trial in All Participating Countries···········································71
8.2
Ethics and Protection of Subject Confidentiality··········································71
8.2.1
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / 
Competent Authorities (CA) ···························································71
8.2.2
Ethical Conduct of the Study···························································71
8.2.3
Informed Consent of Subjects ·························································72
8.2.3.1
Subject Information and Consent················································72
8.2.3.2
Supply of New and Important Information Influencing the Subject’s 
Consent and Revision of the Written Information ·····························72
8.2.4
Subject Confidentiality ·································································72
8.3
Administrative Matters ·······································································73
8.3.1
Arrangement for Use of Information and Publication of the Clinical Study ·····73
8.3.2
Documents and Records Related to the Clinical Study ·····························73
8.3.3
Protocol Amendment and/or Revision················································73
8.3.4
Signatory Investigator for Clinical Study Report····································74
9
QUALITY ASSURANCE········································································74
10
STUDY ORGANIZATION······································································74
10.1
Independent Data-Monitoring Committee (IDMC) | Data and Safety Monitoring 
Board (DSMB) | Monitoring Committee | Other Evaluation Committee(s) ···········74
10.2
Other Study Organization ····································································74
10.2.1
Cardiovascular Adjudication Committee·············································74
10.2.2
Neoplasm Adjudication Committee···················································75
11
REFERENCES ····················································································76
12
APPENDICES ·····················································································79
12.1
Appendix 1: List of Prohibited and Restricted Concomitant Medications ·············79
12.2
Appendix 2: Liver Safety Monitoring and Assessment···································81
12.3
Appendix 3: Common Serious Adverse Events ···········································83
12.4
Appendix 4: Investigator Criteria for Hypertension ······································84
12.5
Appendix 5: Investigator Criteria for Tachycardia········································85


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 7 of 87
13
ATTACHMENT 1: SUBSTANTIAL AMENDMENT 4 ···································86
14
SPONSOR’S SIGNATURES····································································87


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 8 of 87
I.
SIGNATURES
1.  SPONSOR’S SIGNATURE
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to 
Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive 
Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride
for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
ISN/Protocol 178-MA-1008 / Version 5.2 / 22 January 2018
Required signatures (e.g. Protocol authors, Sponsor’s reviewers and contributors, etc.) are 
located in Section 14, Signatures; e-signatures (when applicable) are located at the end of 
this document.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 9 of 87
2.  INVESTIGATOR’S SIGNATURE
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to 
Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive 
Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride
for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
ISN/Protocol 178-MA-1008 / Version 5.2 / 22 January 2018
I have read all pages of this clinical study protocol for which Astellas is the Sponsor. I agree 
to conduct the study as outlined in the protocol and to comply with all the terms and 
conditions set out therein. I confirm that I will conduct the study in accordance with ICH 
GCP guidelines and applicable local regulations. I will also ensure that sub-Investigator(s) 
and other relevant members of my staff have access to copies of this protocol and the ICH 
GCP guidelines to enable them to work in accordance with the provisions of these 
documents.
Principal Investigator:
Signature:
Printed Name:
Date (DD Mmm YYYY)
Address:






Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 12 of 87
III.
LIST OF ABBREVIATIONS AND DEFINITION OF KEY TERMS
List of Abbreviations
Abbreviations
Description of abbreviations
ADR
Adverse Drug Reaction
AE
Adverse Event
ALP
Alkaline Phosphatase
ALT
Alanine Aminotransferase (GPT)
ANCOVA
Analysis of Covariance
APGD
Astellas Pharma Global Development
AST
Aspartate Aminotransferase (GOT)
AUC
Area under the concentration-time curve
AUCinf
Area under the plasma concentration – from time zero to infinity
AUCtau
Area under the plasma concentration – from time zero to tau
AUST
Astellas U.S. Technologies, Inc.
BOO
Bladder Outlet Obstruction
BP
Blood Pressure
BPH
Benign Prostatic Hyperplasia
Bpm
Beats per minute
BPO
Benign Prostatic Obstruction
BUN
Blood Urea Nitrogen
CA
Competent Authority
CBC
Complete Blood Count
Cfu
Colony Forming Unit
CI
Confidence Intervals
CRCL
Creatinine Clearance
Cmax
Maximum concentration
CRF
Case Report Form
CRO
Contract Research Organization
CTD
Clinical Trial Directive
CYP2D6
Cytochrome P450 2D6
CYP3A4
Cytochrome P450 3A4
CYP
Cytochrome P450
DBP
Diastolic Blood Pressure
DILI
Drug-induced Liver Injury
DMC
Data Monitoring Committee
DSMB
Data Safety Monitoring Board
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
eGFR
Estimated Glomerular Filtration Rate
ESRD
End Stage Renal Disease
EOT
End of Treatment
ePRO
Electronic Patient Reported Outcome


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 13 of 87
Abbreviations
Description of abbreviations
EQ-5D-5L
Measure of health status questionnaire developed by the EuroQol Group
EU
Europe
FAS
Full analysis set
FAS-I
Full analysis set – Incontinence
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GGT/γ-GT
γ-Glutamyl Transpeptidase (GGT)
HBPM
Home Blood Pressure Monitoring
HCO3
Bicarbonate
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH 
International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
INR
International Normalized Ratio
IPSS
International Prostate Symptom Score
IRB
Institutional Review Board
IRT
Interactive Response Technology
ISN
International Study Number
Kg
Kilogram
LA-CRF
Liver Abnormality  - Case Report Form
LCE
Leukocyte Esterase
LFT
Liver Function Tests
LOCF
Last Observation Carried Forward
LS
Least Square
LSO
Last Subject Out
LUTS
Lower Urinary Tract Symptoms
MedDRA
Medical Dictionary for Regulatory Activities
Mg
Milligram
Min
Minutes
mL
Milliliter
mmHg
Millimeter of Mercury
msec
Millisecond
N/n
Number
NASH
Non-Alcoholic Steatohepatitis
NA
North America
NDA
New Drug Application
OAB
Overactive Bladder
OAB-q
Overactive Bladder – questionnaire
OCAS
Oral Controlled Absorption System
PBO
Placebo


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 14 of 87
Abbreviations
Description of abbreviations
PCS
Potentially Clinically Significant
PHI
Personal Health Information
PPBC
Patient Perception of Bladder Condition
PPIUS
Patient Perception of Intensity of Urgency Scale
PR
Pulse Rate
PRO
Patient Reported Outcomes
PTM
Placebo to Match
PTNS
Percutaneous Tibial Nerve Stimulation
PVR
Post-Void Residual Volume
QD
Once Daily
Qmax
Maximum urinary flow rate
QoL
Quality of Life
QT
Time interval between QRS complex to end of T wave
QTcF
Fridericia’s Correction Formula
SAE
Serious adverse event
SAF
Safety Analysis Set
SAP
Statistical Analysis Plan
SBP
Systolic Blood Pressure
SD
Standard Deviation
SE
Standard Error
SFL
Screen failure log
SOP
Standard Operating Procedure
SPC
Summary of Product Characteristics
SUSAR
Suspected unexpected serious adverse reactions
t ½
Terminal Elimination Half-Life
TBL
Total bilirubin
TEAE
Treatment Emergent Adverse Event
TMF
Trial Master File
TLF
Tables, Listings and Figures
TS-VAS
Treatment Satisfaction Visual Analog Scale
TUFS
Total Urgency and Frequency Score
ULN
Upper Limit of Normal
US
United States
UTI
Urinary Tract Infection
YM178
Mirabegron/Myrbetriq/Betmiga


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 15 of 87
Definition of Key Study Terms
Terms
Definition of terms
Adverse Event
An adverse event is any untoward medical occurrence in a subject 
administered a study drug and which does not necessarily have a causal 
relationship with this treatment.
Baseline 
The baseline value is defined as the last measurement before the first dose of 
double-blind study drug. For variables based on the electronic diary, the 3 days 
of the diary recorded prior to the randomization visit will be used to derive 
these variables at baseline.
Discontinuation
The act of concluding participation, prior to completion of all protocol-
required elements, in a trial by an enrolled subject.
End of Study
The time of the last subject’s last protocol-defined assessment.
Enrolled
A screened subject who has received the study medication.
Frequency
The complaint of voiding too often during the day.
Incontinence
Any involuntary leakage of urine. For purposes of data analysis specifically for 
this study, both full void incontinence with or without any urgency as well as 
partial void incontinence with passed urine in the toilet will be considered as 
incontinence.
Micturition
Any voluntary micturition (episodes of incontinence only are not included).
Mixed urinary 
incontinence
The complaint of involuntary leakage associated with urgency and also with 
exertion, effort, sneezing or coughing.
Nocturia
Waking at night one or more times to void (i.e. any voiding associated with 
sleep disturbance between the time the subject goes to bed with the intention to 
sleep until the time the subject gets up in the morning with the intention to stay 
awake).
Overactive Bladder
Urgency, with or without urgency incontinence, usually with frequency and 
nocturia, which can be described as the OAB syndrome, urge syndrome or 
urgency-frequency syndrome.
Randomization
The process of assigning trial subjects to treatment or control groups using an 
element of chance to determine assignments in order to reduce bias.
Run-In Failure
Screened subject who did not fulfill protocol inclusion and/or exclusion 
criteria at Visit 2. Subjects who are considered a run-in failure cannot be re-
screened into the study at a later date.
Screened
A subject who has signed informed consent and has performed the screening 
visit.
Screening Failure
Screened subject who did not fulfill protocol inclusion and/or exclusion 
criteria, or decided not to participate anymore (withdrew consent) prior to Visit 
2. Subjects who are considered a screen failure at Visit 1 due to an acute 
condition that resolved (e.g., a treated UTI, an ECG that a cardiologist cleared, 
discontinuation of a prohibited or restricted medication) may be re-screened 
into the study at a later date.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 16 of 87
Terms
Definition of terms
Serious Adverse 
Event
An adverse event is considered “serious” if, in the view of either the 
Investigator or Sponsor, it results in any of the following outcomes: results in 
death, is life threatening, results in persistent or significant 
disability/incapacity or substantial disruption of the ability to conduct normal 
life functions, results in congenital anomaly, or birth defect, requires inpatient 
hospitalization or leads to prolongation of hospitalization, or a medically 
important event.
Stress urinary 
incontinence
The complaint of involuntary leakage on effort or exertion, or on sneezing or 
coughing.
Subject Number
Number assigned to each subject by the Interactive Response System after 
signature of informed consent and prior to any specific procedures.
Treatment-
Emergent Adverse 
Event
An adverse event starting or worsening in the period from first double-blind 
medication intake until 30 days after last double-blind medication intake.
Urgency
A sudden and compelling desire to pass urine that is difficult to defer.
Urgency Urinary 
Incontinence
The complaint of involuntary leakage accompanied by or immediately 
proceeded by urgency.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 17 of 87
IV.
SYNOPSIS
Date and Version # of Protocol Synopsis:
22 January 2018/Version 5.2
Sponsor:  Astellas Pharma Global Development Inc.
(APGD), Medical Affairs, Americas
Protocol Number:  178-MA-1008
Name of Study Drug: Mirabegron
Phase of Development:  4
Title of Study:  
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the 
Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms 
While Taking the Alpha-Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms 
(LUTS) due to Benign Prostatic Hyperplasia (BPH)
Planned Study Period: 
From 2Q2016 to 2Q2018
Study Objective(s): 
Primary Objective:
To study the efficacy of mirabegron versus placebo in men with OAB symptoms while taking 
tamsulosin hydrochloride for LUTS due to BPH.
Secondary Objective:
To assess safety and tolerability of mirabegron versus placebo in men with OAB symptoms while 
taking tamsulosin hydrochloride for LUTS due to BPH.
Other Objectives:
To assess patient reported outcomes (PROs) as measured by Symptom Bother and Total Health 
Related Quality of Life scores as assessed by the Overactive Bladder-questionnaire (OAB-q), 
EQ-5D-5L, Patient Perception of Bladder Condition (PPBC), Patient Perception of Intensity of 
Urgency Scale (PPIUS), International Prostate Symptom Score (IPSS), and Treatment Satisfaction-
Visual Analog Scale (TS-VAS).
Planned Total Number of Study Centers and Location(s):  
Approximately 100 centers
North America and Europe
Study Population:  
Men ≥40 years of age with OAB symptoms who take tamsulosin hydrochloride for LUTS due to 
BPH.
Number of Subjects to be Enrolled / Randomized:  
Approximately 985 subjects will be screened to achieve 640 randomized and approximately 544
completed.
Subjects will be randomized 1:1.
320 randomized to mirabegron; 320 randomized to placebo


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 18 of 87
Study Design Overview:  
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study.
At Screening (Visit 1), subjects will enter into a 4-week open label tamsulosin hydrochloride 0.4 mg 
QD run-in period prior to being randomized into the 12-week double-blind treatment period (Visit 2).  
At the conclusion of the 4-week tamsulosin hydrochloride run-in period, subjects will complete a 
3-day diary just prior to Baseline (Visit 2). Approximately 7 days prior to Visit 2 subjects will receive 
a phone call reminding them about the diary and to answer any questions.
A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in period. 
During this evaluation period at least one telephone contact will take place with the subject. Diaries 
will be completed at home, using the electronic patient-reported outcome (ePRO) device, for 
3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and 
Week 12/End of Treatment (Visit 5). Site staff will contact the subject approximately 7 days prior to 
the scheduled visit to remind the subject that they need to complete the electronic diary, review 
completion instructions and review changes to concomitant medications and adverse events (if 
applicable). 
If subjects meet all entry criteria at the end of the tamsulosin hydrochloride run-in period, subjects 
will be randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks of treatment in 
addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those subjects randomized to 
mirabegron will start at 25 mg and will increase to 50 mg after 4 weeks.  Those subjects randomized 
to placebo will start blinded product matched to the mirabegron 25 mg tablet and will increase to 
blinded product matched to 50 mg mirabegron after 4 weeks. Once a subject has increased dose, he 
will remain on that dose for the remainder of the study unless for safety reasons he is required to 
discontinue study drug.
Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), subjects will 
complete a 3-day diary, using the electronic patient-reported outcome (ePRO) device in which they 
will record micturition frequency, urgency (PPIUS), incontinence and volume voided.  In addition the 
diary will capture morning and evening blood pressure and pulse rate measurements via Home Blood 
Pressure Monitoring (HBPM). At Visit 1, International Prostate Symptom Score (IPSS) will be 
completed. At Visits 2, 3, 4, and 5, subjects will complete the IPSS, EQ-5D-5L, OAB-q, PPBC, and 
TS-VAS.  Maximum urinary flow (Qmax) will be measured at Visit 1 (Screening/tamsulosin
hydrochloride run-in) and Visit 5 (Week 12/End of Treatment).  Post-void residual volume (PVR) 
will be assessed at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2) and at 
Week 4 (Visit 3), Week 8 (Visit 4) and Week 12/End of Treatment (Visit 5). A follow-up phone call 
(Visit 6) will be conducted 4-weeks after End of Treatment (Visit 5). Total study participation is 
approximately 20 weeks.
Inclusion:  
Inclusion Criteria assessed at Visit 1 (Screening):
1.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – approved written 
Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization 
for US sites) must be obtained from the subject or legally authorized representative prior to any 
study-related procedures (including withdrawal of prohibited medication, if applicable).
2.
Men ≥40 years of age with history of OAB symptoms (urinary frequency and urgency with or 
without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to 
treat LUTS due to BPH.
3.
Subject has symptoms of OAB (frequency of ≥8 micturitions per day and urgency episodes of 
≥2 per day) for ≥3 months prior to Screening.
4.
Subject has an IPSS score ≥8.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 19 of 87
5.
Subject has Prostate-Specific Antigen (PSA) <4 ng/mL OR PSA ≥4 but <10 ng/mL with a 
prostate biopsy that is negative for cancer in the past two years.
6.
Subject is willing and able to complete the 3-day diary (including urine volumes, vital sign 
measurements), and Quality of Life questionnaires.
7.
Subject and their spouses/partners who are of childbearing potential must be using a highly 
effective method of birth control, which includes established use of oral, injected or implanted 
hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced 
from Screening and continue throughout the study and for 30 days after the final study drug 
administration. In addition, sperm donation will not be allowed throughout the study and for 
30 days after the final study drug administration.
8.
Subject agrees not to participate in another interventional study while on treatment.
Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
9.
Subject continues to meet all inclusion criteria of Visit 1 (Screening).
10. Subject must experience an average of 8 or more micturitions per day over the 3-day diary period.
11. Subject must experience an average of 2 or more episodes of urgency per day (grade 3 or 4) over 
the 3-day diary period.
Waivers to the inclusion criteria will NOT be allowed.
Exclusion:  
Exclusion Criteria assessed at Visit 1 (Screening):
1.
Subject has PVR >200 mL.
2.
Subject has Qmax <5.0 mL/second with a minimum voided volume of 125 mL.
3.
Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
4.
Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be 
performed for positive leukocytes, nitrites, or turbidity, or at the Investigator’s discretion, and will 
be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI, at Screening 
(Visit 1) the subject may be rescreened after successful treatment of the UTI (confirmed by a 
laboratory result of negative urine culture).
5.
Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
6.
Subject has diabetic neuropathy.
7.
Previous open, robotic or minimally invasive prostate surgery (including transurethral 
procedures). Planned (scheduled) pelvic or prostate surgery during the study period.
8.
Planned (scheduled) cataract or glaucoma surgery during the study period.
9.
Subject with significant stress incontinence as determined by the Investigator.
10. Subject with clinically significant bladder outlet obstruction as determined by the Investigator.
11. Subject has an indwelling catheter or practices intermittent self-catheterization.
12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the last 
12 months.
13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such as 
interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current 
malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the 
bladder, prostate and rectum; organs of the lower gastrointestinal tract are not necessarily 
considered pelvic organs such as the distal ascending colon, the full transverse colon and 
proximal portion of the descending colon are in the abdomen).
14. Subject has received intravesical injection in the past 12 months with botulinum toxin, 
resiniferatoxin, or capsaicin.
15. Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 20 of 87
Percutaneous Tibial Nerve Stimulation [PTNS]).
16. Subject began or has changed a bladder training program or pelvic floor exercises less than 
30 days prior to Screening.
17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
19. Subject has severe renal impairment defined as estimated creatinine clearance less than 
29 mL/min/1.73 m2 as determined by central laboratory calculation of eGFR. A subject with End 
Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for the study.
20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure 
≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2)
electrocardiogram (ECG) defined as QTcF >450 msec.
23. Subject has any clinically significant ECG abnormality, as determined by the Investigator.
24. Subject has AST or ALT >2x upper limit of normal (ULN), or γ-GT >3x ULN and considered 
clinically significant by the Investigator.
25. Subject has a hypersensitivity to any components of mirabegron, tamsulosin hydrochloride, or 
any of the inactive ingredients.
26. Subject has a history of angioedema.
27. Subject has any clinically significant condition, which in the opinion of the Investigator makes the 
subject unsuitable for study participation.
28. Subject has been treated with an experimental device within 28 days or received an 
investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
29. Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), 
except non-metastatic basal or squamous cell carcinoma of the skin that has been treated 
successfully.
30. Subject has ongoing alcohol and/or drug abuse.
31. Subject is using prohibited medications defined in Appendix 1, Part A within 30 days prior to 
Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
32. Subject has stopped, started or changed the dose of a restricted medication (defined in
Appendix 1, Part B) within 30 days prior to Screening (Visit 1) through Follow-Up Phone Call 
(Visit 6).
33. Subject has participated in an interventional trial within 30 days prior to Screening (Visit 1).
34. Subject is involved in the conduct of the study as an employee of the Astellas group, third party 
associated with the study, or the study site team.
35. Subject has previously received mirabegron in the 6 months prior to Screening (Visit 1).
Exclusion Criteria assessed at Visit 2 (Baseline):
36. Subject was non-compliant during the 4-week tamsulosin hydrochloride run-in period, defined as 
taking less than 80% or greater than 120% of study medication.
37. Subject had an average total daily urine volume >3000 mL as recorded in the 3-day diary.
Waivers to the exclusion criteria will NOT be allowed.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 21 of 87
Test Drug Dose:
Mirabegron 25 mg QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet 
(EU/CA). Mirabegron 25 mg dose will be titrated to mirabegron 50 mg QD at 4 weeks. Mirabegron 
50 mg dose will be maintained for the remaining 8 weeks of the study along with tamsulosin 
hydrochloride 0.4 mg capsule (US) / tablet (EU/CA).
Mode of Administration:
Oral same time each day (with or without food).
Study protocol recommends taking at the same time daily as the tamsulosin hydrochloride capsule
(US) / tablet (EU/CA). Tamsulosin hydrochloride should be taken 30 minutes following the same 
meal each day.
Reference Therapy Dose:
Placebo matched to mirabegron 25 mg QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg
capsule (US) / tablet (EU/CA).
Dose will be titrated to placebo matched to mirabegron 50 mg at 4 weeks.
Placebo matched to mirabegron 50 mg will be maintained for the remaining 8 weeks of the study 
along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet (EU/CA).
Mode of Administration:
Oral same time each day (with or without food).
Study protocol recommends taking at the same time daily as the tamsulosin hydrochloride capsule
(US) / tablet (EU/CA). Tamsulosin hydrochloride should be taken 30 minutes following the same 
meal each day.
Drug(s) for Run-In Period: 
Tamsulosin hydrochloride capsule (US) / tablet (EU/CA).
Dose:
0.4 mg QD.
Mode of Administration: 
Oral taken each day approximately 30 minutes following the same meal.
Concomitant Medication Restrictions or Requirements:   
Prohibited Medications (Appendix 1, Part A)
Medications prohibited between Screening/tamsulosin hydrochloride run-in (Visit 1) and 
Week 16/Follow-up phone call (Visit 6) include other alpha-adrenergic blockers , anticholinergics, 
antispasmodics, strong and moderate inhibitors of CYP2D6 with narrow therapeutic index, 
specifically thioridazine, flecainide, propafenone, amitriptyline, paroxetine, and terbinafine, and 
moderate and strong inhibitors of CYP3A4 (see Appendix 1, Part A).  These medications must have 
been discontinued at least 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1).
Current or previous use of mirabegron within 6 months prior to Screening (Visit 1) is also prohibited.
Restricted medications (Appendix 1, Part B)
Medications restricted between Screening/tamsulosin hydrochloride run-in (Visit 1) and Follow-up 
Phone Call (Visit 6) include loop diuretics, 5-Alpha reductase inhibitors and PDE5 inhibitors (see
Appendix 1, Part B). These medications are permitted provided the subject has been taking the 
medication on a long-term basis, i.e. has not stopped, or started, or changed dose within the 30 days 
prior to Screening/tamsulosin hydrochloride run-in (Visit 1), no new drug of the same class has been 
added to the regimen within the 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1), 
and the subject remains on the medication at the same dose during the course of the study.  


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 22 of 87
For 5-alpha reductase inhibitors the subject must have been taking the medication for at least 6 
months. No alpha-blockers other than tamsulosin hydrochloride are allowed. Intermittent use of PDE5 
inhibitors (e.g. tadalafil) for treating erectile dysfunction (ED) is allowed.  PDE5 inhibitors that are 
taken on a daily basis for the management of LUTS are not allowed. 
Restricted Non-Drug Therapy
Subjects participating in any behavioral modification therapy (i.e. pelvic floor exercises, Kegel 
exercises, biofeedback, timed voiding, etc.) or other nondrug therapy must have started the therapy 
within 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1) and must continue the 
same schedule through Follow-Up Phone Call (Visit 6). Neurostimulation for OAB is a strict 
exclusion criterion.
Duration of Treatment:  
Subjects will be randomized to 1 of 2 treatment groups in a 1:1 randomization (mirabegron or 
placebo) for a maximum of 12 weeks after a 4 week run-in period on tamsulosin hydrochloride. A 
Follow-up phone call (Visit 6) will be completed 4 weeks after Week 12/End of Treatment (Visit 5). 
Subject participation will last approximately 20 weeks.
Endpoints for Evaluation:  
Primary:

Change from Baseline (Visit 2) to Week 12/End of Treatment (Visit 5) in mean number of 
micturitions per day based on a 3-day diary.
Secondary:

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean volume voided per micturition.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of incontinence episodes per day (FAS-I).

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of urgency episodes (grade 3 and 4) per day.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in IPSS total score and subscales (Voiding, Storage, and Quality of Life).

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of urgency incontinence episodes per day (FAS-I).

Change from Baseline (Visit 2) to End of Treatment (Visit 5) in Symptom Bother Total 
Health related quality of life and subscale (coping, concern, sleep, social interaction, and 
symptom bother) scores as assessed by OAB-q questionnaire.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
as assessed by EQ-5D-5L questionnaire.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in PPBC.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in Total Urgency and Frequency Score (TUFS) using PPIUS (Grade 3 or 4).

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of nocturia episodes per day.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in TS-VAS scores. 

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in the number of protective garments (e.g. absorbent pads, incontinence briefs, disposable 
underwear).


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 23 of 87
Exploratory:

Performance of subgroup analyses by PSA cutoff scores for < 2, 2-4. 
Safety Variables:

Incidence and severity of treatment emergent adverse events (TEAEs) including AEs of 
special interest.

Vital signs: sitting systolic and diastolic blood pressure and pulse rate (home blood pressure
monitoring [HBPM] and office measurements).

ECG parameters (heart rate, PR, RR, QRS, QT, QTcF intervals).

Laboratory parameters (hematology, serum chemistry, including liver function tests, and 
urinalysis).

PVR and Qmax.
Statistical Methods: See Section 7 STATISTICAL METHODOLOGY
Sample size justification: 
The primary endpoint for this study is change from Baseline to End of Treatment in mean number of 
micturitions per day based on a 3-day diary. 
A number of 272 evaluable subjects per treatment group provides 80% power to detect a reduction of 
0.65 in the mean number of micturitions per day over placebo in the mirabegron group at an alpha 
level of 0.05.  A standard deviation of 2.7 for change from Baseline in micturitions was assumed. 
If 85% of the randomized subjects are evaluable, 640 subjects should be randomized.  With an 
expected drop-out rate of 35% by the end of the tamsulosin hydrochloride run-in phase (V2), 985
subjects need to be screened.
Safety:  
Safety analyses will be done on the Safety Analysis Set (SAF), which consists of subjects who 
received at least one dose of double-blind medication.  Treatment emergent adverse events will be 
coded using the MedDRA dictionary and will be summarized by treatment group. The number and 
percentage of treatment-emergent AEs, SAEs, AEs leading to discontinuation, and AEs related to 
study drug will be summarized by system organ class, preferred term and treatment group. Laboratory 
variables (biochemistry, hematology, and urinalysis) will be descriptively summarized for Baseline 
(Visit 2), Week 4, Week 8, and Week 12/End of Treatment and change from Screening to End of 
Treatment will be summarized by treatment group. Vital sign changes will be summarized by 
treatment group.  Categorical changes in vital signs will also be examined. In addition, post-void 
residual volumes as measured by bladder sonography and Qmax will be summarized by change from 
baseline.  Centrally assessed ECGs will also be summarized by treatment group.
Interim analyses: 
Not applicable.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 24 of 87
V.
FLOW CHART AND SCHEDULE OF ASSESSMENTS
Flow Chart
mirabegron 25 mg QD 
plus tamsulosin
hydrochloride 0.4 mg QD
mirabegron 50 mg QD
plus tamsulosin hydrochloride 0.4 mg QD
placebo matched to 
mirabegron 25 mg QD 
plus tamsulosin 
hydrochloride 0.4 mg QD
placebo matched to mirabegron 50 mg
plus tamsulosin hydrochloride 0.4 mg QD
Treatment 
Period
Open-label
V
V
V
V
V
Screening/tams
ulosin 
hydrochloride
Follow-up 
Phone Call 
V
Double-blind
(4
(8
Randomiz


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 25 of 87
Table 1
Schedule of Assessments
Screening/
Tamsulosin 
Hydrochloride  Run-
In
Treatment Period
Follow-up 
Phone Call
Visit
1
2
3
4
5
6
Day
-28
1
28
56
84
114
Week
-4
0
4
8
12
16
Visit Windows
+/- 3 d
—
+/- 7 d
+/- 7 d
+/- 7 d
+/- 3 d
Visit Windows (Study Days) a
-31 to -25
—
21 to 35
49 to 63
77 to 91
111-117
Informed Consent
X
Inclusion/Exclusion Criteria
X
X
Medical History and OAB History
X
Demographics
X
Enter 4-week tamsulosin hydrochloride run-in b
X
Reminder Phone Call c
X
X
X
X
Randomization d
X
Physical Exam 
X
X
Weight and Height
X
Office Visit Vital Signs (pulse and blood pressure)
X
X
X
X
X
Serum PSA
X
Serum chemistry, hematology & urinalysis e, f
X
X
X
X
X
12-Lead ECG g
X
X
X
X
X
PVR (Ultrasonography or Bladder Scan)
X
X
X
X
X
Uroflowmetry (Qmax) h
X
X
IPSS
X
X
X
X
X
Medication History and OAB Medication History i
X
Concomitant Medications Assessment
X
X
X
X
X
X
Adverse Event Assessment j
X
X
X
X
X
X
Dispense Study Drug 
X
X
X
X
Drug Accountability
X
X
X
X
Dose Titration k
X
Instruct Subject on 3-day Diary l
X
X
X
X
Subject Completes 3-day Diary including HBPM
Xm
Xm
Xm
Xm
EQ-5D-5L
X
X
X
X
Table continued on next page


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 26 of 87
Screening/
Tamsulosin 
Hydrochloride  Run-
In
Treatment Period
Follow-up 
Phone Call
Visit
1
2
3
4
5
6
Day
-28
1
28
56
84
114
Week
-4
0
4
8
12
16
Visit Windows
+/- 3 d
—
+/- 7 d
+/- 7 d
+/- 7 d
+/- 3 d
Visit Windows (Study Days) a
-31 to -25
—
21 to 35
49 to 63
77 to 91
111-117
OAB-q
X
X
X
X
PPBC 
X
X
X
X
PPIUS
X
X
X
X
TS-VAS
X
X
X
X
Review Subject Diary n
X
X
X
X
a. After Visit 1 (Screening/tamsulosin hydrochloride run-in), visit windows/study days will be calculated based on the Visit 2 (Baseline) visit date. Study procedures (e.g., bladder 
scan) for a particular visit do not need to be completed on the visit date if this is not feasible for the subject, as long as study procedures are performed per protocol within the 
applicable visit window. Any procedure not done or performed outside the applicable visit window will be noted as a protocol excursion.
b. Subjects must take at least 22 days, but no more than 34 days of tamsulosin hydrochloride run-in medication.
c. Reminder Phone Call to complete the diary and to answer any questions is to occur approximately 7 days prior to the visit.
d. Randomization is to occur after confirming all eligibility criteria and after performing all other visit procedures at Visit 2.
e. Blood samples need not be fasting. A central laboratory will be used for all laboratory hematology and biochemistry/PSA assessments. Local laboratories will be used for all 
urinalysis and urine culture and sensitivity. 
f. Urine culture and sensitivity must be performed for positive leukocyte esterase (LCE), nitrites, or turbidity, or at the discretion of the PI. It is not required to send isolated trace 
positive leukocyte esterase samples for culture. If a subject has a UTI (defined as > 100,000 CFU), the subject may be rescreened after successful treatment of the UTI 
(confirmed by a laboratory result of negative urine culture).
g. ECGs will be submitted to a central laboratory. Initial inclusion will be based on PI interpretation of ECG eligibility at Screening (Visit 1) and Baseline (Visit 2); however, if 
the QTcF interval is >450 ms on the printed ECG at Baseline (Visit 2), an expedited central ECG reading (within 24 hours) should be requested and reviewed before the subject 
is allowed to be randomized. Final central readings must be reviewed by the Investigator for the duration of the study for immediate safety assessment and subject care.
h. Qmax can be completed within two weeks of Screening (Visit 1). The subject must void a minimum of 125 mL for the uroflow measurement to be considered adequate.
i.
All medications taken within 30 days prior to Screening (Visit 1) must be recorded in the eCRF.
j.
Adverse Event collection will begin from the time of informed consent and continue through the Follow-up Phone Call (Visit 6).
k. All subjects will be titrated to the 50 mg dose of mirabegron or placebo to match (PTM) after 4 weeks of treatment. Patients will remain on 0.4 mg of tamsulosin hydrochloride 
for the duration of the study.
Footnotes continued on next page


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 27 of 87
l.
At the Screening/tamsulosin hydrochloride run-in (Visit 1), all subjects will be provided with an ePRO device (electronic diary) that will be used to record the date and time of 
each  micturition, incontinence, urgency episode, measure of urine volume voided, sleep interruption, and protective garments. Home measurements of am and pm pulse rate 
and systolic and diastolic blood pressure will be electronically captured in the diary. Additionally, the diary will be used to record medication intake every day during the study, 
as well as to complete questionnaires. Training on device use must be done at Visit 1 and as necessary throughout the study.  Approximately 7 days prior to Visit 2 subjects will 
receive a phone call reminding them about the diary and to answer any questions. Subjects will be instructed to begin completing the electronic diary 3 days prior to each in 
office study visit including Visit 2 (Baseline), Visits 3 - 5 (Treatment Period) and to complete the diary for the full 3 days.  
m. For Visits 2, 3, 4 and 5, subjects will complete the electronic diary (including am and pm HBPM) for the 3 days prior to the study visit.
n. Investigator, or designee, must review the subject’s diary with the subject to ensure completion compliance and discuss data captured.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 28 of 87
1
INTRODUCTION
1.1
Background
Overactive bladder (OAB) syndrome is a highly prevalent medical condition. The prevalence 
of OAB is estimated to be 34 million in the US and 22 million in Europe [Irwin et al, 2009; 
Kim et al, 2006; Stewart et al, 2003; Milsom et al, 2001]. International Continence Society 
(ICS) defines OAB as urgency, with or without urge incontinence, usually with frequency 
and nocturia [Abrams et al, 2003; Lee and Lee, 2014]. Prevalence of OAB symptoms 
increases with age, and the prevalence of OAB wet (with incontinence) is greater in women 
than in men [Jaffe and Te, 2005]. In clinical practice, it is recognized that men may 
experience OAB symptoms concurrent with those of benign prostatic hyperplasia (BPH).
BPH is a condition affecting over 50% of men by age 60 [Bechis et al, 2014]. It is also a 
common cause of lower urinary tract symptoms (LUTS) such as frequent urination, urgency, 
nocturia, and the sensation of incomplete bladder emptying [Miller and Tarter, 2009]. In 
2008, an estimated 917 million men worldwide were affected by LUTS from BPH [Irwin et 
al, 2011]. LUTS can be divided into storage and voiding symptoms, with BPH predominantly 
associated with voiding LUTS symptoms. Patients with voiding symptoms may also have 
concomitant storage symptoms. Analysis of the general population identified that the 
combination of storage and voiding LUTS was the most common type of LUTS, affecting 
8.9% of the general population sample in a multinational, population-based study (EPIC) 
[Irwin et al, 2009; Irwin et al, 2006].
Alpha-blockers, such as tamsulosin hydrochloride, are commonly prescribed to manage BPH 
symptoms but may fail to alleviate storage (OAB) symptoms [Lee and Lee, 2014]. Thus, the 
American Urological Association (AUA) has identified combination therapy with an 
α-blocker and anticholinergic as a potential treatment option for patients with BPH and 
coexisting OAB symptoms [AUA Guidelines, 2010].
The use of antimuscarinics (e.g., tolterodine and solifenancin) as add-on therapy to alpha-
blockers such as tamsulosin hydrochloride has been evaluated in a number of clinical studies 
in men with OAB and BPH [ADAM study by Chapple et al, 2009; VICTOR study by Kaplan 
et al, 2009; TIME study by Kaplan et al, 2006]. Evaluated add-on therapies were generally 
found to be well-tolerated and showed an added benefit over alpha-blocker monotherapy in 
improving OAB-related symptoms.
Mirabegron (Myrbetriq®/Betmiga®) is a potent and selective human beta-3 adrenergic 
receptor agonist approved for the treatment of OAB with symptoms of urge, urinary 
incontinence, urgency and urinary frequency [Mirabegron US Package Insert, 2015 and 
Myrbetriq Canadian Monograph, March 2015, EU SmPC, 2015]. For the mirabegron 
monotherapy clinical development program, 32 phase 1 studies and 13 phase 2 and 3 studies 
(10 in patients with OAB, 1 in patients with LUTS/bladder outlet obstruction (BOO) and 2 in 
patients with type 2 diabetes mellitus) were conducted. Several global phase 3 studies have 
demonstrated the efficacy, safety and tolerability of once daily mirabegron in patients with 
OAB. In these clinical trials, the incidence of urinary retention did not increase with 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 29 of 87
mirabegron, and it was lower than that of placebo and the active control antimuscarinic [Nitti 
et al, 2013]. In a phase 2 study of 200 men with LUTS and BOO, mirabegron was also found 
to be safe and generally well-tolerated, with no adverse effects on either the detrusor pressure 
at maximum flow rate or on the maximum flow rate [Study 178-CL-060].
The use of the beta-3 adrenergic agonist mirabegron to treat OAB symptoms as add-on 
therapy to tamsulosin hydrochloride will be evaluated for efficacy, safety, and tolerability of 
the combination therapy. It is anticipated from previous studies of add-on therapies, the 
combination of mirabegron and tamsulosin hydrochloride will show an added benefit over α-
blocker monotherapy in improving OAB-related symptoms.
1.2
Summary of Non-clinical and Clinical Data
Detailed information on the non-clinical studies conducted with mirabegron and tamsulosin
hydrochloride can be found in the approved product labeling, Summary of Product 
Characteristics (SmPC) and US Package Insert for mirabegron and tamsulosin hydrochloride, 
copies of which will be made available to the Investigator, Institutional Review Boards 
[IRB], Independent Ethics Committees [IEC] and other bodies as appropriate. Summaries of 
findings from non-clinical and clinical studies with mirabegron and tamsulosin hydrochloride
which may have relevance for the current study are listed below.
1.2.1
Mirabegron (YM178)
Mirabegron was approved for the treatment of OAB in adults in Japan in 2011 and in the US, 
Canada and Europe in 2012. Mirabegron is a selective human beta-3 adrenergic agonist and 
the first of a new class of compounds with a different mode of action from the current 
standard of care, muscarinic receptor antagonists, in the treatment of patients with OAB. 
Antimuscarinics and mirabegron both reduce micturition frequency and incontinence. Data 
from the phase 2 study 178-CL-100 showed that mirabegron has a similar effect size to 
antimuscarinics. Consistent with the Phase 2 data, one phase 3b comparative trial 
(178-EC-001) between mirabegron and solifenacin in patients dissatisfied with their previous 
antimuscarinic showed that the two drugs had similar effect sizes for micturition frequency 
and incontinence.
1.2.1.1 Summary of Non-clinical Studies of Mirabegron
Mirabegron is a potent and selective agonist of the human beta-3 adrenergic receptor. 
Mirabegron has low intrinsic activity for human beta-1 and beta-2 adrenergic receptors. 
Mirabegron has no significant affinity for other pharmacological targets in a comprehensive 
test battery of receptors, ion channels and enzymes. Mirabegron directly relaxes human 
bladder in vitro through activation of beta-3 adrenergic receptors. Studies in conscious and 
anesthetized rat models of bladder function demonstrate modulation consistent with a 
beneficial profile in OAB patients.
Increases in heart rate have been observed following mirabegron administration to rats, dogs, 
and monkeys. Decreases in blood pressure were observed in dogs but not in rats or monkeys. 
Assessment of the potential for mirabegron to delay cardiac repolarization demonstrated that 
mirabegron and its most abundant human metabolites were free from effects on cardiac 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 30 of 87
repolarization in isolated dog Purkinje fibers and guinea pig papillary muscles. Furthermore, 
in isolated perfused dog ventricular tissue neither mirabegron nor its metabolites induced 
electrophysiological changes. Mirabegron and its five most abundant human metabolites did 
not significantly alter the IKr (hERG), IKs (hKvLOT1/mink), Ito (hKv4.3/KChip2.2), Ina 
(hNAV1.5), or Ica (hCav 1.2) conductance in in vitro studies at relevant concentrations 
(>100-fold human Cmax) at a 100 mg dose.
Single and repeat dose toxicology studies in dogs, monkeys, and rats demonstrate 
cardiovascular changes at high doses. In a 13-week rat toxicology study, significant increases 
in plasma alanine aminotransferase (ALT) were observed at doses of 30 mg/kg and higher 
(22-fold higher than maximum recommended human dose). Modest (less than 2-fold) 
increases in alkaline phosphatase (ALP) and aspartate aminotransferase (AST) were observed 
at high doses (72-fold higher than the maximum recommended human dose), together with 
reversible changes in hepatocytes. Modest elevation of ALT was also observed in monkeys 
but the changes observed were deemed to be below the level of toxicological significance and 
there were no changes in liver histopathology. There were no significant changes in liver 
enzymes or liver histopathology in dogs. Mirabegron was not genotoxic, carcinogenic, or 
teratogenic in the battery of conventional in vitro and in vivo studies.
1.2.1.2 Summary of the Pharmacokinetics of Mirabegron
After oral administration of mirabegron in healthy volunteers, peak mirabegron plasma 
concentrations were attained between 3 to 5 hours. The absolute bioavailability increases 
from 29% at a dose of 25 mg to 45% at a dose of 150 mg under fasted conditions in healthy 
volunteers. Mean Cmax and AUCinf increased more than dose proportionality over the 
recommended dose range. Steady state concentrations were achieved within 7 days of once 
daily dosing with mirabegron. The Cmax and AUCtau of mirabegron and its metabolites 
following multiple oral doses in older adult subjects (≥65 years) were similar in those in 
younger subjects (18 to 45 years). The Cmax and AUCtau of mirabegron were approximately 
40-60% higher in females than in males. The mean terminal t½ is comparable in both sexes. 
Evaluation of special populations in the phase 1 studies demonstrated that volunteers with 
severe renal impairment (CrCL 15 to 29 mL/min or eGFR 15 to 29 mL/min per 1.73 m2) or 
moderate hepatic impairment (Child-Pugh Class B) had an approximately 2-fold increase in 
exposure to mirabegron relative to normal healthy volunteers.
The in vitro oxidative metabolism of mirabegron in human liver microsomes is primarily 
mediated by cytochrome P450 (CYP) 3A4, but a possible role for CYP2D6 could not be 
excluded. In vitro CYP inhibition studies suggest that mirabegron is a moderate and time-
dependent inhibitor of CYP2D6 and a weak inhibitor of CYP3A4.
1.2.1.3 Summary of Clinical Data with Mirabegron
The clinical development program consists of 48 completed clinical studies to date over 
approximately 10 years and is comprised of 13,640 subjects (1,909 volunteers and 
11,731 patients) including patients with OAB, type 2 diabetes mellitus, and lower urinary 
tract symptoms (LUTS)/bladder outlet obstruction (BOO). A total of 34 phase 1 studies and 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 31 of 87
14 phase 2 and 3 studies (11 in patients with OAB, 1 in patients with LUTS/BOO and 2 in 
patients with type 2 diabetes mellitus) have been conducted globally.
Mirabegron has been studied across the dose range of 25 mg to 200 mg once daily in OAB 
patients. Mirabegron 25 mg, 50 mg, and 100 mg demonstrated statistical superiority 
compared to placebo for the co-primary endpoints of incontinence episodes and micturition 
frequency. Both the 50 mg and 100 mg doses also demonstrated superiority compared to 
placebo for almost all key secondary endpoints defined in the phase 3 program.
Evaluation of the combined safety data from the mirabegron clinical program to date shows
mirabegron to be safe and well tolerated. The incidence of Treatment Emergent Adverse 
Events (TEAEs) in the active treatment group is comparable with the incidence in the 
placebo group. The most frequently reported TEAE was hypertension which includes reports 
of blood pressure above the normal range, and BP increased from baseline, occurring 
predominantly in subjects with baseline hypertension. Most commonly reported adverse 
reactions (>2% and >placebo) were hypertension, nasopharyngitis, urinary tract infection and 
headache. Most of the events were mild or moderate in intensity. Other adverse reactions 
occurring at greater than 1% and greater than placebo include constipation, upper respiratory 
infection, arthralgia, diarrhea, tachycardia, abdominal pain and fatigue (Table 2). The number 
of serious TEAEs is low and comparable across mirabegron and placebo treatment groups.
Table 2
Percentage of Patients with Adverse Reactions, Derived from All Adverse 
Events, Exceeding Placebo Rate and Reported by 1% or More Patients 
Treated With MYRBETRIQ® 25 mg or 50 mg Once Daily
Placebo
(%)
MYRBETRIQ®
25 mg
(%)
MYRBETRIQ®
50 mg
(%)
Number of Patients
1380
432
1375
Hypertension*
7.6
11.3
7.5
Nasopharyngitis
2.5
3.5
3.9
Urinary Tract Infection
1.8
4.2
2.9
Headache
3
2.1
3.2
Constipation
1.4
1.6
1.6
Upper Respiratory Tract Infection
1.7
2.1
1.5
Arthralgia
1.1
1.6
1.3
Diarrhea
1.3
1.2
1.5
Tachycardia
0.6
1.6
1.2
Abdominal Pain
0.7
1.4
0.6
Fatigue
1
1.4
1.2
* Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring 
predominantly in subjects with baseline hypertension.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 32 of 87
In the US Package Insert, mirabegron is contraindicated in patients with hypersensitivity 
reactions. It has warnings and precautions for increases in blood pressure, angioedema, 
urinary retention in patients with bladder outlet obstruction, and in patients taking drugs 
metabolized by CYP2D6.
In the Canadian Monograph, mirabegron is contraindicated in patients with severe 
uncontrolled hypertension, patients who are pregnant, and patients who are hypersensitive to 
mirabegron or to any ingredient in the formulation or component of the container. 
Mirabegron has warnings and precautions for neoplasm, Stevens-Johnson syndrome, 
increases in serum ALT/AST and bilirubin, QTc prolongation, increases in blood pressure 
and heart rate, urinary retention, and in patients taking drugs metabolized by CYP2D6. The
monograph does not recommend use of mirabegron in patients with severe hepatic 
impairment, end stage renal disease, pregnant and nursing women, and pediatric patients 
(<18 years of age).
In the EU Summary of Product Characteristics (EU SmPC), mirabegron is contraindicated in 
patients with hypersensitivity reactions and for those with uncontrolled hypertension 
(SBP > 180, or DBP > 110). It has warnings and precautions for increases in blood pressure, 
QTc prolongation, and urinary retention in patients with bladder outlet obstruction. It 
recommends not to use in patients with moderate or severe hepatic impairment (Child-Pugh 
Class B or C) or end stage renal disease.
For further information, please refer to the full prescribing information for mirabegron 
[Mirabegron US Package Insert, 2015 and Myrbetriq Canadian Monograph, March 2015, EU 
SmPC, 2015].
1.2.2
Tamsulosin Hydrochloride
Tamsulosin hydrochloride was registered in Japan in 1993, in the European Community in 
1995 and in the USA in 1997. In the US, tamsulosin hydrochloride is indicated for treatment 
of the signs and symptoms of BPH and in the EU, for lower urinary tract symptoms (LUTS) 
associated with BPH. Since the launch of tamsulosin hydrochloride, a worldwide exposure of 
more than 24 million patient years has demonstrated that tamsulosin hydrochloride is 
effective and safe in the treatment of LUTS associated with BPH. The most common adverse 
event is dizziness and weakness.  Intra-operative Floppy Iris syndrome during cataract and 
glaucoma surgery has been associated with tamsulosin hydrochloride use.  The initiation of 
tamsulosin hydrochloride in patients with scheduled cataract or glaucoma surgery is not 
recommended (see US Package Insert, 2014 and EU SmPC, 2013).
1.2.2.1 Summary of Non-clinical Studies of Tamsulosin Hydrochloride
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. The 
symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet 
obstruction, which is comprised of two underlying components: static and dynamic. The 
static component is related to an increase in prostate size caused, in part, by a proliferation of 
smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the 
degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 33 of 87
component is a function of an increase in smooth muscle tone in the prostate and bladder 
neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the 
sympathetic nervous stimulation of alpha1 adrenoceptors. Antagonism of these adrenoceptors 
can cause smooth muscles in the bladder neck and prostate to relax, resulting in an 
improvement in urine flow rate and a reduction in symptoms of BPH.
Tamsulosin hydrochloride, an alpha1 adrenoceptor blocking agent, exhibits selectivity for 
alpha1 receptors in the human prostate. At least three discrete alpha1 adrenoceptor subtypes 
have been identified: alpha1A, alpha1B, and alpha1D; their distribution differs between human 
organs and tissue. Approximately 70% of the alpha1 receptors in the human prostate are of 
the alpha1A subtype.
1.2.2.2 Summary of the Pharmacokinetics of Tamsulosin Hydrochloride
The pharmacokinetics of tamsulosin hydrochloride have been evaluated in adult healthy 
volunteers and patients with BPH after single and/or multiple administration with doses 
ranging from 0.1 mg to 1 mg. Absorption of tamsulosin hydrochloride from capsules of 
0.4 mg is essentially complete (90%) following oral administration under fasting conditions. 
Tamsulosin hydrochloride exhibits linear kinetics following single and multiple dosing, with 
achievement of steady-state concentrations by the fifth day of a once-a-day dosing. The time 
to maximum concentration (Tmax) is reached by 4 to 5 hours under fasting conditions and by 
6 to 7 hours when administered with food. Taking capsules under fasted conditions results in 
a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak concentrations 
(Cmax) compared to fed conditions.
Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes in the 
liver and less than 10% of the dose is excreted in urine unchanged. However, the 
pharmacokinetic profile of the metabolites in humans has not been established. In vitro 
results indicate the CYP3A4 and CYP2D6 are involved in the metabolism of tamsulosin
hydrochloride as well as some minor participation of other CYP isoenzymes. Inhibition of 
hepatic drug-metabolizing enzymes may lead to increased exposure to tamsulosin
hydrochloride. 
1.2.2.3 Summary of Clinical Data with Tamsulosin Hydrochloride
Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a 
total of 2296 patients (1003 received 0.4 mg capsules tamsulosin hydrochloride once daily, 
491 received 0.8 mg capsules tamsulosin hydrochloride once daily, and 802 were control 
patients) in the US and Europe.
In the two US placebo-controlled, double-blind, 13-week, multi-center studies [Study 1 
(US92-03A) and Study 2 (US93-01)], 1486 men with the signs and symptoms of BPH were 
enrolled. In both studies, patients were randomized to either placebo, tamsulosin 
hydrochloride capsules 0.4 mg once daily, or tamsulosin hydrochloride capsules 0.8 mg once 
daily. Patients in tamsulosin hydrochloride capsules 0.8 mg once daily treatment groups 
received a dose of 0.4 mg once daily for one week before increasing to the 0.8 mg once daily 
dose. The primary efficacy assessments included: 1) total American Urological Association 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 34 of 87
(AUA) Symptom Score questionnaire, which evaluated irritative (frequency, urgency, and 
nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) 
symptoms, where a decrease in score is consistent with improvement in symptoms; and 2) 
peak urine flow rate, where an increased peak urine flow rate value over baseline is 
consistent with decrease urinary obstruction.
Mean total AUA Symptom Scores for both tamsulosin hydrochloride capsules 0.4 mg and 
0.8 mg once daily groups showed a rapid decrease starting at one week after dosing and 
remained decreased through 13 weeks in both studies.
For further information, please refer to the full prescribing information for tamsulosin 
hydrochloride [Flomax® (tamsulosin hydrochloride) Capsules, 0.4 mg US Package Insert, 
2014, Flomax Relief® MR, 2014, and Tamsulosin hydrochloride, EU SmPC, 2013].
1.3
Summary of Key Safety Information for Study Drugs
1.3.1
Summary of Key Safety Information for Mirabegron
Mirabegron was first approved in Japan on 1 July 2011, and was launched to market on 
16 September 2011 under the trade name Betanis®. On 28 June 2012, mirabegron received 
approval in the United States (trade name: Myrbetriq®). The approved indication is the 
treatment of OAB with symptoms of urinary incontinence, urgency, and urinary frequency. 
On 20 December 2012, mirabegron received marketing approval in the EU under the trade 
name Betmiga®. On 6 March 2013, mirabegron received approval in Canada (trade name: 
Myrbetriq®). As of September 3, 2015, mirabegron has regulatory approval in 58 countries.
The safety of mirabegron treatment has been well characterized in 5,863 subjects in the 
phase 2/3 studies, including 5,648 subjects with OAB, treated with mirabegron at doses 
ranging from 25 to 200 mg once daily. Of the 5,648 subjects with OAB who received 
mirabegron, 1,572 subjects received mirabegron continuously for at least 6 months, 
1,482 subjects for at least 9 months, and 622 for at least 1 year.
Important potential risks include QT prolongation with supratherapeutic doses or in high-risk 
populations, increased heart rate, increased blood pressure, non-immediate cutaneous 
hypersensitivity reactions and exposure in utero. The potential risks of QT prolongation, 
increased heart rate, or increased blood pressure are greater with increasing exposure. The 
expected adverse drug reactions for mirabegron are presented in Table 2  The approved 
therapeutic dose of mirabegron in the United States and Canada is 25 mg once daily which 
may be increased to 50 mg once daily based on individual patient efficacy and tolerability 
[Mirabegron US Package Insert, 2015 and Myrbetriq Canadian Monograph, March 2015]. In 
the EU the approved starting dose of mirabegron is 50 mg once daily [EU SmPC, 2015].  The 
favorable benefit risk profile of mirabegron is not expected to change over time.
A mean increase of approximately 1 bpm for pulse rate was observed in OAB patients who 
received mirabegron 50 mg. This magnitude of change was similar for both 12-week and 
long-term studies, for men and women, and in both the mirabegron and tolterodine (active 
control) treatment groups. In patients with OAB, categorical increases in pulse rate were 
noted more frequently with mirabegron and tolterodine than with placebo, with similar 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 35 of 87
changes observed for mirabegron 50 mg and tolterodine. Pulse increases were more 
pronounced in young subjects in comparison to older adults (age 55 years and greater) 
subjects. Changes in pulse were reversible upon discontinuation of treatment.
An approximate mean increase in 1 mmHg from baseline for SBP/DBP was observed in 
OAB patients who received mirabegron 50 mg compared with placebo. This magnitude of 
change was similar for both 12-week and long-term studies, for men and women, and in both 
the mirabegron and tolterodine treatment groups. TEAE and SAE related to hypertension 
were similar for mirabegron 50 mg, placebo, and tolterodine in the 12-week studies, and were 
similar for mirabegron and tolterodine in the long-term study. Blood pressure increases were 
more pronounced in young subjects in comparison to older adult (age 55 years and greater) 
subjects. Changes in blood pressure were reversible upon discontinuation of treatment. Please 
refer to the product insert for expected adverse drug reactions (ADR).
Detailed information on the clinical safety profile for mirabegron can be found in the full 
prescribing information [Mirabegron US Package Insert, 2015, Myrbetriq Canadian 
Monograph, March 2015, and EU SmPC, 2015].
According to current package inserts, no dose adjustment is necessary for older adult patients. 
The pharmacokinetics of mirabegron is not significantly influenced by age. The Cmax and 
AUC of mirabegron following multiple oral doses in older adult volunteers (≥ 65 years) were 
similar to those in younger volunteers (18 to 45 years). Of 5,648 patients who received 
mirabegron in the phase 2 and 3 studies, 2,029 (35.9%) were 65 years of age or older, and 
557 (9.9%) were 75 years of age or older. No overall differences in safety or effectiveness 
were observed between patients younger than 65 years of age and those 65 years of age or 
older in the studies [Mirabegron US Package Insert, 2015 and Myrbetriq Canadian 
Monograph, March 2015, EU SmPC, 2015].
1.3.2
Summary of Key Safety Information for Tamsulosin Hydrochloride
In the phase 3 trials (178-CL-046, 178-CL-047, 178-CL-074), 308 men were on tamsulosin
hydrochloride across treatment groups. There were no differences in rates of hypertension or 
elevated heart rate between men on and off tamsulosin hydrochloride.
1.3.3
Summary of Key Safety Information for Combination of Mirabegron and 
Tamsulosin Hydrochloride
Study 178-CL-080 was an open-label, 2-treatment arm, 2-sequence study to investigate the 
cardiovascular (CV) interactions between mirabegron (100 mg) and tamsulosin hydrochloride
(0.4 mg as a single dose) in healthy male volunteers. Under the conditions of the study, the 
CV results suggest there is no clinically relevant pharmacodynamic interaction between 
tamsulosin hydrochloride and mirabegron. Combination treatment of mirabegron and 
tamsulosin hydrochloride did not appear to affect the safety profiles of either drug. In this 
interaction study, there were no serious adverse events and no events of syncope in either 
treatment arm.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 36 of 87
In Japanese men with OAB induced by benign prostatic obstruction, addition of mirabegron 
to tamsulosin hydrochloride was shown to be more effective for ameliorating storage 
symptoms compared to tamsulosin hydrochloride monotherapy [Ichihara et al, 2014].
1.4
Risk-Benefit Assessment
Subjects randomized to placebo treatment are unlikely to benefit from the study beyond the 
benefits they receive from tamsulosin hydrochloride alone. However, OAB is not a life-
threatening disease and it is not expected that a 12-week exposure to placebo treatment will 
have a negative impact on disease progress, given that subjects will have been on tamsulosin
hydrochloride prior to study entry and it will be continued. Subjects receiving mirabegron are 
likely to benefit from at least a partial relief of symptoms during the study.
There is extensive clinical experience with tamsulosin hydrochloride monotherapy in the 
treatment of BPH.  Clinical equipoise is maintained in the study because an alpha blocker is 
considered standard treatment of men with BPH and because the subjects are continuing on 
their usual prescribed dose as opposed to being placed on a tamsulosin hydrochloride placebo.
Mirabegron has a distinct mechanism of action (beta-3 adrenergic agonist) compared with the 
current standard of care, primarily antimuscarinics, for the treatment of symptoms of OAB. 
Antimuscarinics have been studied concomitantly with alpha blockers and appear to be 
efficacious without added risk.  Muscarinic antagonists and beta-3 adrenergic agonists 
modulate bladder function through distinct molecular pathways. Thus concomitant use of 
tamsulosin hydrochloride and mirabegron offers the possibility of enhancing efficacy in the 
treatment of men with BPH who have co-existing OAB.
2
STUDY OBJECTIVE(S), DESIGN, AND ENDPOINTS
2.1
Study Objectives
The primary objective is to study the efficacy of mirabegron versus placebo in men with 
OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.
The secondary objective is to assess safety and tolerability of mirabegron versus placebo in 
men with OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.
Other objectives are to assess patient reported outcomes (PROs) as measured by Symptom 
Bother and Total Health Related Quality of Life scores as assessed by the Overactive Bladder 
questionnaire (OAB-q), EQ-5D-5L, Patient Perception of Bladder Condition (PPBC), Patient 
Perception of Intensity of Urgency Scale (PPIUS), International Prostate Symptom Score 
(IPSS), and Treatment Satisfaction-Visual Analog Scale (TS-VAS).


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 37 of 87
2.2
Study Design and Dose Rationale
2.2.1
Study Design
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study.
Approximately 985 subjects will be enrolled at up to 100 study centers in North America and 
Europe.
At Screening (Visit 1), subjects will enter into a 4-week open label tamsulosin hydrochloride 
0.4 mg QD run-in period prior to being randomized into the 12-week double-blind treatment 
period (Visit 2).  At the conclusion of the 4-week tamsulosin hydrochloride run-in period, 
subjects will complete a 3-day diary just prior to Baseline (Visit 2). Approximately 7 days 
prior to Visit 2 subjects will receive a phone call reminding them about the diary and to 
answer any questions.
A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in 
period. During this evaluation period at least one telephone contact will take place with the 
subject. Diaries will be completed at home, using the electronic patient-reported outcome 
(ePRO) device, for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 
(Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). Site staff will contact 
the subject approximately 7 days prior to the scheduled visit to remind the subject that they 
need to complete the electronic diary, review completion instructions and review changes to 
concomitant medications and adverse events (if applicable). 
If subjects meet all entry criteria at the end of the tamsulosin hydrochloride run-in period, 
subjects will be randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks 
of treatment in addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those 
subjects randomized to mirabegron will start at 25 mg and will increase to 50 mg after 
4 weeks.  Those subjects randomized to placebo will start blinded product matched to the 
mirabegron 25 mg tablet and will increase to blinded product matched to 50 mg mirabegron 
after 4 weeks. Once a subject has increased dose, he will remain on that dose for the 
remainder of the study unless for safety reasons he is required to discontinue study drug.
Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), subjects 
will complete a 3-day diary, using the electronic patient-reported outcome (ePRO) device in 
which they will record micturition frequency, urgency (PPIUS), incontinence and volume
voided.  In addition the diary will capture morning and evening blood pressure and pulse rate 
measurements via HBPM. At Visit 1, International Prostate Symptom Score (IPSS) will be 
completed. At Visits 2, 3, 4, and 5, subjects will complete the IPSS, EQ-5D-5L, OAB-q, 
PPBC, and TS-VAS.  Maximum urinary flow (Qmax) will be measured at Visit 1 
(Screening/tamsulosin hydrochloride run-in) and Visit 5 (Week 12/End of Treatment).  
Post-void residual volume (PVR) will be assessed at Screening/tamsulosin hydrochloride
run-in (Visit 1), Baseline (Visit 2) and at Week 4 (Visit 3), Week 8 (Visit 4) and Week 
12/End of Treatment (Visit 5). A follow-up phone call (Visit 6) will be conducted 4-weeks 
after End of Treatment (Visit 5). Total study participation is approximately 20 weeks.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 38 of 87
2.2.2
Dose Rationale
The approved dose in the treatment of overactive bladder in the United States and Canada is 
mirabegron 25 mg daily, which may be increased to 50 mg daily based on individual efficacy 
and tolerability [Mirabegron US Package Insert, 2015 and Myrbetriq Canadian Monograph, 
March 2013]. The recommended dose of mirabegron in the European SmPC is 50 mg [EU 
SmPC, 2015]. The dosing regimen for the study is starting with mirabegron 25 mg with an 
obligatory increase to mirabegron 50 mg after 4 weeks of treatment which is intended to 
reflect a pragmatic and clinically plausible regimen. The treatment effect size at Week 4 in 
the phase 3a program approaches the maximum treatment response for incontinence and 
micturition.
2.3
Endpoints
2.3.1
Primary Endpoints
The primary endpoint is:
●
Change from Baseline (Visit 2) to Week 12/ End of Treatment (Visit 5) in mean 
number of micturitions per day based on a 3-day diary.
2.3.2
Secondary Endpoints
The secondary endpoints are:
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean volume voided per micturition.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of incontinence episodes per day (FAS-I).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of urgency episodes (grade 3 and 4) per day.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in IPSS total score and subscales (Voiding, Storage, and Quality of Life).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of urgency incontinence episodes per day (FAS-I).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in Symptom Bother Total Health Related Quality of Life and subscale 
(coping, concern, sleep, social interaction, and symptom bother) scores as assessed by 
OAB-q questionnaire.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) as assessed by EQ-5D-5L questionnaire.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in PPBC. 
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in Total Urgency and Frequency Score (TUFS) using PPIUS (Grade 3 or 4).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of nocturia episodes per day.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 39 of 87
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in TS-VAS scores. 
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in the number of protective garments (e.g. absorbent pads, incontinence 
briefs, disposable underwear).
2.3.3
Exploratory Endpoint
The exploratory endpoint is:
●
Performance of subgroup analyses by PSA cutoff scores for < 2, 2-4. 
2.3.4
Safety Variables
The safety variables are:
●
Incidence and severity of treatment emergent adverse events (TEAEs) including AEs 
of special interest (see Section 5.4.3.2).
●
Vital signs: sitting systolic and diastolic blood pressure and pulse rate (home blood 
pressure monitoring [HBPM] and office measurements).
●
ECG parameters (heart rate, PR, RR, QRS, QT, QTcF intervals).
●
Laboratory parameters (hematology, serum chemistry, including liver function tests, 
and urinalysis).
●
Change in PVR and Qmax.
3
STUDY POPULATION
3.1
Selection of Study Population
The study will enroll men at least 40 years of age who have symptoms of overactive bladder 
while taking the α-blocker tamsulosin hydrochloride for Lower Urinary Tract Symptoms 
(LUTS) due to Benign Prostatic Hyperplasia (BPH). Six hundred forty (640) subjects will be 
randomized to 1 of 2 treatment groups in a 1:1 randomization (mirabegron or placebo); 320
randomized to mirabegron; 320 randomized to placebo.
3.2
Inclusion Criteria
Inclusion Criteria assessed at Visit 1 (Screening).
Subject is eligible for the study if all of the following apply:
1.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written 
Informed Consent and privacy language as per national regulations (e.g., HIPAA 
Authorization for US sites) must be obtained from the subject or legally authorized 
representative prior to any study-related procedures (including withdrawal of prohibited 
medication, if applicable).
2.
Men ≥40 years of age with history of OAB symptoms (urinary frequency and urgency 
with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at 
least 2 months to treat LUTS due to BPH.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 40 of 87
3.
Subject has symptoms of OAB (frequency of ≥8 micturitions per day and urgency 
episodes of ≥2 per day) for ≥3 months prior to Screening.
4.
Subject has an IPSS score ≥8.
5.
Subject has Prostate-Specific Antigen (PSA) < 4 ng/mL OR PSA ≥4 but <10 ng/mL with 
a prostate biopsy that is negative for cancer in the past two years.
6.
Subject is willing and able to complete the 3-day diary (including urine volumes, vital 
sign measurements), and Quality of Life questionnaires.
7.
Subject and their spouses/partners who are of childbearing potential must be using a 
highly effective method of birth control, which includes established use of oral, injected 
or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth 
control must be practiced from Screening and continue throughout the study and for 
30 days after the final study drug administration. In addition, sperm donation will not be 
allowed throughout the study and for 30 days after the final study drug administration.
8.
Subject agrees not to participate in another interventional study while on treatment.
Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
9.
Subject continues to meet all inclusion criteria of Visit 1 (Screening).
10. Subject must experience an average of 8 or more micturitions per day over the 3-day 
diary period. 
11. Subject must experience an average of 2 or more episodes of urgency per day (grade 3 or 
4) over the 3-day diary period.
Waivers to the inclusion criteria will NOT be allowed.
3.3
Exclusion Criteria
Exclusion Criteria assessed at Visit 1 (Screening).
Subject will be excluded from participation if any of the following apply:
1.
Subject has PVR >200 mL.
2.
Subject has Qmax <5.0 mL/second with a minimum voided volume of 125 mL.
3.
Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
4.
Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will 
be performed for positive leukocytes, nitrites, or turbidity, or at the Investigator’s 
discretion, and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject 
has a UTI, at Screening (Visit 1) the subject may be rescreened after successful treatment 
of the UTI (confirmed by a laboratory result of negative urine culture).
5.
Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
6.
Subject has diabetic neuropathy.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 41 of 87
7.
Previous open, robotic or minimally invasive prostate surgery (including transurethral 
procedures). Planned (scheduled) pelvic or prostate surgery planned during the study 
period.
8.
Planned (scheduled) cataract or glaucoma surgery during the study period. 
9.
Subject with significant stress incontinence as determined by the Investigator.
10. Subject with clinically significant bladder outlet obstruction as determined by the 
Investigator. 
11. Subject has an indwelling catheter or practices intermittent self-catheterization.
12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the 
last 12 months.
13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such 
as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or 
current malignant disease of the pelvic organs (i.e., within the confines of the pelvis 
including the bladder, prostate and rectum; organs of the lower gastrointestinal tract are 
not necessarily considered pelvic organs as the distal ascending colon, the full transverse 
colon and proximal portion of the descending colon are in the abdomen).
14. Subject has received intravesical injection in the past 12 months with botulinum toxin, 
resiniferatoxin, or capsaicin.
15. Subject has ever received electro-stimulation therapy for OAB (e.g., sacral nerve 
stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
16. Subject began or has changed a bladder training program or pelvic floor exercises less 
than 30 days prior to Screening.
17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
19. Subject has severe renal impairment defined as estimated creatinine clearance less than 
29 mL/min/1.73 m2 as determined by central laboratory calculation of eGFR. A subject 
with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for 
the study.
20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood 
pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) 
electrocardiogram (ECG) defined as QTcF >450 msec.
23. Subject has a clinically significant ECG abnormality, as determined by the Investigator.
24. Subject has AST or ALT >2x upper limit of normal (ULN), or γ-GT >3x ULN and 
considered clinically significant by the Investigator.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 42 of 87
25. Subject has a hypersensitivity to any components of mirabegron, tamsulosin 
hydrochloride, or any of the inactive ingredients. 
26. Subject has a history of angioedema.
27. Subject has any clinically significant condition, which in the opinion of the Investigator 
makes the subject unsuitable for study participation.
28. Subject has been treated with an experimental device within 28 days or received an 
investigational agent within 28 days or 5 half-lives, whichever is longer, prior to 
Screening.
29. Subject has a concurrent malignancy or history of any malignancy (within the past 
5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has 
been treated successfully.
30. Subject has ongoing alcohol and/or drug abuse.
31. Subject is using prohibited medications defined in Appendix 1, Part A within 30 days 
prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
32. Subject has stopped, started or changed the dose of a restricted medication (defined in
Appendix 1, Part B) within the 30 days prior to Screening (Visit 1) through Follow-Up 
Phone Call (Visit 6).
33. Subject has participated in an interventional trial within 30 days prior to Screening 
(Visit 1).
34. Subject is involved in the conduct of the study as an employee of the Astellas group, 
third party associated with the study, or the study site team.
35. Subject has previously received mirabegron in the 6 months prior to Screening (Visit 1).
Exclusion Criteria assessed at Visit 2 (Baseline):
36. Subject was non-compliant during the 4-week tamsulosin hydrochloride run-in period, 
defined as taking less than 80% or greater than 120% of study medication.
37. Subject had an average total daily urine volume >3000 mL as recorded in the 3-day 
diary.
Waivers to the exclusion criteria will NOT be allowed. 
4
TREATMENT(S)
4.1
Identification of Investigational Product(s)
4.1.1
Test Drug(s)
Mirabegron will be supplied as 25 mg and 50 mg OCAS (Oral Controlled Absorption 
System) modified release tablets. Mirabegron OCAS tablets contain the following excipient: 
Polyethylene Oxide 2000000 NF, Polyethylene Glycol 8000 NF, Hydroxypropyl Cellulose 
NF, Butylated Hydroxytoluene NF, and Magnesium Stearate NF. The tablets are film coated 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 43 of 87
using Opadry® 03F43159 (25 mg) and 03F42192 (50 mg). The opadry formulation contains: 
Hypromellose USP, Polythylene Glycol 8000, Yellow Ferric Oxide NF and Red Ferric Oxide 
NF.
The mirabegron tablets are packaged in blisters and must be stored at room temperature, 
25°C (77°F); excursion permitted to 15°-30°C (59°-86°F).
The clinical trial material of mirabegron OCAS tablets have been manufactured for Astellas 
by Astellas Pharma Technologies, Inc.
All investigational materials must be kept in a secure area inaccessible to unauthorized 
individuals.
4.1.2
Concomitant Medication
Tamsulosin hydrochloride will be supplied as 0.4 mg capsules (US) / tablets (EU/CA) in 
either commercial blister packs or commercial bottles. All storage and handling information 
can be found in the product package insert or the Summary of Product Characteristics (SPC).
4.1.3
Placebo
The placebo to match (PTM) mirabegron OCAS tablets contain Polyethylene Oxide 2000000 
NF, Polyethylene Glycol 8000 NF, Hydroxypropyl Cellulose NF, Butylated Hydroxytoluene 
NF, and Magnesium Stearate NF. The tablets are film coated using Opadry® 03F42192 
which contains: Hypromellose USP, Polyethylene Glycol 8000, Yellow Ferric Oxide and 
Red Ferric Oxide NF.
The PTM mirabegron OCAS tablets have been manufactured for Astellas by Astellas Pharma 
Technologies, Inc.
The mirabegron PTM tablets are packaged in blisters. The blisters must be stored at room 
temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
4.2
Packaging and Labeling
All medication used in this study will be prepared, packaged, and labeled in accordance with 
AUST Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP) 
guidelines, ICH GCP guidelines, and applicable local laws/regulations.
All Investigational Medicinal Products will bear a label conforming to regulatory guidelines, 
Good Manufacturing Practice and local laws and regulations which identifies the contents as 
investigational drug.
4.3
Study Drug Handling
Current ICH GCP Guidelines require the Investigator to ensure that study drug deliveries 
from the Sponsor are received by the Investigator/or designee and
●
that such deliveries are recorded,
●
that study drug is handled and stored according to labeled storage conditions,
●
that study drug is only dispensed to study subjects in accordance with the protocol, and


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 44 of 87
●
that any unused study drug is returned to the Sponsor or standard procedures for the 
alternative disposition of unused study drug are followed.
The supplied study drug should not be stored at a temperature outside the temperature range 
specified on the study drug label. Any temperature excursion outside the temperature range 
should be evaluated by the Sponsor.
Drug inventory and accountability records for the study drugs will be kept by the 
Investigator/or designee. Study drug accountability throughout the study must be documented 
and reconciled. The following guidelines are therefore pertinent:
●
The Investigator agrees not to supply study drugs to any persons except the eligible 
subjects in this study in accordance with the protocol.
●
The Investigator or designee will keep the study drugs in a pharmacy or other locked and 
secure storage facility under controlled storage conditions, accessible only to those 
authorized by the Investigator to dispense these test drugs.
●
A study drug inventory will be maintained by the Investigator or designee. The inventory 
will include details of material received and a clear record of when they were dispensed 
and to which subject.
●
At the conclusion or termination of this study, the Investigator or designee agrees to 
conduct a final drug supply inventory and to record the results of this inventory on the 
Drug Accountability Record. It must be possible to reconcile delivery records with those 
of used and/or returned medication. Any discrepancies must be accounted for and 
documented. Appropriate forms of deliveries and returns must be signed by the site staff 
delegated this responsibility.
●
The site must return study drug to the Sponsor or designee at the end of the study or 
upon expiration.
4.4
Blinding
4.4.1
Blinding Method
This is a randomized, double-blind, placebo-controlled, parallel group study. Randomization 
will be stratified by geographic region (NA, EU). Subjects will be assigned to a treatment 
group in the order which they meet the criteria for randomization. After the completion of the 
4-week open label tamsulosin hydrochloride run-in period, subjects will be randomized to 
either 25 mg mirabegron or PTM for 4 weeks of treatment and then an obligatory increase to 
mirabegron 50 mg or 50 mg PTM for the remainder of the study. Subjects will receive their 
allocated treatment according to a computer-generated randomization schedule prepared by 
the Sponsor or designee prior to the start of the study. The subject, Investigator and Sponsor 
will not be aware of the treatment regimen.
4.4.2
Confirmation of the Indistinguishability of the Study Drugs
Mirabegron and mirabegron PTM tablets will be used in this study. The mirabegron PTM 
will be identical in size, color and appearance to the mirabegron 25 mg and mirabegron 
50 mg tablets.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 45 of 87
4.4.3
Retention of the Assignment Schedule and Procedures for Treatment Code 
Breaking
Study drug treatment may be revealed only for reasons relating to the subject’s safety and 
when critical therapeutic decisions are contingent on knowing the assigned study drug.
Withdrawal of a subject from the study (refer to Section 6.1) is not a sufficient reason to 
break the study blind. Any decision to break the blind should be discussed with the Astellas 
Study Physician (refer to Section II for contact information).
If the blind is broken for a subject, the reason is to be documented as a written entry in the 
source document. Key information will be recorded at the time when the blind is broken. This 
includes the date the blind was broken, the reason, the person who requested the breaking of 
the blind, the name of the person who broke the blind, and the name of the Astellas 
representative contacted.
4.4.4
Breaking the Treatment Code for Emergency
In order to break the treatment code (unblinding) for a subject, the assigned study medication 
information is accessible through the IWRS. The Sponsor must be notified immediately if the 
blind is broken. The date, time, and reason the blind was broken must be recorded in the 
source documents and on the appropriate Electronic Case Report Form (eCRF) if applicable.
Breaking the treatment code, or unblinding of an individual subject’s treatment assignment, 
may be done only for reasons relating to subject safety or when critical therapeutic decisions 
are contingent upon knowing the blinded study drug assignment.
4.4.5
Breaking the Treatment Code by the Sponsor
The Sponsor may break the treatment code for subjects who experience a Suspected 
Unexpected Serious Adverse Reaction (SUSAR), in order to determine if the individual case 
or a group of cases requires expedited regulatory reporting. Individual Emergency Codes will 
be provided to the limited staff, who are responsible to break the codes for all SUSAR cases
for reporting purposes.
4.5
Assignment and Allocation
After a subject signs informed consent, a subject number will be assigned. To obtain a subject 
number, the Investigator or designee will utilize a web or phone-based Interactive Response 
Technology (IRT), available seven days a week and 24 hours a day.
Subjects who meet all the inclusion and none of the exclusion criteria will enter a 4-week 
tamsulosin hydrochloride 0.4 mg capsule (US) / tablet (EU/CA) run-in period (Visit 1). At 
Visit 2 (Baseline), subjects will be randomly assigned to receive mirabegron or placebo using 
a 1:1 randomization schedule. Randomization will be stratified by geographic region (NA, 
EU).
To obtain the randomization treatment, the Investigator or designee will utilize a web or 
phone-based IRT, available seven days a week and 24 hours a day. After submitting certain 
information about the eligible subject, the randomized drug assignment will be provided by 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 46 of 87
the IRT. Study drug assignment will remain blinded to all staff. Each study drug will be 
preprinted with a Medication ID number. The Medication ID number assigned to the subject 
will be noted in the electronic case report form (eCRF) for study drug.
Once a subject number is assigned, if the corresponding subject does not receive study drug, 
the subject number will not be used again. 
5
TREATMENTS AND EVALUATION
5.1
Dosing and Administration of Study Drug(s) and Other 
Medication(s)
5.1.1
Dose/Dose Regimen and Administration Period
Subjects will be randomized to one of two treatment groups in a 1:1 ratio to either 
mirabegron or placebo (PTM). Those subjects randomized to mirabegron will start at 25 mg 
tablet QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet 
(EU/CA). Mirabegron dose will be titrated to mirabegron 50 mg QD at 4 weeks. Mirabegron 
50 mg dose will be maintained for the remaining 8 weeks of the study along with tamsulosin 
hydrochloride capsule 0.4 mg (US) / tablet (EU/CA). Oral mirabegron can be taken with or 
without food, but during the course of the study will be taken the same time each day as the 
concomitant tamsulosin hydrochloride medication.
Those subjects randomized to placebo will start placebo to match (PTM) mirabegron 25 mg 
tablet QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet 
(EU/CA). PTM mirabegron 25 mg will be increased to PTM mirabegron 50 mg and will be
maintained for the remaining 8 weeks of the study along with tamsulosin hydrochloride 
0.4 mg capsule (US) / tablet (EU/CA). Subjects will be instructed to take PTM at the same 
time each day as the concomitant tamsulosin hydrochloride medication.
Subjects will be instructed to take oral tamsulosin hydrochloride 0.4 mg approximately one-
half hour following the same meal each day.
5.1.2
Increase or Reduction in Dose of the Study Drug(s)
The study design employs a dose increase from 25 mg mirabegron to 50 mg mirabegron at 
Week 4 (Visit 3). Once a patient has increased dose, he will remain on that dose for the 
remainder of the study unless for safety reasons that require discontinuation of study drug.
5.1.3
Previous and Concomitant Treatment (Medication and Non-Medication 
Therapy)
5.1.3.1 Previous Medication (Drugs and Therapies)
The Investigator must record the use of previous (all medication taken within 30 days prior to 
Screening [Visit 1]) and current concomitant treatment, both drug and non-drug therapies, 
prescribed and over-the-counter and all alternative medicines, in the eCRFs. This also 
includes drugs used on a chronic and as-needed basis.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 47 of 87
Subjects must be instructed not to start any new medication, both prescribed and over-the-
counter, without consulting the Investigator, unless the new medication is required for 
emergency use. Subjects must be instructed to notify the Investigator immediately if 
medications were required for emergency use.
5.1.3.2 Concomitant Medication (Drugs and Therapies)
Concomitant medications will be captured from Screening/tamsulosin hydrochloride run-in 
(Visit 1) through the Follow-Up Phone Call (Visit 6).
Prohibited Medications (Appendix 1, part A)
Medications prohibited between Screening/tamsulosin hydrochloride run-in (Visit 1) and 
Week 16/Follow-up phone call (Visit 6) include other alpha-adrenergic blockers, 
anticholinergics, antispasmodics, strong and moderate inhibitors of CYP2D6 with narrow 
therapeutic index, specifically thioridazine, flecainide, propafenone, amitriptyline, 
paroxetine, and terbinafine, and moderate and strong inhibitors of CYP3A4 (see Appendix 1,
Part A).  These medications must have been discontinued at least 30 days prior to 
Screening/tamsulosin hydrochloride run-in (Visit 1). Current or previous use of mirabegron 
within 6 months prior to Screening (Visit 1) is also prohibited.
Restricted Medications (Appendix 1, part B)
Medications restricted between Screening/tamsulosin hydrochloride run-in (Visit 1) and 
Week 16/Follow-up Phone Call (Visit 6) include loop diuretics, 5-Alpha reductase inhibitors 
and PDE5 inhibitors (see Appendix 1, Part B). These medications are permitted provided the 
subject has been taking the medication on a long-term basis, i.e. has not stopped, or started, 
or changed dose within the 30 days prior to Screening/tamsulosin hydrochloride run-in 
(Visit 1), no new drug of the same class has been added to the regimen within the 30 days 
prior to Screening/tamsulosin hydrochloride run-in (Visit 1), and the subject remains on the 
medication at the same dose during the course of the study.  For 5-alpha reductase inhibitors
the subject must have been taking the medication for at least 6 months. No alpha-blockers 
other than tamsulosin hydrochloride are allowed. Intermittent use of PDE5 inhibitors 
(e.g. tadalafil) for treating erectile dysfunction (ED) is allowed.  PDE5 inhibitors that are 
taken on a daily basis for the management of LUTS are not allowed. 
Restricted Non-Drug Therapy
Subjects participating in any behavioral modification therapy (i.e., pelvic floor exercises, 
Kegel exercises, biofeedback, timed voiding, etc.) or other nondrug therapy must have started 
the therapy within 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1) and 
must continue the same schedule through Follow-Up Phone Call (Visit 6). Neurostimulation
for OAB is a strict exclusion criterion.
5.1.4
Treatment Compliance
Study subjects should be counseled on the need to meet 100% compliance with study drug.  
Investigator or designee should ensure that study subjects meet this goal throughout the study 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 48 of 87
period.  Compliance will be verified by the accounting of each study drug at each monthly 
visit starting with the Baseline (Visit 2). 
If compliance during the tamsulosin hydrochloride run-in period is less than 80% or greater 
than 120% of study medication the subject is considered non-compliant and will be excluded 
from the study.
If compliance for blinded treatment is less than 80%, the Investigator or designee is to 
counsel the subject and ensure steps are taken to improve compliance. Subjects who are less 
than 80% compliant with the dosage regimen for any two consecutive visit periods during the 
study should be withdrawn from the study.
5.2
Demographics and Baseline Characteristics
5.2.1
Demographics
The subject’s date of birth (or age, if local regulations do not allow recording of subject’s 
date of birth), gender, race, ethnicity, height, and weight will be recorded at 
Screening/tamsulosin hydrochloride run-in (Visit 1).
5.2.2
Medical History
Medical history (other than for overactive bladder), including smoking history will be 
obtained at Screening/tamsulosin hydrochloride run-in (Visit 1) from each subject. All 
relevant past and present conditions, as well as prior surgical procedures will be recorded for 
the main body systems.
5.2.3
Diagnosis of the Target Disease, Severity, and Duration of Disease
A detailed history of OAB and lower urinary tract symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH) for each subject will be obtained at Screening/tamsulosin hydrochloride 
run-in (Visit 1). This includes date of onset of OAB symptoms, OAB symptoms at time of 
diagnosis and at Screening, OAB non-drug therapy and medication history for OAB and 
reason for treatment termination. In addition information regarding the history of BPH and 
LUTS will be collected.
5.3
Efficacy Assessment
5.3.1
Patient Diary – Micturition and Incontinence
During the study, subjects will be requested to complete a “3-day diary” which will be 
implemented on an electronic handheld device. This diary will collect data on micturition and 
incontinence, sleep interruption, protective garments, vital sign measurements and the Patient 
Perception of Intensity of Urgency Scale (PPIUS) prior to Visits 2, 3, 4, and 5. The 
information from the diaries will be used to evaluate the efficacy of treatment. Therefore, 
subjects will receive full instructions and training on how to complete the diary at 
Screening/tamsulosin hydrochloride run-in (Visit 1) and will be counseled on the importance 
of completing the diaries prior to the next visit. The diaries and questionnaires will be 
reviewed during each visit after Screening/tamsulosin hydrochloride run-in (Visit 1) by the 
Investigator or designee to ensure accuracy of completion.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 49 of 87
A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in 
period. The purpose of this training diary is to familiarize the subject with using the 
electronic handheld device and for the Investigator to assess the ability and willingness of the 
subject to complete the diary. During these 2 weeks the Investigator will remotely evaluate 
diary completion and will provide additional instructions if necessary. During this evaluation 
period at least one telephone contact will take place with the subject. The diary that is 
completed during the last 3 days before randomization will be used to establish Baseline data. 
Therefore, it is very important to ensure that any compliance or completion issues are 
discussed during the 2-week training diary.
Diaries will be completed at home for 3 consecutive days prior to each visit: Baseline 
(Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5).  Site 
staff will contact the subject approximately 7 days prior to the scheduled visit to remind the 
subject they need to complete the electronic diary, review completion instructions and review 
changes to concomitant medications and adverse events (if applicable).
A diary day starts at midnight and ends at midnight the following day. Time to bed with 
intention to sleep, time to wake with intention of staying awake, type of episode 
(urination/incontinence), time of episode, urgency severity (see Section 5.3.2), measure of 
urine volume voided, and sleep interruption will be recorded by the subject in the micturition 
diary.
At Baseline (Visit 2), diary data, including frequency of micturition (urination episodes) and 
urgency episodes (grade 3 and 4) with or without incontinence will be reviewed to confirm 
inclusion criteria.
Voiding episodes will be recorded in one of three ways: “urination”, “incontinence”, or “both”
in the electronic diary. Micturitions will be counted for “urination” episodes in which the 
subject fully voids in the toilet.  “Incontinence” will be counted for episodes in which the full 
void was incontinent and the subject did not make it to the toilet to finish urinating. If a 
subject experienced incontinence and then passed urine into the toilet this should be recorded 
as “both”. During analysis, “both” will be counted towards micturition and incontinence. In 
addition to micturition information, the electronic diary will also collect time of medication 
intake and vital signs along with sleep interruption and protective garment use (see Table 1, 
Schedule of Assessments).
5.3.2
Patient Perception of Intensity of Urgency Scale (PPIUS)
The Patient Perception of Intensity of Urgency Scale (PPIUS) will be completed as part of 
the micturition diary.
For each micturition and/or incontinence episode, subjects will be asked to rate the degree of 
associated urgency according to the following validated 5-point scale. The categories are 
recommended by the Committee for Proprietary Medicinal Products [CPMP/EWP/18/01, 
Final].


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 50 of 87
0 – No, urgency, I felt no need to empty my bladder, but did so for other reasons.
1 – Mild urgency, I could postpone voiding as long as necessary, without fear of wetting 
myself.
2 – Moderate urgency, I could postpone voiding for a short while, without fear of wetting 
myself.
3 – Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to 
wet myself.
4 – Urge incontinence, I leaked before arriving at the toilet.
The PPIUS will be completed at Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and 
Week 12/End of Treatment (Visit 5).
5.3.3
Total Urgency and Frequency Score (TUFS)
The Total Urgency and Frequency Score (TUFS) is calculated by adding the PPIUS scores of 
every void in a patient’s 3-day diary, and dividing this by the number of days recorded in the 
diary [Chapple et al, 2014]. 
5.3.4
International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) consists of seven questions concerning 
urinary symptoms and one question concerning quality of life.
The IPSS will be completed at Screening (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5).
5.3.5
OAB Symptoms, Quality of Life, Bladder Health and Treatment Benefit
OAB has significant effects on health-related quality of life (QoL) of afflicted subjects. This 
has been quantified in various empirical studies [Wall et al, 1993]. QoL is determined by 
socio-demographic, clinical, psychological and social factors. This underlies the importance 
of assessing the perceptions of subjects when evaluating the effects of medical or 
pharmacological treatment [Palmtag 2004]. In this study, the Overactive Bladder-
questionnaire (OAB-q), EQ-5D-5L, the Patient Perception of Bladder Condition (PPBC), and 
Treatment Satisfaction – Visual Analog Scale (TS-VAS) will be utilized.
5.3.5.1 Overactive Bladder-questionnaire (OAB-q)
OAB symptoms and QoL in relation to OAB will be assessed by the Overactive Bladder-
questionnaire (OAB-q) [Coyne et al, 2002]. This questionnaire has validated psychometric 
properties, has been used extensively in QoL-research in respondents with OAB, and has 
been shown to be responsive in treatment studies [Coyne et al, 2002]. The OAB-q is a self-
reported questionnaire with 33 items, which contain the dimensions Coping, Concern, Sleep, 
Social Interaction, and a Symptom Bother scale with eight symptoms [Garely et al, 2007].
The OAB-q will be assessed at Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and 
End of Treatment (Visit 5).


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 51 of 87
5.3.5.2 Patient Perception of Bladder Condition (PPBC)
The Patient Perception of Bladder Condition (PPBC) is a validated, global assessment tool 
using a 6-point Likert scale that asks subjects to rate their subjective impression of their 
current bladder condition [Coyne et al, 2006]. The PPBC questionnaire will be assessed at 
Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End of Treatment (Visit 5).
5.3.5.3 EQ-5D-5L
The EQ-5D-5L is an international standardized non-disease specific (i.e., generic) instrument 
for describing and valuing health status. It has a multidimensional measure of health-related 
QoL, capable of being expressed as a single index value and specifically designed to 
complement other health status measures [Euroqol, 1990; Herdman et al, 2011].
The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, 
and Anxiety/Depression. Each dimension has 5 response levels (e.g., no problems, slight 
problems, moderate problems, severe problems, and extreme problems/unable to perform the 
activity). In addition, it has a visual analog scale that elicits a self-rating by the respondent of 
his health status.
EQ-5D-5L will be assessed at Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End 
of Treatment (Visit 5).
5.3.5.4 Treatment Satisfaction – Visual Analog Scale (TS-VAS)
The Treatment Satisfaction – Visual Analog Scale (TS-VAS) is a visual analog scale that 
asks subjects to rate their satisfaction with the treatment by placing a vertical mark on a line 
that runs from 0 (No, not at all) to 10 (Yes, completely). The TS-VAS will be assessed at 
Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End of Treatment (Visit 5).
5.4
Safety Assessment
The safety evaluation including vital signs, adverse event recording, clinical laboratory 
assessments and physical examination will be performed according to Table 1, Schedule of 
Assessments.
Requirements related to the evaluation, reporting and analysis of Drug-Induced Liver Injury 
(DILI) information are found in Appendix 2 (Liver Safety Monitoring and Assessment). In 
the event of a confirmed, marked hepatic abnormality as defined in Appendix 2, it is the 
Investigator’s responsibility to ensure contact with the Sponsor/delegated CRO by telephone 
or fax immediately (i.e., within 24 hours of awareness).
5.4.1
Vital Signs
Vital signs, including pulse rate and blood pressure, will be measured in the diary for 3 days 
prior to each visit and at all in-office visits according to Table 1, Schedule of Assessments.
The Investigator responsibility for reporting the Treatment Emergent Adverse Event (TEAE)
of hypertension will be based on office visit measurements and not on diary review.
For office based vital signs the patient should be seated comfortably for at least 5 minutes 
with the back supported, feet on the floor, arm supported in a horizontal position, and the 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 52 of 87
blood pressure cuff at heart level for each blood pressure measurement. The Investigator will 
use the same device and cuff size throughout the study. The same arm should be used 
throughout the study.
An AE of hypertension will be recorded, independent of Investigator assessment of clinical 
significance or relatedness, if one of the following criteria is met on 2 or more consecutive 
visits:
1. If the average systolic blood pressure is >140 mmHg AND/OR the average diastolic 
blood pressure is >90 mmHg at two consecutive visits after Baseline (Visit 2) in subjects 
who were normotensive (average systolic blood pressure <140 mmHg AND average 
diastolic blood pressure <90 mmHg) [WHO-ISH, 2013] at Baseline (Visit 2).
2. If the average systolic blood pressure is increased ≥20 mmHg AND/OR the average 
diastolic blood pressure is increased ≥10 mmHg at two consecutive visits as compared to 
Baseline (Visit 2) in subjects with hypertension at Baseline (Visit 2).
3. If treatment with antihypertensive drugs is INITIATED for treatment of hypertension OR 
if the dose of prior antihypertensive drugs is INCREASED due to an increase in blood 
pressure.
An AE of “increased Blood Pressure” should be considered if the above conditions are not 
met, but a high blood pressure is recorded (see Appendix 4).
An AE of tachycardia should be considered if resting heart rate (pulse rate) is > 100 bpm (see
Appendix 5). The Investigator responsibility for reporting the TEAE will be based on office 
visit measurements and not on diary review. 
5.4.2
Patient Diary – Subject Measurement Vital Signs
During Visit 1, the Investigator should instruct the subject on how to perform and document 
in the electronic diary the self-measurement of BP and PR. The subject will have an 
opportunity to familiarize himself with the self-measurement of BP and PR and recording of 
the data.
The electronic diary will capture HBPM vital signs. It will be completed in both the morning 
and evening for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), Week 12/End of Treatment (Visit 5). 
Validated devices for measuring BP and PR will be provided to subjects along with detailed 
operating instructions. At home, according to the “The ABCD’s of Blood Pressure 
Measurement” [American Heart Association, April 2012], the subject should rest for at least 
5 minutes before taking the measurements. The subject should be quiet and relaxed, sitting in 
a chair with their feet on the floor, legs should not be crossed, and arms should be bare and 
supported at heart level. The cuff should be put on according to the instructions of the 
Investigator. The subject should not move and should remain silent during the reading as 
moving and talking can affect the reading. The subject should measure his BP and PR in 
triplicate during the 3 consecutive days prior to the next visit, on the arm chosen from the 
Screening measurements.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 53 of 87
Measurement should be taken after waking up in the morning and again in the evening. The 
subject should ensure that the morning measurements of vital signs are taken BEFORE 
breakfast and BEFORE study medication intake. The evening BP measurement is not 
specified in relation to either a meal or the time study drug was taken. It is recommended to 
be taken after 4 pm and before going to bed. 
Three readings at each occasion should be taken, each about 2 minutes apart. Date, time, 
systolic and diastolic BP, and PR will be documented in the electronic diary. The subject 
should take care to have a 30 minute rest after exercise or smoking or intake of caffeine or 
alcohol, prior to taking a measurement.
5.4.3
Adverse Events
Adverse Event collection will begin from the time of informed consent and continue through 
the Follow-up Phone Call (Visit 6). See Section 5.5 Adverse Events and Other Safety 
Aspects for information regarding adverse event collection and data handling.
5.4.3.1 Adverse Events of Possible Hepatic Origin 
See Appendix 2 Liver Safety Monitoring and Assessment for detailed information on liver 
abnormalities, monitoring and assessment, if the AE for a subject enrolled in the study and 
receiving study drug is accompanied by increases in liver function testing (LFT, e.g.: AST, 
ALT, bilirubin, etc.) or is suspected to be due to hepatic dysfunction. 
Subjects with AEs of hepatic origin accompanied by Liver Function Test (LFT) 
abnormalities should be carefully monitored.  
5.4.3.2 Adverse Events of Special Interest
Adverse Events of Special Interest include:
●
Blood pressure and pulse rate (defined in Section 5.4.1, analysis in Section 7.5.3)
●
Acute urinary retention (urinary retention requiring catheterization)
●
Benign prostatic obstruction (BPO) requiring surgery.
5.4.4
Laboratory Assessments
Below is a table of the laboratory tests that will be performed during the conduct of the study. 
See Table 1  Schedule of Assessments for study visit collection dates. For this study, a 
central laboratory will be used for all laboratory hematology and biochemistry/PSA 
assessments. Local laboratories will be used for all urinalysis and urine culture and 
sensitivity. 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 54 of 87
Table 3
Laboratory Assessments
Screening/tamsulosin hydrochloride run-in 
(Visit 1)
Baseline (Visit 2)
Week 4 (Visit 3)
Week 8 (Visit 4)
Week 12/End of Treatment (Visit 5)
Hematology
CBC
Hemoglobin
Hematocrit
Screening/tamsulosin hydrochloride run-in 
(Visit 1)
Baseline (Visit 2)
Week 4 (Visit 3)
Week 8 (Visit 4)
Week 12/End of Treatment (Visit 5)
Biochemistry/PSA
Serum PSA (Visit 1 only)
Sodium
Potassium
Calcium
Chloride
Glucose
Creatinine
Alkaline phosphatase
HCO3
BUN
AST
ALT
GGT
Total bilirubin
Total protein
Albumin
INR
Screening/tamsulosin hydrochloride run-in 
(Visit 1)
Baseline (Visit 2)
Week 4 (Visit 3)
Week 8 (Visit 4)
Week 12/End of Treatment (Visit 5)
Urinalysis 
(Microscopic)
Protein
Glucose
pH
Blood
WBC
RBC
Epithelial cells
LCE
Nitrites
Bacteria
Urine Culture*
*Urine culture and sensitivity must be performed for positive leukocyte esterase (LCE), nitrites, or turbidity, or at the 
discretion of the Investigator. Urine culture and sensitivity at the discretion of the Investigator will be performed at a local 
laboratory. It is not required to send isolated trace positive leukocyte esterase samples for culture.
Clinical significance of out-of-range laboratory findings is to be determined and documented 
by the Investigator/sub-Investigator who is a qualified physician.
Before the start of the study, sampling and shipment procedures will be provided in a 
laboratory manual. The Investigator may decide to repeat the tests, should the results be 
outside normal ranges and considered clinically relevant, or if the original sample could not 
be analyzed.
If the blood sample at Visit 1 cannot be analyzed, the test results are considered a lab error or 
the test results are increased related to a temporary condition unrelated to OAB and likely to 
resolve at short notice, it is acceptable to repeat the laboratory tests to check eligibility 
criteria. The subject should be requested to come for an unscheduled visit between Visit 1 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 55 of 87
and Visit 2. If the repeat test results are still exclusionary, the subject should not be 
randomized. Repeat test to check eligibility criteria can only be repeated once before Visit 2.
Any changes in laboratory values are to be evaluated by the Investigator. Clinically relevant 
changes must be recorded as AEs in the eCRF (see Section 5.5.1).
5.4.5
Physical Examination
The subject will have a physical examination performed at Screening/tamsulosin 
hydrochloride run-in (Visit 1) and at Week 12 (Visit 5). This includes examination of main 
body systems. Date of physical examination and any clinically relevant adverse findings not 
documented in the medical history will be recorded as an AE in the eCRF (see Section 5.5.1).
5.4.6
Electrocardiogram (ECG)
A single 12-lead ECG will be recorded at Screening/tamsulosin hydrochloride run-in 
(Visit 1), Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End of Treatment 
(Visit 5). ECG will be taken with the subject in the supine position (subject is allowed to be 
sitting if unable to be supine).
ECGs will be submitted to a central laboratory to allow for central reading (ECG recordings 
will be performed according to ICH guidelines E14 to make them readable and interpretable 
for potential later assessment by an independent cardiologist). Recordings will be made at a 
speed of 25 mm/s and all leads have to include at least four complexes. This is according to 
the standard setting on the machines.
The ECGs should be transmitted from the machine to the central laboratory (following the 
steps indicated in the user manual). In addition, one print copy of the original ECG traces 
should be maintained in the study file. These should be clearly marked with the subject 
identification number (in such a way that they are anonymized), visit date, and visit number, 
and should be kept with the source documents.
The ECG machine will produce automatically calculated interval duration measurements and 
an evaluation on the printed ECG. The manually read analysis reports of the central ECG 
readings will be made available to the Investigators (within 72 hours). The final ECG reports 
sent by the central laboratory must be reviewed by the Investigator and should be used for 
immediate safety assessment and subject care since there might be slight changes from the 
initial analysis produced by the ECG machines.
If the QTcF interval is >450 ms on the printed ECG at Visit 2, an expedited central ECG 
reading (within 24 hours) should be requested. In this case the final ECG report should be 
received/reviewed before the subject is allowed to be randomized.
The ECG report itself should not be captured on the eCRF, but will be captured in the central 
ECG laboratory database. Only the visit, ECG date, automated QTc, overall ECG 
interpretation and relevant comments will be captured in the eCRF.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 56 of 87
If specific concerns regarding the cardiac safety of a subject exist, a dual approach is 
recommended:
●
On-site evaluation of the ECGs should be conducted by a local cardiologist,
●
In addition, the central ECG laboratory can be contacted (24 hours a day) to provide 
the final centrally read ECG analysis results within a shorter timeframe than the usual 
72 hours (for contact details see the ECG Study Manual provided by the central ECG 
laboratory).
Any abnormalities (based on the Central Reading Interpretation) must be evaluated in clinical 
context (based on subject’s medical history and concomitant medication) and the Investigator 
should determine if it is clinically significant and record with Potentially Clinically 
Significant (PCS). Any clinically significant abnormality should be reported as an AE.
5.4.7
Post-Void Residual Volume (PVR)
Post-Void Residual (PVR) volume will be assessed by ultrasonography or bladder scan at 
Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5).
5.4.8
Uroflowmetry
Maximum flow rate (Qmax) will be assessed at Screening/tamsulosin hydrochloride run-in 
(Visit 1) and Week 12/End of Treatment (Visit 5). The subject must void a minimum of 
125 mL for the uroflow measurement to be considered adequate. 
5.4.9
Follow-up Phone Call to Patients
Subjects will be contacted 4 weeks after Week 12/End of Treatment (Visit 5) by telephone 
for a Follow-up Phone Call (Visit 6) to assess concomitant medications and any adverse 
events that may have occurred following the end of treatment.
5.5
Adverse Events and Other Safety Aspects
5.5.1
Definition of Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a subject administered a study drug 
or has undergone study procedures and which does not necessarily have a causal relationship 
with this treatment.  An AE can therefore be any unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not related to the medicinal (investigational) product. 
Some countries may have additional local requirements for events that are required to be 
reported as AEs or in an expedited manner similar to an SAE.  In these cases, it is the 
Investigator’s responsibility to ensure these AEs or other reporting requirements are followed 
and the information is appropriately recorded in the (e)CRF accordingly.  


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 57 of 87
An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, ECG 
data, physical exam) should be defined as an AE only if the abnormality meets one of the 
following criteria:
●
Induces clinical signs or symptoms
●
Requires active intervention
●
Requires interruption or discontinuation of study medication
●
The abnormality or investigational value is clinically significant in the opinion of the 
Investigator.
5.5.2
Definition of Serious Adverse Events (SAEs)
An adverse event is considered “serious” if, in the view of either the Investigator or Sponsor, 
it results in any of the following outcomes:
●
Results in death
●
Is life threatening (an adverse event is considered “life-threatening” if, in the view of 
either the Investigator or Sponsor, its occurrence places the subject at immediate risk of 
death. It does not include an adverse event that, had it occurred in a more severe form, 
might have caused death)
●
Results in persistent or significant disability/incapacity or substantial disruption of the 
ability to conduct normal life functions 
●
Results in congenital anomaly, or birth defect
●
Requires inpatient hospitalization or leads to prolongation of hospitalization 
(hospitalization for treatment/observation/examination caused by AE is to be considered 
as serious) 
●
Other medically important events.
Medical and scientific judgment should be exercised in deciding whether expedited reporting 
is appropriate in other situations, such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize the 
subject or may require intervention to prevent one of the other outcomes listed in the 
definition above. These events, including those that may result in disability/incapacity, 
should also usually be considered serious. Examples of such events are intensive treatment in 
an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions 
that do not result in hospitalization; or development of drug dependency or drug abuse.
Stroke, myocardial infarction, dysrhythmias, and uncontrolled hypertension will also be 
examined.
In addition to AEs special situations (SS) (with or without an associated AE) occurring on the 
medicinal products administered to the subject as part of the study (e.g., study drug, 
comparator, background therapy) that may require expedited reporting and/or safety 
evaluation include, but are not limited to:
●
Overdose of the medicinal product(s)
●
Suspected abuse/misuse of the medicinal product(s)
●
Inadvertent or accidental exposure to the medicinal product(s)


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 58 of 87
●
Medication error involving the medicinal product(s) (with or without subject/patient 
exposure to the Sponsor medicinal product, e.g., name confusion)
All of the events of interest noted above should be recorded on the eCRF. Any SS that also 
meets the criteria for an SAE should be recorded on the AE page of the eCRF and marked 
‘serious’ and the SAE worksheet and submitted to Astellas. 
The Sponsor has a list of events that they classify as “always serious” events.  If an adverse 
event is reported that is considered to be an event per this classification as “always serious”, 
additional information on the event may be requested.  
5.5.3
Criteria for Causal Relationship to the Study Drug
Adverse events that fall under either "Possible" or "Probable" should be defined as "adverse 
events whose relationship to the study drugs could not be ruled out".
Causal relationship to 
the study drug
Criteria for causal relationship
Not Related
A clinical event, including laboratory test abnormality, with a temporal  
relationship to drug administration which makes a causal relationship 
improbable, and/or in  which other drugs, chemicals or underlying disease 
provide plausible explanations.
Possible
A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, but which could also be 
explained by concurrent disease or other drugs or chemicals. Information 
on drug withdrawal may be lacking or unclear.
Probable
A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, unlikely to be attributed to 
concurrent disease or  other drugs or chemicals, and which follows a 
clinically reasonable response on re- administration (rechallenge) or 
withdrawal (dechallenge).
5.5.4
Criteria for Defining the Severity of an Adverse Event
The following standard with 3 grades is to be used to measure the severity of adverse events, 
including abnormal clinical laboratory values.
●
Mild: 
No disruption of normal daily activities
●
Moderate:
Affect normal daily activities
●
Severe: 
Inability to perform daily activities
5.5.5
Reporting of Serious Adverse Events (SAEs)
The reference safety information for mirabegron to be used for this study is the Company 
Core Data Sheet (CCDS) for mirabegron, Section 4.8- Undesirable Effects.
Please refer to the reference safety information for details of prescribing information 
(contraindications, special warnings and precautions).
In the case of a serious adverse event (SAE), the Investigator must contact the Sponsor by 
telephone or fax immediately (within 24 hours of awareness).


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 59 of 87
The Investigator should complete and submit an SAE Worksheet containing all information 
that is required by the Regulatory Authorities to the Sponsor by fax immediately (within 
24 hours of awareness). If the faxing, scanning or emailing of an SAE Worksheet is not 
possible within 24 hours, the local drug safety contact should be informed by phone. Please 
fax the SAE Worksheet to:
Astellas Pharma Global Development, Inc. – United States
Product Safety & Pharmacovigilance
North America telefax numbers: 
International telefax number: 
Email: 
If there are any questions, or if clarification is needed regarding the SAE, please contact the 
Sponsor's Medical Monitor/Expert or his/her designee (see Section II Contact Details of Key 
Sponsor’s Personnel). 
Follow-up information for the event should be sent promptly (within 7 days of the initial 
notification).
Full details of the SAE should be recorded on the medical records and on the eCRF.
The following minimum information is required:
●
ISN/Study number, 
●
Subject number, sex and age,
●
The date of report,
●
A description of the SAE (event, seriousness of the event)
●
Causal relationship to the study drug.
The Sponsor or Sponsor's designee will submit expedited safety reports (i.e., IND Safety 
Reports) to the regulatory agencies (i.e., FDA) as necessary, and will inform the Investigators 
of such regulatory reports. Investigators must submit safety reports as required by their 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) within timelines set 
by regional regulations (i.e., EU, (e)CTD, FDA). Documentation of the submission to and 
receipt by the IRB/IEC of expedited safety reports should be retained by the site.
The Sponsor or Sponsor’s designee will notify all Investigators responsible for ongoing 
clinical studies with the study drug of all SAEs which require submission per local 
requirements to the IRB/IEC/head of the study site.
The heads of the study sites/Investigators should provide written documentation of IRB/IEC   
notification for each report to the Sponsor.
For Suspected Unexpected Serious Adverse Reactions (SUSAR) from a blinded trial, 
unblinded CIOMS-I report will be submitted to the authorities and IRB/IEC where required.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 60 of 87
5.5.6
Follow-up of Adverse Events
All AEs occurring during or after the subject has discontinued the study are to be followed up 
until resolved or judged to be no longer clinically significant, or until they become chronic to 
the extent that they can be fully characterized. 
If during AE follow-up, the adverse event progresses to an "SAE", or if a subject experiences 
a new SAE, the Investigator must immediately report the information to the Sponsor. 
5.5.7
Monitoring of Common Serious Adverse Events
Common serious adverse events are SAEs commonly anticipated to occur in the study 
population independent of drug exposure. SAEs classified as “common” are provided in
Appendix 3 Most Common Serious Adverse Events for reference. The list does NOT 
change your reporting obligations or prevent the need to report an AE meeting the definition 
of an SAE as detailed above. The purpose of this list is to alert you that some events reported 
as SAEs may not require expedited reporting to the regulatory authorities based on the 
classification of “common serious adverse events” as specified in Appendix 3 Common 
Serious Adverse Events. The Sponsor will monitor these events throughout the course of 
the study for any change in frequency. Any changes to this list will be communicated to the 
participating investigational sites. Investigators must report individual occurrences of these 
events as stated in Section 5.5.5 Reporting of Serious Adverse Events. 
5.5.8
Procedure in Case of Pregnancy
If during the conduct of a clinical trial, a male subject impregnates his partner, the subject 
should report the pregnancy to the Investigator. The Investigator will report the pregnancy to 
the Sponsor or delegated CRO as an SAE.
5.5.9
Emergency Procedures and Management of Overdose
In the event of suspected overdose, refer to the approved Package Insert, SPC, or local 
product information supplied by the manufacturer for each agent. 
5.5.10
Supply of New Information Affecting the Conduct of the Study
When new information becomes available necessary for conducting the clinical study 
properly, the Sponsor will inform all Investigators involved in the clinical study as well as the 
regulatory authorities. Investigators should inform the IRB/IEC of such information when 
needed.
5.6
Test Drug Concentration
Not applicable.
5.7
Other Measurements, Assessments or Methods
Not applicable.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 61 of 87
5.8
Total Amount of Blood
Blood samples will be taken for the purposes of hematology, biochemistry and PSA analysis 
at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). It is anticipated the total amount 
of blood taken will not exceed 50 mL throughout the duration of the study.
6
DISCONTINUATION
6.1
Discontinuation of Individual Subject(s)
A discontinuation is a subject who enrolled in the study and for whom study treatment is 
permanently discontinued prematurely for any reason.  
The subject is free to withdraw from the study treatment and/or study for any reason and at 
any time without giving reason for doing so and without penalty or prejudice. The 
Investigator is also free to terminate a subject's involvement in the study at any time if the 
subject's clinical condition warrants it.
If a subject is discontinued from the study with an ongoing adverse event or an unresolved 
laboratory result that is significantly outside of the reference range, the Investigator will 
attempt to provide follow-up until the condition stabilizes or no longer is clinically 
significant. 
Subjects will be discontinued if they meet any of the following criteria:
●
ALT or AST >3x ULN and total bilirubin >2x ULN
●
ALT or AST >8x ULN on one occasion
●
ALT or AST >5x ULN for more than 2 consecutive weeks
●
ALT or AST >3x ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%)
Subjects may also be discontinued for:
●
Medically important adverse event(s)
●
Protocol deviation(s) (e.g., subject took prohibited medication that in the Investigator’s 
opinion, after discussion with the Medical Monitor, may negatively impact the subject’s 
safety or demonstrated lack of cooperation in following protocol-specified 
procedures/instructions)
●
Withdrawal of consent
●
Investigator and/or Sponsor feel it is in the subject’s best interest
6.2
Discontinuation of the Site
If an Investigator intends to discontinue participation in the study, the Investigator must 
immediately inform the Sponsor.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 62 of 87
6.3
Discontinuation of the Study
The Sponsor may terminate this study prematurely, either in its entirety or at any study site, 
for reasonable cause provided that written notice is submitted in advance of the intended 
termination. Advance notice is not required if the study is stopped due to safety concerns. If 
the Sponsor terminates the study for safety reasons, the Sponsor will immediately notify the 
Investigator and subsequently provide written instructions for study termination.
7
STATISTICAL METHODOLOGY
The statistical analysis will be coordinated by the responsible biostatistician of Astellas. A 
Statistical Analysis Plan (SAP) will be written to provide details of the analysis, along with 
specifications for tables, listings and figures to be produced. The SAP will be finalized before 
database softlock at the latest. Any deviations from the analysis planned in SAP will be 
justified in the Clinical Study Report (CSR).
Prior to Database Lock, a Final Review of Data and TLFs Meeting will be held to allow a 
review of the clinical trial data and to verify the data that will be used for analysis set 
classification. If required, consequences for the statistical analysis will be discussed and 
documented.  A meeting to determine analysis set classifications may also be held prior to 
database hard lock.
In general, baseline is defined as the last measurement before the first dose of double-blind 
study drug. For variables based on the electronic diary, the 3 days of the diary recorded prior 
to Visit 2/Baseline (Week 0) will be used to derive these variables at baseline just as the 
3 diary days before each post-baseline visit will be used to derive these variables at these 
visits.
The End of Treatment (EOT) visit is defined as the last post-baseline visit during the double-
blind study period for which data is available. The EOT visit value for diary variables is the
average or number of the diary measurements for Week 12, as applicable. If no Week 12 
diary data measurements are available, then the last available earlier post-baseline average or 
number of the diary measurements within a designated visit window will be used (LOCF). 
Data from the EOT visit will be analyzed to account for subjects prematurely terminating the 
study and is regarded as the primary visit. The EOT visit will be Week 12/EOT (Visit 5) for 
subjects who complete the study.
All statistical comparisons will be made using a two-sided test at α = 0.05 significance level 
and confidence intervals (CIs) will be reported with a coverage consistent with this 
significance level unless specified otherwise. 
All efficacy and safety variables will be summarized using descriptive statistics. Continuous 
variables will be summarized using the descriptive statistics number of non-missing 
observations (N), mean, standard deviation (SD) or standard error (SE), minimum, median, 
and maximum unless specified otherwise. Categorical variables will be described using N 
and percent.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 63 of 87
7.1
Sample Size
The primary endpoint for this study is change from baseline to end of treatment in mean 
number of micturitions per day based on a 3-day diary.
Based on subgroup analysis of prior OAB studies, 544 subjects (272 evaluable subjects per 
treatment group) provides 80% power to detect a reduction of 0.65 in the mean number of 
micturitions per day over placebo in the mirabegron group at an alpha level of 0.05.  A 
standard deviation for change from baseline in micturitions of 2.7 was assumed. 
If 85% of the randomized subjects are evaluable, 640 subjects should be randomized.  With 
an expected drop-out rate of 35% by the end of the tamsulosin hydrochloride run-in phase
(V2), 985 subjects need to be screened.
7.2
Analysis Set
Three main analysis populations will be defined: Full Analysis Set (FAS), Full Analysis Set -
Incontinence (FAS-I), and Safety Analysis Set (SAF).
Detailed criteria for analysis sets will be laid out in Classification Specifications and the 
allocation of subjects to analysis sets will be determined prior to database hard-lock. 
7.2.1
Full Analysis Set
The FAS will include all subjects who meet all of the following criteria:
●
Subjects who took at least 1 dose of double-blinded study drug after Randomization,
●
Reported at least 1 micturition in the baseline diary and at least 1 micturition 
post-baseline,
The FAS will be used for the summary of all baseline characteristics, including demographic, 
disease state data, prior medications, prior medical history and a statistical analysis of 
efficacy endpoints and QoL instruments.
7.2.2
Full Analysis Set - Incontinence (FAS-I)
The FAS-I will include all subjects who meet all of the following criteria:
●
Subjects who took at least 1 dose of double-blinded study drug after Randomization,
●
Reported at least 1 micturition in the baseline diary and at least 1 micturition post-
baseline,
●
Reported at least 1 incontinence episode in the baseline diary.
The FAS-I will be used for the analysis of incontinence episodes.
7.2.3
Safety Analysis Set (SAF)
The SAF will consist of all randomized subjects who received at least one dose of 
double-blind study medication. The SAF will be used for summarizing demographic and 
baseline OAB characteristics and safety data. 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 64 of 87
7.3
Demographics and Other Baseline Characteristics
Demographic and OAB baseline characteristics will be summarized using descriptive 
statistics by treatment group, mirabegron and placebo.
7.4
Analysis of Efficacy 
Efficacy analysis will be conducted on the FAS and PPS. Incontinence episodes will be 
analyzed with the FAS-I. The interpretation of results from statistical tests will be based on 
the FAS.
7.4.1
Analysis of Primary Endpoint
7.4.1.1 Primary Analysis
The primary efficacy variable is change from baseline to end of treatment in mean number of 
micturitions per day based on a 3-day electronic diary. The primary analysis will be 
performed for the FAS at the EOT visit, i.e. Week 12 for subjects who complete the study or 
last post-baseline visit during the double-blind study period for subjects who discontinue 
early.
The hypothesis for comparison is as follows:
H0: Difference between mirabegron and placebo in change from baseline to end of treatment 
in mean number of micturitions per day based on a 3-day electronic diary is 0.
H1: Difference between mirabegron and placebo in change from baseline to end of treatment 
in mean number of micturitions per day based on a 3-day electronic diary is not equal to 0.
Change from baseline to end of treatment in mean number of micturitions per day will be 
analyzed using Analysis of Covariance (ANCOVA). The response variable will be the mean 
change in number of micturition episodes per day from baseline to end of the study with 
treatment group, geographic region, and age group as fixed factors and baseline as a covariate. 
Within the framework of this ANCOVA model, LS means and two-sided 95% CIs for the 
mean change from baseline within each treatment group will be provided. Differences in LS 
means between mirabegron and placebo will be derived together with 95% CIs and p-values. 
Further details may be found in the SAP.
7.4.1.2 Secondary Analysis
The primary analysis will be repeated for completers only, i.e. without utilizing LOCF 
imputation for subjects with missing Week 12 values. Additionally, Week 4 and Week 8 
values will be analyzed similarly to End of Treatment.
An analysis of change from baseline in mean number of micturitions per day using a Mixed 
Model Repeated Measures (MMRM) with age group, geographic region, time (visit), and a 
time-by-treatment interaction as factors and the number of micturition episodes at baseline as 
covariate will serve as another sensitivity analysis. The repeated measures model will present 
LS means and two-sided 95% CIs for changes from baseline within each treatment group. 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 65 of 87
7.4.1.3 Subgroup Analysis
Subgroup analyses will include analyses by geographic region, age group, by previous OAB 
medication, and reason for treatment termination if previously treated.  If sample sizes are 
sufficient, subgroup analyses by race will be performed.  More details on subgroup analyses 
will be provided in the SAP.
7.4.2
Analysis of Secondary Endpoints 
Secondary variables are change to end of treatment in mean incontinence episodes per day, 
mean volume voided per micturition, mean number of urgency episodes (grade 3 and 4) per 
day, IPSS total score and subscales (Voiding, Storage, and Quality of Life), Symptom Bother 
and Total Health related quality of life scores as assessed by OAB-q questionnaire (and 
subscales), TUFS, PPBC, EQ-5D-5L, and TS-VAS.
An analysis of change from baseline in PRO values using a Mixed Model Repeated Measures 
(MMRM) with geographic region, age group, time (visit), and a time-by-treatment interaction 
as factors and PRO value at baseline as a covariate will serve as a sensitivity analysis. The 
repeated measures model will present LS means and two-sided 95% CIs for changes from 
baseline within each treatment group.
Analysis of mean change in number of incontinence episodes per day from Baseline to End 
of Treatment will be performed on the FAS-I using ANCOVA model, p-values will be 
calculated by stratified ranking ANCOVA. The response variable is standardized ranks on 
change from Baseline to End of Treatment, with Baseline standardized ranks as covariates 
and geographic region as a stratum. Standardized ranks are used to adjust for differences in 
the number of subjects at each geographic region. Further details may be found in the 
Statistical Analysis Plan.
The number of incontinence episodes and protective garment use during the 3-day diary 
period will be analyzed using a mixed effects Poisson regression model with treatment group, 
age group, and geographic region as factors and number of incontinence episodes at baseline 
as a covariate. Differences in LS means between mirabegron and placebo will be calculated 
together with 95% CI.
Other secondary efficacy variables will be analyzed using the same ANCOVA model as 
described for micturitions (refer to Section 7.4.1.1). Descriptive analyses of the EQ-5D-5L 
will be in the Clinical Study Report.  Other planned utility indices and analyses will be 
calculated in a separate report from the Statistical Analysis Plan and Clinical Study Report.
Responder analyses will be performed for 50% reduction in micturition frequency and for 
number of subjects with less than 8 micturitions per day at End of Treatment.
7.4.3
Analysis of Exploratory Endpoints
Subgroup analyses by PSA cutoff scores for < 2, 2-4 will be performed. 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 66 of 87
7.5
Analysis of Safety
7.5.1
Adverse Events
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA).  The number and percentage of treatment-emergent AEs, SAEs, AEs leading to 
discontinuation, and AEs related to study drug will be summarized by system organ class, 
preferred term and treatment group. The number and percentage of TEAEs by severity and 
relationship to study drug will also be summarized. All AEs will be listed.
7.5.2
Laboratory Assessments
Laboratory variables (biochemistry, hematology, and urinalysis) will be descriptively 
summarized for Baseline (Visit 2), Week 4, Week 8, and Week 12/EOT and change from 
Screening to EOT will be summarized by treatment group.
For each hematology and biochemistry laboratory parameter, laboratory test results will be 
classified as low (L), normal (N), or high (H) according to the laboratory-supplied reference 
ranges. Shift tables of reference range changes from Screening to Week 12/EOT and most 
extreme value during the double-blind treatment period by treatment group will be 
summarized.
7.5.3
Vital Signs
Pulse rate, systolic blood pressure, and diastolic blood pressure will be summarized by 
treatment group using descriptive statistics (mean, standard deviation, minimum, maximum 
and median) for baseline value, post-baseline time point values (Week 4, Week 8, and 
Week 12/EOT), and change from baseline to each post-baseline time points. The average 
change from baseline to end of treatment for each vital sign variable will be analyzed using 
the ANCOVA model with treatment group and geographic region as fixed factors and 
baseline vital sign value as covariate.  Results will be summarized separately for office based 
measurements and HBPM. No p-values will be calculated.
An analysis of change from baseline of vital signs using a Mixed Model Repeated Measures 
(MMRM) model with geographic region, age group, time (visit), and a time-by-treatment 
interaction as factors and the baseline values as covariate will serve as another sensitivity 
analysis. The repeated measures model will present LS means and two-sided 95% CIs for 
changes from baseline within each treatment group. 
Number and percentage of subjects with more than 2/5/10/15/20 mmHg increase from 
baseline in SBP, more than 2/5/10/15 mmHg increase in DBP or more than 5/10/15 bpm 
increase from baseline in pulse rate, on 2 consecutive post-baseline visits will be summarized 
by treatment group. Number and percentage of subjects with vital sign values shifting 
between JNC-7 defined risk categories will be summarized by treatment group. These 
categories are listed below:


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 67 of 87
Category
Systolic BP (mm Hg)
Diastolic BP (mm Hg)
Normal 
< 120
<80
Prehypertension
120-139
80-89
Hypertension Stage 1
140-159
90-99
Hypertension Stage 2
>=160
>=100
Number and percentage of subjects with a PR > 100 bpm at any office visit or by HBPM will 
be summarized by treatment group separately.
7.5.4
Physical Examination
Physical examination will be listed by treatment group.
7.5.5
ECGs
ECG variables (heart rate, PR interval, RR interval, QRS interval, QT interval, and QTc 
interval) will be summarized using frequency tables and percentages for each treatment group 
at Baseline, Week 4, Week 8, and Week 12/EOT, including changes from Baseline to EOT.
The overall ECG interpretation from the local Investigator (normal, abnormal – not clinically 
significant, abnormal – clinically significant) will be summarized by treatment group and 
visit. Also a shift table will be produced for showing the shift from baseline by treatment 
group and visit. Parameters from central ECG readings (QT, QTcB, QTcF, HR, PR, QRS, 
RR, coded abnormalities and overall conclusion) and their change from baseline will be 
summarized using descriptive statistics by treatment group and visit. Numbers and 
percentages of subjects with QTcF values >450 ms, >480 ms or >500 ms or with changes 
from baseline in QTcF ≥30 msec or ≥60 msec will be summarized by treatment group.
7.5.6
PVR
PVR volume and its change from baseline will be summarized by treatment and visit. Shifts 
in PVR from baseline to each visit and from baseline to worst post-baseline value will be 
produced.  Number and percentages of subjects with a PVR > 200 ml will be tabulated.  
7.5.7
Qmax
Qmax will be analyzed from change from baseline (collected at the beginning of the run-in 
period) and summarized by treatment and visit.  Numbers and percentages of subjects with 
Qmax < 5.0 mL/s will be tabulated.
7.6
Analysis of Pharmacokinetics
Not applicable.
7.7
Analysis of Pharmacodynamics
Not applicable.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 68 of 87
7.8
Protocol Deviations and Other Analyses
Protocol deviations as defined in Section 8.1.6 Protocol Deviations will be summarized for 
all randomized subjects by treatment group and total as well as by site. A data listing will be 
provided by site and subject.
The protocol deviation criteria will be uniquely identified in the summary table and listing. 
The unique identifiers will be as follows:
PD1 - Entered into the study even though they did not satisfy entry criteria, 
PD2 - Developed withdrawal criteria during the study and was not withdrawn,
PD3 - Received wrong treatment or incorrect dose,
PD4 - Received excluded concomitant treatment. 
Any other analyses will be specified in the Statistical Analysis Plan (SAP).
7.9
Interim Analysis (and Early Discontinuation of the Clinical Study)
No formal interim analysis is planned.
7.10
Handling of Missing Data, Outliers, Visit Windows, and Other 
Information
For efficacy variables and vital sign data, analysis at End of Treatment will take into account 
subjects who withdraw before Week 12 and therefore do not have efficacy measurements 
available for that visit. The End of Treatment analysis is a Last Observation Carried Forward 
(LOCF) approach. As a secondary analysis, a mixed model repeated measures analysis will 
be performed for selected variables as described in Sections 7.4.1 and 7.4.2
Other imputation rules to account for missing data will be described in the SAP.
Subjects do not always adhere strictly to the visit timing the protocol. Visit windows around 
the target days for each visit will be defined in the SAP.
8
OPERATIONAL AND ADMINISTRATIVE CONSIDERATIONS
8.1
Procedure for Clinical Study Quality Control
8.1.1
Data Collection
The Investigator or site designee is responsible to ensure that all data in the eCRFs and 
queries are accurate and complete and that all entries are verifiable with source documents. 
These documents should be appropriately maintained by the site.
The Investigator or designee will enter data collected using an Electronic Data Capture 
(EDC) system.
Laboratory tests are performed and sent to a Central Lab for testing. The Central Lab will 
compile the results and send to data file to Astellas or designee for inclusion in the clinical 
database.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 69 of 87
The monitor should verify the data in the eCRFs with source documents and confirm that 
there are no inconsistencies between them.
For screening failures, the minimum demographic data (sex, birth date or age, race and 
informed consent date) and reason for screening failure will be collected in the screen failure 
log (SFL), if applicable. This information can be entered into the study database.
Subject diaries will be completed by the subjects on an electronic device. The information 
completed by the subjects on the electronic device will be automatically uploaded into a 
central website. The Investigator or site designee should review the diary data on the website 
for correct completion while the subject is at the site. The diary data will be transferred 
electronically to Sponsor or designee at predefined intervals during the study. The vendor 
will provide Sponsor or designee with a complete and clean copy of the data.
8.1.2
Specification of Source Documents
Source data must be available at the site to document the existence of the study subjects and 
to substantiate the integrity of study data collected. Source data must include the original 
documents relating to the study, as well as the medical treatment and medical history of the 
subject.
The following information should be included in the source medical records:
●
Demographic data (age, sex, race, ethnicity, height and body weight)
●
Inclusion and exclusion criteria details
●
Participation in study and original signed and dated informed consent forms 
●
Visit dates
●
Medical history and physical examination details
●
Key efficacy and safety data, if applicable (as specified in the protocol)
●
Adverse events and concomitant medication 
●
Results of relevant examinations (e.g., ECG charts, X-ray films etc.)
●
Laboratory printouts (if applicable)
●
Dispensing and return of study drug details
●
Reason for premature discontinuation (if applicable)
●
Randomization number (if applicable)
8.1.3
Clinical Study Monitoring
The Sponsor or delegated CRO is responsible for monitoring the clinical study to ensure that 
subject's human rights, safety, and well-being are protected, that the study is properly 
conducted in adherence to the current protocol and GCP, and study data reported by the 
Investigator/sub-Investigator are accurate and complete and that they are verifiable with 
study-related records such as source documents. The Sponsor is responsible for assigning 
study monitor(s) to this study for proper monitoring. They will monitor the study in 
accordance with planned monitoring procedures.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 70 of 87
8.1.4
Direct Access to Source Data/Documents
The Investigator and the study site must accept monitoring and auditing by the Sponsor or 
delegated CRO as well as inspections from the IRB/IEC and relevant regulatory authorities. 
In these instances, they must provide all study-related records, such as source documents 
(refer to Section 8.1.2 "Specification of Source Documents") when they are requested by the 
Sponsor monitors and auditors, the IRB/IEC, or regulatory authorities. The confidentiality of 
the subject's identities shall be well protected consistent with local and national regulations 
when the source documents are subject to direct access.
8.1.5
Data Management
Data Management will be coordinated by the CRO appointed by the Sponsor in accordance 
with the CRO’s standard operating procedures (SOPs) for data management. All study 
specific processes and definitions will be documented by Data Management. Coding of 
medical terms and medications will be performed using MedDRA and World Health 
Organization (WHO) Drug Dictionary respectively. Data analysis will be performed 
according to Astellas data standards.
8.1.6
Protocol Deviations
A protocol deviation is generally an unplanned excursion from the protocol that is not 
implemented or intended as a systematic change. The Investigator is responsible for ensuring 
the study is conducted in accordance with the procedures and evaluations described in this 
protocol and must protect the rights, safety, and welfare of subjects. The Investigator should 
not implement any deviation from, or changes of, the protocol, unless it is necessary to 
eliminate an immediate hazard to trial subjects.  
A protocol waiver is a documented prospective approval of a request from an Investigator to 
deviate from the protocol. Protocol waivers are strictly prohibited.
For the purposes of this protocol, deviations requiring notification to Sponsor are defined as 
any subject who: 
●
Entered into the study even though they did not satisfy entry criteria
●
Developed withdrawal criteria during the study and not withdrawn
●
Received wrong treatment or incorrect dose
●
Received excluded concomitant treatment. 
When a deviation from the protocol is identified for an individual subject, the Investigator or 
designee must ensure the Sponsor is notified. The Sponsor will follow-up with the 
Investigator, as applicable, to assess the deviation and the possible impact to the safety and / 
or efficacy of the subject to determine subject continuation in the study. 
If a deviation impacts the safety of a subject, the Investigator must contact the Sponsor 
immediately.
The Investigator will also assure that deviations meeting IRB/IEC and applicable regulatory 
authorities’ criteria are documented and communicated appropriately. All documentation and 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 71 of 87
communications to the IRB/IEC and applicable regulatory authorities will be provided to the 
Sponsor and maintained within the Trial Master File (TMF).
NOTE:  Other deviations outside of the categories defined above that are required to be 
reported by the IRB/IEC in accordance with local requirements will be reported, as 
applicable.
8.1.7
End of Trial in All Participating Countries
The end of trial in all participating countries is defined as the Last Subject’s Last Visit.
8.2
Ethics and Protection of Subject Confidentiality
8.2.1
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / 
Competent Authorities (CA)
Good Clinical Practice (GCP) requires that the clinical protocol, any protocol amendments, 
the Investigator’s Brochure (IB), the informed consent and all other forms of subject 
information related to the study (e.g., advertisements used to recruit subjects) and any other 
necessary documents be reviewed by an IEC/IRB.  The IEC/IRB will review the ethical, 
scientific and medical appropriateness of the study before it is conducted.  IEC/IRB approval 
of the protocol, informed consent and subject information and/or advertising, as relevant, will 
be obtained prior to the authorization of drug shipment to a study site.
Any substantial amendments to the protocol will require IEC/IRB approval prior to 
implementation of the changes made to the study design at the site.  The Investigator will be 
required to submit, maintain and archive study essential documents according to ICH GCP.
Any serious adverse events that meet reporting criteria, as dictated by local regulations, will 
be reported to both responsible Ethics Committees and Regulatory Agencies, as required. 
During the conduct of the study, the Investigator should promptly provide written reports 
(e.g., ICH Expedited Reports, and any additional reports required by local regulations) to the 
IEC/IRB of any changes that affect the conduct of the study and/or increase the risk to 
subjects. Written documentation of the submission to the IEC/IRB should also be provided to 
Sponsor.
If required by local regulations, the Investigator shall make accurate and adequate written 
progress reports to the IEC/IRB at appropriate intervals, not exceeding one year. The 
Investigator shall make an accurate and adequate final report to the IRB/IEC within 90 days 
after the close-out visit for APGD-Sponsored studies, or for APEB/APEL-Sponsored studies 
within one year after last subject out (LSO) or termination of the study.
8.2.2
Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, ICH guidelines, applicable 
regulations and guidelines governing clinical study conduct and the ethical principles that 
have their origin in the Declaration of Helsinki. 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 72 of 87
8.2.3
Informed Consent of Subjects
8.2.3.1 Subject Information and Consent
The Investigator or his/her representative will explain the nature of the study to the subject or 
his guardian or legal representative, and answer all questions regarding this study.  Prior to 
any study related screening procedures being performed on the subject, the informed consent 
statement will be reviewed and signed and dated by the subject or his guardian or legal 
representative, the person who administered the informed consent and any other signatories 
according to local requirements. A copy of the signed informed consent form will be given to 
the subject and the original will be placed in the subject’s medical record. An entry must also 
be made in the subject’s dated source documents to confirm that informed consent was 
obtained prior to any study-related procedures and that the subject received a signed copy.
The signed consent forms will be retained by the Investigator and made available (for review 
only) to the study monitor and auditor regulatory authorities and other applicable individuals 
upon request.
8.2.3.2 Supply of New and Important Information Influencing the Subject’s Consent 
and Revision of the Written Information
1.
The Investigator or his/her representative will immediately inform the subject orally 
whenever new information becomes available that may be relevant to the subject’s 
consent or may influence the subject’s willingness to continue to participate in the study 
(e.g., report of serious drug adverse drug reaction). The communication must be 
documented in the subject’s medical records and must document whether the subject is 
willing to remain in the study or not.
2.
The Investigator must update their ICF and submit it for approval to the IRB/IEC. The 
Investigator or his/her representative must obtain written informed consent from the 
subject on all updated ICFs throughout their participation in the study. The Investigator 
or his/her designee must re-consent subjects with the updated ICF even if relevant 
information was provided orally. The Investigator or his/her representative who obtained 
the written informed consent and the subject should sign and date the informed consent 
form. A copy of the signed informed consent form will be given to the subject and the 
original will be placed in the subject’s medical record. An entry must be made in the 
subject’s records documenting the re-consent process.
8.2.4
Subject Confidentiality
The Sponsor affirms the subject's right to protection against invasion of privacy. Only a 
subject identification number and/or initials will identify subject data retrieved by the 
Sponsor. However, the Sponsor requires the Investigator to permit the Sponsor, Sponsor's 
representative(s), the IRB/IEC and when necessary, representatives of the regulatory health 
authorities to review and/or to copy any medical records relevant to the study.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 73 of 87
The Sponsor will ensure that the use and disclosure of protected health information (PHI) 
obtained during a research study complies with the federal and/or regional legislation related 
to the privacy and protection of personal information (i.e., HIPAA). 
8.3
Administrative Matters
8.3.1
Arrangement for Use of Information and Publication of the Clinical Study
Information concerning the study drug, patent applications, processes, unpublished scientific 
data, the Investigator's Brochure (IB) and other pertinent information is confidential and 
remains the property of the Sponsor. Details should be disclosed only to the persons involved 
in the approval or conduct of the study. The Investigator may use this information for the 
purpose of the study only. It is understood by the Investigator that the Sponsor will use the 
information obtained during the clinical study in connection with the development of the drug 
and therefore may disclose it as required to other clinical Investigators or to regulatory 
agencies. In order to allow for the use of the information derived from this clinical study, the 
Investigator understands that he/she has an obligation to provide the Sponsor with all data 
obtained during the study.
Publication of the study results is discussed in the Clinical Study Agreement.
8.3.2
Documents and Records Related to the Clinical Study
The Investigator will archive all study data (e.g., Subject Identification Code List, source 
data, and Investigator's File) and relevant correspondence. These documents are to be kept on 
file for the appropriate term determined by local regulation (for US sites, two years after 
approval of the NDA or discontinuation of the IND). It is recommended, however, that 
records be retained for at least five years in the event follow-up is necessary to help 
determine any potential hazards to subjects who took part in the study. The Sponsor will 
notify the site/Investigator if the NDA is approved or if the IND is discontinued. The 
Investigator agrees to obtain the Sponsor's agreement prior to disposal, moving, or 
transferring of any study-related records. The Sponsor will archive and retain all documents 
pertaining to the study according to local regulations.
Data generated by the methods described in the protocol will be recorded in the subjects' 
medical records and/or study progress notes. All data will be entered into the EDC system for 
each subject.
8.3.3
Protocol Amendment and/or Revision
Any changes to the study that arise after approval of the protocol must be documented as 
protocol amendments: substantial amendments and/or non-substantial amendments. 
Depending on the nature of the amendment, either IRB/IEC/CA approval or notification may 
be required. The changes will become effective only after the approval of the Sponsor, the 
Investigator, the regulatory authority, and the IRB/IEC (if applicable).
Amendments to this protocol must be signed by the Sponsor and the Investigator. Written 
verification of IRB/IEC approval will be obtained before any amendment is implemented 
which affects subject safety or the evaluation of safety, and/or efficacy. Modifications to the 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 74 of 87
protocol that are administrative in nature do not require IRB/IEC approval, but will be 
submitted to the IRB/IEC for their information, if required by local regulations.
If there are changes to the Informed Consent, written verification of IRB/IEC approval must 
be forwarded to the Sponsor.  An approved copy of the new Informed Consent must also be 
forwarded to the Sponsor.
8.3.4
Signatory Investigator for Clinical Study Report
ICH E3 guidelines recommend and EU Directive 2001/83/EC requires that a final study 
report be signed by the representative for the Coordinating Investigator(s) or the Principal 
Investigator(s). The representative for the Coordinating Investigator (s) or the Principal 
Investigator(s) will have the responsibility to review the final study results to confirm to the 
best of his/her knowledge it accurately describes the conduct and results of the study. The 
representative for Coordinating Investigator(s) or the Principal Investigator(s) will be 
selected from the participating Investigators by the Sponsor prior to database lock.
9
QUALITY ASSURANCE
The Sponsor is implementing and maintaining quality assurance and quality control systems 
with written SOPs to ensure that trials are conducted and data are generated, documented, 
recorded, and reported in compliance with the protocol, GCP, and applicable regulatory 
requirement(s).
The Sponsor or Sponsor's designee may arrange to audit the clinical study at any or all 
investigational sites and facilities. The audit may include on-site review of regulatory 
documents, case report forms, and source documents. Direct access to these documents will 
be required by the auditors.
10
STUDY ORGANIZATION
10.1
Independent Data-Monitoring Committee (IDMC) | Data and Safety 
Monitoring Board (DSMB) | Monitoring Committee | Other 
Evaluation Committee(s)
Not applicable.
10.2
Other Study Organization
10.2.1
Cardiovascular Adjudication Committee
A cardiovascular adjudication committee is in place to assess all serious adverse events of 
potential cardiovascular nature occurring in the study. The committee will consist of three 
independent members of appropriate expertise who are not directly involved in the clinical 
study and who are blinded to the treatment allocation. Event related information of the cases 
will be sent to the committee for blinded assessment. The assessments will be captured on 
paper CRFs, and entered into a clinical database. A separate charter describes the 
classification of those events to be adjudicated (including but not limited to cardiac 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 75 of 87
arrhythmia and thromboembolic events) and the specification of the event-related documents, 
listing, data flow, method(s) for data collection and data transfer.
10.2.2
Neoplasm Adjudication Committee
A neoplasm adjudication committee is in place to assess all potential neoplasm events 
occurring in the study. The committee will consist of three independent reviewers of 
appropriate expertise who are not directly involved in the clinical study and who are blinded 
to the treatment allocation. Event related information of the cases will be sent to the 
committee for blinded assessment. The assessments will be captured on paper CRFs, and 
entered into a clinical database. A separate charter describes the classification of those events 
to be adjudicated and the specification of the event-related documents, listings, data flow, 
method(s) for data collection and data transfer.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 76 of 87
11
REFERENCES
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardization of 
terminology in lower urinary tract function: report from the standardization sub-committee of 
the International Continence Society. Urology 2003;61:37-49.
American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH), 
Revised, 2010, American Urological Association Education and Research, Inc.
Bechis SK, Otsetov AG, Ge R, Olumi AF. Personalized medicine for management of benign prostatic 
hyperplasia. J Urol. 2014;192(1):16-23.
Chapple C, Drake M, Van Kerrebroeck M, Cardozo L, Drogendijk T, Klaver M, et al. Total urgency 
and frequency score as a measure of urgency and frequency in overactive bladder and storage 
lower urinary tract symptoms. BJUI. 2014;113:696-703.
Chapple C, Herschorn S, Abrams P, Sun F, Brodsky M, Guan Z. Tolterodine treatment improves 
storage symptoms suggestive of overactive bladder in men treated with α-blockers. E. Urol. 
2009;56:534-43.
Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, et al. Psychometric validation of an 
overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. 
Quality of Life Research. 2002;11:563-74.
Coyne K, Matza L, Kopp Z, Abrams P. The validation of the patient perception of bladder condition 
(PPBC): a single-item global measure for patients with overactive bladder. European Urology. 
2006;49:1079-86.
The EuroQol Group. EuroQoL – a new facility for the measurement of health-related quality of life. 
Health Policy. 1990;16(3):199-208.
Garely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: 
symptom bother and health-related quality of life outcomes. Annals of Pharmacotherapy. 
2007;41(3):391-8.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary 
testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 
2011;20(10):1727-36.
Ichihara K, Masumori N, Fukuta F, Tsukamoto T, Iwasawa A, Tanaka Y. A randomized controlled 
study to evaluate the efficacy of tamsulosin monotherapy and its combination with mirabegron 
on patients with overactive bladder induced by benign prostatic obstruction. J Urol. 
2014;193(3):921-6.
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S et al. Population-based survey of 
urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five 
countries: results of the EPIC study. Eur Urol. 2006;50:1306-14.
Irwin DE, Milson I, Kopp Z, Abrams P, Artibani W, Herschon S. Prevalence, severity, and symptom 
bother of lower urinary tract symptoms among men in the EPIC study: impact of overactive 
bladder. Eur Urol. 2009;56:14-20.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 77 of 87
Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower 
urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. 
BJU Int.2011;108:1132-8.
Jaffe WI and Te AE. Overactive bladder in the male patient: epidemiology, etiology, evaluation, and 
treatment. Current Urology Reports. 2005;6:410-8.
Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendm T, Guan Z. Tolterodine and 
tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder. 
JAMA. 2006;296:2319-28.
Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenancin 
add-on therapy to α-blocker treated men with residual urgency and frequency. J Eurol. 
2009;182:2825-30.
Kim SH, Boye M, Bhattacharyya SK, Coyne K, Dhawan R. Medical visit among adults with 
symptoms commonly associated with an overactive bladder. BJU Int. 2006;97:551-4.
Lee SH and Lee JY. Current role of treatment in men with lower urinary tract symptoms combined 
with overactive bladder. Prostate Int. 2014;2(2):43-9.
Miller J and Tarter TH. Combination therapy with dutasteride and tamsulosin for the treatment of 
symptomatic enlarged prostate. Clinical Interventions in Aging. 2009;4:251-8.
Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the 
symptoms of an overactive bladder and how are they managed? A population-based prevalence 
study. BJU Int 2001;87:760-6.
Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A and Martin NE. Urodynamics and safety 
of the β3-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and 
bladder outlet obstruction. J Urol. 2013;190:1320-7.
Palmtag H. The patient’s perspective: redefining end points. Urology. 2004;64(Suppl 6A):17-20.
Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey AR et al. Prevalence and 
burden of overactive bladder in the United States. World J Urol. 2003;20:327-36.
The ABCD’s of Blood Pressure Measurement. American Heart Association, April 2012.
Wall LL, Norton PA, DeLancey JOL. Practical Urogynecology, Baltimore, Williams & Wilkins,1993.
WHO-ISH. World Health Organization/International Summary of Safety (ISS) Final. Data on File, 
2013.
Company Reports:
Adapted from Astellas. Myrbetriq®. Integrated Summary of Safety (ISS) Final. Data on File.
Betmiga® Summary of Product Characteristics, 2015.
Astellas. Data on file. 2012.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 78 of 87
Company Core Data Sheet for mirabegron.
Flomax® CR, Canadian Monograph, 2014.
Flomax® Package Insert – Astellas Global Development, Inc., 2014.
Mirabegron (YM178) Package Insert – Astellas Global Development, Inc., 2015.
Myrbetriq Canadian Product Monograph. March 2015.
Tamsulosin hydrochloride, EU SmPC, 2013.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 79 of 87
12
APPENDICES
12.1
Appendix 1: List of Prohibited and Restricted Concomitant 
Medications
Part A – Prohibited Medications
Use of these medications in any formulation is not permitted between Screening (Visit 1) and
Week 16/Follow-Up Phone Call (Visit 6) and must have been discontinued at least 30 days 
prior to Screening.  Current or previous use of mirabegron within 6 months prior to Screening 
(Visit 1) is also prohibited. This list is not exhaustive.  In case of doubt, the Investigator must 
contact the local study monitor.
Alpha1 and Nonselective Adrenergic Blockers
Alfuzosin
Prazosin
Doxazosin
Terazosin
Silodosin
Trazodone
Phenoxybenzamine
Phentolamine
Tolazoline
Typical/atypical antipsychotics
Anticholinergics/Antispasmodics
Atropine
Baclofen
Biperiden
Clomipramine
Cyclobenzaprine
Darifenacin
Dicyclomine/Dicycloverine
Emepronium
Glycopyrronium/Glycopyrrolate
Fesoterodine
Flavoxate
Hyoscine
Hyoscyamine
Ipratropium
Isopropamide
Orphenadrine
Oxybutynin
Oxyphencyclimine
Propantheline
Propiverine
Scopolamine/(Butyl)hyoscine
Tolterodine
Trospium
Otilonium
Tiotropium
Solifenacin
Potent and Moderate CYP3A4 Inhibitors
Indinavir
Nelfinavir
Ritonavir
Clarithromycin
Itraconazole
Ketoconazole
Nefazadone
Saquinavir
Telithromycin
Cimetidine
Clotrimazole
Cyclosporine
Erythromycin
Fluconazole
Itraconazole
Ketoconazole
Macrolide antibiotics
Strong and Moderate Inhibitors of CYP2D6 Substrates and those with Narrow Therapeutic Index 
Aripiprazole (neuroleptic)
Amitriptyline/ Nortriptyline
(TCA)
Donepezil (Acetylcholinesterase 
inhibitor)
Thioridazine (anti-psychotic)
Flecainide (anti-arrhythmic)
Propafenone (anti-arrhythmic)
Imipramine/Desipramine
(TCA)
Tramadol (analgesic)
Venlafaxine/Desvenlaxafine (SNRI)
Paroxetine
Terbinafine


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 80 of 87
Part B - Medications Permitted With Restrictions
Medications restricted between Screening (Visit 1) and Follow-Up Phone Call (Visit 6)
include loop diuretics, PDE5 inhibitors, and 5-Alpha reductase inhibitors.  All medications in 
Part B of Appendix 1Appendix 1: List of Prohibited and Restricted Concomitant Medications
are permitted provided the subject has been taking this medication on a long-term basis, i.e. 
has not stopped, or started or changed dose within 30 days prior to Screening (Visit 1), no 
new drug of the same class has been added to the regimen within the 30 days prior to 
Screening (Visit 1), and the subject remains on the medication at the same dose during the 
course of the study.  
Loop Diuretics
Furosemide
Bumetanide
Piretanide
5-alpha Reductase Inhibitors (minimum 6 months duration)
Dutasteride
Finasteride
PDE5 Inhibitors (only intermittent use for ED is allowed, daily use for BPH/LUTS is prohibited)
Sildenafil
Tadalafil
Vardenafil


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 81 of 87
12.2
Appendix 2: Liver Safety Monitoring and Assessment
If laboratory testing for a subject enrolled in study and receiving study drug reveals an 
increase in serum aminotransferases (AT) to >3X ULN, bilirubin > 2 × ULN, at least all four 
of the usual serum hepatic measures (ALT, AST, ALP, and TBL) must be repeated. Testing 
should be repeated within 48-72 hours of notification of the test results. Alerts will be 
generated by the central lab regarding moderate and severe liver abnormality to inform the 
Investigator, study monitor and study team. Subjects should be asked if they have any 
symptoms suggestive of hepatobiliary dysfunction.
Definition of Liver Abnormalities
Confirmed abnormalities will be characterized as moderate and severe where ULN:
ALT or AST
Total Bilirubin
Moderate
> 3× ULN 
or
> 2× ULN
Severe*
> 3× ULN
and
> 2× ULN
In addition, the subject should be considered to have severe hepatic abnormalities for any of 
the following:
●
ALT or AST > 8× ULN
●
ALT or AST > 5× ULN for more than 2 weeks  
●
ALT or AST > 3× ULN and INR > 1.5 (If INR testing is applicable/evaluated).
●
ALT or AST > 3× ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (> 5%). 
The Investigator may determine that abnormal liver function results, other than as described 
above, may qualify as moderate or severe abnormalities and require additional monitoring 
and follow-up.
Follow-up Procedures
Confirmed moderate and severe abnormalities in hepatic functions should be thoroughly 
characterized by obtaining appropriate expert consultations, detailed pertinent history, 
physical examination and laboratory tests. The site should complete the Liver Abnormality 
Case Report Form (LA-CRF) or an appropriate document. Subjects with confirmed abnormal 
liver function testing should be followed as described below.
Confirmed moderately abnormal LFTs should be repeated 2-3 times weekly then weekly or 
less if abnormalities stabilize or the study drug has been discontinued and the subject is 
asymptomatic.
Severe hepatic liver function abnormalities as defined above, in the absence of another 
etiology, may be considered an important medical event and may be reported as a Serious 
Adverse Event (SAE).  The Sponsor should be contacted and informed of all subjects for 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 82 of 87
whom severe hepatic liver function abnormalities possibly attributable to study drug are 
observed.
To further assess abnormal hepatic laboratory findings, the Investigator is expected to:
●
Obtain a more detailed history of symptoms and prior or concurrent diseases.  Symptoms 
and new onset-diseases should be recorded as ‘adverse events’ on the AE page of the 
(e)CRF. Illnesses and conditions such as hypotensive events, and decompensated cardiac 
disease that may lead to secondary liver abnormalities should be noted. Non-alcoholic 
steatohepatitis (NASH) is seen in obese hyperlipoproteinemic, and/or diabetic patients 
and may be associated with fluctuating aminotransferase levels.   The Investigator should 
ensure that the medical history form captures any illness that pre-dates study enrollment 
that may be relevant in assessing hepatic function. 
●
Obtain a history of concomitant drug use (including non-prescription medication, 
complementary and alternative medications), alcohol use, recreational drug use, and 
special diets.  Medications, including dose, should be entered on the concomitant 
medication page of the (e)CRF.  Information on alcohol, other substance use, and diet 
should be entered on the LA-CRF or an appropriate document.
●
Obtain a history of exposure to environmental chemical agents.
●
Based on the subject’s history,  other testing may be appropriate including: 
o
acute viral hepatitis (A, B, C, D, E or other infectious agents) 
o
ultrasound or other imaging to assess biliary tract disease
o
other laboratory tests including INR, direct bilirubin
●
Consider gastroenterology or hepatology consultations.
●
Submit results for any additional testing and possible etiology on the LA-CRF or an 
appropriate document.
Study Discontinuation
In the absence of an explanation for increased LFT’s, such as viral hepatitis, pre-existing or 
acute liver disease or exposure to other agents associated with liver injury, the subject may be 
discontinued from the study. The Investigator may determine that it is not in the subject’s 
best interest to continue study enrollment. Discontinuation of treatment should be considered 
if:
●
ALT or AST > 8 × ULN
●
ALT or AST > 5 × ULN for more than 2 weeks 
●
ALT or AST > 3 × ULN and TBL > 2 × ULN or INR > 1.5) (If INR testing is 
applicable/evaluated)
●
ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (> 5%). 
Reference
Guidance for Industry titled “Drug-Induced Liver Injury: Premarketing Clinical Evaluation” issued by 
FDA on July 2009.  


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 83 of 87
12.3
Appendix 3: Common Serious Adverse Events
For this protocol, there is no list of common serious adverse events that the Sponsor 
considers to be associated with the disease state being studied for which a single occurrence 
will be excluded from IND safety reporting. All SAEs should be reported. 


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 84 of 87
12.4
Appendix 4: Investigator Criteria for Hypertension
Investigator Criteria for Determining TEAE of Hypertension
During each office visit a systolic and diastolic blood pressure will be measured. The 
Investigator responsibility for reporting the TEAE of hypertension will be based on office 
visit measurements and not on diary review. 
For post-baseline assessments, the Investigator will use the following criteria, as defined in 
the protocol, to determine if a subject is considered hypertensive:
An AE of hypertension will be recorded if one of the following criteria is met on 
2 consecutive visits:
1.
If the average systolic blood pressure is ≥ 140 mmHg AND/OR the average diastolic 
blood pressure is ≥ 90 mmHg at two consecutive visits after Baseline (Visit 2) in subjects 
who were normotensive (average systolic blood pressure < 140 mmHg and average 
diastolic blood pressure < 90 mmHg [WHO-ISH, 2013]) at Baseline (Visit 2).
2.
If the average systolic blood pressure is increased >20 mmHg AND/OR the average 
diastolic blood pressure is increased > 10 mmHg at two consecutive visits as compared 
to Baseline (Visit 2) in subjects with hypertension at Baseline (Visit 2).
3.
If treatment with antihypertensive drugs is initiated for treatment of hypertension or if 
the dose of prior antihypertensive drugs is increased due to an increase in blood pressure.
In addition, the Investigator can record an AE based on clinical assessment.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 85 of 87
12.5
Appendix 5: Investigator Criteria for Tachycardia
Investigator Criteria for Determining TEAE of Tachycardia
During each office visit pulse rate will be measured.  The Investigator responsibility for 
reporting the TEAE of tachycardia will be based on office visit measurements and not on 
diary review.  Tachycardia is defined as a resting heart frequency > 100 beats per minute 
(bpm) measured as pulse rate. If pulse rate is > 100 bpm at the office visit, the Investigator is 
to record an AE of tachycardia. However, if the Investigator’s clinical assessment was that 
this did not constitute an AE of tachycardia, then an AE will as not be recorded.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 86 of 87
13
ATTACHMENT 1: SUBSTANTIAL AMENDMENT 4
I.  The purpose of this amendment is:
Substantial Changes
1.  Updated Reference Safety Information (RSI)
DESCRIPTION OF CHANGE:
Revised RSI from the US Package Insert, Canadian Monograph, and SmPC to the Company 
Core Data Sheet for mirabegron. 
RATIONALE:
Astellas Pharmacovigilance (PV) refers to the Company Core Data Sheet for mirabegron as the 
physical reference for RSI. There is no change in the risk to patients or what safety information is 
reported with this update to the protocol. This update provides consistency of RSI with PV and the 
protocol.
II.  Amendment Summary of Changes:
Substantial Changes:
1. Updated Reference Safety Information (RSI)
Page 58, 5.5.5 Reporting of Serious Adverse Events (SAEs)
WAS:
The reference safety information for mirabegron to be used for this study is the US Package 
Insert for the US, EU SmPC for EU countries and the Canadian Monograph for Canada. The 
reference safety information is equal in each document.
IS AMENDED TO:
The reference safety information for mirabegron to be used for this study is the Company 
Core Data Sheet (CCDS) for mirabegron, Section 4.8 Undesirable effects.US Package 
Insert for the US, EU SmPC for EU countries and the Canadian Monograph for Canada. The 
reference safety information is equal in each document.
1. Updated Reference Safety Information (RSI)
Page 77, 11 References
ADDED:
Company Core Data Sheet for mirabegron.



SAP_001.pdf: 
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
Center Study to Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Men with Overactive Bladder (OAB) Symptoms
While Taking the Alpha Blocker Tamsulosin Hydrochloride for 
Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH)
PLUS
ISN/Protocol 178-MA-1008
ClinicalTrials.gov Identifier: NCT02757768
Date of Statistical Analysis Plan Version 1.2: 27 Sep 2018
Sponsor: Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062, USA


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
67$7,67,&$/ $1$/<6,6 3/$1
)LQDO 9HUVLRQ 
GDWHG 6HSWHPEHU  
$ 3KDVH  'RXEOH%OLQG 5DQGRPL]HG 3ODFHER&RQWUROOHG 0XOWL&HQWHU 6WXG\ WR
(YDOXDWH WKH (IILFDF\ 6DIHW\ DQG 7ROHUDELOLW\ RI 0LUDEHJURQ LQ 0HQ ZLWK 2YHUDFWLYH
%ODGGHU 2$% 6\PSWRPV :KLOH 7DNLQJ WKH $OSKD %ORFNHU 7DPVXORVLQ +\GURFKORULGH
IRU /RZHU 8ULQDU\ 7UDFW 6\PSWRPV /876 GXH WR %HQLJQ 3URVWDWLF +\SHUSODVLD
%3+
,613URWRFRO 1XPEHU 0$
3URWRFRO 'DWH 9HUVLRQ  GDWHG 2FWREHU  
,1' 1XPEHU 
$VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
0HGLFDO $IIDLUV $PHULFDV
 $VWHOODV :D\
1RUWKEURRN ,/ 
7KLV FRQILGHQWLDO GRFXPHQW LV WKH SURSHUW\ RI WKH VSRQVRU 1R XQSXEOLVKHG LQIRUPDWLRQ
FRQWDLQHG LQ WKLV GRFXPHQW PD\ EH GLVFORVHG ZLWKRXW SULRU ZULWWHQ DSSURYDO RI WKH VSRQVRU
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7DEOH RI &RQWHQWV
/,67 2) $%%5(9,$7,216 $1' .(< 7(506 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā 

,1752'8&7,21āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

)/2: &+$57 $1' 9,6,7 6&+('8/(āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

678'< 2%-(&7,9(6 $1' '(6,*1āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6WXG\ 2EMHFWLYHV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

3ULPDU\ 2EMHFWLYH āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6HFRQGDU\ 2EMHFWLYH āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

2WKHU 2EMHFWLYHVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6WXG\ 'HVLJQāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

5DQGRPL]DWLRQāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6$03/( 6,=( āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$1$/<6,6 6(76 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

)XOO $QDO\VLV 6HW )$6 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

)XOO $QDO\VLV VHW ± ,QFRQWLQHQFH )$6, āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

)XOO $QDO\VLV VHW ± 1RFWXULD )$61 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6DIHW\ $QDO\VLV 6HW 6$) āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

5DQGRPL]HG $QDO\VLV 6HW 5$6āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$1$/<6,6 9$5,$%/(6 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

(IILFDF\ (QGSRLQWVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

3ULPDU\ (IILFDF\ (QGSRLQWāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6HFRQGDU\ (IILFDF\ (QGSRLQWVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

2WKHU (IILFDF\ 9DULDEOHV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6DIHW\ 9DULDEOHVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

2WKHU 9DULDEOHVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

'XUDWLRQ RI ([SRVXUH āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

3HUFHQW 2YHUDOO &RPSOLDQFH āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

3UHYLRXV 3URKLELWHG DQG &RQFRPLWDQW 0HGLFDWLRQāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

'HPRJUDSKLFVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

0HGLFDO +LVWRU\āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

'LDJQRVLV RI WKH 7DUJHW 'LVHDVH 6HYHULW\ DQG 'XUDWLRQ RI 'LVHDVHāāāāāāāāāāāāāā

67$7,67,&$/ 0(7+2'2/2*< āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

*HQHUDO &RQVLGHUDWLRQVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

/DVW 2EVHUYDWLRQ &DUULHG )RUZDUG /2&)āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

0RGHO 6WUXFWXUH  $QDO\VLV RI &RYDULDQFH $1&29$āāāāāāāāāāāāāāāāāāāāāāāāāāāā

0L[HG 0RGHO 5HSHDWHG 0HDVXUHV 0050 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

/RJLVWLF 5HJUHVVLRQāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

0L[HG (IIHFWV 3RLVVRQ QHJDWLYH ELQRPLDO 5HJUHVVLRQ 0RGHOāāāāāāāāāāāāāāāāāāāā

6WXG\ 3RSXODWLRQ āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

'LVSRVLWLRQ RI 3DWLHQWVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

3URWRFRO 'HYLDWLRQV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

'HPRJUDSKLF DQG 2WKHU %DVHOLQH &KDUDFWHULVWLFV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

3UHYLRXV DQG &RQFRPLWDQW 0HGLFDWLRQV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6WXG\ 'UXJVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

([SRVXUHāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

7UHDWPHQW &RPSOLDQFHāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI (IILFDF\ āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI 3ULPDU\ (QGSRLQW āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI 6HFRQGDU\ (QGSRLQWV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI ([SORUDWRU\ (QGSRLQWVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI 6DIHW\āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$GYHUVH (YHQWV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

&OLQLFDO /DERUDWRU\ (YDOXDWLRQ āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

9LWDO 6LJQVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

(OHFWURFDUGLRJUDPV (&*Vāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

395 9ROXPHāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

4PD[ āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

:HLJKW +HLJKW DQG %0,āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI 3KDUPDFRNLQHWLFV 3.āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$QDO\VLV RI 3KDUPDFRG\QDPLFV 3'āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

6XEJURXSV RI ,QWHUHVW āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

2WKHU $QDO\VHV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

+DQGOLQJ RI 0LVVLQJ 'DWD 2XWOLHUV 9LVLW :LQGRZV DQG 2WKHU ,QIRUPDWLRQ āāāāāāāāā

0LVVLQJ 'DWD āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

2XWOLHUV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

9LVLW :LQGRZV āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

'2&80(17 5(9,6,21 +,6725<āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

5()(5(1&(6 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$33(1',&(6 āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$SSHQGL[  $GYHUVH (YHQWV RI 3RVVLEOH +HSDWLF 2ULJLQ āāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$SSHQGL[  ,QWHUQDWLRQDO 3URVWDWH 6\PSWRP 6FRUH  TXHVWLRQQDLUHāāāāāāāāāāāāāāāāāāāā

$SSHQGL[  2YHUDFWLYH %ODGGHU 4XHVWLRQQDLUHāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$SSHQGL[ D (4'/ 4XHVWLRQQDLUHāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$SSHQGL[ E (4'/ ± 9LVXDO DQDORJ VFDOHāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā

$SSHQGL[  6LJQDWXUHVāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāāā
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
/,67 2) $%%5(9,$7,216 $1' .(< 7(506
/LVW RI $EEUHYLDWLRQV
$EEUHYLDWLRQ
'HVFULSWLRQ RI DEEUHYLDWLRQV
$(
$GYHUVH (YHQW
$/3
$ONDOLQH 3KRVSKDWDVH
$/7
$ODQLQH $PLQRWUDQVIHUDVH *37
$1&29$
$QDO\VLV RI &RYDULDQFH
$5,
$OSKD 5HGXFWDVH ,QKLELWRUV
$67
$VSDUWDWH $PLQRWUDQVIHUDVH *27
$7&
$QDWRPLFDO 7KHUDSHXWLF &KHPLFDO
%3
%ORRG 3UHVVXUH
%3+
%HQLJQ 3URVWDWLF +\SHUSODVLD
%0,
%RG\ 0DVV ,QGH[
%SP
%HDWV SHU PLQXWH
&$
&DQDGD
&)8
&RORQ\ )RUPLQJ 8QLW
&,
&RQILGHQFH ,QWHUYDOV
&303
&RPPLWWHH IRU 3URSULHWDU\ 0HGLFLQDO 3URGXFWV
&6
&ODVVLILFDWLRQ 6SHFLILFDWLRQV
&65
&OLQLFDO 6WXG\ 5HSRUW
&<3'
&\WRFKURPH 3 '
&<3$
&\WRFKURPH 3 $
'%3
'LDVWROLF %ORRG 3UHVVXUH
(&*
(OHFWURFDUGLRJUDP
H&5)
(OHFWURQLF &DVH 5HSRUW )RUP
(R7
(QG RI 7UHDWPHQW
H352
(OHFWURQLF 3DWLHQW 5HSRUWHG 2XWFRPHV
(4'/
0HDVXUH RI KHDOWK VWDWXV TXHVWLRQQDLUH GHYHORSHG E\ WKH (XUR4RO
*URXS
(8
(XURSH
)$6
)XOO $QDO\VLV 6HW
)$6,
)XOO $QDO\VLV 6HW ± ,QFRQWLQHQFH
)$61
)XOO $QDO\VLV 6HW ± 1RFWXULD
)'$
)RRG DQG 'UXJ $GPLQLVWUDWLRQ
+%30
+RPH %DVHG %ORRG 3UHVVXUH 0RQLWRULQJ
+54/
+HDOWK 5HODWHG 4XDOLW\ RI /LIH
,&+
,QWHUQDWLRQDO &RQIHUHQFH RQ +DUPRQL]DWLRQ RI 7HFKQLFDO 5HTXLUHPHQWV
IRU 5HJLVWUDWLRQ RI 3KDUPDFHXWLFDOV IRU +XPDQ 8VH
,'
,GHQWLILFDWLRQ
,366
,QWHUQDWLRQDO 3URVWDWH 6\PSWRP 6FRUH
,57
,QWHUDFWLYH 5HVSRQVH 7HFKQRORJ\
.J
.LORJUDP
/&(
/HXNRF\WH (VWHUDVH
/2&)
/DVW 2EVHUYDWLRQ &DUULHG )RUZDUG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
$EEUHYLDWLRQ
'HVFULSWLRQ RI DEEUHYLDWLRQV
/6
/HDVW 6TXDUH
/876
/RZHU 8ULQDU\ 7UDFW 6\PSWRPV
0HG'5$
0HGLFDO 'LFWLRQDU\ IRU 5HJXODWRU\ $FWLYLWLHV
0J
0LOOLJUDP
0,
0\RFDUGLDO ,QIDUFWLRQ
0LQ
0LQXWHV
P/
0LOOLOLWHU
PP+J
0LOOLPHWHU RI 0HUFXU\
0050
0L[HG 0RGHO 5HSHDWHG 0HDVXUHV
1$
1RUWK $PHULFD
1$
1RW $SSOLFDEOH
2$%
2YHUDFWLYH %ODGGHU
2$%T
2YHUDFWLYH %ODGGHU ± TXHVWLRQQDLUH
25
2GGV 5DWLR
3'
3URWRFRO 'HYLDWLRQ
36$
3URVWDWH6SHFLILF $QWLJHQ
3%2
3ODFHER
3&6
3RWHQWLDO &OLQLFDOO\ 6LJQLILFDQW
3.
3KDUPDFRNLQHWLFV
33%&
3DWLHQW 3HUFHSWLRQ RI %ODGGHU &RQGLWLRQ
33,86
3DWLHQW 3HUFHSWLRQ RI ,QWHQVLW\ RI 8UJHQF\ 6FDOH
35
3XOVH 5DWH
352
3DWLHQW 5HSRUWHG 2XWFRPHV
37
3UHIHUUHG 7HUP
370
3ODFHER WR 0DWFK
395
3RVW9RLG 5HVLGXDO 9ROXPH
4
)LUVW 4XDUWLOH
4
7KLUG 4XDUWLOH
4'
2QFH 'DLO\
2$%T
2YHUDFWLYH %ODGGHU TXHVWLRQQDLUH
4PD[
0D[LPXP XULQDU\ IORZ UDWH
4R/
4XDOLW\ RI /LIH
47F)
)ULGHULFLD¶V &RUUHFWLRQ )RUPXOD
5$6
5DQGRPL]HG $QDO\VLV 6HW
55
5HVSRQVH 5DWH
6%3
6\VWROLF %ORRG 3UHVVXUH
6$(
6HULRXV $GYHUVH (YHQW
6$)
6DIHW\ $QDO\VLV 6HW
6$3
6WDWLVWLFDO $QDO\VLV 3ODQ
6$6
6WDWLVWLFDO $QDO\VLV 6\VWHP
6'
6WDQGDUG 'HYLDWLRQ
6(
6WDQGDUG (UURU
62&
6\VWHP 2UJDQ &ODVV
7($(
7UHDWPHQW (PHUJHQW $GYHUVH (YHQW
7/)
7DEOHV /LVWLQJV DQG )LJXUHV
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
$EEUHYLDWLRQ
'HVFULSWLRQ RI DEEUHYLDWLRQV
769$6
7UHDWPHQW 6DWLVIDFWLRQ 9LVXDO $QDORJ 6FDOH
78)6
7RWDO 8UJHQF\ DQG )UHTXHQF\ 6FRUH
8/1
8SSHU /LPLW RI 1RUPDO
87,
8ULQDU\ 7UDFW ,QIHFWLRQ
:+2
:RUOG +HDOWK 2UJDQL]DWLRQ
:+2''
:RUOG +HDOWK 2UJDQL]DWLRQ ± 'UXJ 'LFWLRQDU\
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
/LVW RI .H\ 7HUPV
7HUPV
'HILQLWLRQ RI WHUPV
$GYHUVH (YHQW
$Q DGYHUVH HYHQW LV DQ\ XQWRZDUG PHGLFDO RFFXUUHQFH LQ D
SDWLHQW DGPLQLVWHUHG D VWXG\ GUXJ DQG ZKLFK GRHV QRW
QHFHVVDULO\ KDYH D FDXVDO UHODWLRQVKLS ZLWK WKLV WUHDWPHQW
%DVHOLQH
7KH EDVHOLQH YDOXH LV GHILQHG DV WKH ODVW PHDVXUHPHQW EHIRUH WKH
ILUVW GRVH RI GRXEOHEOLQG VWXG\ GUXJ )RU YDULDEOHV EDVHG RQ WKH
HOHFWURQLF GLDU\ WKH  GD\V RI WKH GLDU\ UHFRUGHG SULRU WR WKH
UDQGRPL]DWLRQ YLVLW ZLOO EH XVHG WR GHULYH WKHVH YDULDEOHV DW
EDVHOLQH
'LVFRQWLQXDWLRQ
7KH DFW RI FRQFOXGLQJ SDUWLFLSDWLRQ SULRU WR FRPSOHWLRQ RI
DOO SURWRFRO UHTXLUHG HOHPHQWV LQ D WULDO E\ DQ HQUROOHG
SDWLHQW
(QG RI 6WXG\
7KH WLPH RI WKH ODVW SDWLHQW¶V ODVW SURWRFROGHILQHG DVVHVVPHQW
(QUROOHG
$ VFUHHQHG SDWLHQW ZKR KDV UHFHLYHG WKH VWXG\ PHGLFDWLRQ
)UHTXHQF\
7KH FRPSODLQW RI YRLGLQJ WRR RIWHQ GXULQJ WKH GD\
,QFRQWLQHQFH
$Q\ LQYROXQWDU\ OHDNDJH RI XULQH )RU SXUSRVHV RI GDWD DQDO\VLV
VSHFLILFDOO\ IRU WKLV VWXG\ ERWK IXOO YRLG LQFRQWLQHQFH ZLWK RU
ZLWKRXW DQ\ XUJHQF\ DV ZHOO DV SDUWLDO YRLG LQFRQWLQHQFH ZLWK
SDVVHG XULQH LQ WKH WRLOHW ZLOO EH FRQVLGHUHG DV LQFRQWLQHQFH
0LFWXULWLRQ
$Q\ YROXQWDU\ PLFWXULWLRQ HSLVRGHV RI LQFRQWLQHQFH RQO\ DUH QRW
LQFOXGHG
0L[HG XULQDU\
LQFRQWLQHQFH
7KH FRPSODLQW RI LQYROXQWDU\ OHDNDJH DVVRFLDWHG ZLWK XUJHQF\
DQG DOVR ZLWK H[HUWLRQ HIIRUW VQHH]LQJ RU FRXJKLQJ
1RFWXULD
:DNLQJ DW QLJKW RQH RU PRUH WLPHV WR YRLG LH DQ\ YRLGLQJ
DVVRFLDWHG ZLWK VOHHS GLVWXUEDQFH EHWZHHQ WKH WLPH WKH SDWLHQW
JRHV WR EHG ZLWK WKH LQWHQWLRQ WR VOHHS XQWLO WKH WLPH WKH SDWLHQW
JHWV XS LQ WKH PRUQLQJ ZLWK WKH LQWHQWLRQ WR VWD\ DZDNH
2YHUDFWLYH %ODGGHU
8UJHQF\ ZLWK RU ZLWKRXW XUJHQF\ LQFRQWLQHQFH XVXDOO\ ZLWK
IUHTXHQF\ DQG QRFWXULD ZKLFK FDQ EH GHVFULEHG DV WKH 2$%
V\QGURPH XUJH V\QGURPH RU XUJHQF\IUHTXHQF\ V\QGURPH
5DQGRPL]DWLRQ
7KH SURFHVV RI DVVLJQLQJ WULDO SDWLHQWV WR WUHDWPHQW RU FRQWURO
JURXSV XVLQJ DQ HOHPHQW RI FKDQFH WR GHWHUPLQH DVVLJQPHQWV LQ
RUGHU WR UHGXFH ELDV
5XQ,Q )DLOXUH
6FUHHQHG SDWLHQW ZKR GLG QRW IXOILOO SURWRFRO LQFOXVLRQ DQGRU
H[FOXVLRQ FULWHULD DW 9LVLW  3DWLHQWV ZKR DUH FRQVLGHUHG D UXQ
LQ IDLOXUH FDQQRW EH UH VFUHHQHG LQWR WKH VWXG\ DW D ODWHU GDWH
6FUHHQHG
$ SDWLHQW ZKR KDV VLJQHG LQIRUPHG FRQVHQW DQG KDV SHUIRUPHG
WKH VFUHHQLQJ YLVLW
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7HUPV
'HILQLWLRQ RI WHUPV
6FUHHQLQJ )DLOXUH
6FUHHQHG SDWLHQW ZKR GLG QRW IXOILOO SURWRFRO LQFOXVLRQ DQGRU
H[FOXVLRQ FULWHULD RU GHFLGHG QRW WR SDUWLFLSDWH DQ\PRUH ZLWKGUHZ
FRQVHQW SULRU WR 9LVLW
 3DWLHQWV ZKR DUH FRQVLGHUHG D VFUHHQ IDLOXUH DW 9LVLW  GXH WR DQ
DFXWH FRQGLWLRQ WKDW UHVROYHG HJ D WUHDWHG 87, DQ (&* WKDW D
FDUGLRORJLVW FOHDUHG GLVFRQWLQXDWLRQ RI D SURKLELWHG RU UHVWULFWHG
PHGLFDWLRQ PD\ EH UHVFUHHQHG LQWR WKH VWXG\ DW D ODWHU GDWH
6HULRXV $GYHUVH
(YHQW
$Q DGYHUVH HYHQW LV FRQVLGHUHG ³VHULRXV´ LI LQ WKH YLHZ RI HLWKHU
WKH ,QYHVWLJDWRU RU 6SRQVRU LW UHVXOWV LQ DQ\ RI WKH IROORZLQJ
RXWFRPHV UHVXOWV LQ GHDWK LV OLIH WKUHDWHQLQJ UHVXOWV LQ SHUVLVWHQW
RU VLJQLILFDQW GLVDELOLW\LQFDSDFLW\ RU VXEVWDQWLDO GLVUXSWLRQ RI WKH
DELOLW\ WR FRQGXFW QRUPDO OLIH IXQFWLRQV UHVXOWV LQ FRQJHQLWDO
DQRPDO\ RU ELUWK GHIHFW UHTXLUHV LQSDWLHQW KRVSLWDOL]DWLRQ RU OHDGV
WR SURORQJDWLRQ RI KRVSLWDOL]DWLRQ RU D PHGLFDOO\ LPSRUWDQW HYHQW
6WUHVV XULQDU\
LQFRQWLQHQFH
7KH FRPSODLQW RI LQYROXQWDU\ OHDNDJH RQ HIIRUW RU H[HUWLRQ RU RQ
VQHH]LQJ RU FRXJKLQJ
3DWLHQW 1XPEHU
1XPEHU DVVLJQHG WR HDFK SDWLHQW E\ WKH ,QWHUDFWLYH 5HVSRQVH
6\VWHP DIWHU VLJQDWXUH RI LQIRUPHG FRQVHQW DQG SULRU WR DQ\
VSHFLILF SURFHGXUHV
7UHDWPHQW
(PHUJHQW $GYHUVH
(YHQW
$Q DGYHUVH HYHQW VWDUWLQJ RU ZRUVHQLQJ LQ WKH SHULRG IURP ILUVW
GRXEOHEOLQG PHGLFDWLRQ LQWDNH XQWLO  GD\V DIWHU ODVW GRXEOHEOLQG
PHGLFDWLRQ LQWDNH
8UJHQF\
$ VXGGHQ DQG FRPSHOOLQJ GHVLUH WR SDVV XULQH WKDW LV GLIILFXOW WR
GHIHU
8UJHQF\ 8ULQDU\
,QFRQWLQHQFH
7KH FRPSODLQW RI LQYROXQWDU\ OHDNDJH DFFRPSDQLHG E\ RU
LPPHGLDWHO\ SURFHHGHG E\ XUJHQF\
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

,1752'8&7,21
7KLV 6WDWLVWLFDO $QDO\VLV 3ODQ 6$3 FRQWDLQV D PRUH WHFKQLFDO DQG GHWDLOHG HODERUDWLRQ RI WKH
SULQFLSDO IHDWXUHV RI WKH DQDO\VLV GHVFULEHG LQ WKH SURWRFRO DQG LQFOXGHV GHWDLOHG SURFHGXUHV
IRU H[HFXWLQJ WKH VWDWLVWLFDO DQDO\VLV RI WKH SULPDU\ DQG VHFRQGDU\ HQGSRLQWV DQG RWKHU GDWD
7KH 6$3 LV ILQDOL]HG DQG VLJQHG SULRU WR DQ\ RI WKH IROORZLQJ VWXG\ XQEOLQGLQJ GDWDEDVH
KDUG ORFN LQWHULP DQDO\VLV RU DFFXPXODWLRQ RI VXEVWDQWLDO DPRXQW RI GDWD LQ DQ RSHQODEHO
VWXG\ WR HQVXUH ODFN RI ELDV )RU RSHUDWLRQDO HIILFLHQF\ DQ HDUOLHU WLPH LV XVXDOO\ WDUJHWHG ,I
QHHGHG UHYLVLRQV WR WKH DSSURYHG 6$3 PD\ EH PDGH SULRU WR GDWDEDVH KDUG ORFN 5HYLVLRQV
ZLOO EH YHUVLRQ FRQWUROOHG
7KLV VWDWLVWLFDO DQDO\VLV LV FRRUGLQDWHG E\
ZLWK DFFRXQWDELOLW\ WR WKH UHVSRQVLEOH
ELRVWDWLVWLFLDQ RI $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF $Q\ FKDQJHV IURP WKH DQDO\VHV
SODQQHG LQ WKH 6$3 ZLOO EH MXVWLILHG LQ WKH &OLQLFDO 6WXG\ 5HSRUW &65
3ULRU WR GDWDEDVH KDUG ORFN D ILQDO UHYLHZ RI GDWD DQG 7DEOHV /LVWLQJV DQG )LJXUHV 7/)V
PHHWLQJ ZLOO EH KHOG WR DOORZ D UHYLHZ RI WKH FOLQLFDO WULDO GDWD DQG WR YHULI\ WKH GDWD WKDW ZLOO
EH XVHG IRU DQDO\VLV VHW FODVVLILFDWLRQ ,I UHTXLUHG FRQVHTXHQFHV IRU WKH VWDWLVWLFDO DQDO\VLV
ZLOO EH GLVFXVVHG DQG GRFXPHQWHG $ PHHWLQJ WR GHWHUPLQH DQDO\VLV VHW FODVVLILFDWLRQV PD\
DOVR EH KHOG SULRU WR GDWDEDVH KDUG ORFN

)/2: &+$57 $1' 9,6,7 6&+('8/(
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7DEOH 
6FKHGXOH RI $VVHVVPHQWV
6FUHHQLQJ
7DPVXORVLQ
+\GURFKORULGH
5XQ,Q
7UHDWPHQW 3HULRG
)ROORZ
XS
3KRQH
&DOO
9LVLW






'D\






:HHN






9LVLW :LQGRZV
  G
²
  G
  G
  G
  G
9LVLW :LQGRZV 6WXG\ 'D\V D
 WR 
²
 WR

 WR

 WR



,QIRUPHG &RQVHQW
;
,QFOXVLRQ([FOXVLRQ &ULWHULD
;
;
0HGLFDO +LVWRU\ DQG 2$% +LVWRU\
;
'HPRJUDSKLFV
;
(QWHU ZHHN WDPVXORVLQ K\GURFKORULGH
UXQLQ E
;
5HPLQGHU 3KRQH &DOO F
;
;
;
;
5DQGRPL]DWLRQ G
;
3K\VLFDO ([DP
;
;
:HLJKW DQG +HLJKW
;
2IILFH 9LVLW 9LWDO 6LJQV SXOVH DQG EORRG
SUHVVXUH
;
;
;
;
;
6HUXP 36$
;
6HUXP FKHPLVWU\ KHPDWRORJ\ 	
XULQDO\VLV H I
;
;
;
;
;
/HDG (&* J
;
;
;
;
;
395 8OWUDVRQRJUDSK\ RU %ODGGHU 6FDQ
;
;
;
;
;
8URIORZPHWU\ 4PD[ K
;
;
,366
;
;
;
;
;
0HGLFDWLRQ +LVWRU\ DQG 2$% 0HGLFDWLRQ
+LVWRU\ L
;
&RQFRPLWDQW 0HGLFDWLRQV $VVHVVPHQW
;
;
;
;
;
;
$GYHUVH (YHQW $VVHVVPHQW M
;
;
;
;
;
;
'LVSHQVH 6WXG\ 'UXJ
;
;
;
;
'UXJ $FFRXQWDELOLW\
;
;
;
;
'RVH 7LWUDWLRQ N
;
,QVWUXFW 3DWLHQW RQ GD\ 'LDU\ O
;
;
;
;
3DWLHQW &RPSOHWHV GD\ 'LDU\ LQFOXGLQJ
+%30
;P
;P
;P
;P
(4'/
;
;
;
;
7DEOH FRQWLQXHG RQ QH[W SDJH
2$%T
;
;
;
;
33%&
;
;
;
;
33,86
;
;
;
;
769$6
;
;
;
;
5HYLHZ 3DWLHQW 'LDU\ Q
;
;
;
;
D $IWHU 9LVLW  6FUHHQLQJWDPVXORVLQ K\GURFKORULGH UXQLQ YLVLW ZLQGRZVVWXG\ GD\V ZLOO EH FDOFXODWHG EDVHG
RQ WKH 9LVLW  %DVHOLQH YLVLW GDWH 6WXG\ SURFHGXUHV HJ EODGGHU VFDQ IRU D SDUWLFXODU YLVLW GR QRW QHHG WR
EH FRPSOHWHG RQ WKH YLVLW GDWH LI WKLV LV QRW IHDVLEOH IRU WKH SDWLHQW DV ORQJ DV VWXG\ SURFHGXUHV DUH SHUIRUPHG
SHU SURWRFRO ZLWKLQ WKH DSSOLFDEOH YLVLW ZLQGRZ $Q\ SURFHGXUH QRW GRQH RU SHUIRUPHG RXWVLGH WKH DSSOLFDEOH
YLVLW ZLQGRZ ZLOO EH QRWHG DV D SURWRFRO H[FXUVLRQ
E 3DWLHQWV PXVW WDNH DW OHDVW  GD\V EXW QR PRUH WKDQ  GD\V RI WDPVXORVLQ K\GURFKORULGH UXQLQ PHGLFDWLRQ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
F 5HPLQGHU 3KRQH &DOO WR FRPSOHWH WKH GLDU\ DQG WR DQVZHU DQ\ TXHVWLRQV LV WR RFFXU DSSUR[LPDWHO\  GD\V
SULRU WR WKH YLVLW
G 5DQGRPL]DWLRQ LV WR RFFXU DIWHU FRQILUPLQJ DOO HOLJLELOLW\ FULWHULD DQG DIWHU SHUIRUPLQJ DOO RWKHU YLVLW
SURFHGXUHV DW 9LVLW 
H %ORRG VDPSOHV QHHG QRW EH IDVWLQJ $ FHQWUDO ODERUDWRU\ ZLOO EH XVHG IRU DOO ODERUDWRU\ KHPDWRORJ\ DQG
ELRFKHPLVWU\36$ DVVHVVPHQWV /RFDO ODERUDWRULHV ZLOO EH XVHG IRU DOO XULQDO\VLV DQG XULQH FXOWXUH DQG
VHQVLWLYLW\
I 8ULQH FXOWXUH DQG VHQVLWLYLW\ PXVW EH SHUIRUPHG IRU SRVLWLYH OHXNRF\WH HVWHUDVH /&( QLWULWHV RU WXUELGLW\
RU DW WKH GLVFUHWLRQ RI WKH 3, ,W LV QRW UHTXLUHG WR VHQG LVRODWHG WUDFH SRVLWLYH OHXNRF\WH HVWHUDVH VDPSOHV IRU
FXOWXUH ,I D SDWLHQW KDV D 87, GHILQHG DV !  &)8 WKH SDWLHQW PD\ EH UHVFUHHQHG DIWHU VXFFHVVIXO
WUHDWPHQW RI WKH 87, FRQILUPHG E\ D ODERUDWRU\ UHVXOW RI QHJDWLYH XULQH FXOWXUH
J (&*V ZLOO EH VXEPLWWHG WR D FHQWUDO ODERUDWRU\ ,QLWLDO LQFOXVLRQ ZLOO EH EDVHG RQ 3, LQWHUSUHWDWLRQ RI (&*
HOLJLELOLW\ DW 6FUHHQLQJ 9LVLW  DQG %DVHOLQH 9LVLW  KRZHYHU LI WKH 47F) LQWHUYDO LV ! PV RQ WKH
SULQWHG (&* DW %DVHOLQH 9LVLW  DQ H[SHGLWHG FHQWUDO (&* UHDGLQJ ZLWKLQ  KRXUV VKRXOG EH UHTXHVWHG
DQG UHYLHZHG EHIRUH WKH SDWLHQW LV DOORZHG WR EH UDQGRPL]HG )LQDO FHQWUDO UHDGLQJV PXVW EH UHYLHZHG E\ WKH
,QYHVWLJDWRU IRU WKH GXUDWLRQ RI WKH VWXG\ IRU LPPHGLDWH VDIHW\ DVVHVVPHQW DQG SDWLHQW FDUH
K 4PD[ FDQ EH FRPSOHWHG ZLWKLQ WZR ZHHNV RI 6FUHHQLQJ 9LVLW  7KH SDWLHQW PXVW YRLG D PLQLPXP RI  P/
IRU WKH XURIORZ PHDVXUHPHQW WR EH FRQVLGHUHG DGHTXDWH
L
$OO PHGLFDWLRQV WDNHQ ZLWKLQ  GD\V SULRU WR 6FUHHQLQJ 9LVLW  PXVW EH UHFRUGHG LQ WKH H&5)
M
$GYHUVH (YHQW FROOHFWLRQ ZLOO EHJLQ IURP WKH WLPH RI LQIRUPHG FRQVHQW DQG FRQWLQXH WKURXJK WKH )ROORZXS
3KRQH &DOO 9LVLW 
N $OO SDWLHQWV ZLOO EH WLWUDWHG WR WKH  PJ GRVH RI PLUDEHJURQ RU SODFHER WR PDWFK 370 DIWHU  ZHHNV RI
WUHDWPHQW 3DWLHQWV ZLOO UHPDLQ RQ  PJ RI WDPVXORVLQ K\GURFKORULGH IRU WKH GXUDWLRQ RI WKH VWXG\
O $W WKH 6FUHHQLQJWDPVXORVLQ K\GURFKORULGH UXQLQ 9LVLW  DOO SDWLHQWV ZLOO EH SURYLGHG ZLWK DQ H352 GHYLFH
HOHFWURQLF GLDU\ WKDW ZLOO EH XVHG WR UHFRUG WKH GDWH DQG WLPH RI HDFK PLFWXULWLRQ LQFRQWLQHQFH XUJHQF\
HSLVRGH PHDVXUH RI XULQH YROXPH YRLGHG DQG VOHHS LQWHUUXSWLRQ +RPH PHDVXUHPHQWV RI DP DQG SP SXOVH
UDWH DQG V\VWROLF DQG GLDVWROLF EORRG SUHVVXUH ZLOO EH HOHFWURQLFDOO\ FDSWXUHG LQ WKH GLDU\ $GGLWLRQDOO\ WKH
GLDU\ ZLOO EH XVHG WR UHFRUG PHGLFDWLRQ LQWDNH HYHU\ GD\ GXULQJ WKH VWXG\ DV ZHOO DV WR FRPSOHWH
TXHVWLRQQDLUHV 7UDLQLQJ RQ GHYLFH XVH PXVW EH GRQH DW 9LVLW  DQG DV QHFHVVDU\ WKURXJKRXW WKH VWXG\
$SSUR[LPDWHO\  GD\V SULRU WR 9LVLW  SDWLHQWV ZLOO UHFHLYH D SKRQH FDOO UHPLQGLQJ WKHP DERXW WKH GLDU\ DQG
WR DQVZHU DQ\ TXHVWLRQV 3DWLHQWV ZLOO EH LQVWUXFWHG WR EHJLQ FRPSOHWLQJ WKH HOHFWURQLF GLDU\  GD\V SULRU WR
HDFK LQ RIILFH VWXG\ YLVLW LQFOXGLQJ 9LVLW  %DVHOLQH 9LVLWV    7UHDWPHQW 3HULRG DQG WR FRPSOHWH WKH
GLDU\ IRU WKH IXOO  GD\V
P)RU 9LVLWV    DQG  SDWLHQWV ZLOO FRPSOHWH WKH HOHFWURQLF GLDU\ LQFOXGLQJ DP DQG SP +%30 IRU WKH 
GD\V SULRU WR WKH VWXG\ YLVLW
Q ,QYHVWLJDWRU RU GHVLJQHH PXVW UHYLHZ WKH SDWLHQW¶V GLDU\ ZLWK WKH SDWLHQW WR HQVXUH FRPSOHWLRQ FRPSOLDQFH
DQG GLVFXVV GDWD FDSWXUHG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

678'< 2%-(&7,9(6 $1' '(6,*1

6WXG\ 2EMHFWLYHV

3ULPDU\ 2EMHFWLYH
7KH SULPDU\ REMHFWLYH LV WR VWXG\ WKH HIILFDF\ RI PLUDEHJURQ YHUVXV SODFHER 3%2 LQ PHQ
ZLWK RYHUDFWLYH EODGGHU 2$% V\PSWRPV ZKLOH WDNLQJ WDPVXORVLQ K\GURFKORULGH IRU ORZHU
XULQDU\ WUDFW V\PSWRPV /876 GXH WR EHQLJQ SURVWDWLF K\SHUSODVLD %3+

6HFRQGDU\ 2EMHFWLYH
7KH VHFRQGDU\ REMHFWLYH LV WR DVVHVV WKH VDIHW\ DQG WROHUDELOLW\ RI PLUDEHJURQ YHUVXV 3%2 LQ
PHQ ZLWK 2$% V\PSWRPV ZKLOH WDNLQJ WDPVXORVLQ K\GURFKORULGH IRU /876 GXH WR %3+

2WKHU 2EMHFWLYHV
7R DVVHVV SDWLHQW UHSRUWHG RXWFRPHV 352V DV PHDVXUHG E\ 6\PSWRP %RWKHU DQG 7RWDO
+HDOWK 5HODWHG 4XDOLW\ RI /LIH 4R/ VFRUHV DV DVVHVVHG E\ WKH 2YHUDFWLYH %ODGGHU
TXHVWLRQQDLUH 2$%T (4'/ 3DWLHQW 3HUFHSWLRQ RI %ODGGHU &RQGLWLRQ 33%& 3DWLHQW
3HUFHSWLRQ RI ,QWHQVLW\ RI 8UJHQF\ 6FDOH 33,86 ,QWHUQDWLRQDO 3URVWDWH 6\PSWRP 6FRUH
,366 DQG 7UHDWPHQW 6DWLVIDFWLRQ9LVXDO $QDORJ 6FDOH 769$6

6WXG\ 'HVLJQ
7KLV LV D UDQGRPL]HG GRXEOHEOLQG SODFHERFRQWUROOHG SDUDOOHOJURXS PXOWLFHQWHU VWXG\
$SSUR[LPDWHO\  SDWLHQWV ZLOO EH VFUHHQHG WR DFKLHYH  UDQGRPL]HG DQG  FRPSOHWHG
SDWLHQWV DW XS WR  VWXG\ FHQWHUV LQ 1RUWK $PHULFD DQG (XURSH
$W 6FUHHQLQJ 9LVLW  SDWLHQWV ZLOO HQWHU LQWR D ZHHN RSHQ ODEHO WDPVXORVLQ K\GURFKORULGH
 PJ 4' UXQLQ SHULRG SULRU WR EHLQJ UDQGRPL]HG LQWR WKH ZHHN GRXEOHEOLQG WUHDWPHQW
SHULRG 9LVLW  $W WKH FRQFOXVLRQ RI WKH ZHHN WDPVXORVLQ K\GURFKORULGH UXQLQ SHULRG
SDWLHQWV ZLOO FRPSOHWH D GD\ GLDU\ MXVW SULRU WR %DVHOLQH 9LVLW 
4XDOLI\LQJ SDWLHQWV ZLOO EH UDQGRPL]HG WR  RI  WUHDWPHQW JURXSV 0LUDEHJURQ RU SODFHER
IRU  ZHHNV RI WUHDWPHQW LQ DGGLWLRQ WR WKH FRQWLQXDWLRQ RI WDPVXORVLQ K\GURFKORULGH  PJ
4' 7KUHH GD\V EHIRUH 9LVLWV  %DVHOLQH  :HHN   :HHN  DQG  :HHN 
SDWLHQWV ZLOO FRPSOHWH D GD\ GLDU\ XVLQJ WKH HOHFWURQLF SDWLHQWUHSRUWHG RXWFRPH H352
GHYLFH LQ ZKLFK WKH\ ZLOO UHFRUG PLFWXULWLRQ IUHTXHQF\ XUJHQF\ 33,86 LQFRQWLQHQFH DQG
YROXPH YRLGHG ,Q DGGLWLRQ WKH GLDU\ ZLOO FDSWXUH PRUQLQJ DQG HYHQLQJ EORRG SUHVVXUH DQG
SXOVH UDWH PHDVXUHPHQWV YLD +%30 $W 9LVLW  ,QWHUQDWLRQDO 3URVWDWH 6\PSWRP 6FRUH ,366
ZLOO EH FRPSOHWHG $W 9LVLWV    DQG  SDWLHQWV ZLOO FRPSOHWH WKH ,366 (4'/ 2$%
T 33%& DQG 769$6 0D[LPXP XULQDU\ IORZ 4PD[ ZLOO EH PHDVXUHG DW 9LVLW 
6FUHHQLQJ WDPVXORVLQ K\GURFKORULGH UXQLQ DQG 9LVLW  :HHN (QG RI 7UHDWPHQW
3RVWYRLG UHVLGXDO YROXPH 395 ZLOO EH DVVHVVHG DW 6FUHHQLQJWDPVXORVLQ K\GURFKORULGH UXQ
LQ 9LVLW  %DVHOLQH 9LVLW  DQG DW :HHN  9LVLW  :HHN  9LVLW  DQG :HHN (QG RI
7UHDWPHQW 9LVLW  $ IROORZXS SKRQH FDOO 9LVLW  ZLOO EH FRQGXFWHG ZHHNV DIWHU (QG RI
7UHDWPHQW 9LVLW  7RWDO VWXG\ SDUWLFLSDWLRQ LV DSSUR[LPDWHO\  ZHHNV
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

5DQGRPL]DWLRQ
$IWHU D SDWLHQW VLJQV LQIRUPHG FRQVHQW D SDWLHQW QXPEHU ZLOO EH DVVLJQHG 7R REWDLQ D SDWLHQW
QXPEHU WKH ,QYHVWLJDWRU RU GHVLJQHH ZLOO XWLOL]H D ZHE RU SKRQHEDVHG ,QWHUDFWLYH 5HVSRQVH
7HFKQRORJ\ ,57 3DWLHQWV ZKR PHHW DOO WKH LQFOXVLRQ DQG QRQH RI WKH H[FOXVLRQ FULWHULD ZLOO
HQWHU D ZHHN WDPVXORVLQ K\GURFKORULGH  PJ FDSVXOH 86  WDEOHW (8&$ UXQLQ SHULRG
9LVLW  $W 9LVLW  %DVHOLQH SDWLHQWV ZLOO EH UDQGRPO\ DVVLJQHG WR UHFHLYH PLUDEHJURQ RU
SODFHER XVLQJ D  UDQGRPL]DWLRQ VFKHGXOH 5DQGRPL]DWLRQ ZLOO EH VWUDWLILHG E\ JHRJUDSKLF
UHJLRQ 1$ (8 $IWHU VXEPLWWLQJ FHUWDLQ LQIRUPDWLRQ DERXW WKH HOLJLEOH SDWLHQW WKH
UDQGRPL]HG GUXJ DVVLJQPHQW ZLOO EH SURYLGHG E\ WKH ,57 6WXG\ GUXJ DVVLJQPHQW ZLOO UHPDLQ
EOLQGHG WR DOO VWDII (DFK VWXG\ GUXJ ZLOO EH SUHSULQWHG ZLWK D 0HGLFDWLRQ ,' QXPEHU WKDW ZLOO
EH QRWHG LQ WKH HOHFWURQLF FDVH UHSRUW IRUP H&5) 2QFH D SDWLHQW QXPEHU LV DVVLJQHG LI WKH
FRUUHVSRQGLQJ SDWLHQW GRHV QRW UHFHLYH VWXG\ GUXJ WKH SDWLHQW QXPEHU ZLOO QRW EH XVHG DJDLQ
7KRVH SDWLHQWV UDQGRPL]HG WR PLUDEHJURQ ZLOO VWDUW DW  PJ WDEOHW 4' DORQJ ZLWK WDPVXORVLQ
K\GURFKORULGH  PJ FDSVXOH 86  WDEOHW (8&$ DQG ZLOO LQFUHDVH WR  PJ 4' DIWHU 
ZHHNV 7KRVH SDWLHQWV UDQGRPL]HG WR 3%2 ZLOO VWDUW EOLQGHG SURGXFW PDWFKHG WR WKH
PLUDEHJURQ  PJ WDEOHW DQG ZLOO LQFUHDVH WR EOLQGHG SURGXFW PDWFKHG WR  PJ PLUDEHJURQ
DIWHU  ZHHNV RI WKH VWXG\ DORQJ ZLWK WDPVXORVLQ K\GURFKORULGH  PJ FDSVXOH 86  WDEOHW
(8&$ 2QFH D SDWLHQW KDV LQFUHDVHG GRVH WKH\ ZLOO UHPDLQ RQ WKDW GRVH IRU WKH UHPDLQGHU
RI WKH VWXG\ XQOHVV IRU VDIHW\ UHDVRQV WKDW UHTXLUH GLVFRQWLQXDWLRQ RI VWXG\ GUXJ

6$03/( 6,=(
7KH SULPDU\ HQGSRLQW IRU WKLV VWXG\ LV FKDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ
QXPEHU RI PLFWXULWLRQV SHU GD\ EDVHG RQ D GD\ GLDU\
%DVHG RQ VXEJURXS DQDO\VLV RI SULRU 2$% VWXGLHV  SDWLHQWV  HYDOXDEOH SDWLHQWV SHU
WUHDWPHQW JURXS SURYLGHV  SRZHU WR GHWHFW D UHGXFWLRQ RI  LQ WKH PHDQ QXPEHU RI
PLFWXULWLRQV SHU GD\ RYHU SODFHER LQ WKH PLUDEHJURQ JURXS DW DQ DOSKD OHYHO RI  $
VWDQGDUG GHYLDWLRQ IRU FKDQJH IURP EDVHOLQH LQ PLFWXULWLRQV RI  ZDV DVVXPHG
,I  RI WKH UDQGRPL]HG SDWLHQWV DUH HYDOXDEOH  SDWLHQWV VKRXOG EH UDQGRPL]HG :LWK DQ
H[SHFWHG GURSRXW UDWH RI  LQ WKH WDPVXORVLQ K\GURFKORULGH UXQLQ SKDVH  SDWLHQWV
QHHG WR EH VFUHHQHG

$1$/<6,6 6(76
,Q DFFRUGDQFH ZLWK ,QWHUQDWLRQDO &RQIHUHQFH RQ +DUPRQL]DWLRQ ,&+ UHFRPPHQGDWLRQV LQ
JXLGHOLQHV ( DQG ( WKH IROORZLQJ DQDO\VLV VHWV ZLOO EH XVHG IRU WKH DQDO\VHV
'HWDLOHG FULWHULD IRU DQDO\VLV VHWV ZLOO EH ODLG RXW LQ &ODVVLILFDWLRQ 6SHFLILFDWLRQV &6 DQG WKH
DOORFDWLRQ RI SDWLHQWV WR DQDO\VLV VHWV ZLOO EH GHWHUPLQHG SULRU WR GDWDEDVH KDUG ORFN

)XOO $QDO\VLV 6HW )$6
7KH )$6 ZLOO LQFOXGH DOO SDWLHQWV ZKR PHHW DOO RI WKH IROORZLQJ FULWHULD
x
3DWLHQWV ZKR WRRN DW OHDVW  GRVH RI GRXEOHEOLQGHG VWXG\ GUXJ DIWHU 5DQGRPL]DWLRQ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
x
5HSRUWHG DW OHDVW  PLFWXULWLRQ LQ WKH EDVHOLQH GLDU\ DQG DW OHDVW  PLFWXULWLRQ
SRVWEDVHOLQH
7KH )$6 ZLOO EH XVHG IRU WKH VXPPDU\ RI DOO EDVHOLQH FKDUDFWHULVWLFV LQFOXGLQJ
GHPRJUDSKLFV GLVHDVH VWDWH GDWD DQG VWDWLVWLFDO DQDO\VLV RI HIILFDF\ HQGSRLQWV DQG 4R/
LQVWUXPHQWV

)XOO $QDO\VLV VHW ± ,QFRQWLQHQFH )$6,
7KH )$6, ZLOO LQFOXGH DOO SDWLHQWV ZKR PHHW DOO RI WKH IROORZLQJ FULWHULD
x
3DWLHQWV ZKR WRRN DW OHDVW  GRVH RI GRXEOHEOLQGHG VWXG\ GUXJ DIWHU 5DQGRPL]DWLRQ
x
5HSRUWHG DW OHDVW  PLFWXULWLRQ LQ WKH EDVHOLQH GLDU\ DQG DW OHDVW  PLFWXULWLRQ SRVW
EDVHOLQH
x
5HSRUWHG DW OHDVW  LQFRQWLQHQFH HSLVRGH LQ WKH EDVHOLQH GLDU\
7KH )$6, ZLOO EH XVHG IRU WKH DQDO\VLV RI LQFRQWLQHQFH HSLVRGHV

)XOO $QDO\VLV VHW ± 1RFWXULD )$61
7KH )$61 ZLOO LQFOXGH DOO )$6 SDWLHQWV ZKR UHSRUWHG DW OHDVW  QRFWXULD HSLVRGH LQ WKH
EDVHOLQH GLDU\
7KH )$61 ZLOO EH XVHG IRU WKH DQDO\VLV RI 1RFWXULD HSLVRGHV

6DIHW\ $QDO\VLV 6HW 6$)
7KH 6$) ZLOO FRQVLVW RI DOO UDQGRPL]HG SDWLHQWV ZKR UHFHLYHG DW OHDVW RQH GRVH RI
GRXEOHEOLQG VWXG\ PHGLFDWLRQ 7KH 6$) ZLOO EH XVHG IRU VXPPDUL]LQJ GHPRJUDSKLF DQG
EDVHOLQH 2$% FKDUDFWHULVWLFV DQG VDIHW\ GDWD

5DQGRPL]HG $QDO\VLV 6HW 5$6
7KH 5DQGRPL]HG $QDO\VLV 6HW 5$6 ZLOO FRQVLVW RI DOO UDQGRPL]HG SDWLHQWV 7KH 5$6 ZLOO
EH XVHG WR VXPPDUL]H GLVSRVLWLRQ RI SDWLHQWV ZKR ZHUH UDQGRPL]HG WR GRXEOHEOLQG
WUHDWPHQW

$1$/<6,6 9$5,$%/(6

(IILFDF\ (QGSRLQWV

3ULPDU\ (IILFDF\ (QGSRLQW
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN (QG RI 7UHDWPHQW 9LVLW  LQ PHDQ
QXPEHU RI PLFWXULWLRQV SHU GD\ EDVHG RQ D GD\ GLDU\

6HFRQGDU\ (IILFDF\ (QGSRLQWV
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  DQG :HHN  LQ PHDQ QXPEHU RI
PLFWXULWLRQV SHU GD\ EDVHG RQ D GD\ GLDU\
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ PHDQ YROXPH YRLGHG SHU PLFWXULWLRQ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ PHDQ QXPEHU RI LQFRQWLQHQFH HSLVRGHV SHU GD\ )$6,
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ PHDQ QXPEHU RI XUJHQF\ HSLVRGHV JUDGH  DQG  SHU GD\
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ ,366 WRWDO VFRUH DQG VXEVFDOHV 9RLGLQJ 6WRUDJH DQG 4XDOLW\ RI /LIH
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ PHDQ QXPEHU RI XUJHQF\ LQFRQWLQHQFH HSLVRGHV SHU GD\ )$6,
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ 6\PSWRP %RWKHU 7RWDO +HDOWK 5HODWHG 4XDOLW\ RI /LIH DQG VXEVFDOH FRSLQJ
FRQFHUQ VOHHS VRFLDO LQWHUDFWLRQ DQG V\PSWRP ERWKHU VFRUHV DV DVVHVVHG E\ 2$%T
TXHVWLRQQDLUH
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ 33%&
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ 7RWDO 8UJHQF\ DQG )UHTXHQF\ 6FRUH 78)6 XVLQJ 33,86 *UDGH  RU 
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ PHDQ QXPEHU RI QRFWXULD HSLVRGHV SHU GD\ )$61
x
&KDQJH IURP %DVHOLQH 9LVLW  WR :HHN  :HHN  :HHN  DQG (QG RI 7UHDWPHQW
LQ 769$6 VFRUHV

3DWLHQW 'LDU\  0LFWXULWLRQ DQG ,QFRQWLQHQFH
'XULQJ WKH VWXG\ SDWLHQWV ZLOO EH UHTXHVWHG WR FRPSOHWH D 專GD\ GLDU\ ZKLFK ZLOO EH
LPSOHPHQWHG RQ DQ HOHFWURQLF KDQGKHOG GHYLFH 7KLV GLDU\ ZLOO FROOHFW GDWD RQ PLFWXULWLRQ DQG
LQFRQWLQHQFH VOHHS LQWHUUXSWLRQ YLWDO VLJQ PHDVXUHPHQWV DQG WKH 3DWLHQW 3HUFHSWLRQ RI
,QWHQVLW\ RI 8UJHQF\ 6FDOH 33,86 SULRU WR 9LVLWV    DQG  7KH LQIRUPDWLRQ IURP WKH
GLDULHV ZLOO EH XVHG WR HYDOXDWH WKH HIILFDF\ RI WUHDWPHQW 7KHUHIRUH SDWLHQWV ZLOO UHFHLYH IXOO
LQVWUXFWLRQV DQG WUDLQLQJ RQ KRZ WR FRPSOHWH WKH GLDU\ DW 6FUHHQLQJWDPVXORVLQ K\GURFKORULGH
UXQLQ 9LVLW  DQG ZLOO EH FRXQVHOHG RQ WKH LPSRUWDQFH RI FRPSOHWLQJ WKH GLDULHV SULRU WR WKH
QH[W YLVLW 7KH GLDULHV DQG TXHVWLRQQDLUHV ZLOO EH UHYLHZHG GXULQJ HDFK YLVLW DIWHU
6FUHHQLQJWDPVXORVLQ K\GURFKORULGH UXQLQ 9LVLW  E\ WKH ,QYHVWLJDWRU RU GHVLJQHH WR HQVXUH
DFFXUDF\ RI FRPSOHWLRQ
'LDULHV ZLOO EH FRPSOHWHG DW KRPH IRU  FRQVHFXWLYH GD\V SULRU WR HDFK YLVLW %DVHOLQH 9LVLW
 :HHN  9LVLW  :HHN  9LVLW  :HHN  9LVLW  DQG (QG RI 7UHDWPHQW
$ GLDU\ GD\ VWDUWV DW PLGQLJKW DQG HQGV DW PLGQLJKW WKH IROORZLQJ GD\ 7LPH WR EHG ZLWK
LQWHQWLRQ WR VOHHS WLPH WR DZDNH ZLWK LQWHQWLRQ RI VWD\LQJ DZDNH W\SH RI HSLVRGH
XULQDWLRQLQFRQWLQHQFHERWK WLPH RI HSLVRGH XUJHQF\ VHYHULW\ DQG PHDVXUH RI XULQH
YROXPH YRLGHG DQG VOHHS LQWHUUXSWLRQ ZLOO EH UHFRUGHG E\ WKH SDWLHQW LQ WKH PLFWXULWLRQ GLDU\
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
$W %DVHOLQH 9LVLW  GLDU\ GDWD LQFOXGLQJ IUHTXHQF\ RI PLFWXULWLRQ XULQDWLRQ HSLVRGHV DQG
XUJHQF\ HSLVRGHV JUDGH  DQG  ZLWK RU ZLWKRXW LQFRQWLQHQFH ZLOO EH UHYLHZHG WR FRQILUP
LQFOXVLRQ FULWHULD
9RLGLQJ HSLVRGHV ZLOO EH UHFRUGHG LQ RQH RI WKUHH ZD\V ³XULQDWLRQ´ ³LQFRQWLQHQFH´ RU
³ERWK´ LQ WKH HOHFWURQLF GLDU\ 0LFWXULWLRQV ZLOO EH FRXQWHG IRU ³XULQDWLRQ´ HSLVRGHV LQ ZKLFK
WKH SDWLHQW IXOO\ YRLGV LQ WKH WRLOHW ³,QFRQWLQHQFH´ ZLOO EH FRXQWHG IRU HSLVRGHV LQ ZKLFK WKH
IXOO YRLG ZDV LQFRQWLQHQW DQG WKH SDWLHQW GLG QRW PDNH LW WR WKH WRLOHW WR ILQLVK XULQDWLQJ ,I D
SDWLHQW H[SHULHQFHG LQFRQWLQHQFH DQG WKHQ SDVVHG XULQH LQWR WKH WRLOHW WKLV VKRXOG EH UHFRUGHG
DV ³ERWK´ 'XULQJ DQDO\VLV ³ERWK´ ZLOO EH FRXQWHG WRZDUGV PLFWXULWLRQ DQG LQFRQWLQHQFH ,Q
DGGLWLRQ WR PLFWXULWLRQ LQIRUPDWLRQ WKH HOHFWURQLF GLDU\ ZLOO DOVR FROOHFW WLPH RI PHGLFDWLRQ
LQWDNH DQG YLWDO VLJQV DORQJ ZLWK VOHHS LQWHUUXSWLRQ
'HILQLWLRQV RI HIILFDF\ YDULDEOHV EDVHG RQ WKH GD\ PLFWXULWLRQ GLDU\ DUH SUHVHQWHG LQ 7DEOH

DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7DEOH  0LFWXULWLRQ 'LDU\ 'HILQLWLRQV DQG &DOFXODWLRQV
0HDVXUHPHQW
'HILQLWLRQ
&DOFXODWLRQ
0LFWXULWLRQ
$Q\ YROXQWDU\ PLFWXULWLRQ
H[FOXGLQJ LQFRQWLQHQFH
RQO\ HSLVRGHV
$ PLFWXULWLRQ HSLVRGH LV
FRXQWHG DV PLFWXULWLRQ
UHJDUGOHVV RI ZKHWKHU
YROXPH YRLGHG ZDV UHFRUGHG
RU QRW $ PLFWXULWLRQ
UHFRUGHG EHIRUH PLGQLJKW RI
WKH ILUVW GD\ RU DIWHU
PLGQLJKW RQ WKH UG GD\ RI
WKH GD\ PLFWXULWLRQ GLDU\
SHULRG ZLOO QRW EH FRXQWHG
$ PLFWXULWLRQ ZLOO DOVR EH
FRXQWHG LI WKH SDWLHQW
DVVHVVHG DQ HSLVRGH DV ERWK
PLFWXULWLRQ DQG
LQFRQWLQHQFH
9DOLG 'LDU\ 'D\
$ GLDU\ GD\ LQ ZKLFK DW OHDVW
RQH YROXQWDU\ PLFWXULWLRQ
HSLVRGH RFFXUV $ GLDU\ GD\
ZLWK HSLVRGHV RI
LQFRQWLQHQFH RQO\ LV QRW
FRQVLGHUHG D YDOLG GLDU\ GD\
$ GLDU\ GD\ LV FRQVLGHUHG
YDOLG LI DW OHDVW RQH
PLFWXULWLRQ ZDV UHFRUGHG RQ
WKLV FDOHQGDU GD\ 'D\V RI
YLVLWV WR WKH FOLQLF
GHWHUPLQHG E\ WKH GDWH RI
TXHVWLRQQDLUH FRPSOHWLRQ
ZLOO QRW EH FRXQWHG DV YDOLG
GLDU\ GD\V
1XPEHU RI 9DOLG 'LDU\
'D\V
1XPEHU RI YDOLG GLDU\ GD\V
SHU HDFK GD\ PLFWXULWLRQ
GLDU\ SHULRG
&RXQW RI WKH YDOLG GLDU\
GD\V GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
'D\V RI YLVLWV WR WKH FOLQLF
ZLOO QRW EH FRXQWHG DV YDOLG
GLDU\ GD\V
9DOLG 'LDU\
$ YDOLG GLDU\ LV D GLDU\ ZLWK
DW OHDVW  YDOLG GLDU\ GD\V
ZLWKLQ WKH DQDO\VLV YLVLW
ZLQGRZ ,I PRUH WKDQ 
YDOLG GLDU\ GD\V DUH UHFRUGHG
WKHQ WKH ODVW  GD\V ZLOO EH
XVHG LQ WKH FDOFXODWLRQV ,I
WKHUH LV QR µJR WR EHG WLPH¶
RQ WKH ODVW GD\ WKDW GD\ ZLOO
EH GHOHWHG
1RW DSSOLFDEOH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
0HDVXUHPHQW
'HILQLWLRQ
&DOFXODWLRQ
0HDQ 1XPEHU RI
0LFWXULWLRQV SHU GD\
$YHUDJH QXPEHU RI WLPHV D
SDWLHQW XULQDWHV H[FOXGLQJ
LQFRQWLQHQFH RQO\ HSLVRGHV
DQG H[FOXGLQJ GXSOLFDWH
UHFRUGV >VDPH WLPH DQG
HSLVRGH FKDUDFWHULVWLFV@ SHU
GD\ GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
1XPEHU RI PLFWXULWLRQV
UHFRUGHG RQ YDOLG GLDU\ GD\V
GXULQJ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG GLYLGHG E\ WKH
QXPEHU RI YDOLG GLDU\ GD\V
GXULQJ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
8ULQDU\ ,QFRQWLQHQFH
(SLVRGH RU ,QFRQWLQHQFH
(SLVRGH
7KH FRPSODLQW RI DQ\
LQYROXQWDU\ OHDNDJH RI XULQH
$Q LQFRQWLQHQFH HSLVRGH LV
FRXQWHG LI LW ZDV UHFRUGHG LQ
WKH GLDU\ RQ D YDOLG GLDU\
GD\ $Q LQFRQWLQHQFH ZLOO
DOVR EH FRXQWHG LI WKH SDWLHQW
DVVHVVHG DQ HSLVRGH DV ERWK
PLFWXULWLRQ DQG
LQFRQWLQHQFH
1XPEHU RI ,QFRQWLQHQFH
(SLVRGHV
1XPEHU RI WLPHV D SDWLHQW
UHFRUGV DQ LQFRQWLQHQFH
HSLVRGH GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
7RWDO QXPEHU RI
LQFRQWLQHQFH HSLVRGHV
UHFRUGHG GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
0HDQ 1XPEHU RI
,QFRQWLQHQFH (SLVRGHV SHU
GD\
$YHUDJH QXPEHU RI WLPHV D
SDWLHQW UHFRUGV DQ
LQFRQWLQHQFH HSLVRGH SHU
GD\ GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
1XPEHU RI LQFRQWLQHQFH
HSLVRGHV UHFRUGHG RQ YDOLG
GLDU\ GD\V GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
GLYLGHG E\ WKH QXPEHU RI
YDOLG GLDU\ GD\V GXULQJ WKH
GD\ PLFWXULWLRQ GLDU\
SHULRG
0HDQ 9ROXPH 9RLGHG SHU
0LFWXULWLRQ
0HDQ YROXPH YRLGHG P/
SHU PLFWXULWLRQ GXULQJ 
GD\V RI WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
6XP RI HDFK YROXPH YRLGHG
IRU HDFK UHFRUG ZLWK YROXPH
YRLGHG !  RQ YDOLG GLDU\
GD\V GLYLGHG E\ WKH WRWDO
QXPEHU RI UHFRUGV ZLWK D
YROXPH YRLGHG !  RQ YDOLG
GLDU\ GD\V GXULQJ  GD\V
ZLWK YROXPH PHDVXUHPHQWV
LQ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
0HDVXUHPHQW
'HILQLWLRQ
&DOFXODWLRQ
6HYHULW\ RI 8ULQDU\ 8UJHQF\
EDVHG RQ 33,86
(DFK PLFWXULWLRQ DQGRU
LQFRQWLQHQFH HSLVRGH LV
JUDGHG XVLQJ WKH IROORZLQJ 
SRLQW VFDOH EDVHG RQ 33,86
  1R XUJHQF\ , IHOW QR
QHHG WR HPSW\ P\ EODGGHU
EXW GLG VR IRU RWKHU UHDVRQV
  0LOG XUJHQF\ , FRXOG
SRVWSRQH YRLGLQJ DV ORQJ DV
QHFHVVDU\ ZLWKRXW IHDU RI
ZHWWLQJ P\VHOI
  0RGHUDWH XUJHQF\ ,
FRXOG SRVWSRQH YRLGLQJ IRU D
VKRUW ZKLOH ZLWKRXW IHDU RI
ZHWWLQJ P\VHOI
  6HYHUH XUJHQF\ , FRXOG
QRW SRVWSRQH YRLGLQJ EXW
KDG WR UXVK WR WKH WRLOHW LQ
RUGHU QRW WR ZHW P\VHOI
  8UJHQF\ LQFRQWLQHQFH ,
OHDNHG EHIRUH DUULYLQJ WR WKH
WRLOHW
1RW DSSOLFDEOH
8UJHQF\ 8ULQDU\
,QFRQWLQHQFH (SLVRGH RU
8UJHQF\ ,QFRQWLQHQFH
(SLVRGH
7KH LQYROXQWDU\ OHDNDJH RI
XULQH DFFRPSDQLHG E\ RU
LPPHGLDWHO\ SUHFHGHG E\
XUJHQF\
2QH XUJHQF\ LQFRQWLQHQFH
HSLVRGH LV FRXQWHG IRU HDFK
UHFRUG RI WKH GLDU\ LQ ZKLFK
WKH IROORZLQJ RFFXUV
LQFRQWLQHQFH HSLVRGH LV
UHFRUGHG
$1'
VHYHULW\ RI XULQDU\ XUJHQF\
UHFRUGHG LV  RU 
127( 2QO\ XUJHQF\
LQFRQWLQHQFH HSLVRGHV
UHFRUGHG RQ D YDOLG GLDU\
GD\ ZLOO EH FRXQWHG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
0HDVXUHPHQW
'HILQLWLRQ
&DOFXODWLRQ
1XPEHU RI 8UJHQF\
,QFRQWLQHQFH (SLVRGHV
1XPEHU RI WLPHV D SDWLHQW
UHFRUGV DQ XUJHQF\
LQFRQWLQHQFH HSLVRGH GXULQJ
WKH GD\ PLFWXULWLRQ GLDU\
SHULRG
1XPEHU RI XUJHQF\
LQFRQWLQHQFH HSLVRGHV
UHFRUGHG RQ YDOLG GLDU\ GD\V
RI WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
0HDQ 1XPEHU RI 8UJHQF\
,QFRQWLQHQFH (SLVRGHV SHU
GD\
$YHUDJH QXPEHU RI WLPHV D
SDWLHQW UHFRUGV DQ XUJHQF\
LQFRQWLQHQFH HSLVRGH SHU
GD\ GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
1XPEHU RI XUJHQF\
LQFRQWLQHQFH HSLVRGHV
UHFRUGHG RQ YDOLG GLDU\ GD\V
GXULQJ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG GLYLGHG E\ WKH
QXPEHU RI YDOLG GLDU\ GD\V
GXULQJ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
8UJHQF\ (SLVRGHV VHYHULW\
RI  RU 
7KH FRPSODLQW RI D VXGGHQ
FRPSHOOLQJ GHVLUH WR SDVV
XULQH ZKLFK LV GLIILFXOW WR
GHIHU
2QH XUJHQF\ HSLVRGH LV
FRXQWHG IRU HDFK UHFRUG RI
WKH GLDU\ LQ ZKLFK WKH
IROORZLQJ RFFXUV
PLFWXULWLRQ RU LQFRQWLQHQFH
HSLVRGH LV UHFRUGHG
$1'
VHYHULW\ RI XULQDU\ XUJHQF\
UHFRUGHG LV  RU 
127( 2QO\ XUJHQF\
HSLVRGHV UHFRUGHG RQ D YDOLG
GLDU\ GD\ ZLOO EH FRXQWHG ,I
DQ HSLVRGH ZDV UHFRUGHG DV
ERWK D PLFWXULWLRQ DQG DQ
LQFRQWLQHQFH HSLVRGH ZLWK D
XULQDU\ XUJHQF\ RI  RU  LW
ZLOO EH FRXQWHG DV RQH
XUJHQF\ HSLVRGH
0HDQ 1XPEHU RI 8UJHQF\
(SLVRGHV VHYHULW\ RI  RU 
SHU GD\
$YHUDJH QXPEHU RI WLPHV D
SDWLHQW UHFRUGV DQ XUJHQF\
HSLVRGH VHYHULW\ RI  RU 
ZLWK RU ZLWKRXW LQFRQWLQHQFH
SHU GD\ GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
6XP RI HDFK UHFRUG ZLWK DQ
XUJHQF\ HSLVRGH VHYHULW\ RI
 RU  UHFRUGHG RQ D YDOLG
GLDU\ GD\ GLYLGHG E\ WKH
QXPEHU RI YDOLG GLDU\ GD\V
GXULQJ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
0HDVXUHPHQW
'HILQLWLRQ
&DOFXODWLRQ
1RFWXULD
:DNLQJ DW QLJKW RQH RU PRUH
WLPHV WR YRLG LH DQ\
YRLGLQJ DVVRFLDWHG ZLWK
VOHHS GLVWXUEDQFH EHWZHHQ
WKH GDWHWLPH WKH SDWLHQW
JRHV WR EHG ZLWK WKH
LQWHQWLRQ WR VOHHS XQWLO WKH
GDWHWLPH WKH SDWLHQWV JHWV
XS LQ WKH PRUQLQJ ZLWK WKH
LQWHQWLRQ WR VWD\ DZDNH $
³QLJKW WLPH´ HSLVRGH LV
FRQVLGHUHG DV D QRFWXULD
HSLVRGH $ ³QLJKW WLPH´
HSLVRGH RI LQFRQWLQHQFH RQO\
WKDW DUH QRW DVVRFLDWHG ZLWK
XUJHQF\ LV QRW FRQVLGHUHG DV
D QRFWXULD HSLVRGH
$ QRFWXULD HSLVRGH LV
FRXQWHG IRU HDFK PLFWXULWLRQ
UHFRUG ZKLFK RFFXUUHG
EHWZHHQ WKH GDWHWLPH RI
JRLQJ WR EHG ZLWK WKH
LQWHQWLRQ WR VOHHS
H[FOXVLYH DQG WKH GDWHWLPH
RI JHWWLQJ XS ZLWK WKH
LQWHQWLRQ WR VWD\ DZDNH
H[FOXVLYH RQ D YDOLG GLDU\
GD\ DQG ZKLFK ZDV
DFFRPSDQLHG E\ D VOHHS
LQWHUUXSWLRQ 1RFWXULD ZLOO
RQO\ EH GHWHUPLQHG IRU
SDWLHQWV ZKR DUH QRW QLJKW
VKLIW ZRUNHUV
1XPEHU RI 1RFWXULD
(SLVRGHV
1XPEHU RI QRFWXULD HSLVRGHV
GXULQJ WKH GD\ PLFWXULWLRQ
GLDU\ SHULRG
6XP RI HDFK QRFWXULD
HSLVRGH UHFRUGHG
0HDQ QXPEHU RI 1RFWXULD
(SLVRGHV SHU GD\
$YHUDJH QXPEHU RI WLPHV D
SDWLHQW UHFRUGV D QRFWXULD
HSLVRGH SHU GD\ GXULQJ WKH
GD\ PLFWXULWLRQ GLDU\
SHULRG
1XPEHU RI QRFWXULD
HSLVRGHV UHFRUGHG RQ YDOLG
GLDU\ GD\V GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG
GLYLGHG E\ WKH QXPEHU RI
YDOLG GLDU\ GD\V GXULQJ WKH
GD\ PLFWXULWLRQ GLDU\
SHULRG

3DWLHQW 3HUFHSWLRQ RI ,QWHQVLW\ RI 8UJHQF\ 6FDOH 33,86
7KH 33,86 LV D VFDOH WKDW ZLOO EH FRPSOHWHG DV SDUW RI WKH PLFWXULWLRQ GLDU\
)RU HDFK PLFWXULWLRQ DQGRU LQFRQWLQHQFH HSLVRGH SDWLHQWV ZLOO EH DVNHG WR UDWH WKH GHJUHH RI
DVVRFLDWHG XUJHQF\ DFFRUGLQJ WR WKH IROORZLQJ YDOLGDWHG SRLQW FDWHJRULFDO VFDOH 7KH
FDWHJRULHV DUH UHFRPPHQGHG E\ WKH &RPPLWWHH IRU 3URSULHWDU\ 0HGLFLQDO 3URGXFWV
>&303(:3 )LQDO@
 ± 1R XUJHQF\ , IHOW QR QHHG WR HPSW\ P\ EODGGHU EXW GLG VR IRU RWKHU UHDVRQV
 ± 0LOG XUJHQF\ , FRXOG SRVWSRQH YRLGLQJ DV ORQJ DV QHFHVVDU\ ZLWKRXW IHDU RI
ZHWWLQJ P\VHOI
 ± 0RGHUDWH XUJHQF\ , FRXOG SRVWSRQH YRLGLQJ IRU D VKRUW ZKLOH ZLWKRXW IHDU RI
ZHWWLQJ P\VHOI
 ± 6HYHUH XUJHQF\ , FRXOG QRW SRVWSRQH YRLGLQJ EXW KDG WR UXVK WR WKH WRLOHW LQ RUGHU
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
QRW WR ZHW P\VHOI
 ± 8UJH LQFRQWLQHQFH , OHDNHG EHIRUH DUULYLQJ DW WKH WRLOHW
7KH 33,86 ZLOO EH FRPSOHWHG DW %DVHOLQH 9LVLW  :HHN  9LVLW  :HHN  9LVLW  :HHN
 9LVLW  DQG (QG RI 7UHDWPHQW

7RWDO 8UJHQF\ DQG )UHTXHQF\ 6FRUH 78)6
7KH 78)6 LV FDOFXODWHG E\ DGGLQJ WKH 33,86 VFRUHV RI HYHU\ YRLG LQ D SDWLHQW¶V GD\ GLDU\
DQG GLYLGLQJ WKLV E\ WKH QXPEHU RI GD\V UHFRUGHG LQ WKH GLDU\

,QWHUQDWLRQDO 3URVWDWH 6\PSWRP 6FRUH ,366
7KH ,366 FRQVLVWV RI VHYHQ TXHVWLRQV FRQFHUQLQJ XULQDU\ V\PSWRPV DQG RQH TXHVWLRQ
FRQFHUQLQJ TXDOLW\ RI OLIH DQG LW FDQ EH GLYLGHG LQWR YRLGLQJ V\PSWRPV LQFRPSOHWH HPSW\LQJ
LQWHUPLWWHQF\ ZHDN VWUHDP DQG VWUDLQLQJ DQG VWRUDJH V\PSWRPV IUHTXHQF\ XUJHQF\ DQG
QRFWXULD 6HH 7DEOH  EHORZ 7KH ,366 FODVVLILFDWLRQ UDQJHV IURP PLOG  WR  WR PRGHUDWH
 RU VHYHUH 
7DEOH  &DOFXODWLRQ RI ,366 6XEVFDOH 6FRUHV DQG ,366 7RWDO 6FRUH 6FDOH
6FDOH
6XP ,WHP 9DOXHV
/RZHVW DQG +LJKHVW 3RVVLEOH 6FRUHV
9RLGLQJ

 
6WRUDJH

 
,366 7RWDO

 
4XDOLW\ RI /LIH

 
7KH ,366 ZLOO EH FRPSOHWHG DW 6FUHHQLQJ 9LVLW  %DVHOLQH 9LVLW  :HHN  9LVLW 
:HHN  9LVLW  :HHN  9LVLW  DQG (QG RI 7UHDWPHQW
$Q H[DPSOH RI WKH ,366 TXHVWLRQQDLUH LV JLYHQ LQ VHFWLRQ  $SSHQGL[ 

2$% 6\PSWRPV 4XDOLW\ RI /LIH %ODGGHU +HDOWK DQG 7UHDWPHQW %HQHILW
2$% KDV VLJQLILFDQW HIIHFWV RQ KHDOWKUHODWHG 4R/ RI WKH DIIOLFWHG SDWLHQWV 7KLV KDV EHHQ
TXDQWLILHG LQ YDULRXV HPSLULFDO VWXGLHV >:DOO HW DO @ 4R/ LV GHWHUPLQHG E\ VRFLR
GHPRJUDSKLF FOLQLFDO SV\FKRORJLFDO DQG VRFLDO IDFWRUV 7KLV XQGHUOLQHV WKH LPSRUWDQFH RI
DVVHVVLQJ WKH SHUFHSWLRQV RI SDWLHQWV WKHPVHOYHV ZKHQ HYDOXDWLQJ WKH HIIHFWV RI PHGLFDO RU
SKDUPDFRORJLFDO WUHDWPHQW >3DOPWDJ @ ,Q WKLV VWXG\ WKH 2YHUDFWLYH %ODGGHU
TXHVWLRQQDLUH 2$%T (4'/ WKH 3DWLHQW 3HUFHSWLRQ RI %ODGGHU &RQGLWLRQ 33%& DQG
7UHDWPHQW 6DWLVIDFWLRQ 将9LVXDO $QDORJ 6FDOH 769$6 ZLOO EH XWLOL]HG

2YHUDFWLYH %ODGGHUTXHVWLRQQDLUH
7KH 2$%T FRQVLVWV RI D WRWDO RI  LWHPVTXHVWLRQV HDFK ZLWK UHVSRQVH RSWLRQV EDVHG RQ D
SRLQW /LNHUW VFDOH  WKURXJK  DQG ZLWK D UHFDOO SHULRG RI WKH SDVW IRXU ZHHNV 7KH LWHPV
DUH JURXSHG LQWR 6\PSWRP %RWKHU DQG HDFK VXEVFDOH RI +HDOWK 5HODWHG 4XDOLW\ RI /LIH
+54/ DV GHVFULEHG EHORZ
6\PSWRP %RWKHU $QVZHUV RQ TXHVWLRQV  WKURXJK  ZLOO EH VXPPHG ZKLFK PHDQV WKH ORZHVW
DQG KLJKHVW SRVVLEOH UDZ VFRUHV DUH  DQG  UHVSHFWLYHO\ ZLWK D SRVVLEOH UDZ VFRUH UDQJH RI
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
 7KH IROORZLQJ IRUPXOD ZLOO EH XVHG WR WUDQVIRUP WKH 6\PSWRP %RWKHU VFRUH ZKLFK ZLOO
UDQJH IURP  WR   ZRUVW VHYHULW\
7UDQVIRUPHG 6FRUH с
ሺ୅ୡ୲୳ୟ୪ୖୟ୵ୗୡ୭୰ୣି୐୭୵ୣୱ୲୔୭ୱୱ୧ୠ୪ୣୖୟ୵ୗୡ୭୰ୣሻ
୔୭ୱୱ୧ୠ୪ୣୖୟ୵ୗୡ୭୰ୣୖୟ୬୥ୣ
ǆ 
$ QHJDWLYH FKDQJH IURP EDVHOLQH WR D VFKHGXOHG YLVLW LQ V\PSWRP ERWKHU VFRUH LQGLFDWHV DQ
LPSURYHPHQW
)RU WKH +54/ VXEVFDOHV FRSLQJ FRQFHUQ VOHHS DQG VRFLDO LQWHUDFWLRQ UDZ VFRUHV ZLOO EH
FDOFXODWHG XVLQJ WKH LWHPV GHVFULEHG LQ WKH WDEOH EHORZ 7KH +54/ WRWDO VFRUH ZLOO EH
FDOFXODWHG E\ DGGLQJ HDFK LQGLYLGXDO +54/ VXEVFDOH VFRUH WRJHWKHU >&R\QH HW DO @
ZKHUH D KLJKHU VFRUH LQGLFDWHV EHWWHU +54/
7KH 2$%T ZLOO EH DVVHVVHG DW %DVHOLQH 9LVLW  :HHN  9LVLW  :HHN  9LVLW  :HHN
 9LVLW  DQG (QG RI 7UHDWPHQW
7DEOH  &DOFXODWLRQ RI +54/ 6XEVFDOH 6FRUHV DQG +54/ 7RWDO 6FRUH 6FDOH
6FDOH
6XP ,WHP 9DOXHV
/RZHVW DQG
+LJKHVW
3RVVLEOH 5DZ
6FRUHV
3RVVLEOH
5DZ
6FRUH
5DQJH
&RSLQJ

 

&RQFHUQ

 

6OHHS

 

6RFLDO LQWHUDFWLRQ

 

+54/ 7RWDO
6XP RI +54/ VXEVFDOHV
 

7KH UDZ VFRUHV ZLOO EH WUDQVIRUPHG E\ WKH IROORZLQJ IRUPXOD ZLWK KLJKHU WUDQVIRUPHG VFRUHV
LQGLFDWLQJ EHWWHU TXDOLW\ RI OLIH >&R\QH HW DO @
7UDQVIRUPHG 6FRUH  
ሺୌ୧୥୦ୣୱ୲୔୭ୱୱ୧ୠ୪ୣୗୡ୭୰ୣି୅ୡ୲୳ୟ୪ୖୟ୵ୗୡ୭୰ୣሻ
୔୭ୱୱ୧ୠ୪ୣୖୟ୵ୗୡ୭୰ୣୖୟ୬୥ୣ
ǆ 
$ SRVLWLYH FKDQJH IURP EDVHOLQH WR D VFKHGXOHG YLVLW IRU D +54/ VFRUH LQGLFDWHV
LPSURYHPHQW
)RU WKH V\PSWRP ERWKHU VFRUH DQG WKH VXEVFDOH DQDO\VLV LI   RI WKH VFDOH LWHPV DUH
PLVVLQJ WKH VFDOH VKRXOG EH UHWDLQHG ZLWK WKH PHDQ VFDOH VFRUH RI WKH LWHPV SUHVHQW XVHG WR
LPSXWH D VFRUH IRU WKH PLVVLQJ LWHPV ,I   RI WKH LWHPV DUH PLVVLQJ QR VFDOH VFRUH VKRXOG
EH FDOFXODWHG WKH VXEVFDOH VFRUH VKRXOG EH FRQVLGHUHG PLVVLQJ ,I D VXEVFDOH VFRUH IRU
FDOFXODWLRQ RI +54/ 7RWDO LV PLVVLQJ WKH +54/ 7RWDO VFRUH ZLOO QRW EH FDOFXODWHG
$Q H[DPSOH RI WKH 2$% TXHVWLRQQDLUH LV JLYHQ LQ VHFWLRQ  $SSHQGL[ 

3DWLHQW 3HUFHSWLRQ RI %ODGGHU &RQGLWLRQ 33%&
7KH 33%& LV D YDOLGDWHG JOREDO DVVHVVPHQW WRRO XVLQJ D SRLQW /LNHUW VFDOH WKDW DVNV
SDWLHQWV WR UDWH WKHLU VXEMHFWLYH LPSUHVVLRQ RI WKHLU FXUUHQW EODGGHU FRQGLWLRQ >&R\QH HW DO
@
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7KH 33%& KDV WKH IROORZLQJ UHVSRQVH RSWLRQV ZKHUH D KLJKHU YDOXH HTXDWHV D ZRUVH
FRQGLWLRQ
x
  0\ EODGGHU FRQGLWLRQ GRHV QRW FDXVH PH DQ\ SUREOHPV DW DOO
x
  0\ EODGGHU FRQGLWLRQ FDXVHV PH VRPH YHU\ PLQRU SUREOHPV
x
  0\ EODGGHU FRQGLWLRQ FDXVHV PH VRPH PLQRU SUREOHPV
x
  0\ EODGGHU FRQGLWLRQ FDXVHV PH VRPH PRGHUDWH SUREOHPV
x
  0\ EODGGHU FRQGLWLRQ FDXVHV PH VHYHUH SUREOHPV
x
  0\ EODGGHU FRQGLWLRQ FDXVHV PH PDQ\ VHYHUH SUREOHPV
7KH 33%& TXHVWLRQQDLUH ZLOO EH DVVHVVHG DW %DVHOLQH 9LVLW  :HHN  9LVLW  :HHN 
9LVLW  :HHN  9LVLW  DQG (QG RI 7UHDWPHQW

(4'/
7KH (4'/ LV DQ LQWHUQDWLRQDO VWDQGDUGL]HG QRQGLVHDVH VSHFLILF LH JHQHULF LQVWUXPHQW
IRU GHVFULELQJ DQG YDOXLQJ KHDOWK VWDWXV ,W KDV D PXOWLGLPHQVLRQDO PHDVXUH RI KHDOWKUHODWHG
4R/ FDSDEOH RI EHLQJ H[SUHVVHG DV D VLQJOH LQGH[ YDOXH DQG VSHFLILFDOO\ GHVLJQHG WR
FRPSOHPHQW RWKHU KHDOWK VWDWXV PHDVXUHV >(XURTRO  +HUGPDQ HW DO @
7KH (4'/ KDV ILYH GLPHQVLRQV 0RELOLW\ 6HOI&DUH 8VXDO $FWLYLWLHV 3DLQ'LVFRPIRUW
DQG $Q[LHW\'HSUHVVLRQ (DFK GLPHQVLRQ KDV  UHVSRQVH OHYHOV HJ  QR SUREOHPV
 VOLJKW SUREOHPV  PRGHUDWH SUREOHPV  VHYHUH SUREOHPV DQG  H[WUHPH
SUREOHPVXQDEOH WR SHUIRUP WKH DFWLYLW\ ,Q DGGLWLRQ LW KDV D YLVXDO DQDORJ VFDOH WKDW HOLFLWV D
VHOIUDWLQJ E\ WKH UHVSRQGHQW RI KLV KHDOWK VWDWXV
(4'/ ZLOO EH DVVHVVHG DW %DVHOLQH 9LVLW  :HHN  9LVLW  :HHN  9LVLW  :HHN
 DQG (QG RI 7UHDWPHQW
$Q H[DPSOH RI WKH (4'/ TXHVWLRQQDLUH DQG YLVXDO DQDORJ VFDOH LV JLYHQ LQ VHFWLRQV 
DQG  $SSHQGL[ D 	E

7UHDWPHQW 6DWLVIDFWLRQ ± 9LVXDO $QDORJ 6FDOH 769$6
7KH 769$6 LV D YLVXDO DQDORJ VFDOH WKDW DVNV SDWLHQWV WR UDWH WKHLU VDWLVIDFWLRQ ZLWK WKH
WUHDWPHQW E\ SODFLQJ D YHUWLFDO PDUN RQ D OLQH WKDW UXQV IURP  1R QRW DW DOO WR  <HV
FRPSOHWHO\ VDWLVILHG 7KH 769$6 ZLOO EH DVVHVVHG DW %DVHOLQH 9LVLW  :HHN  9LVLW 
:HHN  9LVLW  :HHN  9LVLW  DQG (QG RI 7UHDWPHQW

2WKHU (IILFDF\ 9DULDEOHV
7KH H[SORUDWRU\ HQGSRLQW LV
x
3HUIRUPDQFH RI VXEJURXS DQDO\VHV E\ 36$ FXWRII VFRUHV IRU   
x
3HUIRUPDQFH RI VXEJURXS DQDO\VHV E\ DOSKD UHGXFWDVH LQKLELWRU $5, XVH DW
EDVHOLQH <HV RU 1R XVH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

6DIHW\ 9DULDEOHV
6DIHW\ ZLOO EH DVVHVVHG E\ HYDOXDWLRQ RI WKH IROORZLQJ YDULDEOHV
x
7UHDWPHQWHPHUJHQW DGYHUVH HYHQWV 7($(V IUHTXHQF\ VHYHULW\ VHULRXVQHVV DQG
UHODWLRQVKLS WR VWXG\ GUXJ
x
$GYHUVH (YHQWV RI 3RVVLEOH +HSDWLF 2ULJLQ 6HH 6HFWLRQ   $SSHQGL[ 
x
$FXWH 8ULQDU\ 5HWHQWLRQ XULQDU\ UHWHQWLRQ UHTXLULQJ FDWKHWHUL]DWLRQ
x
%HQLJQ SURVWDWLF REVWUXFWLRQ %32 UHTXLULQJ VXUJHU\
x
8ULQDU\ 7UDFW ,QIHFWLRQV
x
&OLQLFDO ODERUDWRU\ YDULDEOHV KHPDWRORJ\ VHUXP FKHPLVWU\ LQFOXGLQJ OLYHU IXQFWLRQ
WHVWV DQG XULQDO\VLV
x
&DUGLRYDVFXODU HYHQWV YLWDO VLJQV VLWWLQJ V\VWROLF DQG GLDVWROLF EORRG SUHVVXUH DQG
SXOVH UDWH KRPH EORRG SUHVVXUH PRQLWRULQJ >+%30@ DQG RIILFH PHDVXUHPHQWV 0,
VWURNH G\VUK\WKPLDV DQG XQFRQWUROOHG K\SHUWHQVLRQ
x
3K\VLFDO ([DPLQDWLRQ
x
OHDG HOHFWURFDUGLRJUDP (&*
x
&KDQJH LQ 3RVW9RLG 5HVLGXDO 9ROXPH 395 DQG 4PD[
7($( LV GHILQHG DV DQ DGYHUVH HYHQW REVHUYHG DIWHU VWDUWLQJ DGPLQLVWUDWLRQ RI WKH WHVW
GUXJFRPSDUDWLYH GUXJ ,I WKH DGYHUVH HYHQW RFFXUV RQ 'D\  DQG WKH RQVHW FKHFN ER[ LV
PDUNHG ³2QVHW DIWHU ILUVW GRVH RI VWXG\ GUXJ´ RU WKH RQVHW FKHFN ER[ LV OHIW EODQN WKHQ WKH
DGYHUVH HYHQW ZLOO EH FRQVLGHUHG WUHDWPHQW HPHUJHQW ,I WKH DGYHUVH HYHQW RFFXUV RQ 'D\ 
DQG WKH RQVHW FKHFN ER[ LV PDUNHG ³2QVHW EHIRUH ILUVW GRVH RI VWXG\ GUXJ´ WKHQ WKH DGYHUVH
HYHQW ZLOO QRW EH FRQVLGHUHG WUHDWPHQW HPHUJHQW ,I D SDWLHQW H[SHULHQFHV DQ HYHQW ERWK
GXULQJ WKH SUHLQYHVWLJDWLRQDO SHULRG DQG GXULQJ WKH LQYHVWLJDWLRQDO SHULRG WKH HYHQW ZLOO EH
FRQVLGHUHG DV D 7($( RQO\ LI LW KDV ZRUVHQHG LQ VHYHULW\ LH LW LV UHSRUWHG ZLWK D QHZ VWDUW
GDWH $OO DGYHUVH HYHQWV FROOHFWHG WKDW EHJLQ ZLWKLQ  GD\V DIWHU WDNLQJ WKH ODVW GRVH RI
VWXG\ GUXJ ZLOO DOVR EH FRXQWHG DV 7($(V
$ GUXJUHODWHG 7($( LV GHILQHG DV DQ\ 7($( ZLWK SRVVLEOH RU SUREDEOH UHODWLRQVKLS WR VWXG\
WUHDWPHQW DV DVVHVVHG E\ WKH LQYHVWLJDWRU RU ZLWK PLVVLQJ DVVHVVPHQW RI WKH FDXVDO
UHODWLRQVKLS

2WKHU 9DULDEOHV

'XUDWLRQ RI ([SRVXUH
)RU HDFK SDWLHQW WKH GXUDWLRQ RI H[SRVXUH RQ GRXEOHEOLQG WUHDWPHQW ZLOO EH FDOFXODWHG LQ GD\V
XVLQJ WKH IROORZLQJ IRUPXOD
'DWH RI ODVW GRVH RI VWXG\ GUXJ ± 'DWH RI ILUVW GRVH RI VWXG\ GUXJ  
ZKHUH WKH GDWHV RI WKH ILUVW DQG ODVW NQRZQ GRXEOHEOLQG WUHDWPHQW DUH UHFRUGHG RQ WKH VWXG\
GUXJ GRVLQJ H&5) SDJHV ,I WKH\ DUH PLVVLQJ WKHQ LPSXWHG GDWHV DV SHU 6XEVHFWLRQ 
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
ZLOO EH XVHG $Q\ JDSV LQ GRVLQJ ZLOO EH LQFOXGHG LQ WKH WRWDO QXPEHU RI GD\V RQ GRXEOH
EOLQG WUHDWPHQW
)RU HDFK SDWLHQW WKH GXUDWLRQ RI H[SRVXUH RQ 7DPVXORVLQ ZLOO EH FDOFXODWHG LQ GD\V XVLQJ WKH
IROORZLQJ IRUPXOD
'DWH RI ODVW GRVH RI 7DPVXORVLQ ± 'DWH RI ILUVW GRVH RI 7DPVXORVLQ  
ZKHUH WKH GDWHV RI WKH ILUVW DQG ODVW NQRZQ 7DPVXORVLQ WUHDWPHQW DUH UHFRUGHG RQ 7DPVXORVLQ
GRVLQJ H&5) SDJHV

3HUFHQW 2YHUDOO &RPSOLDQFH
'XULQJ WKH GRXEOHEOLQG WUHDWPHQW SHULRG SDWLHQWV DUH VXSSRVHG WR WDNH D PJ WDEOHW RQFH
GDLO\ DQG ZLOO LQFUHDVH WR PJ DIWHU  ZHHNV 2YHUDOO FRPSOLDQFH WR WKH GRVLQJ VFKHGXOH
ZLOO EH H[DPLQHG IRU SDWLHQWV LQ WKH VDIHW\ SRSXODWLRQ ZKRVH WRWDO WDEOHW FRXQW DQG GXUDWLRQ RI
H[SRVXUH LV NQRZQ 7KH SHUFHQW FRPSOLDQFH LV GHILQHG DV WKH WRWDO QXPEHU RI WDEOHWV
FRQVXPHG GLYLGHG E\ WKH WRWDO QXPEHU RI WDEOHWV WKDW VKRXOG KDYH EHHQ WDNHQ WLPHV 
7RWDO QXPEHU RI WDEOHWV FRQVXPHG [   >2YHUDOO GXUDWLRQ RI H[SRVXUH 
'XUDWLRQ RI H[SRVXUH RQ PJ@
ZKHUH WRWDO QXPEHU RI WDEOHWV FRQVXPHG ZLOO EH FDOFXODWHG DV
7RWDO QXPEHU RI WDEOHWV GLVSHQVHG ± 7RWDO QXPEHU RI WDEOHWV UHWXUQHG
7KH TXDQWLW\ RI VWXG\ GUXJ GLVSHQVHG WR DQG UHWXUQHG E\ WKH SDWLHQW ZLOO EH FRXQWHG DQG
UHFRUGHG RQ WKH VWXG\ GUXJ GRVLQJ H&5) SDJHV
2YHUDOO FRPSOLDQFH RI 7DPVXORVLQ ZLOO EH FRPSXWHG LQ D VLPLODU SDWWHUQ XVLQJ WKH IROORZLQJ
IRUPXOD
7RWDO QXPEHU RI WDEOHWV FRQVXPHG [   2YHUDOO GXUDWLRQ RI 7DPVXORVLQ H[SRVXUH

3UHYLRXV 3URKLELWHG DQG &RQFRPLWDQW 0HGLFDWLRQ

3UHYLRXV 0HGLFDWLRQ
3UHYLRXV PHGLFDWLRQ LV GHILQHG DV PHGLFDWLRQ ZLWK DW OHDVW RQH GRVH WDNHQ ZLWKLQ  GD\V
SULRU WR VFUHHQLQJ LH ILUVW RU ODVW PHGLFDWLRQ LQWDNH LV SULRU WR ILUVW WDPVXORVLQ K\GURFKORULGH
UXQLQ GRVH GDWH H[FOXVLYH $OO SUHYLRXV 2$% PHGLFDWLRQV UHJDUGOHVV RI ZKHQ WKH\ ZHUH
WDNHQ ZLOO EH FROOHFWHG RQ WKH H&5) 3UHYLRXV QRQ2$% PHGLFDWLRQV ZLOO RQO\ EH FROOHFWHG RQ
WKH H&5) LI WDNHQ ZLWKLQ  GD\V SULRU WR VFUHHQLQJ

3URKLELWHG 0HGLFDWLRQ
8VH RI WKHVH PHGLFDWLRQV LQ DQ\ IRUPXODWLRQ LV QRW SHUPLWWHG EHWZHHQ 6FUHHQLQJ 9LVLW  DQG
:HHN )ROORZXS SKRQH FDOO 9LVLW  &XUUHQW RU SUHYLRXV XVH RI PLUDEHJURQ ZLWKLQ  PRQWKV
SULRU WR 6FUHHQLQJ 9LVLW  LV DOVR SURKLELWHG 7KLV OLVW LV QRW H[KDXVWLYH ,Q FDVH RI GRXEW WKH
,QYHVWLJDWRU PXVW FRQWDFW WKH ORFDO VWXG\ PRQLWRU 7KHVH PHGLFDWLRQV PXVW KDYH EHHQ
GLVFRQWLQXHG DW OHDVW  GD\V SULRU WR 6FUHHQLQJ 9LVLW 
7DEOH  3DUW $ ±3URKLELWHG 0HGLFDWLRQV
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
$OSKD DQG 1RQVHOHFWLYH $GUHQHUJLF %ORFNHUV
$OIX]RVLQ
3UD]RVLQ
'R[D]RVLQ
7HUD]RVLQ
6LORGRVLQ
7UD]RGRQH
3KHQR[\EHQ]DPLQH
3KHQWRODPLQH
7ROD]ROLQH
7\SLFDODW\SLFDO DQWLSV\FKRWLFV
$QWLFKROLQHUJLFV$QWLVSDVPRGLFV
$WURSLQH
%DFORIHQ
%LSHULGHQ
&ORPLSUDPLQH
&\FOREHQ]DSULQH
'DULIHQDFLQ
'LF\FORPLQH'LF\FORYHULQH
(PHSURQLXP
*O\FRS\UURQLXP*O\FRS\UURODWH
)HVRWHURGLQH
)ODYR[DWH
+\RVFLQH
+\RVF\DPLQH
,SUDWURSLXP
,VRSURSDPLGH
2USKHQDGULQH
2[\EXW\QLQ
2[\SKHQF\FOLPLQH
3URSDQWKHOLQH
3URSLYHULQH
6FRSRODPLQH%XW\OK\RVFLQH
7ROWHURGLQH
7URVSLXP
2WLORQLXP
7LRWURSLXP
6ROLIHQDFLQ
3RWHQW DQG 0RGHUDWH &<3$ ,QKLELWRUV
,QGLQDYLU
1HOILQDYLU
5LWRQDYLU
&ODULWKURP\FLQ
,WUDFRQD]ROH
.HWRFRQD]ROH
1HID]DGRQH
6DTXLQDYLU
7HOLWKURP\FLQ
&LPHWLGLQH
&ORWULPD]ROH
&\FORVSRULQH
(U\WKURP\FLQ
)OXFRQD]ROH
,WUDFRQD]ROH
.HWRFRQD]ROH
0DFUROLGH DQWLELRWLFV
6WURQJ DQG 0RGHUDWH ,QKLELWRUV RI &<3' 6XEVWUDWHV DQG WKRVH ZLWK 1DUURZ 7KHUDSHXWLF
,QGH[
$ULSLSUD]ROH QHXUROHSWLF
$PLWULSW\OLQH 1RUWULSW\OLQH
7&$
'RQHSH]LO $FHW\OFKROLQHVWHUDVH
LQKLELWRU
7KLRULGD]LQH DQWLSV\FKRWLF
)OHFDLQLGH DQWLDUUK\WKPLF
3URSDIHQRQH DQWLDUUK\WKPLF
,PLSUDPLQH'HVLSUDPLQH 7&$
7UDPDGRO DQDOJHVLF
9HQODID[LQ'HVYHQOD[DILQH
615,
3DUR[HWLQH
7HUELQDILQH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
3DUW % 0HGLFDWLRQV 3HUPLWWHG :LWK 5HVWULFWLRQV
0HGLFDWLRQV UHVWULFWHG EHWZHHQ 6FUHHQLQJ 9LVLW  DQG )ROORZ8S 3KRQH &DOO 9LVLW  LQFOXGH
ORRS GLXUHWLFV 3'( LQKLELWRUV DQG $OSKD UHGXFWDVH LQKLELWRUV $OO PHGLFDWLRQV LQ 3DUW % RI
$SSHQGL[  DUH SHUPLWWHG SURYLGHG WKH SDWLHQW KDV EHHQ WDNLQJ WKLV PHGLFDWLRQ RQ D ORQJWHUP
EDVLV LH KDV QRW VWRSSHG RU VWDUWHG RU FKDQJHG GRVH ZLWKLQ WKH  GD\V SULRU WR 6FUHHQLQJ 9LVLW
 QR QHZ GUXJ RI WKH VDPH FODVV KDV EHHQ DGGHG WR WKH UHJLPHQ ZLWKLQ WKH  GD\V SULRU WR
6FUHHQLQJ 9LVLW  DQG WKH SDWLHQW UHPDLQV RQ WKH PHGLFDWLRQ DW WKH VDPH GRVH GXULQJ WKH FRXUVH
RI WKH VWXG\ )RU DOSKD UHGXFWDVH LQKLELWRUV WKH SDWLHQW PXVW KDYH EHHQ WDNLQJ WKH PHGLFDWLRQ
IRU DW OHDVW  PRQWKV 1R DOSKDEORFNHUV RWKHU WKDQ WDPVXORVLQ K\GURFKORULGH DUH DOORZHG
,QWHUPLWWHQW XVH RI 3'( LQKLELWRUV HJ WDGDODILO IRU WUHDWLQJ HUHFWLOH G\VIXQFWLRQ (' LV
DOORZHG 3'( LQKLELWRUV WKDW DUH WDNHQ RQ D GDLO\ EDVLV IRU WKH PDQDJHPHQW RI /876 DUH QRW
DOORZHG
7DEOH  3DUW % ± 0HGLFDWLRQV 3HUPLWWHG :LWK 5HVWULFWLRQV
/RRS 'LXUHWLFV
)XURVHPLGH
%XPHWDQLGH
3LUHWDQLGH
DOSKD 5HGXFWDVH ,QKLELWRUV PLQLPXP  PRQWKV GXUDWLRQ
'XWDVWHULGH
)LQDVWHULGH
3'( ,QKLELWRUV RQO\ LQWHUPLWWHQW XVH IRU (' LV DOORZHG GDLO\ XVH IRU %3+/876 LV
SURKLELWHG
6LOGHQDILO
7DGDODILO
9DUGHQDILO

&RQFRPLWDQW 0HGLFDWLRQ
&RQFRPLWDQW PHGLFDWLRQ GXULQJ WKH WDPVXORVLQ K\GURFKORULGH UXQLQ SHULRG LV GHILQHG DV
PHGLFDWLRQ ZLWK DW OHDVW RQH GRVH WDNHQ EHWZHHQ WKH GDWH RI ILUVW GRVH LQFOXVLYH RI UXQLQ VWXG\
PHGLFDWLRQ DQG WKH GDWH RI ILUVW GRVH QRW LQFOXVLYH RI GRXEOHEOLQG VWXG\ GUXJ
&RQFRPLWDQW PHGLFDWLRQ GXULQJ WKH GRXEOHEOLQG WUHDWPHQW SHULRG LV GHILQHG DV PHGLFDWLRQ ZLWK
DW OHDVW RQH GRVH WDNHQ EHWZHHQ WKH GDWH RI ILUVW GRVH LQFOXVLYH RI GRXEOHEOLQG VWXG\ PHGLFDWLRQ
DQG WKH ODVW GRVH RI GRXEOHEOLQG WUHDWPHQW LQFOXVLYH
)RU DERYH YDULDEOHV LPSXWDWLRQ PHWKRGV ZLOO EH XVHG LQ FDVH RI PLVVLQJ PHGLFDWLRQ LQWDNH GDWHV

'HPRJUDSKLFV
7KH SDWLHQW¶V DJH VH[ UDFH HWKQLFLW\ KHLJKW DQG ZHLJKW ZLOO EH UHFRUGHG DW 6FUHHQLQJ 9LVLW


0HGLFDO +LVWRU\
0HGLFDO KLVWRU\ RWKHU WKDQ IRU RYHUDFWLYH EODGGHU LQFOXGLQJ VPRNLQJ KLVWRU\ ZLOO EH
REWDLQHG DW 6FUHHQLQJ 9LVLW  IURP HDFK SDWLHQW $OO UHOHYDQW SDVW DQG SUHVHQW FRQGLWLRQV DV
ZHOO DV SULRU VXUJLFDO SURFHGXUHV ZLOO EH UHFRUGHG IRU WKH PDLQ ERG\ V\VWHPV

'LDJQRVLV RI WKH 7DUJHW 'LVHDVH 6HYHULW\ DQG 'XUDWLRQ RI 'LVHDVH
$ GHWDLOHG KLVWRU\ RI 2$% DQG ORZHU XULQDU\ WUDFW V\PSWRPV /876 GXH WR %HQLJQ 3URVWDWLF
+\SHUSODVLD %3+ IRU HDFK SDWLHQW ZLOO EH REWDLQHG DW 6FUHHQLQJ 9LVLW  7KLV LQFOXGHV GDWH
RI RQVHW RI 2$% V\PSWRPV 2$% V\PSWRPV DW WLPH RI GLDJQRVLV DQG DW 6FUHHQLQJ 2$%
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
QRQGUXJ WKHUDS\ DQG PHGLFDWLRQ KLVWRU\ IRU 2$% DQG UHDVRQ IRU WUHDWPHQW WHUPLQDWLRQ ,Q
DGGLWLRQ LQIRUPDWLRQ UHJDUGLQJ WKH KLVWRU\ RI %3+ DQG /876 ZLOO EH FROOHFWHG

67$7,67,&$/ 0(7+2'2/2*<

*HQHUDO &RQVLGHUDWLRQV
,Q JHQHUDO EDVHOLQH LV GHILQHG DV WKH ODVW PHDVXUHPHQW EHIRUH WKH ILUVW GRVH RI GRXEOHEOLQG
VWXG\ GUXJ )RU YDULDEOHV EDVHG RQ WKH PLFWXULWLRQ HOHFWURQLF GLDU\ WKH  GD\V RI WKH GLDU\
UHFRUGHG SULRU WR WKH EDVHOLQH YLVLW ZLOO EH XVHG WR GHULYH WKHVH YDULDEOHV DW EDVHOLQH MXVW DV WKH
 GLDU\ GD\V EHIRUH HDFK SRVWEDVHOLQH YLVLW ZLOO EH XVHG WR GHULYH WKHVH YDULDEOHV DW WKHVH
YLVLWV
7KH (QG RI 7UHDWPHQW (R7 YLVLW LV GHILQHG DV WKH ODVW SRVWEDVHOLQH YLVLW GXULQJ WKH GRXEOH
EOLQG WUHDWPHQW SHULRG IRU ZKLFK GDWD LV DYDLODEOH 7KH (R7 YLVLW YDOXH IRU GLDU\ YDULDEOHV LV
WKH DYHUDJH RU QXPEHU RI WKH GLDU\ PHDVXUHPHQWV IRU :HHN  DV DSSOLFDEOH ,I QR :HHN 
GLDU\ GDWD PHDVXUHPHQWV DUH DYDLODEOH WKHQ WKH ODVW DYDLODEOH HDUOLHU SRVWEDVHOLQH DYHUDJH RU
QXPEHU RI WKH GLDU\ PHDVXUHPHQWV ZLWKLQ D GHVLJQDWHG YLVLW ZLQGRZ ZLOO EH XVHG /2&)
'DWD IURP WKH (R7 YLVLW ZLOO EH DQDO\]HG WR DFFRXQW IRU SDWLHQWV SUHPDWXUHO\ WHUPLQDWLQJ WKH
VWXG\ DQG LV UHJDUGHG DV WKH SULPDU\ YLVLW 7KH (27 YLVLW ZLOO EH :HHN (R7 9LVLW  IRU
SDWLHQWV ZKR FRPSOHWH WKH VWXG\
)RU FRQWLQXRXV YDULDEOHV GHVFULSWLYH VWDWLVWLFV ZLOO LQFOXGH WKH QXPEHU RI SDWLHQWV Q PHDQ
VWDQGDUG GHYLDWLRQ 6' PHGLDQ PLQLPXP DQG PD[LPXP :KHQ QHHGHG WKH XVH RI RWKHU
SHUFHQWLOHV HJ    DQG  ZLOO EH PHQWLRQHG LQ WKH UHOHYDQW VHFWLRQ
)UHTXHQFLHV DQG SHUFHQWDJHV ZLOO EH GLVSOD\HG IRU FDWHJRULFDO GDWD 3HUFHQWDJHV E\ FDWHJRULHV
ZLOO EH EDVHG RQ WKH QXPEHU RI SDWLHQWV ZLWK QR PLVVLQJ GDWD LH ZLOO DGG XS WR 
$OO VWDWLVWLFDO FRPSDULVRQV ZLOO EH PDGH XVLQJ D WZRVLGHG WHVW DW Į   VLJQLILFDQFH OHYHO
DQG FRQILGHQFH LQWHUYDOV ZLOO EH UHSRUWHG ZLWK D FRYHUDJH FRQVLVWHQW ZLWK WKLV VLJQLILFDQFH
OHYHO
$OO GDWD SURFHVVLQJ VXPPDUL]DWLRQ DQG DQDO\VHV ZLOO EH SHUIRUPHG XVLQJ 6$6 9HUVLRQ 
RU KLJKHU 6SHFLILFDWLRQV IRU WDEOH ILJXUHV DQG GDWD OLVWLQJ IRUPDWV FDQ EH IRXQG LQ WKH 7/)
VSHFLILFDWLRQV IRU WKLV VWXG\
)RU WKH GHILQLWLRQ RI VXEJURXSV RI LQWHUHVW SOHDVH UHIHU WR VHFWLRQ 

/DVW 2EVHUYDWLRQ &DUULHG )RUZDUG /2&)
)RU WKH HIILFDF\ GLDU\ GDWD WKH (R7 YDOXH ZLOO EH FDOFXODWHG DV WKH DYHUDJH RU WKH FRXQW RI WKH
YDOLG GLDU\ PHDVXUHPHQWV UHSRUWHG LQ WKH ODVW  YDOLG GLDU\ GD\V RI WKH DQDO\VLV YLVLW ZLQGRZ
SULRU WR (R7 )RU SDWLHQWV ZKR ZLWKGUDZ EHIRUH ZHHN  WKH ODVW DYDLODEOH SRVWEDVHOLQH
DYHUDJH RI WKH GLDU\ GDWD PHDVXUHPHQWV ZLOO EH FDUULHG IRUZDUG DV WKH (R7 YDOXH /2&)
)RU WKH QRQGLDU\ HIILFDF\ GDWD DQG VDIHW\ GDWD WKH (R7 YDOXH ZLOO EH WKH ODVW PHDVXUHPHQW
ZLWKLQ WKH ZHHN  YLVLW GD\ ZLQGRZV )RU SDWLHQWV ZKR ZLWKGUDZ EHIRUH ZHHN  WKH ODVW
PHDVXUHPHQW ZLWKLQ WKH DQDO\VLV YLVLW ZLQGRZ RI WKH ODVW DYDLODEOH SRVWEDVHOLQH YLVLW ZLOO EH
FDUULHG IRUZDUG DV WKH (R7 YDOXH /2&)
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

0RGHO 6WUXFWXUH  $QDO\VLV RI &RYDULDQFH $1&29$
&KDQJHV IURP EDVHOLQH WR D SRVWEDVHOLQH YLVLW IRU YDULDEOHV IRU ZKLFK D QRUPDO GLVWULEXWLRQ LV
DVVXPHG ZLOO EH DQDO\]HG XVLQJ WKH IROORZLQJ $1&29$ PRGHO
&KLMNV  ȕ  ȕ%DVHLMNV  7UWL  5HJLRQM  $JH*USN  א
:KHUH &KLMNV LV WKH FKDQJH IURP EDVHOLQH IRU SDWLHQW V IURP WUHDWPHQW JURXS L JHRJUDSKLF
UHJLRQ 1$(8 JURXS M DQG DJH JURXS N ȕ DQG ȕ DUH WKH LQWHUFHSW DQG WKH VORSH RI &KLMNV DV
D IXQFWLRQ RI WKH EDVHOLQH YDOXH DQG א      Ǥ
7KH $1&29$ PRGHO UHVXOWV ZLOO EH SUHVHQWHG ZLWK OHDVW VTXDUHV /6 PHDQV DQG WZRVLGHG
 FRQILGHQFH LQWHUYDOV &,V IRU PHDQ FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK WUHDWPHQW JURXS
'LIIHUHQFHV LQ /6 PHDQV EHWZHHQ 0LUDEHJURQ YHUVXV SODFHER ZLOO EH GHULYHG WRJHWKHU ZLWK
WZRVLGHG  &,V 7VWDWLVWLFV FRUUHVSRQGLQJ WR WKH 7\SH ,,, VXPV RI VTXDUHV IRU WKH
GLIIHUHQFHV LQ WKH /6 PHDQV ZLOO EH XVHG WR REWDLQ SYDOXHV IRU WKH FRPSDULVRQV 'LVWULEXWLRQ
DVVXPSWLRQV XQGHUO\LQJ WKH DQDO\VLV ZLOO EH DVVHVVHG E\ UHVLGXDO SORWV
7KH 6$6 FRGH XVHG WR LPSOHPHQW WKLV WHVW ZLOO EH VLPLODU WR WKDW VKRZQ EHORZ
352& 0,;(' GDWD GDWDVHW &297(67 12&/35,17 0(7+2' 0/
&/$66 7UW *HQGHU 5HJLRQ $JH*US
02'(/ &K %DVH 7UW 5HJLRQ $JH*US  62/87,21 &/
/60($16 7UW  &/ 20 $7 0($16 3',))
(67,0$7( µ0LUDEHJURQ YHUVXV SODFHER¶ 7UW   (67 &/
581
6$6 FRGH XVHG WR LPSOHPHQW WKH VWUDWLILHG UDQN $1&29$ ZLOO EH VLPLODU WR WKDW VKRZQ
EHORZ
352& 5$1. GDWD GDWDVHW 13/86 7,(6 0($1 287 5$1.
9$5 %DVH &K 
5$1.6 %$6(5$1. &+5$1. 
%< 5HJLRQ 
581 
352& 0,;(' GDWD 5$1. 0(7+2' 0/ 5(6,'8$/ 2873 287
.((3 5HJLRQ &+5$1. %$6(5$1. 7UW 5HVLG
%< 5HJLRQ
02'(/ &+5$1.  %$6(5$1.
581 
352& )5(4 GDWD RXW 
7$%/(6 5HJLRQ7UW5HVLG QRSULQW &0+ 
2'6 287387 &0+  RXW 
581 

0L[HG 0RGHO 5HSHDWHG 0HDVXUHV 0050
&KDQJHV IURP EDVHOLQH WR HDFK SRVWEDVHOLQH YLVLW ³W´ HJ LQ PHDQ QXPEHU RI PLFWXULWLRQV
SHU GD\ 352 YDOXHV 9LWDO VLJQV HWF ZLOO EH DQDO\]HG XVLQJ WKH IROORZLQJ 0050 PRGHO
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
&KLMNVW  ȕ  ȕ%DVHLMNV  7UWL  5HJLRQM  $JH*USN  7LPHW ൅ȗ ൅Ǧ
൅א
:KHUH &KLMNVW LV WKH FKDQJH IURP EDVHOLQH LH WLPH   ZHHN IRU SDWLHQW V IURP WUHDWPHQW
JURXS L JHRJUDSKLF UHJLRQ JURXS M DJH JURXS N DQG IRU JLYHQ WLPH SRLQW W LH WLPH    DQG
 ZHHNV ȕ DQG ȕ DUH WKH LQWHUFHSW DQG WKH VORSH RI &KLMNV DV D IXQFWLRQ RI WKH EDVHOLQH
YDOXH DQG א      Ǥ ȗ   ǦǦ
    Ǧ        
Ǧ   ǦǤ
7KH 0050 PRGHO UHVXOWV ZLOO EH SUHVHQWHG ZLWK /6 PHDQV VWDQGDUG HUURUV DQG WZRVLGHG
 &,V IRU PHDQ FKDQJH IURP EDVHOLQH DW DOO WLPH SRLQWV   DQG  ZHHNV ZLWKLQ HDFK
WUHDWPHQW JURXS 7KH GHQRPLQDWRU GHJUHHV RI IUHHGRP ZLOO EH FDOFXODWHG DFFRUGLQJ WR WKH
.HQZDUG5RJHU PHWKRG ,Q DGGLWLRQ GLIIHUHQFHV LQ /6 PHDQV EHWZHHQ 0LUDEHJURQ YHUVXV
SODFHER DW HDFK WLPH SRLQW ZLOO EH GHULYHG WRJHWKHU ZLWK WZRVLGHG  &,V 7VWDWLVWLFV
FRUUHVSRQGLQJ WR WKH 7\SH ,,, VXPV RI VTXDUHV IRU WKH GLIIHUHQFHV LQ WKH /6 PHDQV ZLOO EH
XVHG WR REWDLQ SYDOXHV IRU WKH FRPSDULVRQV
7KH 6$6 FRGH XVHG WR LPSOHPHQW WKLV WHVW ZLOO EH VLPLODU WR WKDW VKRZQ EHORZ
352& 0,;(' GDWD GDWDVHW &297(67 12&/35,17 0(7+2' 0/
&/$66 ,' 7UW 7LPH *HQGHU 5HJLRQ $JH*US
02'(/ FK %DVH 7UW 5HJLRQ $JH*US 7LPH 7LPH7UW  62/87,21 &/
'')0 .HQZDUG5RJHU
5(3($7(' 7LPH 68%-(&7  ,' 7<3(  81 5 5&255
/60($16 7UW7LPH  &/ 3',))
(67,0$7( µ0LUDEHJURQ YHUVXV SODFHER¶ 7UW   (67 &/
581
,Q FDVH RI QRQFRQYHUJHQFH RI WKH DERYH PRGHO RU PHPRU\ VSDFH LVVXHV WKH VDPH PRGHO EXW
ZLWK 6DWWHUWKZDLWH DSSUR[LPDWLRQ UHSODFHPHQW RI .HQZDUG5RJHU PHWKRG ZLOO EH SUHIHUUHG

/RJLVWLF 5HJUHVVLRQ
)RU WKH UHVSRQGHU DQDO\VHV D ORJLVWLF UHJUHVVLRQ PRGHO IRU WKH UHVSRQVH UDWH 55 DW D
VSHFLILHG YLVLW ZLOO EH PRGHOHG ZLWK WKH ORJLW OLQN DV IROORZV
ORJLW(55LMNV  ȕ  ȕ%DVHLMNV  7UWL  5HJLRQM  $JH*USN  א
 (55LMNV LV WKH SUREDELOLW\ WKDW D SDWLHQW V IURP WUHDWPHQW JURXS L JHRJUDSKLFDO
UHJLRQ JURXS M DQG DJH JURXS N GHPRQVWUDWHV D UHVSRQVH
7KH RGGV UDWLR 25 DV ZHOO DV LWV WZRVLGHG ZDOG  &,V DQG SYDOXH IRU 0LUDEHJURQ
YHUVXV SODFHER XVH ZLOO EH GHULYHG
7KH 6$6 FRGH XVHG WR LPSOHPHQW WKLV WHVW ZLOO EH VLPLODU WR WKDW VKRZQ EHORZ
352& *(102' GDWD GDWDVHW RUGHU GDWD
&/$66 7UW 5HJLRQ $JH*US
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
02'(/ 5HVSRQGHUHYHQW 

  %DVH 7UW 5HJLRQ $JH*US ',67 ELQ
/,1. ORJLW
/5&, W\SH ZDOG
(67,0$7( µ0LUDEHJURQ YHUVXV SODFHER¶ 7UW   (;3
/60($16 7UW  ',)) &/ &255 3',))
581

0L[HG (IIHFWV 3RLVVRQ QHJDWLYH ELQRPLDO 5HJUHVVLRQ 0RGHO
7KH DQDO\VLV IRU FRXQW GDWD &RXQWLMNV DW D VSHFLILHG YLVLW HJ WKH QXPEHU RI LQFRQWLQHQFH
HSLVRGHV ,QFOXGHV QRFWXULD HSLVRGHV SULRU WR (R7 ZLOO EH SHUIRUPHG XVLQJ D 0L[HG (IIHFWV
3RLVVRQ 1HJDWLYH %LQRPLDO UHJUHVVLRQ PRGHO IRU D SDWLHQW V IURP WUHDWPHQW JURXS L
JHRJUDSKLF UHJLRQ JURXS M DJH JURXS N 7KH FRXQW GDWD ZLOO EH PRGHOHG ZLWK WKH ORJ OLQN
IXQFWLRQ DV IROORZV
ORJ(&RXQWLMNV  ORJ'D\LMNV  ȕ  ȕ%DVHLMNV  7UWL  5HJLRQM  $JH*USN 
א
ZKHUH WKH RIIVHW YDULDEOH ORJ'D\LMNV LV WKH ORJ RI WKH QXPEHU RI YDOLG GLDU\ GD\V RI HDFK
SDWLHQW ZLWK D VORSH 
7KH 55 DV ZHOO DV LWV WZRVLGHG  &,V DQG SYDOXH IRU WUHDWPHQW RYHU SODFHER ZLOO EH
GHULYHG
7R IL[ WKH ILQDO PRGHO ZKHWKHU 3RLVVRQ RU 1HJDWLYH %LQRPLDO WKH EHORZ VWHSV ZLOO EH
IROORZHG
6WHS  PRGHO ILW IRU HTXLGLVSHUVLRQ FRQGLWLRQDO PHDQ  FRQGLWLRQDO YDULDQFH IRU 3RLVVRQ
ZLOO EH DVVHVVHG XVLQJ VFDOHG GHYLDQFH RU 6FDOHG 3HDUVRQ FKLVTXDUH Ȥ XQGHU ³&ULWHULD IRU
$VVHVVLQJ *RRGQHVV RI )LW´ 3RLVVRQ PRGHO ZLOO EH IL[HG LQ FDVH WKH GHYLDQFH YDOXH LV
DSSUR[LPDWHO\  2U HOVH 6WHS  ZLOO EH IROORZHG
6WHS  ,Q FDVH WKH GHYLDQFH YDOXH ! RYHU GLVSHUVLRQ QHJDWLYH ELQRPLDO 1% UHJUHVVLRQ
PRGHO ZLOO EH IL[HG LQVWHDG 3RLVVRQ
7KH 6$6 FRGH XVHG WR LPSOHPHQW WKLV WHVW ZLOO EH VLPLODU WR WKDW VKRZQ EHORZ
352& *(102' GDWD GDWDVHW RUGHU GDWD
&/$66 7UW 5HJLRQ $JH*US
02'(/ &RXQW %DVH 7UW 5HJLRQ $JH*US W\SH /,1. ORJ ',67 QHJELQ
RIIVHW OGD\
(67,0$7( ¶0LUDEHJURQ YHUVXV SODFHER¶ 7UW 
  (;3
/60($16 7UW  ',)) &/ &255 3',))
581
127( ',67 VKRXOG EH 3RLVVRQ ',67  3RLVVRQ LQ FDVH GDWD ILWV WR 3RLVVRQ PRGHO
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

6WXG\ 3RSXODWLRQ

'LVSRVLWLRQ RI 3DWLHQWV
7KH IROORZLQJ SDWLHQW GDWD ZLOO EH SUHVHQWHG
x
1XPEHU RI SDWLHQWV ZLWK LQIRUPHG FRQVHQW GLVFRQWLQXHG EHIRUH UDQGRPL]DWLRQ
UDQGRPL]HG RYHUDOO RQO\
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV UDQGRPL]HG LQ HDFK DQDO\VLV VHW E\ WUHDWPHQW
JURXS DQG RYHUDOO
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV FRPSOHWHG DQG GLVFRQWLQXHG WUHDWPHQW E\ SULPDU\
UHDVRQ IRU WUHDWPHQW GLVFRQWLQXDWLRQ IRU UDQGRPL]HG SDWLHQWV E\ WUHDWPHQW JURXS
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV FRPSOHWHG DQG GLVFRQWLQXHG WKH VWXG\ E\ SULPDU\
UHDVRQ IRU VWXG\ GLVFRQWLQXDWLRQ IRU UDQGRPL]HG SDWLHQWV DQG E\ WUHDWPHQW JURXS

3URWRFRO 'HYLDWLRQV
3URWRFRO GHYLDWLRQV DV GHILQHG LQ WKH VWXG\ SURWRFRO 6HFWLRQ  3URWRFRO 'HYLDWLRQV ZLOO
EH DVVHVVHG IRU DOO UDQGRPL]HG SDWLHQWV 7KH QXPEHU DQG SHUFHQWDJH RI SDWLHQWV PHHWLQJ DQ\
FULWHULD ZLOO EH VXPPDUL]HG IRU HDFK FULWHULRQ DQG RYHUDOO E\ WUHDWPHQW JURXS DQG WRWDO DV
ZHOO DV E\ VWXG\ VLWH 3DWLHQWV GHYLDWLQJ IURP D FULWHULRQ PRUH WKDQ RQFH ZLOO EH FRXQWHG RQFH
IRU WKH FRUUHVSRQGLQJ FULWHULRQ $Q\ SDWLHQWV ZKR KDYH PRUH WKDQ RQH SURWRFRO GHYLDWLRQ ZLOO
EH FRXQWHG RQFH LQ WKH RYHUDOO VXPPDU\ $ GDWD OLVWLQJ ZLOO EH SURYLGHG E\ VLWH DQG SDWLHQW
7KH SURWRFRO GHYLDWLRQ FULWHULD ZLOO EH XQLTXHO\ LGHQWLILHG LQ WKH VXPPDU\ WDEOH DQG OLVWLQJ
7KH XQLTXH LGHQWLILHUV ZLOO EH DV IROORZV
3URWRFRO 'HYLDWLRQ 3'  (QWHUHG LQWR WKH VWXG\ HYHQ WKRXJK WKH\ GLG QRW VDWLVI\
HQWU\ FULWHULD
3'  'HYHORSHG ZLWKGUDZDO FULWHULD GXULQJ WKH VWXG\ DQG ZDV QRW ZLWKGUDZQ
3'  5HFHLYHG ZURQJ WUHDWPHQW RU LQFRUUHFW GRVH
3'  5HFHLYHG H[FOXGHG FRQFRPLWDQW WUHDWPHQW

'HPRJUDSKLF DQG 2WKHU %DVHOLQH &KDUDFWHULVWLFV
'HPRJUDSKLF DQG RWKHU EDVHOLQH FKDUDFWHULVWLFV ZLOO EH VXPPDUL]HG XVLQJ GHVFULSWLYH
VWDWLVWLFV E\ WUHDWPHQW JURXS
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV UDQGRPL]HG LQ HDFK FRXQWU\ DQG VLWH ZLOO EH SUHVHQWHG E\
WUHDWPHQW JURXS IRU )$6 DQG 6$)
7KRVH SDWLHQWV UDQGRPL]HG WR 0LUDEHJURQ ZLOO VWDUW DW  PJ DQG ZLOO LQFUHDVH WR  PJ DIWHU
 ZHHNV 7KRVH SDWLHQWV UDQGRPL]HG WR 3%2 ZLOO VWDUW EOLQGHG SURGXFW PDWFKHG WR WKH
0LUDEHJURQ  PJ WDEOHW DQG ZLOO LQFUHDVH WR EOLQGHG SURGXFW PDWFKHG WR  PJ DIWHU 
ZHHNV 2QFH D SDWLHQW KDV LQFUHDVHG GRVH KH ZLOO UHPDLQ RQ WKDW GRVH IRU WKH UHPDLQGHU RI
WKH VWXG\ XQOHVV IRU VDIHW\ UHDVRQV WKDW UHTXLUH GLVFRQWLQXDWLRQ RI VWXG\ GUXJ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
'HVFULSWLYH VWDWLVWLFV IRU DJH LQ \HDUV ZHLJKW ERG\ PDVV LQGH[ %0, DQG KHLJKW DW VWXG\
HQWU\ ZLOO EH SUHVHQWHG )UHTXHQF\ WDEXODWLRQV IRU VH[ HWKQLFLW\ DJH JURXS  
DQG   DQG UDFH ZLOO EH SUHVHQWHG 7KLV ZLOO EH GRQH IRU WKH 6$) DQG )$6 E\
WUHDWPHQW JURXS
'HPRJUDSKLF YDULDEOHV DUH EDVHG RQ WKH ODVW DYDLODEOH YDOXH SULRU WR ILUVW GRVH RI
GRXEOHEOLQG WUHDWPHQW
%0, LV FDOFXODWHG DV %0, NJP  ZHLJKW NJ  KHLJKW P
2$% UHODWHG EDVHOLQH FKDUDFWHULVWLFV VXPPDUL]HG LQ 7DEOH  DQG UHFRUGHG RQ WKH H&5) IURP
WKH 6FUHHQLQJ 9LVLW ZLOO EH VXPPDUL]HG IRU WKH )$6 E\ WUHDWPHQW JURXS
'XUDWLRQ RI WKH 2$% V\PSWRPV LQ PRQWKV LV FDOFXODWHG DV WKH QXPEHU RI PRQWKV IURP RQVHW
GDWH RI 2$% V\PSWRPV DW GLDJQRVLV WR WKH LQIRUPHG FRQVHQW GDWH DW WKH VFUHHQLQJ
'DWH RI ,QIRUPHG &RQVHQW  RQVHW GDWH RI 2$% V\PSWRPV DW GLDJQRVLV    
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7DEOH 
2$% 5HODWHG %DVHOLQH &KDUDFWHULVWLFV IURP H&5)
&KDUDFWHULVWLF
6XPPDUL]HG DV
&DWHJRULHV
'XUDWLRQ RI 2$% V\PSWRPV LQ PRQWKV
&RQWLQXRXV
1$
2$% 6HYHULW\ DW %DVHOLQH %DVHG RQ
1XPEHU RI 0LFWXULWLRQ SHU GD\
&DWHJRULFDO
x

x
  
x
!
2$% 6HYHULW\ DW %DVHOLQH %DVHG RQ
1XPEHU RI ,QFRQWLQHQFH (SLVRGHV SHU GD\
&DWHJRULFDO
x
!  
x
!  
x
!
,366 DW 6FUHHQLQJ
&DWHJRULFDO
7RWDO ,366 6FRUH
x
0LOG 
x
0RGHUDWH 
x
6HYHUH 
&RQWLQXRXV
6WRUDJH
9RLGLQJ
7RWDO 6FRUH
4R/
3UHYLRXV 2$% 0HGLFDWLRQ
&DWHJRULFDO
x
<HV
x
1R
3UHYLRXV QRQGUXJ WUHDWPHQW IRU 2$%
SULRU WR VFUHHQLQJ
)UHH 7H[W
x
<HV
o%LRIHHGEDFN
o([HUFLVHV
o(OHFWULFDO 6WLPXODWLRQ
o%HKDYLRUDO
o3HVVDULHV
o,PSODQWV
o6XUJHU\
o2WKHU LI DYDLODEOH
x
1R
$5, XVH IURP WKH SULRUFRQ PHGV
GXVWDVWHULGH DQG ILQDVWHULGH
&DWHJRULFDO
x
<HV
x
1R
2$% UHODWHG EDVHOLQH FKDUDFWHULVWLFV GHULYHG IURP WKH GD\ PLFWXULWLRQ GLDU\ SULRU WR WKH
5XQLQ 9LVLW DQG WKH 5DQGRPL]DWLRQ 9LVLW ZLOO EH VXPPDUL]HG DV FRQWLQXRXV YDULDEOHV RYHUDOO
IRU )$6 ZLWK IROORZLQJ OLVWHG FKDUDFWHULVWLFV LQ 7DEOH  2QO\ SDWLHQWV ZLWK D EDVHOLQH YDOXH !
 ZLOO EH LQFOXGHG LQ HDFK LQGLYLGXDO VXPPDU\
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7DEOH 
2$% 5HODWHG %DVHOLQH &KDUDFWHULVWLFV IURP 'D\ 0LFWXULWLRQ 'LDU\
&KDUDFWHULVWLF
6XPPDUL]HG DV
&DWHJRULHV
1XPEHU RI LQFRQWLQHQFH HSLVRGHV UHSRUWHG GXULQJ WKH GD\ GLDU\
&RQWLQXRXV
1$
0HDQ QXPEHU RI LQFRQWLQHQFH HSLVRGHV SHU GD\
&RQWLQXRXV
1$
1XPEHU RI XUJHQF\ LQFRQWLQHQFH HSLVRGHV UHSRUWHG GXULQJ WKH GD\
GLDU\
&RQWLQXRXV
1$
0HDQ QXPEHU RI XUJHQF\ LQFRQWLQHQFH HSLVRGHV SHU GD\
&RQWLQXRXV
1$
0HDQ QXPEHU RI PLFWXULWLRQV SHU GD\
&RQWLQXRXV
1$
0HDQ QXPEHU RI XUJHQF\ HSLVRGHV JUDGH  RU  SHU GD\
&RQWLQXRXV
1$
1XPEHU RI QRFWXULD HSLVRGHV UHSRUWHG GXULQJ WKH GD\ GLDU\
&RQWLQXRXV
1$
0HDQ QXPEHU RI QRFWXULD HSLVRGHV SHU GD\
&RQWLQXRXV
1$
0HGLFDO KLVWRU\ LV FRGHG LQ 0HG'5$ DQG ZLOO EH VXPPDUL]HG E\ 6\VWHP 2UJDQ &ODVV
62& DQG 3UHIHUUHG 7HUP 37 DV ZHOO DV E\ 37 DORQH E\ WUHDWPHQW JURXS IRU WKH )$6

3UHYLRXV DQG &RQFRPLWDQW 0HGLFDWLRQV
3UHYLRXV PHGLFDWLRQV DUH FRGHG ZLWK :RUOG +HDOWK 2UJDQL]DWLRQ ± 'UXJ 'LFWLRQDU\ :+2
'' DQG ZLOO EH VXPPDUL]HG E\ WKHUDSHXWLF VXEJURXS $QDWRPLFDO 7KHUDSHXWLF &KHPLFDO
$7& QG OHYHO DQG FKHPLFDO VXEJURXS $7& WK OHYHO DQG SUHIHUUHG :RUOG +HDOWK
2UJDQL]DWLRQ :+2 QDPH E\ WUHDWPHQW JURXS IRU WKH )$6
$V ZLWK SUHYLRXV PHGLFDWLRQ FRQFRPLWDQW PHGLFDWLRQ ZLOO EH VXPPDUL]HG IRU HDFK WUHDWPHQW
JURXS E\ WKHUDSHXWLF VXEJURXS $7& QG OHYHO DQG FKHPLFDO VXEJURXS $7& WK OHYHO DQG
SUHIHUUHG :+2 QDPH IRU WKH 6$) 3DWLHQWV WDNLQJ WKH VDPH PHGLFDWLRQ PXOWLSOH WLPHV ZLOO
EH FRXQWHG RQFH SHU PHGLFDWLRQ DQG LQYHVWLJDWLRQDO SHULRG $ PHGLFDWLRQ WKDW FDQ EH
FODVVLILHG LQWR VHYHUDO FKHPLFDO DQGRU WKHUDSHXWLF VXEJURXSV LV SUHVHQWHG LQ DOO FKHPLFDO DQG
WKHUDSHXWLF VXEJURXSV

6WXG\ 'UXJV

([SRVXUH
7KH IROORZLQJ LQIRUPDWLRQ RQ GUXJ H[SRVXUH ZLOO EH SUHVHQWHG IRU HDFK WUHDWPHQW JURXS IRU
WKH 6$)
x
'HVFULSWLYH VWDWLVWLFV IRU QXPEHU RI GD\V WUHDWPHQW ZDV UHFHLYHG ZLOO EH SUHVHQWHG E\
WUHDWPHQW JURXS
x
1XPEHU DQG SHUFHQW RI SDWLHQWV ZLWK GRVH LQFUHDVH IURP PJ WR PJ E\ WUHDWPHQW
JURXS
'XUDWLRQ RI H[SRVXUH ZLOO EH VXPPDUL]HG LQ WZR ZD\V
x
'HVFULSWLYH VWDWLVWLFV ZLOO EH SUHVHQWHG E\ WUHDWPHQW JURXS
x
&RXQWV DQG SHUFHQWDJHV RI H[SRVXUH WLPH ZLOO EH FDWHJRUL]HG DFFRUGLQJ WR WKH
IROORZLQJ FDWHJRULHV E\ WUHDWPHQW JURXS
ż
 WR  GD\V
ż
 WR  GD\V
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
ż
 WR  GD\V
ż
 WR  GD\V
ż
 WR  GD\V
ż
 GD\V RU PRUH
ż
8QNQRZQ
x
&RXQWV DQG SHUFHQWDJHV RI FXPXODWLYH H[SRVXUH ZLOO EH FDWHJRUL]HG DFFRUGLQJ WR WKH
IROORZLQJ FDWHJRULHV E\ WUHDWPHQW JURXS
ż
 GD\V
ż
 GD\V
ż
 GD\V
ż
 GD\V
ż
 GD\V
&RXQWV DQG SHUFHQWDJHV RI SDWLHQWV LQ HDFK RI WKHVH FDWHJRULHV ZLOO EH VXPPDUL]HG IRU HDFK
WUHDWPHQW JURXS IRU WKH 6$)

7UHDWPHQW &RPSOLDQFH
2YHUDOO FRPSOLDQFH ZLOO EH H[DPLQHG IRU SDWLHQWV LQ 6$) ZKRVH WRWDO VWXG\ GUXJ FRXQW DQG
ILUVW DQG ODVW GD\V RI WUHDWPHQW DUH NQRZQ
3HUFHQW RYHUDOO FRPSOLDQFH ZLOO EH VXPPDUL]HG LQ WZR ZD\V IRU 6$)
x
'HVFULSWLYH VWDWLVWLFV ZLOO EH SUHVHQWHG E\ WUHDWPHQW JURXS
x
3HUFHQW FRPSOLDQFH ZLOO EH FDWHJRUL]HG DFFRUGLQJ WR WKH IROORZLQJ FDWHJRULHV E\
WUHDWPHQW JURXS
ż

ż
!  WR 
ż
! 
ż
8QNQRZQ

$QDO\VLV RI (IILFDF\

$QDO\VLV RI 3ULPDU\ (QGSRLQW

3ULPDU\ DQDO\VLV
7KH SULPDU\ DQDO\VLV VHW IRU HIILFDF\ DQDO\VHV ZLOO EH )$6 7KH SULPDU\ HIILFDF\ YDULDEOH LV
FKDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\ EDVHG RQ D
GD\ HOHFWURQLF GLDU\
0HDQ QXPEHU RI PLFWXULWLRQV SHU GD\
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
7KH K\SRWKHVLV EHLQJ WHVWHG IRU WKH PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\ FDQ EH VWDWHG DV
+ 'LIIHUHQFH EHWZHHQ PLUDEHJURQ DQG SODFHER LQ FKDQJH IURP EDVHOLQH WR HQG RI
WUHDWPHQW LQ PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\ EDVHG RQ D GD\ HOHFWURQLF GLDU\ LV

+ 'LIIHUHQFH EHWZHHQ PLUDEHJURQ DQG SODFHER LQ FKDQJH IURP EDVHOLQH WR HQG RI
WUHDWPHQW LQ PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\ EDVHG RQ D GD\ HOHFWURQLF GLDU\ LV
QRW HTXDO WR 
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\ ZLOO EH
WHVWHG XVLQJ DQ $1&29$ PRGHO 7KH UHVSRQVH YDULDEOH ZLOO EH WKH PHDQ FKDQJH LQ QXPEHU
RI PLFWXULWLRQV HSLVRGHV SHU GD\ IURP EDVHOLQH WR WKH HQG RI WKH VWXG\ ZLWK WUHDWPHQW JURXS
JHRJUDSKLF UHJLRQ DQG DJH JURXS   DV IL[HG IDFWRUV DQG EDVHOLQH PHDQ QXPEHU
RI PLFWXULWLRQV HSLVRGHV SHU GD\ DV WKH FRYDULDWH LQ WKH PRGHO $V SDUW RI WKH $1&29$
UHVXOWV /6 PHDQV DQG WZRVLGHG  &,V IRU PHDQ FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK
WUHDWPHQW JURXS ZLOO EH SURYLGHG 'LIIHUHQFHV LQ /6 PHDQV EHWZHHQ 0LUDEHJURQ DQG SODFHER
ZLOO EH GHULYHG WRJHWKHU ZLWK  &,V DQG SYDOXHV

6HFRQGDU\ $QDO\VLV RI 3ULPDU\ (QGSRLQW
5HVLGXDO SORWV ZLOO EH SURGXFHG WR FKHFN WKH DVVXPSWLRQV RI WKH XQGHUO\LQJ VWDWLVWLFDO PRGHOV
IRU PHDQ QXPEHU RI PLFWXULWLRQV HSLVRGHV SHU GD\ ,I WKH ILW RI WKH PRGHOV LV TXHVWLRQDEOH WKH
GHSHQGHQW YDULDEOH PD\ EH ORJDULWKPLFDOO\ WUDQVIRUPHG LQ RUGHU WR LPSURYH WKH ILW RU D QRQ
SDUDPHWULF DQDO\VLV FRXOG EH DSSOLHG DV D VHFRQGDU\ DQDO\VLV 2XWOLHUV DUH GHILQHG DQG
KDQGOHG SHU VHFWLRQ  ,I RXWOLHUV DUH SUHVHQW WKHQ DGGLWLRQDO VHQVLWLYLW\ DQDO\VHV ZLOO EH
SHUIRUPHG ZLWK WKH RXWOLHUV H[FOXGHG WR DVVHVV WKHLU LPSDFW RQ WKH UHVXOWV
7KH SULPDU\ DQDO\VLV ZLOO EH UHSHDWHG IRU FRPSOHWHUV RQO\ LH ZLWKRXW XWLOL]LQJ /2&)
LPSXWDWLRQ IRU SDWLHQWV ZLWK PLVVLQJ YDOXHV IRU HQG RI WUHDWPHQW :HHN  $GGLWLRQDOO\
:HHN  DQG :HHN  YDOXHV ZLOO EH DQDO\]HG VLPLODUO\ WR (QG RI 7UHDWPHQW LH WKH VWDWLVWLFDO
WHVWV DSSOLHG ZLOO EH WKH VDPH DV WKH WHVW DSSOLHG WR WKH RQHV GHVFULEHG LQ 6HFWLRQ 
$Q DQDO\VLV RI FKDQJH IURP EDVHOLQH LQ PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\ XVLQJ D 0L[HG
0RGHO 5HSHDWHG 0HDVXUHV 0050 ZLWK DJH JURXS JHRJUDSKLF UHJLRQ WLPH YLVLW DQG D
WLPHE\WUHDWPHQW LQWHUDFWLRQ DV IDFWRUV DQG WKH QXPEHU RI PLFWXULWLRQ HSLVRGHV DW EDVHOLQH DV
FRYDULDWH ZLOO VHUYH DV DQRWKHU VHQVLWLYLW\ DQDO\VLV 7KH UHSHDWHG PHDVXUHV PRGHO ZLOO SUHVHQW
/6 PHDQV DQG WZRVLGHG  &,V IRU FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK WUHDWPHQW JURXS

6XEJURXS $QDO\VLV
6XEJURXS DQDO\VLV RI WKH SULPDU\ HQGSRLQW ZLOO EH FRQGXFWHG XVLQJ DQ $1&29$ PRGHO
7KH VXEJURXSV WR EH FRQVLGHUHG IRU WKH DQDO\VLV ZLOO LQFOXGH
x
*HRJUDSKLF UHJLRQ 1$ (8
x
$JH JURXS   DQG  
x
3UHYLRXV 2$% PHGLFDWLRQ <HV 1R
x
$5, XVH DW EDVHOLQH <HV QR RQO\ IRU GLDU\ YDULDEOHV
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
x
5DFH D FDWHJRU\ WR EH LQFOXGHG LQ FDVH RI DW OHDVW  SDWLHQWV ZLWKLQ WKDW FDWHJRU\
7KH PRGHOV IRU WKH VXEJURXS DQDO\VLV ZLOO KDYH WKH WUHDWPHQW DUP DV D IL[HG IDFWRU DQG
EDVHOLQH YDOXHV DV WKH FRYDULDWH LQ WKH PRGHO /6 PHDQV WZRVLGHG  &,V DQG SYDOXHV IRU
PHDQ FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK VXEJURXS ZLOO EH SURYLGHG

$QDO\VLV RI 6HFRQGDU\ (QGSRLQWV
7KH VHFRQGDU\ HIILFDF\ YDULDEOHV DUH
x
&KDQJH IURP EDVHOLQH WR ZHHN  DQG ZHHN  LQ PHDQ QXPEHU RI PLFWXULWLRQV SHU GD\
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ LQFRQWLQHQFH HSLVRGHV SHU GD\
)$6,
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ YROXPH YRLGHG SHU PLFWXULWLRQ
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ QXPEHU RI XUJHQF\ HSLVRGHV JUDGH
 DQG  SHU GD\
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ ,366 WRWDO VFRUH DQG VXEVFDOHV 9RLGLQJ
6WRUDJH DQG 4XDOLW\ RI /LIH
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ QXPEHU RI XUJHQF\ LQFRQWLQHQFH
HSLVRGHV SHU GD\ )$6,
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ V\PSWRP ERWKHU DQG WRWDO KHDOWK UHODWHG
TXDOLW\ RI OLIH VFRUHV DV DVVHVVHG E\ 2$%T TXHVWLRQQDLUH DQG VXEVFDOHV FRSLQJ
FRQFHUQ VOHHS VRFLDO LQWHUDFWLRQ DQG V\PSWRP ERWKHU DQG
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ QXPEHU RI QRFWXULD HSLVRGHV SHU
GD\ )$61
x
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ 78)6 XVLQJ 33,86 JUDGH  RU 
33%& DQG 769$6
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
&KDQJH IURP EDVHOLQH WR HQG RI WUHDWPHQW LQ PHDQ LQFRQWLQHQFH HSLVRGHV SHU GD\
$QDO\VLV RI PHDQ FKDQJH LQ QXPEHU RI LQFRQWLQHQFH HSLVRGHV SHU GD\ IURP %DVHOLQH WR (QG
RI 7UHDWPHQW ZLOO EH SHUIRUPHG RQ WKH )$6, XVLQJ $1&29$ PRGHO SYDOXHV ZLOO EH
FDOFXODWHG E\ VWUDWLILHG UDQNLQJ $1&29$ 7KH UHVSRQVH YDULDEOH LV VWDQGDUGL]HG UDQNV RQ
FKDQJH IURP %DVHOLQH ZLWK WUHDWPHQW JURXS DJH JURXS  !  \HDUV DQG JHRJUDSKLF
UHJLRQ DV IL[HG IDFWRUV DQG EDVHOLQH YDOXH DV D FRYDULDWH
3RLVVRQ RU QHJDWLYH ELQRPLDO UHJUHVVLRQ IRU FRXQW YDULDEOHV
7KH DQDO\VLV IRU FRXQW GDWD ܥ݋ݑ݊ݐ௜௝௞௟௠௦ DW (R7 HJ WKH QXPEHU RI LQFRQWLQHQFH HSLVRGHV
SULRU WR (R7 ZLOO EH SHUIRUPHG XVLQJ D 0L[HG (IIHFWV 3RLVVRQ 1HJDWLYH %LQRPLDO 1%
UHJUHVVLRQ PRGHO IRU D SDWLHQW V IURP WUHDWPHQW JURXS L VH[ JURXS M DJH JURXS N SUHYLRXV
2$% WUHDWPHQW JURXS O DQG JHRJUDSKLF UHJLRQ P 7KH FRXQW GDWD ZLOO EH PRGHOHG ZLWK WKH
ORJ OLQN IXQFWLRQ DV IROORZV
݈݋݃ሺܧሺܥ݋ݑ݊ݐ௜௝௞௟௠௦ሻሻൌ݈݋݃ሺܦܽݕ௜௝௞௟௠௦ሻ൅ߚ଴൅ߚଵܤܽݏ݁௜௝௞௟௠൅ܶݎݐ௜൅ܵ݁ݔ௝
൅ܣ݃݁ܩݎ݌௞൅ܱܣܤݐݎݐ௟൅ܴ݁݃݅݋݊௠൅߳௜௝௞௟௠௦
ZKHUH WKH RIIVHW YDULDEOH ݈݋݃ሺܦܽݕ௜௝௞௟௠௦ሻLV WKH ORJ RI WKH QXPEHU RI YDOLG GLDU\ GD\V RI HDFK
SDWLHQW ZLWK D VORSH 
7KH 55 DV ZHOO DV LWV WZRVLGHG  &,V DQG SYDOXH IRU 0LUDEHJURQ YV SODFHER ZLOO EH
GHULYHG
7KH 6$6 FRGH XVHG WR LPSOHPHQW WKLV WHVW ZLOO EH VLPLODU WR WKDW VKRZQ EHORZ
'$7$ GDWDVHW
6(7 GDWDVHW
ORJW  ORJQXPEHU RI YDOLG GLDU\ GD\V
581
352& *(102' GDWD GDWDVHW RUGHU GDWD
&/$66 7UW 6H[ $JH*US 2$%WUW 5HJLRQ
02'(/ &RXQW %DVH 7UW 6H[ $JH*US 2$%WUW 5HJLRQ  W\SH /,1. ORJ
',67 QHJELQ 2))6(7  ORJW 
2WKHU HIILFDF\ DQDO\VLV
2WKHU VHFRQGDU\ HIILFDF\ YDULDEOHV ZLOO EH DQDO\]HG XVLQJ WKH VDPH $1&29$ PRGHO DV
GHVFULEHG IRU PLFWXULWLRQV UHIHU WR VHFWLRQ  2WKHU SODQQHG XWLOLW\ LQGLFHV DQG DQDO\VHV
ZLOO EH FDOFXODWHG LQ D VHSDUDWH UHSRUW IURP WKH 6WDWLVWLFDO $QDO\VLV 3ODQ DQG &OLQLFDO 6WXG\
5HSRUW
6KLIW WDEOHV IRU ,366 VFRUHV E\ FDWHJRU\ PLOGPRGHUDWHVHYHUH 6FRUH  0LOG 
0RGHUDWH  6HYHUH
6KLIW WDEOHV WKDW LQFOXGH QXPEHU DQG SHUFHQW RI SDWLHQWV IURP RQH FDWHJRU\ DW EDVHOLQH WR
DQRWKHU 0LOG0RGHUDWH6HYHUH FDWHJRU\ DW ZHHN   DQG (27 E\ WUHDWPHQW JURXS ZLOO
EH SUHVHQWHG IRU ,366 WRWDO VFRUH DQG VXEVFDOH VFRUHV
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
,366 KDV /RZHU XULQDU\ WUDFW V\PSWRPV /876 DUH FDWHJRUL]HG DV VWRUDJH XUJHQF\
IUHTXHQF\ QRFWXULD LWHPV    YRLGLQJ VHQVDWLRQ RI LQFRPSOHWH HPSW\LQJ KHVLWDQF\
ZHDN VWUHDP DQG VWUDLQLQJ LWHPV     DQG 42/ LWHP  6WRUDJH DQG YRLGLQJ
V\PSWRPV ZLOO EH VXPPDUL]HG VHSDUDWHO\
5HVSRQGHU DQDO\VLV
5HVSRQGHU DQDO\VHV ZLOO EH SHUIRUPHG IRU
1XPEHU RI SDWLHQWV ZLWK  UHGXFWLRQ LQ PLFWXULWLRQ IUHTXHQF\ DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK OHVV WKDQ  PLFWXULWLRQV SHU GD\ DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK  LQFRQWLQHQFH HSLVRGHV SHU GD\ DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK  UHGXFWLRQ LQ LQFRQWLQHQFH DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK  UHGXFWLRQ LQ JUDGH  RU  XUJHQF\ HSLVRGHV DW (QG RI
7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK  SRLQW GHFUHDVH LQ ,366 VFRUH DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK ,366 VFRUHV OHVV WKDQ  DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK JUHDWHU WKDQ RU HTXDO WR  SRLQWV LPSURYHPHQW LQ 6\PSWRP %RWKHU
7RWDO +54/ VFRUHV DQG HDFK +54/ VXEVFDOH VFRUHV DW (QG RI 7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK JUHDWHU WKDQ RU HTXDO WR  SRLQW GHFUHDVH LQ 33%& VFRUH DW (QG RI
7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK JUHDWHU WKDQ RU HTXDO WR  SRLQW GHFUHDVH LQ 33%& VFRUH DW (QG RI
7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK  UHGXFWLRQ LQ QXPEHU RI QRFWXULD HSLVRGHV DW (QG RI
7UHDWPHQW
1XPEHU RI SDWLHQWV ZLWK OHVV WKDQ  QRFWXULD HSLVRGHV SHU GD\ DW (QG RI 7UHDWPHQW
6HQVLWLYLW\ $QDO\VLV
$Q DQDO\VLV RI FKDQJH IURP EDVHOLQH LQ 352 YDOXHV XVLQJ DQ 0050 ZLWK JHRJUDSKLF
UHJLRQ DJH JURXS WLPH YLVLW DQG D WLPHE\WUHDWPHQW LQWHUDFWLRQ DV IDFWRUV DQG 352 YDOXH
DW EDVHOLQH DV D FRYDULDWH ZLOO VHUYH DV D VHQVLWLYLW\ DQDO\VLV 7KH UHSHDWHG PHDVXUHV PRGHO
ZLOO SUHVHQW /6 PHDQV DQG WZRVLGHG  &,V IRU FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK
WUHDWPHQW JURXS

$QDO\VLV RI ([SORUDWRU\ (QGSRLQWV
6XEJURXS DQDO\VHV E\ 36$ FXWRII VFRUHV IRU   DQG $5, XVH DW EDVHOLQH ZLOO EH
SHUIRUPHG RQ DOO DSSOLFDEOH SULPDU\ DQG VHFRQGDU\ HIILFDF\ HQGSRLQWV ZKLFK ZHUH DQDO\]HG
XVLQJ $1&29$ RU UDQNLQJ $1&29$ UHIHU WR VHFWLRQ 
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$QDO\VLV RI 6DIHW\
6DIHW\ DQDO\VLV ZLOO EH SHUIRUPHG IRU DGYHUVH HYHQWV $(V DQG YLWDO VLJQV XVLQJ WKH 6$) 1R
LQIHUHQWLDO FRPSDULVRQ EHWZHHQ WUHDWPHQW JURXSV ZLOO EH SHUIRUPHG IRU WKH VDIHW\ DQDO\VLV LQ
WKLV VWXG\

$GYHUVH (YHQWV
6XPPDULHV DQG OLVWLQJV RI VHULRXV DGYHUVH HYHQWV 6$(V DQG 6HULRXV 7($(V LQFOXGH 6$(V
XSJUDGHG E\ WKH VSRQVRU EDVHG RQ UHYLHZ RI WKH 6SRQVRU¶V OLVW RI µ$OZD\V 6HULRXV¶ WHUPV LI
DQ\ XSJUDGH ZDV GRQH
$GYHUVH HYHQWV ZLOO EH FRGHG XVLQJ WKH 0HGLFDO 'LFWLRQDU\ IRU 5HJXODWRU\ $FWLYLWLHV
0HG'5$ $OO $(V ZLOO EH OLVWHG
7KH QXPEHU DQG SHUFHQWDJH RI 7($(V VHULRXV 7($(V DQG GLVFRQWLQXDWLRQV GXH WR D 7($(
ZLOO EH VXPPDUL]HG E\ 6\VWHP 2UJDQ &ODVV 3UHIHUUHG 7HUP DQG WUHDWPHQW JURXS ,Q
DGGLWLRQ 7($(V ZLOO EH VXPPDUL]HG E\ UHODWLRQVKLS WR VWXG\ GUXJ DV GHWHUPLQHG E\ WKH
,QYHVWLJDWRU DQG E\ VHYHULW\ IRU HDFK WUHDWPHQW JURXS
$Q RYHUYLHZ WDEOH ZLOO LQFOXGH WKH IROORZLQJ GHWDLOV
x
1XPEHU RI 7($(V
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK 7($(V
x
1XPEHU RI GUXJ UHODWHG 7($(V
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK FDXVDOO\ GUXJ UHODWHG 7($(V
x
1XPEHU RI VHULRXV 7($(V
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK VHULRXV 7($(V
x
1XPEHU RI VHULRXV GUXJ UHODWHG 7($(V
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK VHULRXV GUXJ UHODWHG 7($(V
x
1XPEHU RI 7($(V OHDGLQJ WR SHUPDQHQW GLVFRQWLQXDWLRQ RI VWXG\ GUXJ
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK 7($(V OHDGLQJ WR SHUPDQHQW GLVFRQWLQXDWLRQ
RI VWXG\ GUXJ
x
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK XULQDU\ WUDFW LQIHFWLRQ DQG
x
1XPEHU RI GHDWKV
7KH QXPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK 7($(V DV FODVVLILHG E\ 62& DQG 37 ZLOO EH
VXPPDUL]HG IRU HDFK WUHDWPHQW JURXS 6XPPDULHV ZLOO EH SURYLGHG IRU
x
7($(V
x
&RPPRQ 7($(V  LQ RQH JURXS
x
&RPPRQ 7($(V  LQ RQH JURXS
x
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
x
'UXJ UHODWHG 7($(V
x
6HYHUH 7($(V
x
6HULRXV 7($(V
x
'UXJ UHODWHG VHULRXV 7($(V
x
7($(V OHDGLQJ WR SHUPDQHQW GLVFRQWLQXDWLRQ RI VWXG\ GUXJ
x
'UXJ UHODWHG 7($(V OHDGLQJ WR SHUPDQHQW GLVFRQWLQXDWLRQ RI VWXG\ GUXJ
x
1RQVHULRXV 7($(V RYHU  LQ DQ\ RQH WUHDWPHQW JURXS
x
7($(V E\ VXEJURXS DV LQGLFDWHG LQ VHFWLRQ 
7KH QXPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK 7($(V DV FODVVLILHG E\ 37 RQO\ ZLOO EH
VXPPDUL]HG IRU HDFK WUHDWPHQW JURXS DQG E\ WKH VXEJURXSV RI LQWHUHVW IRXQG LQ 6HFWLRQ 
7KH QXPEHU RI 7($(V DQG WKH QXPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK 7($(V DV FODVVLILHG
E\ 62& DQG 37 ZLOO DOVR EH VXPPDUL]HG E\ VHYHULW\ ,Q WKH SDWLHQW FRXQW LI D SDWLHQW KDV
PXOWLSOH 7($(V ZLWK WKH VDPH 62& RU 37 EXW ZLWK GLIIHULQJ VHYHULW\ WKHQ WKH SDWLHQW ZLOO
EH FRXQWHG RQO\ RQFH ZLWK WKH ZRUVW VHYHULW\ KRZHYHU LI DQ\ RI WKH VHYHULW\ YDOXHV DUH
PLVVLQJ WKHQ WKH SDWLHQW ZLOO EH FRXQWHG RQO\ RQFH ZLWK PLVVLQJ VHYHULW\ ,Q WKH DGYHUVH
HYHQW FRXQW WKH DGYHUVH HYHQWV ZLOO EH SUHVHQWHG LQ HDFK FDWHJRU\ WR ZKLFK WKH\ ZHUH
FODVVLILHG 'UXJ UHODWHG VHYHUH 7($(V ZLOO EH SUHVHQWHG LQ D VLPLODU ZD\
$GGLWLRQDO VXPPDULHV ZLOO EH SURYLGHG IRU WKH IROORZLQJ $(V RI VSHFLDO LQWHUHVW
x
9LWDO VLJQV V\VWROLF DQG GLDVWROLF EORRG SUHVVXUH DQG SXOVH UDWH
x
$FXWH XULQDU\ UHWHQWLRQ XULQDU\ UHWHQWLRQ UHTXLULQJ FDWKHWHUL]DWLRQ
x
%HQLJQ SURVWDWLF REVWUXFWLRQ %32 UHTXLULQJ VXUJHU\

&OLQLFDO /DERUDWRU\ (YDOXDWLRQ
/DERUDWRU\ YDULDEOHV ELRFKHPLVWU\ KHPDWRORJ\ DQG XULQDO\VLV ZLOO EH GHVFULSWLYHO\
VXPPDUL]HG IRU EDVHOLQH 9LVLW  :HHN  :HHN  DQG :HHN (27 DQG FKDQJH IURP
6FUHHQLQJ WR (27 ZLOO EH VXPPDUL]HG E\ WUHDWPHQW JURXS
4XDQWLWDWLYH FOLQLFDO ODERUDWRU\ YDULDEOHV LH KHPDWRORJ\ ELRFKHPLVWU\ DQG XULQDO\VLV ZLOO
EH VXPPDUL]HG XVLQJ PHDQ VWDQGDUG GHYLDWLRQ PLQLPXP PD[LPXP 4 4 DQG PHGLDQ
IRU HDFK WUHDWPHQW JURXS DW HDFK YLVLW $GGLWLRQDOO\ D ZLWKLQSDWLHQW FKDQJH ZLOO EH
FDOFXODWHG DV WKH SRVWEDVHOLQH PHDVXUHPHQW PLQXV WKH EDVHOLQH PHDVXUHPHQW DQG
VXPPDUL]HG LQ WKH VDPH ZD\
)RU HDFK KHPDWRORJ\ DQG ELRFKHPLVWU\ ODERUDWRU\ SDUDPHWHU ODERUDWRU\ WHVW UHVXOWV ZLOO EH
FODVVLILHG DV ORZ / QRUPDO 1 RU KLJK + DW HDFK YLVLW DFFRUGLQJ WR WKH ODERUDWRU\
VXSSOLHG UHIHUHQFH UDQJHV 6KLIW WDEOHV RI UHIHUHQFH UDQJH FKDQJHV IURP 6FUHHQLQJ WR :HHN
(27 DQG PRVW H[WUHPH YDOXH GXULQJ WKH GRXEOHEOLQG WUHDWPHQW SHULRG E\ WUHDWPHQW JURXS
ZLOO EH VXPPDUL]HG IRU DOO ODERUDWRU\ YDOXHV
/DERUDWRU\ DEQRUPDOLWLHV ZLOO EH HYDOXDWHG EDVHG RQ WKH 3RWHQWLDOO\ &OLQLFDOO\ 6LJQLILFDQW
3&6 ODERUDWRU\ FULWHULD )RU HDFK ODERUDWRU\ 3&6 FULWHULRQ WKH QXPEHU DQG SHUFHQW RI
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
SDWLHQWV ZKR KDYH D ODERUDWRU\ YDOXH PHHWLQJ WKH 3&6 FULWHULD GXULQJ WKH GRXEOHEOLQG
WUHDWPHQW SHULRG ZLOO EH VXPPDUL]HG E\ WUHDWPHQW JURXS 7KH GLUHFWLRQV RI FKDQJHV KLJK RU
ORZ LQ 3&6 ZLOO EH LQGLFDWHG LQ WKH WDEOHV 7KH SUHGHILQHG FULWHULD IRU 3&6 ODERUDWRU\
YDOXHV DUH SUHVHQWHG EHORZ
3RWHQWLDOO\ &OLQLFDOO\ 6LJQLILFDQW /DERUDWRU\ &ULWHULD
/DERUDWRU\ 3DUDPHWHU
8QLW
/RZ 3&6 &ULWHULRQ
+LJK 3&6 &ULWHULRQ
+HPDWRORJ\
+HPRJORELQ
J/
 
!
+HPDWRFULW
)UDFWLRQ
 
! 
(U\WKURF\WH 5HG %ORRG &HOO
&RXQW
[/
 
! 
3ODWHOHW &RXQW
[ /
 
! 
/HXNRF\WH :KLWH %ORRG
&HOO &RXQW
[ /
 
! 
3RWDVVLXP
0HT/
 
! 

/LYHU IXQFWLRQ WHVWV
7KH IROORZLQJ SRWHQWLDOO\ FOLQLFDOO\ VLJQLILFDQW FULWHULD LQ OLYHU IXQFWLRQ WHVWV IRU $ONDOLQH
3KRVSKDWDVH $/3 $ODQLQH 7UDQVDPLQDVH $/7 WRWDO ELOLUXELQ $VSDUWDWH 7UDQVDPLQDVH
$67 DQG WKHLU FRPELQDWLRQ DUH GHILQHG 7KH SDWLHQW¶V KLJKHVW YDOXH GXULQJ WKH
LQYHVWLJDWLRQDO SHULRG ZLOO EH XVHG
3DUDPHWHU
&ULWHULD
$/7
! [8SSHU /LPLW RI 1RUPDO 8/1
! [8/1
! [8/1
! [8/1
$67
! [8/1
! [8/1
! [8/1
! [8/1
$/7 RU $67
! [8/1
7RWDO %LOLUXELQ
! [8/1
$/3
! [8/1
$/7 DQGRU $67 $1' 7RWDO %LOLUXELQ
$/7 DQGRU $67 ! [8/1 DQG
WRWDO ELOLUXELQ ! [8/1
 &RPELQDWLRQ RI YDOXHV PHDVXUHG ZLWKLQ VDPH VDPSOH
7KH QXPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK SRWHQWLDOO\ FOLQLFDOO\ VLJQLILFDQW YDOXHV LQ OLYHU
IXQFWLRQ WHVWV GXULQJ WKH LQYHVWLJDWLRQDO SHULRG ZLOO EH SUHVHQWHG E\ WUHDWPHQW JURXS

9LWDO 6LJQV
7KH EDVHOLQH YLVLW LV WKH ODVW PHDVXUHPHQW WDNHQ SULRU WR LQLWLDO VWXG\ GUXJ DGPLQLVWUDWLRQ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
3XOVH UDWH V\VWROLF EORRG SUHVVXUH DQG GLDVWROLF EORRG SUHVVXUH ZLOO EH VXPPDUL]HG E\
WUHDWPHQW JURXS E\ +RPH %DVHG %ORRG 3UHVVXUH 0RQLWRULQJ +%30 DQG RIILFH EDVHG DQG
WKH VXEJURXSV RI LQWHUHVW IRXQG LQ 6HFWLRQ  XVLQJ GHVFULSWLYH VWDWLVWLFV PHDQ VWDQGDUG
GHYLDWLRQ PLQLPXP PD[LPXP DQG PHGLDQ IRU EDVHOLQH YDOXH VSHFLILHG SRVWEDVHOLQH WLPH
SRLQW YDOXHV :HHN  :HHN  DQG :HHN (R7 DQG FKDQJH IURP EDVHOLQH WR HDFK
VSHFLILHG SRVWEDVHOLQH WLPH SRLQW )RU +%30 D YLVLW LV GHILQHG DV D VHW RI  RU OHVV YDOLG
GLDU\ GD\V SULRU WR HDFK YLVLW 0RUQLQJ DQG HYHQLQJ EORRG SUHVVXUH ZLOO EH UHSRUWHG
VHSDUDWHO\ 7KH ILUVW UHDGLQJ RI +%30 IURP HDFK WLPH SHULRG ZLOO EH GLVFDUGHG DQG WKH
VXEVHTXHQW WZR UHDGLQJV IRU HDFK WLPH SHULRG ZLOO EH DYHUDJHG RYHU WKH GD\ GLDU\ ,I RQO\ 
PHDVXUHPHQWV ZHUH UHFRUGHG RQ RQH GD\ ERWK PHDVXUHPHQWV ZLOO EH NHSW $YHUDJH FKDQJH
IURP EDVHOLQH WR HQG RI WUHDWPHQW IRU HDFK YLWDO VLJQ YDULDEOH IRU +%30 DQG RIILFH EDVHG ZLOO
EH DQDO\]HG XVLQJ WKH $1&29$ PRGHO ZLWK WUHDWPHQW JURXS DQG JHRJUDSKLF UHJLRQ DV IL[HG
IDFWRUV DQG EDVHOLQH YLWDO VLJQ YDOXH DV FRYDULDWH $JH JURXS    
ZLOO EH LQFOXGHG DV WKH VWUDWLILFDWLRQ IDFWRU ,W VKRXOG EH QRWHG WKDW DJH JURXS ZDV RPLWWHG
IURP WKH GHVFULSWLRQ RI WKH DQDO\VLV LQ WKH SURWRFRO $V SDUW RI WKH $1&29$ UHVXOWV /6
PHDQV DQG WZRVLGHG  &,V IRU PHDQ FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK WUHDWPHQW JURXS
ZLOO EH SURYLGHG 'LIIHUHQFHV LQ /6 PHDQV EHWZHHQ PLUDEHJURQ DQG SODFHER ZLOO EH GHULYHG
WRJHWKHU ZLWK  &,V
$Q DQDO\VLV RI FKDQJH IURP EDVHOLQH RI YLWDO VLJQV XVLQJ DQ 0050 PRGHO ZLWK JHRJUDSKLF
UHJLRQ DJH JURXS WLPH YLVLW DQG D WLPHE\WUHDWPHQW LQWHUDFWLRQ DV IDFWRUV DQG WKH EDVHOLQH
YDOXHV DV FRYDULDWH ZLOO VHUYH DV DQRWKHU VHQVLWLYLW\ DQDO\VLV 7KH UHSHDWHG PHDVXUHV PRGHO
ZLOO SUHVHQW /6 PHDQV DQG WZRVLGHG  &,V IRU FKDQJHV IURP EDVHOLQH ZLWKLQ HDFK
WUHDWPHQW JURXS
)RU PHDVXUHPHQW EDVHG RQ +%30 WKH DYHUDJLQJ DSSURDFK GHVFULEHG DERYH ZLOO EH DSSOLHG
+\SHUWHQVLRQ HYHQWV IURP WKH +%30 ZLOO EH LGHQWLILHG EXW ZRQ¶W EH VXPPDUL]HG DV $( $Q
$( RI K\SHUWHQVLRQ ZLOO EH UHFRUGHG LI RQH RI WKH IROORZLQJ FULWHULD LV PHW RQ  RU PRUH
FRQVHFXWLYH RIILFHEDVHG YLVLWV 
 ,I WKH DYHUDJH V\VWROLF EORRG SUHVVXUH LV !  PP+J $1'25 WKH DYHUDJH GLDVWROLF
EORRG SUHVVXUH LV !  PP+J DW WZR FRQVHFXWLYH YLVLWV DIWHU %DVHOLQH 9LVLW  LQ
SDWLHQWV ZKR ZHUH QRUPRWHQVLYH DYHUDJH V\VWROLF EORRG SUHVVXUH   PP+J DQG
DYHUDJH GLDVWROLF EORRG SUHVVXUH   PP+J >:+2,6+ @ DW %DVHOLQH 9LVLW

 ,I WKH DYHUDJH V\VWROLF EORRG SUHVVXUH LV LQFUHDVHG !  PP+J $1'25 WKH DYHUDJH
GLDVWROLF EORRG SUHVVXUH LV LQFUHDVHG !  PP+J DW WZR FRQVHFXWLYH YLVLWV DV
FRPSDUHG WR %DVHOLQH 9LVLW  LQ SDWLHQWV ZLWK K\SHUWHQVLRQ DW %DVHOLQH 9LVLW 
 ,I WUHDWPHQW ZLWK DQWLK\SHUWHQVLYH GUXJV LV LQLWLDWHG IRU WUHDWPHQW RI K\SHUWHQVLRQ RU LI
WKH GRVH RI SULRU DQWLK\SHUWHQVLYH GUXJV LV LQFUHDVHG GXH WR DQ LQFUHDVH LQ EORRG
SUHVVXUH
$Q $( RI ³LQFUHDVHG´ %ORRG 3UHVVXUH VKRXOG EH FRQVLGHUHG LI WKH DERYH FRQGLWLRQV DUH QRW
PHW EXW D KLJK EORRG SUHVVXUH LV UHFRUGHG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
$Q $( RI WDFK\FDUGLD VKRXOG EH FRQVLGHUHG LI UHVWLQJ KHDUW IUHTXHQF\ SXOVH UDWH LV ! 
ESP
$Q $( RI ZKLWH FRDW K\SHUWHQVLRQ ZLOO EH UHFRUGHG LI WKH RIILFH PHDVXUHPHQW LV PRUH WKDQ
 JUHDWHU WKDQ ODVW PHDVXUHPHQW IRU WKH SUHFHGLQJ KRPH EDVHG GLDU\ $Q $( RI PDVNHG
K\SHUWHQVLRQ ZLOO EH UHFRUGHG LI ODVW KRPH EDVHG PHDVXUHPHQW LV PRUH WKDQ  JUHDWHU WKDQ
WKH IROORZLQJ RIILFH PHDVXUHPHQW 7KH SHUFHQWDJH RI SDWLHQWV ZLWK ZKLWH FRDW K\SHUWHQVLRQ
PDVNHG K\SHUWHQVLRQ RU QR GLIIHUHQFH DW  YLVLW RU WZR RU PRUH YLVLWV ZLOO EH VXPPDUL]HG
7DEOHV IRU SRWHQWLDOO\ FOLQLFDOO\ VLJQLILFDQW YLWDO VLJQV ZLOO EH JHQHUDWHG XVLQJ EDVHOLQH YDOXH
DQG KLJKHVW YDOXH REWDLQHG GXULQJ WUHDWPHQW IRU HDFK SDWLHQW IRU HDFK WUHDWPHQW JURXS
1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK PRUH WKDQ  PP+J LQFUHDVH IURP
EDVHOLQH LQ 6%3 PRUH WKDQ  PP+J LQFUHDVH LQ '%3 RU PRUH WKDQ  ESP
LQFUHDVH IURP EDVHOLQH LQ SXOVH UDWH RQ  FRQVHFXWLYH SRVWEDVHOLQH YLVLWV ZLOO EH VXPPDUL]HG
E\ WUHDWPHQW JURXS 1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK YLWDO VLJQ YDULDEOHV VKLIWLQJ
EHWZHHQ -1& GHILQHG ULVN FDWHJRULHV ZLOO EH VXPPDUL]HG E\ WUHDWPHQW JURXS 7KHVH
FDWHJRULHV DUH OLVWHG EHORZ
&DWHJRU\
6\VWROLF %3 PP +J
'LDVWROLF %3 PP +J
1RUPDO
 

3UHK\SHUWHQVLRQ


+\SHUWHQVLRQ 6WDJH 


+\SHUWHQVLRQ 6WDJH 


1XPEHU DQG SHUFHQWDJH RI SDWLHQWV ZLWK D 35 !  ESP DW DQ\ RIILFH YLVLW RU E\ +%30 ZLOO
EH VXPPDUL]HG E\ WUHDWPHQW JURXS VHSDUDWHO\
7KH IROORZLQJ 9LWDO 6LJQ GDWD ZLOO EH SUHVHQWHG JUDSKLFDOO\ E\ WUHDWPHQW JURXS DFURVV YLVLWV
x
&KDQJH IURP EDVHOLQH LQ YLWDO VLJQ UHVXOWV XVLQJ PHDQ   &, SORW
x
6FDWWHU SORW RI PD[LPXP YLWDO VLJQ UHVXOWV RQ WUHDWPHQW YHUVXV EDVHOLQH YDOXH VHSDUDWH
SORW IRU 6%3 '%3 DQG SXOVH

(OHFWURFDUGLRJUDPV (&*V
(&* YDULDEOHV KHDUW UDWH 35 LQWHUYDO 55 LQWHUYDO 456 LQWHUYDO 47 LQWHUYDO DQG 47F
LQWHUYDO ZLOO EH VXPPDUL]HG XVLQJ GHVFULSWLYH VWDWLVWLFV RU IUHTXHQFLHV DQG SHUFHQWDJHV IRU
HDFK WUHDWPHQW JURXS DW %DVHOLQH :HHN  :HHN  DQG :HHN (27 LQFOXGLQJ FKDQJHV
IURP EDVHOLQH WR (27
1XPEHU DQG SHUFHQW RI SDWLHQWV ZLWK QRUPDO QRW FOLQLFDOO\ VLJQLILFDQW DEQRUPDO DQG
FOLQLFDOO\ VLJQLILFDQW DEQRUPDO UHVXOWV DV DVVHVVHG E\ ORFDO LQYHVWLJDWRU IRU WKH  OHDG (&*
ZLOO EH WDEXODWHG E\ WUHDWPHQW JURXS DW HDFK WUHDWPHQW YLVLW
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
6KLIW WDEOHV WKDW LQFOXGH QXPEHU DQG SHUFHQW RI SDWLHQWV ZLOO EH SUHVHQWHG IRU  OHDG (&*
UHDGLQJ FKDQJHV IURP QRUPDO DW EDVHOLQH WR DEQRUPDO DW ZHHN   DQG (27 E\ WUHDWPHQW
JURXS
7KH 47F) LQWHUYDO ZLOO EH VXPPDUL]HG XVLQJ IUHTXHQF\ WDEOHV IRU HDFK WUHDWPHQW JURXS DQG
WLPH SRLQW IRU YDOXHV RI FOLQLFDO LPSRUWDQFH XVLQJ WKH UDQJH FULWHULD EHORZ ,W ZLOO EH
VXPPDUL]HG E\ )'$ *XLGDQFH FDWHJRULHV
47F) ,QWHUYDO &ULWHULD 9DOXH PVHF
)'$ &DWHJRULHV
 
! 
! 
! 
7KH 47F) LQWHUYDO ZLOO DOVR EH VXPPDUL]HG E\ WKH IUHTXHQFLHV RI SDWLHQWV ZLWK D FKDQJH IURP
EDVHOLQH RI FOLQLFDO LPSRUWDQFH XVLQJ WKH FULWHULD LGHQWLILHG EHORZ 7KHVH VXPPDULHV ZLOO EH
SURYLGHG IRU HDFK WUHDWPHQW JURXS DQG WLPH SRLQW
9DULDEOH
&KDQJH IURP %DVHOLQH
47F) ,QWHUYDO PVHF

! 
!
! 

395 9ROXPH
395 YROXPH LQ P/ DQG FRUUHVSRQGLQJ FKDQJH IURP EDVHOLQH YDOXHV ZLOO EH VXPPDUL]HG E\
WUHDWPHQW JURXS DQG YLVLW EDVHOLQH DQG :HHN  IRU FRQWLQXRXV YDOXHV DV ZHOO DV XVLQJ WKH
IROORZLQJ FDWHJRULHV
x
  P/
x
!  P/
x
!  P/
x
! P/
$ VKLIW WDEOH IRU FKDQJHV IURP EDVHOLQH WR HDFK SRVWEDVHOLQH YLVLW IRU 395 YROXPH EDVHG RQ
WKHVH FDWHJRULHV DERYH ZLOO EH SHUIRUPHG IRU HDFK WUHDWPHQW JURXS

4PD[
4PD[ ZLOO EH DQDO\]HG IURP FKDQJH IURP EDVHOLQH FROOHFWHG DW WKH EHJLQQLQJ RI WKH UXQLQ
SHULRG DQG VXPPDUL]HG E\ WUHDWPHQW JURXS DQG YLVLW 1XPEHUV DQG SHUFHQWDJHV RI SDWLHQWV
ZKR VKLIW WR 4PD[   P/V ZLOO EH WDEXODWHG
,Q DGGLWLRQ 4PD[ ZLOO DOVR EH VXPPDUL]HG DIWHU RXWOLHUV ZHUH UHPRYHG DV GHILQHG LQ VHFWLRQ

DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

:HLJKW +HLJKW DQG %0,
$ GHVFULSWLYH VXPPDU\ IRU YDOXHV RI KHLJKW EDVHOLQH RQO\ ZHLJKW LQ NJ DQG %0, LQ NJP
DW HDFK SRVWEDVHOLQH YLVLW DQG WKH FKDQJHV IURP EDVHOLQH ZLOO EH SURYLGHG DW HDFK YLVLW $
OLVWLQJ ZLOO DOVR EH SURYLGHG

$QDO\VLV RI 3KDUPDFRNLQHWLFV 3.
1RW DSSOLFDEOH

$QDO\VLV RI 3KDUPDFRG\QDPLFV 3'
1RW DSSOLFDEOH

6XEJURXSV RI ,QWHUHVW
3ULPDU\ HIILFDF\ HQGSRLQW DQG VHOHFWHG VDIHW\ YDULDEOHV WUHDWPHQW HPHUJHQW DGYHUVH HYHQWV
DQG YLWDO VLJQV ZLOO EH VXPPDUL]HG E\ WUHDWPHQW JURXS IRU WKH VXEJURXSV GHILQHG RQ WKH
EDVLV RI WKH FDWHJRUL]HG YDULDEOHV OLVWHG EHORZ LQ FDVH RI DW OHDVW  SDWLHQWV IRU HDFK
WUHDWPHQW JURXS ZLWKLQ WKDW FDWHJRU\
*URXSLQJ YDULDEOH
6XEJURXSV
*HRJUDSKLF 5HJLRQ
1RUWK $PHULFD
(XURSH
$JH JURXS
 \HDUV
 \HDUV
 \HDUV
 \HDUV
3UHYLRXV 2$% PHGLFDWLRQ
<HV
1R
36$ FXWRII H[SORUDWRU\ HQGSRLQW


$5, DW EDVHOLQH
<HV
1R
+\SHUWHQVLRQ DW EDVHOLQH IRU YLWDO VLJQV
<HV
1R
5DFH
:KLWH
%ODFN RU $IULFDQ $PHULFDQ
$VLDQ
$PHULFDQ ,QGLDQ$ODVNDQ 1DWLYH
+DZDLLDQ RU 2WKHU 3DFLILF ,VODQGHU
2WKHU

2WKHU $QDO\VHV
1RW DSSOLFDEOH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

+DQGOLQJ RI 0LVVLQJ 'DWD 2XWOLHUV 9LVLW :LQGRZV DQG 2WKHU
,QIRUPDWLRQ

0LVVLQJ 'DWD
0LVVLQJ SULPDU\ DQG VHFRQGDU\ HIILFDF\ HQGSRLQWV ZLOO EH KDQGOHG E\ /2&) IRU FRQWLQXRXV
YDULDEOHV DQG QRQUHVSRQGHU LPSXWDWLRQ IRU ELQDU\ YDULDEOHV
)RU DOO 2$%T VFDOHV DQG VXEVFDOHV LI  RI WKH LWHPV DUH PLVVLQJ WKH VFDOHVXEVFDOH
VKRXOG EH UHWDLQHG ZLWK WKH PHDQ VFDOH VFRUH RI WKH LWHPV SUHVHQW XVHG WR LPSXWH D VFRUH IRU WKH
PLVVLQJ LWHPV ,I  RI WKH LWHPV DUH PLVVLQJ QR VFDOHVXEVFDOH VFRUH VKRXOG EH FDOFXODWHG
WKH VFDOHVXEVFDOH VFRUH VKRXOG EH FRQVLGHUHG PLVVLQJ
$V D JHQHUDO SULQFLSOH LPSXWDWLRQ RI PLVVLQJ GDWHV IRU YDULDEOHV ZLOO QRW EH GRQH ([FHSWLRQV
DUH IRU VWDUW DQG VWRS GDWHV RI VWXG\ GUXJ LQWDNH $(V DQG FRQFRPLWDQW PHGLFDWLRQV 7KH
LPSXWHG GDWHV ZLOO EH XVHG WR GHWHUPLQH ZKHWKHU WKH PHGLFDWLRQ ZDV WDNHQ SULRU WR RU GXULQJ
WKH GRXEOHEOLQG WUHDWPHQW SHULRG /LVWLQJV RI WKH $(V DQG FRQFRPLWDQW PHGLFDWLRQV ZLOO
SUHVHQW WKH DFWXDO SDUWLDO GDWHV LPSXWHG GDWHV ZLOO QRW EH VKRZQ
 ,PSXWDWLRQ RI 6WXG\ 'UXJ 6WDUW 'DWHV DQG 6WXG\ 'UXJ (QG 'DWHV
,PSXWDWLRQ RI 6WXG\ 'UXJ 6WDUW 'DWHV
5XQ,Q 3HULRG
)RU SDWLHQWV ZKR DUH QRW 6FUHHQ )DLOXUHV WKH ILUVW GRVH GDWH RI WDPVXORVLQ K\GURFKORULGH UXQ
LQ ZLOO EH LPSXWHG LI ERWK RI WKH IROORZLQJ FULWHULD DUH PHW
x
7KHUH LV D PLVVLQJ RU SDUWLDO GDWH IRU WKH ILUVW GRVH RI WDPVXORVLQ K\GURFKORULGH UXQLQ
VWXG\ GUXJ $1'
x
7KH QXPEHU RI WDEOHWV GLVSHQVHG DW WKH 6FUHHQLQJ 9LVLW GRHV QRW HTXDO WKH QXPEHU RI
WDEOHWV UHWXUQHG LQFOXGLQJ PLVVLQJ YDOXHV
,I ERWK FULWHULD DUH PHW WKHQ WKH ILUVW GRVH GDWH RI WDPVXORVLQ K\GURFKORULGH UXQLQ VWXG\ GUXJ
LV GHILQHG DV WKH ILUVW QRQPLVVLQJ GDWH LQ WKH IROORZLQJ RUGHU
 'LVSHQVH GDWH DW 6FUHHQLQJ 9LVLW  GD\
 'DWH RI WKH 6FUHHQLQJ 9LVLW  GD\
'RXEOH%OLQG 7UHDWPHQW 3HULRG
)RU SDWLHQWV ZKR DUH UDQGRPL]HG WR GRXEOHEOLQG WUHDWPHQW WKH ILUVW GRVH GDWH RI GRXEOH
EOLQG WUHDWPHQW VWXG\ GUXJ ZLOO EH LPSXWHG LI ERWK RI WKH IROORZLQJ FULWHULD DUH PHW
x
7KHUH LV D PLVVLQJ RU SDUWLDO GDWH IRU WKH ILUVW GRVH RI GRXEOHEOLQG WUHDWPHQW $1'
x
7KH QXPEHU RI WDEOHWV GLVSHQVHG DW WKH 5DQGRPL]DWLRQ 9LVLW GRHV QRW HTXDO WKH
QXPEHU RI WDEOHWV UHWXUQHG LQFOXGLQJ PLVVLQJ YDOXHV $1'
x
'LVSHQVHG GDWH LV QRQPLVVLQJ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
,I DOO WKH DERYH FULWHULD DUH PHW WKHQ WKH ILUVW GRVH GDWH RI GRXEOHEOLQG WUHDWPHQW LV GHILQHG
DV
'LVSHQVH GDWH DW WKH 5DQGRPL]DWLRQ 9LVLW  GD\
,PSXWDWLRQ RI 6WXG\ 'UXJ (QG 'DWHV
5XQ,Q 3HULRG
)RU SDWLHQWV ZKR DUH QRW 6FUHHQ )DLOXUHV WKH ODVW GRVH GDWH RI WDPVXORVLQ K\GURFKORULGH UXQ
LQ ZLOO EH LPSXWHG LI ERWK RI WKH IROORZLQJ FULWHULD DUH PHW
x
7KHUH LV D PLVVLQJ RU SDUWLDO GDWH IRU WKH ODVW GRVH RI WDPVXORVLQ K\GURFKORULGH UXQLQ
VWXG\ GUXJ $1'
x
7KH QXPEHU RI WDEOHWV GLVSHQVHG DW WKH 6FUHHQLQJ 9LVLW GRHV QRW HTXDO WKH QXPEHU RI
WDEOHWV UHWXUQHG LQFOXGLQJ PLVVLQJ YDOXHV
,I ERWK FULWHULD DUH PHW WKHQ WKH ODVW GRVH GDWH RI WDPVXORVLQ K\GURFKORULGH UXQLQ VWXG\ GUXJ
LV GHILQHG DV WKH ILUVW QRQPLVVLQJ GDWH LQ WKH IROORZLQJ RUGHU
 'DWH RI WKH GD\ EHIRUH WKH ILUVW GRVH RI GRXEOHEOLQG WUHDWPHQW LQ WKH GRXEOHEOLQG
WUHDWPHQW SHULRG
 'D\ RI WKH GLVSHQVH GDWH DW WKH UDQGRPL]DWLRQ YLVLW
 'D\ RI WKH UDQGRPL]DWLRQ YLVLW 9LVLW 
 'DWH RI WKH ILUVW GRVH RI 7DPVXORVLQ +\GURFKORULGH UXQLQ VWXG\ GUXJ   GD\
 'LVSHQVHG GDWH DW WKH 6FUHHQLQJ 9LVLW   GD\
 'DWH RI WKH 6FUHHQLQJ 9LVLW   GD\
'RXEOH%OLQG 7UHDWPHQW 3HULRG
)RU SDWLHQWV ZKR DUH UDQGRPL]HG WR GRXEOHEOLQG WUHDWPHQW WKH ODVW GRVH GDWH RI GRXEOHEOLQG
WUHDWPHQW VWXG\ GUXJ ZLOO EH LPSXWHG LI DOO WKH IROORZLQJ FULWHULD DUH PHW
x
7KHUH LV D PLVVLQJ RU SDUWLDO GDWH IRU WKH ODVW GRVH RI GRXEOHEOLQG WUHDWPHQW $1'
x
7KH QXPEHU RI WDEOHWV GLVSHQVHG DW WKH 5DQGRPL]DWLRQ 9LVLW GRHV QRW HTXDO WKH
QXPEHU RI WDEOHWV UHWXUQHG LQFOXGLQJ PLVVLQJ YDOXHV
,I RQO\ WKH GD\ LV PLVVLQJ IRU WKH ODVW GRVH GDWH RI GRXEOHEOLQG WUHDWPHQW WKH ODVW GD\ RI WKH
PRQWK XQGHU FRQVLGHUDWLRQ ZLOO EH XVHG
,I WKH PRQWK DQGRU \HDU DUH PLVVLQJ IRU WKH ODVW GRVH GDWH RI GRXEOHEOLQG WUHDWPHQW WKHQ WKH
ODVW GRVH GDWH RI GRXEOH EOLQG WUHDWPHQW LV GHILQHG DV WKH ILUVW QRQPLVVLQJ GDWH LQ WKH
IROORZLQJ RUGHU
 /DVW GLVSHQVH GDWH RI WKH GRXEOHEOLQG SHULRG   GD\
 'DWH RI WKH ILUVW GRVH RI GRXEOHEOLQG WUHDWPHQW LQ WKH GRXEOHEOLQG WUHDWPHQW SHULRG 
 GD\
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
 'DWH RI WKH UDQGRPL]DWLRQ YLVLW   GD\
)RU LPSXWLQJ WKH ODVW GRVH GDWH RI WDPVXORVLQ K\GURFKORULGH UXQLQ VWXG\ GUXJ DQG GRXEOH
EOLQG WUHDWPHQW VWXG\ GUXJ DQ LPSXWHG ILUVW GRVH GDWH VKRXOG QRW EH XVHG EXW WKH QH[W
LPSXWDWLRQ UXOH VKRXOG EH XVHG LQVWHDG
 ,PSXWDWLRQ RI $GYHUVH (YHQW 2QVHW 'DWH
)RU $(V D PLVVLQJ RU LQFRPSOHWH RQVHW GDWH ZLOO EH LPSXWHG DFFRUGLQJ WR WKH IROORZLQJ
FRQYHQWLRQV
,I DQ RQVHW GDWH LV PLVVLQJ RU RQO\ WKH \HDU LV NQRZQ WKH LPSXWHG RQVHW GDWH ZLOO EH WKH ODWHVW
RI WKH IROORZLQJ QRQPLVVLQJ GDWHV
x
'DWH RI ILUVW GRVH RI GRXEOHEOLQG WUHDWPHQW
x
'DWH RI UDQGRPL]DWLRQ YLVLW   GD\
x
'DWH RI ODVW GRVH RI VLQJOHEOLQG UXQLQ VWXG\ GUXJ   GD\
,I RQO\ WKH PRQWK DQG \HDU LV NQRZQ IRU RQVHW GDWH VHW WKH VXUURJDWH RQVHW GDWH WR WKH ILUVW
GD\ RI WKDW PRQWK DQG WKHQ DSSO\ WKH IROORZLQJ UXOHV

,I WKH PRQWK DQG \HDU RI WKH RQVHW GDWH LV SULRU WR WKH PRQWK DQG \HDU RI WKH ILUVW GRVH RI
GRXEOHEOLQG WUHDWPHQW WKHQ WKH VXUURJDWH RQVHW GDWH ZLOO EH WKH LPSXWHG RQVHW GDWH

,I WKH PRQWK DQG \HDU RI WKH RQVHW GDWH LV RQ RU DIWHU WKH PRQWK DQG \HDU RI WKH ILUVW GRVH
RI GRXEOHEOLQG WUHDWPHQW RU LI WKH ILUVW GRVH RI GRXEOHEOLQG WUHDWPHQW LV PLVVLQJ WKHQ
WKH LPSXWHG RQVHW GDWH ZLOO EH WKH ODWHVW RI WKH IROORZLQJ QRQPLVVLQJ GDWHV
x
'DWH RI ILUVW GRVH RI GRXEOHEOLQG WUHDWPHQW
x
'DWH RI UDQGRPL]DWLRQ YLVLW   GD\
x
'DWH RI ODVW GRVH RI VLQJOHEOLQG UXQLQ VWXG\ GUXJ   GD\
x
6XUURJDWH RQVHW GDWH
,I WKH LPSXWHG RQVHW GDWH LV DIWHU D FRPSOHWH DGYHUVH HYHQW HQG GDWH WKH LPSXWHG RQVHW GDWH
ZLOO EH WKH VDPH DV WKH FRPSOHWH DGYHUVH HYHQW HQG GDWH
 ,PSXWDWLRQ RI &RQFRPLWDQW 0HGLFDWLRQ DQG 1RQ'UXJ 7UHDWPHQW 6WDUW DQG
(QG 'DWH
6WDUW DQG VWRS GDWHV IRU DOO FRQFRPLWDQW PHGLFDWLRQV DQG QRQGUXJ WUHDWPHQW DUH FROOHFWHG RQ
WKH H&5) +RZHYHU LQ FDVH RI PLVVLQJ RU SDUWLDO LQIRUPDWLRQ LQ WKHVH GDWHV WKH IROORZLQJ
UXOHV ZLOO EH XVHG
,I VWDUW GDWH LV PLVVLQJ RU SDUWLDO
x
LI PRQWK LV PLVVLQJ XVH -DQXDU\
x
LI GD\ LV PLVVLQJ XVH WKH ILUVW GD\ RI WKH PRQWK XQGHU FRQVLGHUDWLRQ
x
LI \HDU LV PLVVLQJ XVH \HDU RI WKH LQIRUPHG FRQVHQW GDWH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
x
LI HQWLUH GDWH LV PLVVLQJ XVH LQIRUPHG FRQVHQW GDWH
,I VWRS GDWH LV PLVVLQJ RU SDUWLDO DQG WKH PHGLFDWLRQ LV QRW RQJRLQJ
x
LI PRQWK LV PLVVLQJ XVH 'HFHPEHU
x
LI GD\ LV PLVVLQJ XVH WKH ODVW GD\ RI WKH PRQWK XQGHU FRQVLGHUDWLRQ
x
LI \HDU RU WKH HQWLUH GDWH LV PLVVLQJ VHW WR 'HFHPEHU VW 
,I WKH LPSXWHG VWDUW GDWH LV DIWHU WKH VWRS GDWH WKHQ WKH LPSXWHG VWDUW GDWH ZLOO EH RQH GD\
SULRU WR WKH VWRS GDWH
,I WKH PHGLFDWLRQ RU QRQGUXJ WUHDWPHQW LV RQJRLQJ WKH VWRS GDWH ZLOO UHPDLQ PLVVLQJ
 ,PSXWDWLRQ RI 2$% 6\PSWRPV 2QVHW 'DWH
,I WKH RQVHW GDWH RI 2$% V\PSWRPV LV SDUWLDOO\ PLVVLQJ WKH IROORZLQJ UXOHV ZLOO WDNH HIIHFW
x
0LVVLQJ GD\ EXW PRQWK DQG \HDU DUH SUHVHQW WKH GD\ ZLOO EH LPSXWHG DV WKH WK GD\
RI WKH PRQWK
x
0LVVLQJ GD\ DQG PRQWK EXW \HDU LV SUHVHQW WKH GD\ DQG PRQWK ZLOO EH LPSXWHG DV
 -XQH RI WKH \HDU
x
0LVVLQJ \HDU EXW GD\ DQG PRQWK DUH SUHVHQW 1R LPSXWDWLRQV ZLOO RFFXU DQG WKH
SDWLHQW ZLOO EH H[FOXGHG IURP DOO VXPPDULHV UHODWHG WR GXUDWLRQ RI 2$% V\PSWRPV
x
0LVVLQJ GD\ PRQWK DQG \HDU 1R LPSXWDWLRQV ZLOO RFFXU DQG WKH SDWLHQW ZLOO EH
H[FOXGHG IURP DOO VXPPDULHV UHODWHG WR GXUDWLRQ RI 2$% V\PSWRPV
x
,I DQ\ VXFK LPSXWHG GDWH IDOOV DIWHU WKH LQIRUPHG FRQVHQW GDWH WKHQ WKH RQVHW GDWH ZLOO
EH VDPH DV WKH LQIRUPHG FRQVHQW GDWH

2XWOLHUV
$Q RXWOLHU LV GHILQHG DV DQ REVHUYDWLRQ IRU ZKLFK WKH UHVLGXDO LV PRUH WKDQ WKUHH LQWHUTXDUWLOH
UDQJHV DERYH WKH WK SHUFHQWLOH RU EHORZ WKH WK SHUFHQWLOH 2XWOLHUV ZLOO EH LGHQWLILHG EDVHG
RQ GLDJQRVWLFV SHUIRUPHG IRU WKH FRSULPDU\ DQG VHFRQGDU\ HIILFDF\ YDULDEOHV E\ XVLQJ
VWDQGDUGL]HG UHVLGXDOV IURP $1&29$ PRGHO 6HFWLRQ  ,I RXWOLHUV DUH SUHVHQW WKHQ
DGGLWLRQDO VHQVLWLYLW\ DQDO\VHV ZLOO EH SHUIRUPHG ZLWK WKH RXWOLHUV H[FOXGHG WR DVVHVV WKHLU
LPSDFW RQ WKH UHVXOWV

9LVLW :LQGRZV
3DWLHQWV GR QRW DOZD\V DGKHUH VWULFWO\ WR WKH YLVLW WLPLQJ LQ WKH SURWRFRO 7KHUHIRUH WKH
GHVLJQDWLRQ RI YLVLWV GXULQJ WKH GRXEOHEOLQG WUHDWPHQW SHULRG ZLOO EH EDVHG RQ WKH GD\ RI
HYDOXDWLRQ UHODWLYH WR WKH VWDUW RI WKH GRXEOHEOLQG WUHDWPHQW SHULRG GD\ RI ILUVW GRVH RI
GRXEOHEOLQG WUHDWPHQW LQ GRXEOHEOLQG WUHDWPHQW SHULRG  'D\  RI GRXEOHEOLQG WUHDWPHQW
SHULRG UDWKHU WKDQ WKH QRPLQDO YLVLW UHFRUGHG LQ WKH &5)
7R DVVLJQ D PHDVXUHPHQW WR D VWXG\ YLVLW GXULQJ WKH GRXEOHEOLQG WUHDWPHQW SHULRG WKH ILUVW
VWHS FRQVLVWV RI VHOHFWLQJ DOO PHDVXUHPHQWV IDOOLQJ ZLWKLQ WKH GRXEOHEOLQG WUHDWPHQW SHULRG
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
DV GHILQHG DERYH 7R IXUWKHU GHWHUPLQH WKH VWXG\ YLVLW PHDVXUHPHQW PXWXDOO\ H[FOXVLYH
UHODWLYH GD\ ZLQGRZV DUH XVHG
,I D SDWLHQW KDV PRUH WKDQ RQH YLVLW ZLWK D PHDVXUHPHQW LQFOXGHG ZLWKLQ D ZLQGRZ WKH
DVVHVVPHQW FORVHVW WR WKH VFKHGXOHG GD\ ZLOO EH XVHG ,Q FDVH RI WLHV EHWZHHQ REVHUYDWLRQV
ORFDWHG RQ GLIIHUHQW VLGHV RI WKH VFKHGXOHG GD\ WKH ODWHU DVVHVVPHQW ZLOO EH XVHG ,Q FDVH RI
WLHV ORFDWHG RQ WKH VDPH VLGH RI WKH VFKHGXOHG GD\ LH PRUH WKDQ RQH YDOXH IRU WKH VDPH
GD\ WKH PHDQ RI WKH YDOXHV ZLOO EH XVHG IRU FRQWLQXRXV YDULDEOHV DQG WKH ZRUVW YDOXH IRU
FDWHJRULFDO YDULDEOHV
,W VKRXOG EH QRWHG WKDW LI PRUH WKDQ RQH PHDVXUHPHQW IRU D SDUDPHWHU LV UHFRUGHG ZLWKLQ WKH
VDPH YLVLW ZLQGRZ WKH DERYH FRQYHQWLRQV PD\ QRW OHDG WR WKH PRVW FRQVHUYDWLYH DSSURDFK
IRU WKH E\YLVLW VXPPDULHV RI FDWHJRULFDO RU QXPHULFDO YDULDEOHV 7KH ZRUVW LQGLYLGXDO
FDWHJRULFDO RU QXPHULFDO YDOXH ZLWKLQ D YLVLW ZLQGRZ PD\ QRW EH LGHQWLILHG DV WKH YDOXH
UHSUHVHQWDWLYH IRU WKH DQDO\VLV YLVLW GXH WR WKH UXOHV DERYH +RZHYHU WKH ZRUVW LQGLYLGXDO
FDWHJRULFDO RU QXPHULFDO YDOXH ZLOO EH DFFRXQWHG IRU LQ WDEOHV VXPPDUL]LQJ WKH ZRUVW
LQGLYLGXDO FDWHJRULFDO RU QXPHULFDO YDOXH UHSRUWHG GXULQJ WKH GRXEOHEOLQG WUHDWPHQW SHULRG
$OO LQGLYLGXDO YDOXHV ZLOO EH SURYLGHG LQ D OLVWLQJ
 $QDO\VLV 9LVLW :LQGRZV IRU (IILFDF\ DQG 6DIHW\ 9DULDEOHV
$OO WKH HIILFDF\ DQG VDIHW\ DVVHVVPHQWV IRU D WUHDWPHQW SHULRG ZLOO EH DOORFDWHG EDVHG RQ WKH
WDEOHV EHORZ
(IILFDF\
$QDO\VLV YLVLW
7DUJHW GD\
$FWXDO DVVHVVPHQW GD\
6FUHHQLQJ7DPVXORVLQ
+\GURFKORULGH 5XQ,Q
'D\ 
 WR 
%DVHOLQH
'D\ 
'D\ D
:HHN 
'D\ 

:HHN 
'D\ 

:HHN 
'D\ 

(QG RI 7UHDWPHQW
'D\ 
 /DVW GD\ RI SRVWEDVHOLQH DVVHVVPHQW
:HHN )ROORZXS 3KRQH &DOO
'D\ 
 WR 
D
$IWHU VFUHHQLQJWDPVXORVLQ K\GURFKORULGH UXQLQ YLVLW ZLQGRZVVWXG\ GD\V ZLOO EH FDOFXODWHG EDVHG RQ WKH
%DVHOLQH 9LVLW  GDWH
6DIHW\
$QDO\VLV YLVLW
7DUJHW GD\
$FWXDO DVVHVVPHQW GD\
6FUHHQLQJ7DPVXORVLQ
+\GURFKORULGH 5XQ,Q
'D\ 
 WR 
%DVHOLQH
'D\ 
'D\ D
:HHN 
'D\ 

:HHN 
'D\ 

:HHN (QG RI 7UHDWPHQW
'D\ 

:HHN )ROORZXS 3KRQH &DOO
'D\ 
 WR 
D
$IWHU VFUHHQLQJWDPVXORVLQ K\GURFKORULGH UXQLQ YLVLW ZLQGRZVVWXG\ GD\V ZLOO EH FDOFXODWHG EDVHG RQ WKH
%DVHOLQH 9LVLW  GDWH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
)RU HIILFDF\ YDULDEOHV UHFRUGHG LQ WKH GD\ PLFWXULWLRQ GLDU\ WKH IROORZLQJ UXOHV ZLOO DSSO\
x
$V PLFWXULWLRQ GLDU\ GDWD DUH WR EH UHFRUGHG IURP PLGQLJKW  GD\V SULRU WR D YLVLW WR
PLGQLJKW  GD\ SULRU WR D YLVLW PLFWXULWLRQ GLDU\ UHFRUGV ZKLFK KDYH WKH VDPH GDWH DV
D YLVLW GDWH VKRXOG EH H[FOXGHG IURP WKH DQDO\VLV 1RQPLFWXULWLRQ TXHVWLRQQDLUH
DVVHVVPHQW GDWHV ZLOO EH FRPSDUHG WR WKH H'LDU\ GDWHV DQG XVHG WR IODJ ZKLFK GLDU\
UHFRUGV VKRXOG EH H[FOXGHG
x
$Q\ GLDU\ GD\V ZKLFK DUH !  GD\V DIWHU WKH ODVW GRVH RI GRXEOHEOLQG WUHDWPHQW ZLOO
QRW EH LQFOXGHG LQ WKH DQDO\VLV
x
$YHUDJH YDOXHV RU QXPEHU RI HSLVRGHV IRU FRXQW GDWD ZLOO RQO\ EH FDOFXODWHG LI DW OHDVW
 YDOLG GLDU\ GD\V DUH DYDLODEOH ZLWKLQ WKH VSHFLILHG ZLQGRZ ,Q WKH FDVH WKDW RQO\ 
YDOLG GLDU\ GD\ LV DYDLODEOH WKHQ QR YDOXH ZLOO EH FDOFXODWHG
x
,I WKHUH DUH PRUH WKDQ  YDOLG GLDU\ GD\V DYDLODEOH IRU D YLVLW WKH DYHUDJH ZLOO EH
EDVHG RQ WKH ODVW  GD\V SULRU WR WKH VFKHGXOHG YLVLW
x
'XSOLFDWH UHFRUGV VDPH WLPH DQG HSLVRGH FKDUDFWHULVWLFV SHU GD\ GXULQJ WKH GD\
PLFWXULWLRQ GLDU\ SHULRG ZLOO EH H[FOXGHG

'2&80(17 5(9,6,21 +,6725<
9HUVLRQ
'DWH
&KDQJHV
&RPPHQWUDWLRQDOH IRU FKDQJH

-XO\
1$
)LQDO 9HUVLRQ 

$XJ
8SGDWHG EDVHG RQ
VSRQVRU¶V FRPPHQWV
)LQDO 9HUVLRQ 

6HS
8SGDWHG EDVHG RQ
VSRQVRU¶V FRPPHQWV
)LQDO 9HUVLRQ 

5()(5(1&(6
&R\QH .6 0DW]D /6 .RSS = $EUDPV 3 7KH YDOLGDWLRQ RI WKH SDWLHQW SHUFHSWLRQ RI EODGGHU
FRQGLWLRQ 33%& D VLQJOHLWHP JOREDO PHDVXUH IRU SDWLHQWV ZLWK RYHUDFWLYH EODGGHU (XURSHDQ
8URORJ\ 
&R\QH .6 0DW]D /6 7KRPSVRQ & -XPDGLORYD = %DYHQGDP 7 7KH UHVSRQVLYHQHVV RI WKH 2$%T
DPRQJ 2$% SDWLHQW VXEJURXSV 1HXURXURORJ\ DQG 8URG\QDPLFV 
+HUGPDQ 0 *XGH[ & HW DO 'HYHORSPHQW DQG 3UHOLPLQDU\ WHVWLQJ RI WKH QHZ ILYHOHYHO YHUVLRQ RI
(4' (4'/ 4XDO /LIH 5HV  'HF  
,&+ +DUPRQL]HG 7ULSDUWLWH *XLGHOLQH (  6WUXFWXUH DQG &RQWHQW RI &OLQLFDO 6WXG\ 5HSRUWV
1RYHPEHU  ZZZLFKRUJ *XLGHOLQHV (IILFDF\ 7RSLFV
,&+ +DUPRQL]HG 7ULSDUWLWH *XLGHOLQH (  6WDWLVWLFDO 3ULQFLSOHV IRU &OLQLFDO 7ULDOV )HEUXDU\ 
ZZZLFKRUJ *XLGHOLQHV (IILFDF\ 7RSLFV
3DOPWDJ + 7KH SDWLHQW¶V SHUVSHFWLYH UHGHILQLQJ HQG SRLQWV 8URORJ\ 6XSSO $
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
:DOO // 1RUWRQ 3$ 'H/DQFH\ -2/ 3UDFWLFDO 8URJ\QHFRORJ\ %DOWLPRUH :LOOLDPV 	 :LONLQV
:+2,6+ :RUOG +HDOWK 2UJDQL]DWLRQ,QWHUQDWLRQDO 6XPPDU\ RI 6DIHW\ ,66 )LQDO 'DWD RQ
)LOH 
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$33(1',&(6

$SSHQGL[  $GYHUVH (YHQWV RI 3RVVLEOH +HSDWLF 2ULJLQ
0HG'5$ +HSDWLF 'LVRUGHUV 604
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
ŽŶŐĞŶŝƚĂů͕ ĨĂŵŝůŝĂů͕ ŶĞŽŶĂƚĂů ĂŶĚ ŐĞŶĞƚŝĐ ĚŝƐŽƌĚĞƌƐ ŽĨ ƚŚĞ ůŝǀĞƌ ;^DYͿ
ĐĐĞƐƐŽƌǇ ůŝǀĞƌ ůŽďĞ
ůĂŐŝůůĞ ƐǇŶĚƌŽŵĞ
ĞƌĞďƌŽŚĞƉĂƚŽƌĞŶĂů ƐǇŶĚƌŽŵĞ
ŽŶŐĞŶŝƚĂů ĂďƐĞŶĐĞ ŽĨ ďŝůĞ ĚƵĐƚƐ
ŽŶŐĞŶŝƚĂů ĐǇƐƚŝĐ ĚŝƐĞĂƐĞ ŽĨ ůŝǀĞƌ
ŽŶŐĞŶŝƚĂů ŚĞƉĂƚŝĐ ĨŝďƌŽƐŝƐ
ŽŶŐĞŶŝƚĂů ŚĞƉĂƚŽďŝůŝĂƌǇ ĂŶŽŵĂůǇ
ŽŶŐĞŶŝƚĂů ŚĞƉĂƚŽŵĞŐĂůǇ
ǇƐƚŝĐ ĨŝďƌŽƐŝƐ ŚĞƉĂƚŝĐ ĚŝƐĞĂƐĞ
ŝůĂƚĂƚŝŽŶ ŝŶƚƌĂŚĞƉĂƚŝĐ ĚƵĐƚ ĐŽŶŐĞŶŝƚĂů
'ůǇĐŽŐĞŶ ƐƚŽƌĂŐĞ ĚŝƐĞĂƐĞ ƚǇƉĞ /
'ůǇĐŽŐĞŶ ƐƚŽƌĂŐĞ ĚŝƐĞĂƐĞ ƚǇƉĞ ///
'ůǇĐŽŐĞŶ ƐƚŽƌĂŐĞ ĚŝƐĞĂƐĞ ƚǇƉĞ /s
'ůǇĐŽŐĞŶ ƐƚŽƌĂŐĞ ĚŝƐĞĂƐĞ ƚǇƉĞ s/
,ĞƉĂƚŝƚŝƐ ŶĞŽŶĂƚĂů
,ĞƉĂƚŽĐĞůůƵůĂƌ ĚĂŵĂŐĞ ŶĞŽŶĂƚĂů
,ĞƉĂƚŽͲůĞŶƚŝĐƵůĂƌ ĚĞŐĞŶĞƌĂƚŝŽŶ
,ĞƉĂƚŽƐƉůĞŶŽŵĞŐĂůǇ ŶĞŽŶĂƚĂů
,ĞƌĞĚŝƚĂƌǇ ŚĂĞŵŽĐŚƌŽŵĂƚŽƐŝƐ
EĞŽŶĂƚĂů ĐŚŽůĞƐƚĂƐŝƐ
EĞŽŶĂƚĂů ŚĞƉĂƚŽŵĞŐĂůǇ
WŽůǇĐǇƐƚŝĐ ůŝǀĞƌ ĚŝƐĞĂƐĞ
WŽƌƉŚǇƌŝĂ ĂĐƵƚĞ
,ǇƉĞƌďŝůŝƌƵďŝŶĂĞŵŝĂ ŶĞŽŶĂƚĂů
:ĂƵŶĚŝĐĞ ŶĞŽŶĂƚĂů
<ĞƌŶŝĐƚĞƌƵƐ
WŽƌƉŚǇƌŝĂ ŶŽŶͲĂĐƵƚĞ
ƌƵŐ ƌĞůĂƚĞĚ ŚĞƉĂƚŝĐ ĚŝƐŽƌĚĞƌƐ Ͳ ĐŽŵƉƌĞŚĞŶƐŝǀĞ ƐĞĂƌĐŚ ;^DYͿ
ŚŽůĞƐƚĂƐŝƐ ĂŶĚ ũĂƵŶĚŝĐĞ ŽĨ ŚĞƉĂƚŝĐ ŽƌŝŐŝŶ ;^DYͿ
ŝůŝƌƵďŝŶ ĞǆĐƌĞƚŝŽŶ ĚŝƐŽƌĚĞƌ
ŚŽůĂĞŵŝĂ
ŚŽůĞƐƚĂƐŝƐ
ŚŽůĞƐƚĂƚŝĐ ůŝǀĞƌ ŝŶũƵƌǇ
ŚŽůĞƐƚĂƚŝĐ ƉƌƵƌŝƚƵƐ
ƌƵŐͲŝŶĚƵĐĞĚ ůŝǀĞƌ ŝŶũƵƌǇ
,ĞƉĂƚŝƚŝƐ ĐŚŽůĞƐƚĂƚŝĐ
,ǇƉĞƌďŝůŝƌƵďŝŶĂĞŵŝĂ
/ĐƚĞƌƵƐ ŝŶĚĞǆ ŝŶĐƌĞĂƐĞĚ
:ĂƵŶĚŝĐĞ
:ĂƵŶĚŝĐĞ ĐŚŽůĞƐƚĂƚŝĐ
:ĂƵŶĚŝĐĞ ŚĞƉĂƚŽĐĞůůƵůĂƌ
DŝǆĞĚ ůŝǀĞƌ ŝŶũƵƌǇ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
KĐƵůĂƌ ŝĐƚĞƌƵƐ
ĞĨŝĐŝĞŶĐǇ ŽĨ ďŝůĞ ƐĞĐƌĞƚŝŽŶ
zĞůůŽǁ ƐŬŝŶ
ƌƵŐ ƌĞůĂƚĞĚ ŚĞƉĂƚŝĐ ĚŝƐŽƌĚĞƌƐ Ͳ ƐĞǀĞƌĞ ĞǀĞŶƚƐ ŽŶůǇ ;^DYͿ
,ĞƉĂƚŝĐ ĨĂŝůƵƌĞ͕ ĨŝďƌŽƐŝƐ ĂŶĚ ĐŝƌƌŚŽƐŝƐ ĂŶĚ ŽƚŚĞƌ ůŝǀĞƌ ĚĂŵĂŐĞͲƌĞůĂƚĞĚ
ĐŽŶĚŝƚŝŽŶƐ ;^DYͿ
ĐƵƚĞ ŚĞƉĂƚŝĐ ĨĂŝůƵƌĞ
ĐƵƚĞ ǇĞůůŽǁ ůŝǀĞƌ ĂƚƌŽƉŚǇ
ƐĐŝƚĞƐ
ƐƚĞƌŝǆŝƐ
ĂĐƚĞƌĂƐĐŝƚĞƐ
ŝůŝĂƌǇ ĐŝƌƌŚŽƐŝƐ
ŝůŝĂƌǇ ĐŝƌƌŚŽƐŝƐ ƉƌŝŵĂƌǇ
ŝůŝĂƌǇ ĨŝďƌŽƐŝƐ
ŚŽůĞƐƚĂƚŝĐ ůŝǀĞƌ ŝŶũƵƌǇ
ŚƌŽŶŝĐ ŚĞƉĂƚŝĐ ĨĂŝůƵƌĞ
ŽŵĂ ŚĞƉĂƚŝĐ
ƌǇƉƚŽŐĞŶŝĐ ĐŝƌƌŚŽƐŝƐ
ŝĂďĞƚŝĐ ŚĞƉĂƚŽƉĂƚŚǇ
ƌƵŐͲŝŶĚƵĐĞĚ ůŝǀĞƌ ŝŶũƵƌǇ
ƵŽĚĞŶĂů ǀĂƌŝĐĞƐ
'ĂůůďůĂĚĚĞƌ ǀĂƌŝĐĞƐ
'ĂƐƚƌŝĐ ǀĂƌŝĐĞƐ
'ĂƐƚƌŝĐ ǀĂƌŝĐĞƐ ŚĂĞŵŽƌƌŚĂŐĞ
,ĞƉĂƚĞĐƚŽŵǇ
,ĞƉĂƚŝĐ ĂƚƌŽƉŚǇ
,ĞƉĂƚŝĐ ĐĂůĐŝĨŝĐĂƚŝŽŶ
,ĞƉĂƚŝĐ ĐŝƌƌŚŽƐŝƐ
,ĞƉĂƚŝĐ ĞŶĐĞƉŚĂůŽƉĂƚŚǇ
,ĞƉĂƚŝĐ ĞŶĐĞƉŚĂůŽƉĂƚŚǇ ƉƌŽƉŚǇůĂǆŝƐ
,ĞƉĂƚŝĐ ĨĂŝůƵƌĞ
,ĞƉĂƚŝĐ ĨŝďƌŽƐŝƐ
,ĞƉĂƚŝĐ ŚǇĚƌŽƚŚŽƌĂǆ
,ĞƉĂƚŝĐ ŝŶĨŝůƚƌĂƚŝŽŶ ĞŽƐŝŶŽƉŚŝůŝĐ
,ĞƉĂƚŝĐ ůĞƐŝŽŶ
,ĞƉĂƚŝĐ ŶĞĐƌŽƐŝƐ
,ĞƉĂƚŝĐ ƐƚĞĂƚŽƐŝƐ
,ĞƉĂƚŝƚŝƐ ĨƵůŵŝŶĂŶƚ
,ĞƉĂƚŽďŝůŝĂƌǇ ĚŝƐĞĂƐĞ
,ĞƉĂƚŽĐĞůůƵůĂƌ ĨŽĂŵǇ ĐĞůů ƐǇŶĚƌŽŵĞ
,ĞƉĂƚŽĐĞůůƵůĂƌ ŝŶũƵƌǇ
,ĞƉĂƚŽƉƵůŵŽŶĂƌǇ ƐǇŶĚƌŽŵĞ
,ĞƉĂƚŽƌĞŶĂů ĨĂŝůƵƌĞ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
,ĞƉĂƚŽƌĞŶĂů ƐǇŶĚƌŽŵĞ
,ĞƉĂƚŽƚŽǆŝĐŝƚǇ
/ŶƚĞƐƚŝŶĂů ǀĂƌŝĐĞƐ
>ŝǀĞƌ ĂŶĚ ƐŵĂůů ŝŶƚĞƐƚŝŶĞ ƚƌĂŶƐƉůĂŶƚ
>ŝǀĞƌ ĚŝƐŽƌĚĞƌ
>ŝǀĞƌ ŝŶũƵƌǇ
>ŝǀĞƌ ŽƉĞƌĂƚŝŽŶ
>ŝǀĞƌ ƚƌĂŶƐƉůĂŶƚ
>ƵƉŽŝĚ ŚĞƉĂƚŝĐ ĐŝƌƌŚŽƐŝƐ
DŝǆĞĚ ůŝǀĞƌ ŝŶũƵƌǇ
EŽĚƵůĂƌ ƌĞŐĞŶĞƌĂƚŝǀĞ ŚǇƉĞƌƉůĂƐŝĂ
EŽŶͲĂůĐŽŚŽůŝĐ ƐƚĞĂƚŽŚĞƉĂƚŝƚŝƐ
KĞĚĞŵĂ ĚƵĞ ƚŽ ŚĞƉĂƚŝĐ ĚŝƐĞĂƐĞ
KĞƐŽƉŚĂŐĞĂů ǀĂƌŝĐĞƐ ŚĂĞŵŽƌƌŚĂŐĞ
WĞƌŝƉĂŶĐƌĞĂƚŝĐ ǀĂƌŝĐĞƐ
WŽƌƚĂů ŚǇƉĞƌƚĞŶƐŝŽŶ
WŽƌƚĂů ŚǇƉĞƌƚĞŶƐŝǀĞ ĞŶƚĞƌŽƉĂƚŚǇ
WŽƌƚĂů ŚǇƉĞƌƚĞŶƐŝǀĞ ŐĂƐƚƌŽƉĂƚŚǇ
WŽƌƚĂů ƚƌŝĂĚŝƚŝƐ
WŽƌƚĂů ǀĞŝŶ ĚŝůĂƚĂƚŝŽŶ
WŽƌƚŽƉƵůŵŽŶĂƌǇ ŚǇƉĞƌƚĞŶƐŝŽŶ
ZĞŶĂů ĂŶĚ ůŝǀĞƌ ƚƌĂŶƐƉůĂŶƚ
ZĞƚƌŽŐƌĂĚĞ ƉŽƌƚĂů ǀĞŝŶ ĨůŽǁ
ZĞǇĞΖƐ ƐǇŶĚƌŽŵĞ
ZĞǇŶŽůĚΖƐ ƐǇŶĚƌŽŵĞ
^ƉůĞŶŝĐ ǀĂƌŝĐĞƐ
^ƉůĞŶŝĐ ǀĂƌŝĐĞƐ ŚĂĞŵŽƌƌŚĂŐĞ
^ƵďĂĐƵƚĞ ŚĞƉĂƚŝĐ ĨĂŝůƵƌĞ
sĂƌŝĐĞƐ ŽĞƐŽƉŚĂŐĞĂů
sĂƌŝĐŽƐĞ ǀĞŝŶƐ ŽĨ ĂďĚŽŵŝŶĂů ǁĂůů
ŶŽƌĞĐƚĂů ǀĂƌŝĐĞƐ
ŶŽƌĞĐƚĂů ǀĂƌŝĐĞƐ ŚĂĞŵŽƌƌŚĂŐĞ
/ŶƚƌĂŚĞƉĂƚŝĐ ƉŽƌƚĂů ŚĞƉĂƚŝĐ ǀĞŶŽƵƐ ĨŝƐƚƵůĂ
WĞƌŝƚŽŶĞŽǀĞŶŽƵƐ ƐŚƵŶƚ
WŽƌƚĂů ƐŚƵŶƚ
^ŵĂůůͲĨŽƌͲƐŝǌĞ ůŝǀĞƌ ƐǇŶĚƌŽŵĞ
^ƉŝĚĞƌ ŶĂĞǀƵƐ
,ĞƉĂƚŝƚŝƐ͕ ŶŽŶͲŝŶĨĞĐƚŝŽƵƐ ;^DYͿ
ĐƵƚĞ ŐƌĂĨƚ ǀĞƌƐƵƐ ŚŽƐƚ ĚŝƐĞĂƐĞ ŝŶ ůŝǀĞƌ
ůůĞƌŐŝĐ ŚĞƉĂƚŝƚŝƐ
ƵƚŽŝŵŵƵŶĞ ŚĞƉĂƚŝƚŝƐ
ŚƌŽŶŝĐ ŐƌĂĨƚ ǀĞƌƐƵƐ ŚŽƐƚ ĚŝƐĞĂƐĞ ŝŶ ůŝǀĞƌ
ŚƌŽŶŝĐ ŚĞƉĂƚŝƚŝƐ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
'ƌĂĨƚ ǀĞƌƐƵƐ ŚŽƐƚ ĚŝƐĞĂƐĞ ŝŶ ůŝǀĞƌ
,ĞƉĂƚŝƚŝƐ
,ĞƉĂƚŝƚŝƐ ĂĐƵƚĞ
,ĞƉĂƚŝƚŝƐ ĐŚŽůĞƐƚĂƚŝĐ
,ĞƉĂƚŝƚŝƐ ĐŚƌŽŶŝĐ ĂĐƚŝǀĞ
,ĞƉĂƚŝƚŝƐ ĐŚƌŽŶŝĐ ƉĞƌƐŝƐƚĞŶƚ
,ĞƉĂƚŝƚŝƐ ĨƵůŵŝŶĂŶƚ
,ĞƉĂƚŝƚŝƐ ƚŽǆŝĐ
/ƐĐŚĂĞŵŝĐ ŚĞƉĂƚŝƚŝƐ
>ƵƉƵƐ ŚĞƉĂƚŝƚŝƐ
EŽŶͲĂůĐŽŚŽůŝĐ ƐƚĞĂƚŽŚĞƉĂƚŝƚŝƐ
ZĂĚŝĂƚŝŽŶ ŚĞƉĂƚŝƚŝƐ
'ƌĂŶƵůŽŵĂƚŽƵƐ ůŝǀĞƌ ĚŝƐĞĂƐĞ
>ŝǀĞƌ ƐĂƌĐŽŝĚŽƐŝƐ
>ŝǀĞƌ ŶĞŽƉůĂƐŵƐ͕ ďĞŶŝŐŶ ;ŝŶĐů ĐǇƐƚƐ ĂŶĚ ƉŽůǇƉƐͿ ;^DYͿ
ĞŶŝŐŶ ŚĞƉĂƚŝĐ ŶĞŽƉůĂƐŵ
&ŽĐĂů ŶŽĚƵůĂƌ ŚǇƉĞƌƉůĂƐŝĂ
,ĂĞŵĂŶŐŝŽŵĂ ŽĨ ůŝǀĞƌ
,ĂĞŵŽƌƌŚĂŐŝĐ ŚĞƉĂƚŝĐ ĐǇƐƚ
,ĞƉĂƚŝĐ ĂĚĞŶŽŵĂ
,ĞƉĂƚŝĐ ĐǇƐƚ
,ĞƉĂƚŝĐ ĐǇƐƚ ƌƵƉƚƵƌĞĚ
,ĞƉĂƚŝĐ ŚĂĞŵĂŶŐŝŽŵĂ ƌƵƉƚƵƌĞ
>ŝǀĞƌ ŶĞŽƉůĂƐŵƐ͕ ŵĂůŝŐŶĂŶƚ ĂŶĚ ƵŶƐƉĞĐŝĨŝĞĚ ;^DYͿ
>ŝǀĞƌ ŵĂůŝŐŶĂŶƚ ƚƵŵŽƵƌƐ ;^DYͿ
,ĞƉĂƚŝĐ ĂŶŐŝŽƐĂƌĐŽŵĂ
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ŵĞƚĂƐƚĂƚŝĐ
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ /
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ //
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ ///
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ /s
,ĞƉĂƚŽďůĂƐƚŽŵĂ
,ĞƉĂƚŽďůĂƐƚŽŵĂ ƌĞĐƵƌƌĞŶƚ
,ĞƉĂƚŽĐĞůůƵůĂƌ ĐĂƌĐŝŶŽŵĂ
DŝǆĞĚ ŚĞƉĂƚŽĐĞůůƵůĂƌ ĐŚŽůĂŶŐŝŽĐĂƌĐŝŶŽŵĂ
>ŝǀĞƌ ƚƵŵŽƵƌƐ ŽĨ ƵŶƐƉĞĐŝĨŝĞĚ ŵĂůŝŐŶĂŶĐǇ ;^DYͿ
,ĞƉĂƚŝĐ ŶĞŽƉůĂƐŵ
,ĞƉĂƚŽďŝůŝĂƌǇ ŶĞŽƉůĂƐŵ
>ŝǀĞƌ ƌĞůĂƚĞĚ ŝŶǀĞƐƚŝŐĂƚŝŽŶƐ͕ ƐŝŐŶƐ ĂŶĚ ƐǇŵƉƚŽŵƐ ;^DYͿ
ůĂŶŝŶĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ĂďŶŽƌŵĂů
ůĂŶŝŶĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
ŵŵŽŶŝĂ ĂďŶŽƌŵĂů
ŵŵŽŶŝĂ ŝŶĐƌĞĂƐĞĚ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
ƐĐŝƚĞƐ
ƐƉĂƌƚĂƚĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ĂďŶŽƌŵĂů
ƐƉĂƌƚĂƚĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
ĂĐƚĞƌĂƐĐŝƚĞƐ
ŝůĞ ŽƵƚƉƵƚ ĂďŶŽƌŵĂů
ŝůĞ ŽƵƚƉƵƚ ĚĞĐƌĞĂƐĞĚ
ŝůŝƌƵďŝŶ ĐŽŶũƵŐĂƚĞĚ ĂďŶŽƌŵĂů
ŝůŝƌƵďŝŶ ĐŽŶũƵŐĂƚĞĚ ŝŶĐƌĞĂƐĞĚ
ŝŽƉƐǇ ůŝǀĞƌ ĂďŶŽƌŵĂů
ůŽŽĚ ďŝůŝƌƵďŝŶ ĂďŶŽƌŵĂů
ůŽŽĚ ďŝůŝƌƵďŝŶ ŝŶĐƌĞĂƐĞĚ
ůŽŽĚ ďŝůŝƌƵďŝŶ ƵŶĐŽŶũƵŐĂƚĞĚ ŝŶĐƌĞĂƐĞĚ
ƌŽŵŽƐƵůƉŚƚŚĂůĞŝŶ ƚĞƐƚ ĂďŶŽƌŵĂů
ŚŝůĚͲWƵŐŚͲdƵƌĐŽƚƚĞ ƐĐŽƌĞ ŝŶĐƌĞĂƐĞĚ
&ŽĞƚŽƌ ŚĞƉĂƚŝĐƵƐ
'ĂůĂĐƚŽƐĞ ĞůŝŵŝŶĂƚŝŽŶ ĐĂƉĂĐŝƚǇ ƚĞƐƚ ĂďŶŽƌŵĂů
'ĂůĂĐƚŽƐĞ ĞůŝŵŝŶĂƚŝŽŶ ĐĂƉĂĐŝƚǇ ƚĞƐƚ ĚĞĐƌĞĂƐĞĚ
'ĂŵŵĂͲŐůƵƚĂŵǇůƚƌĂŶƐĨĞƌĂƐĞ ĂďŶŽƌŵĂů
'ĂŵŵĂͲŐůƵƚĂŵǇůƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
'ƵĂŶĂƐĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƉůĂƐƚŝŶ ĂďŶŽƌŵĂů
,ĞƉĂƉůĂƐƚŝŶ ĚĞĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĂƌƚĞƌǇ ĨůŽǁ ĚĞĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĐŽŶŐĞƐƚŝŽŶ
,ĞƉĂƚŝĐ ĞŶǌǇŵĞ ĂďŶŽƌŵĂů
,ĞƉĂƚŝĐ ĞŶǌǇŵĞ ĚĞĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĞŶǌǇŵĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĨƵŶĐƚŝŽŶ ĂďŶŽƌŵĂů
,ĞƉĂƚŝĐ ŚǇĚƌŽƚŚŽƌĂǆ
,ĞƉĂƚŝĐ ŵĂƐƐ
,ĞƉĂƚŝĐ ƉĂŝŶ
,ĞƉĂƚŝĐ ƐĞƋƵĞƐƚƌĂƚŝŽŶ
,ĞƉĂƚŝĐ ǀĂƐĐƵůĂƌ ƌĞƐŝƐƚĂŶĐĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŽďŝůŝĂƌǇ ƐĐĂŶ ĂďŶŽƌŵĂů
,ĞƉĂƚŽŵĞŐĂůǇ
,ĞƉĂƚŽƐƉůĞŶŽŵĞŐĂůǇ
,ǇƉĞƌĂŵŵŽŶĂĞŵŝĂ
,ǇƉĞƌďŝůŝƌƵďŝŶĂĞŵŝĂ
,ǇƉĞƌĐŚŽůŝĂ
,ǇƉĞƌƚƌĂŶƐĂŵŝŶĂƐĂĞŵŝĂ
<ĂǇƐĞƌͲ&ůĞŝƐĐŚĞƌ ƌŝŶŐ
>ŝǀĞƌ ĨƵŶĐƚŝŽŶ ƚĞƐƚ ĂďŶŽƌŵĂů
>ŝǀĞƌ ŝŶĚƵƌĂƚŝŽŶ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
>ŝǀĞƌ ƉĂůƉĂďůĞ ƐƵďĐŽƐƚĂů
>ŝǀĞƌ ƐĐĂŶ ĂďŶŽƌŵĂů
>ŝǀĞƌ ƚĞŶĚĞƌŶĞƐƐ
DŝƚŽĐŚŽŶĚƌŝĂů ĂƐƉĂƌƚĂƚĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
DŽůĂƌ ƌĂƚŝŽ ŽĨ ƚŽƚĂů ďƌĂŶĐŚĞĚͲĐŚĂŝŶ ĂŵŝŶŽ ĂĐŝĚ ƚŽ ƚǇƌŽƐŝŶĞ
KĞĚĞŵĂ ĚƵĞ ƚŽ ŚĞƉĂƚŝĐ ĚŝƐĞĂƐĞ
WĞƌŝŚĞƉĂƚŝĐ ĚŝƐĐŽŵĨŽƌƚ
ZĞƚƌŽŐƌĂĚĞ ƉŽƌƚĂů ǀĞŝŶ ĨůŽǁ
dŽƚĂů ďŝůĞ ĂĐŝĚƐ ŝŶĐƌĞĂƐĞĚ
dƌĂŶƐĂŵŝŶĂƐĞƐ ĂďŶŽƌŵĂů
dƌĂŶƐĂŵŝŶĂƐĞƐ ŝŶĐƌĞĂƐĞĚ
hůƚƌĂƐŽƵŶĚ ůŝǀĞƌ ĂďŶŽƌŵĂů
hƌŝŶĞ ďŝůŝƌƵďŝŶ ŝŶĐƌĞĂƐĞĚ
yͲƌĂǇ ŚĞƉĂƚŽďŝůŝĂƌǇ ĂďŶŽƌŵĂů
ϱΖŶƵĐůĞŽƚŝĚĂƐĞ ŝŶĐƌĞĂƐĞĚ
ůŽŽĚ ĂůŬĂůŝŶĞ ƉŚŽƐƉŚĂƚĂƐĞ ĂďŶŽƌŵĂů
ůŽŽĚ ĂůŬĂůŝŶĞ ƉŚŽƐƉŚĂƚĂƐĞ ŝŶĐƌĞĂƐĞĚ
ůŽŽĚ ĐŚŽůŝŶĞƐƚĞƌĂƐĞ ĂďŶŽƌŵĂů
ůŽŽĚ ĐŚŽůŝŶĞƐƚĞƌĂƐĞ ĚĞĐƌĞĂƐĞĚ
ĞĨŝĐŝĞŶĐǇ ŽĨ ďŝůĞ ƐĞĐƌĞƚŝŽŶ
'ůƵƚĂŵĂƚĞ ĚĞŚǇĚƌŽŐĞŶĂƐĞ ŝŶĐƌĞĂƐĞĚ
,ĂĞŵŽƌƌŚĂŐŝĐ ĂƐĐŝƚĞƐ
,ǇƉŽĂůďƵŵŝŶĂĞŵŝĂ
>ĞƵĐŝŶĞ ĂŵŝŶŽƉĞƉƚŝĚĂƐĞ ŝŶĐƌĞĂƐĞĚ
WĞƌŝƉŽƌƚĂů ŽĞĚĞŵĂ
WĞƌŝƚŽŶĞĂů ĨůƵŝĚ ƉƌŽƚĞŝŶ ĂďŶŽƌŵĂů
WĞƌŝƚŽŶĞĂů ĨůƵŝĚ ƉƌŽƚĞŝŶ ĚĞĐƌĞĂƐĞĚ
WĞƌŝƚŽŶĞĂů ĨůƵŝĚ ƉƌŽƚĞŝŶ ŝŶĐƌĞĂƐĞĚ
WŶĞƵŵŽďŝůŝĂ
WŽƌƚĂů ǀĞŝŶ ĨůŽǁ ĚĞĐƌĞĂƐĞĚ
WŽƌƚĂů ǀĞŝŶ ƉƌĞƐƐƵƌĞ ŝŶĐƌĞĂƐĞĚ
ZĞƚŝŶŽů ďŝŶĚŝŶŐ ƉƌŽƚĞŝŶ ĚĞĐƌĞĂƐĞĚ
hƌŽďŝůŝŶŽŐĞŶ ƵƌŝŶĞ ĚĞĐƌĞĂƐĞĚ
hƌŽďŝůŝŶŽŐĞŶ ƵƌŝŶĞ ŝŶĐƌĞĂƐĞĚ
>ŝǀĞƌͲƌĞůĂƚĞĚ ĐŽĂŐƵůĂƚŝŽŶ ĂŶĚ ďůĞĞĚŝŶŐ ĚŝƐƚƵƌďĂŶĐĞƐ ;^DYͿ
ŶƚŝƚŚƌŽŵďŝŶ /// ĚĞĐƌĞĂƐĞĚ
ůŽŽĚ ĨŝďƌŝŶŽŐĞŶ ĂďŶŽƌŵĂů
ůŽŽĚ ĨŝďƌŝŶŽŐĞŶ ĚĞĐƌĞĂƐĞĚ
ůŽŽĚ ƚŚƌŽŵďŝŶ ĂďŶŽƌŵĂů
ůŽŽĚ ƚŚƌŽŵďŝŶ ĚĞĐƌĞĂƐĞĚ
ůŽŽĚ ƚŚƌŽŵďŽƉůĂƐƚŝŶ ĂďŶŽƌŵĂů
ůŽŽĚ ƚŚƌŽŵďŽƉůĂƐƚŝŶ ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ ĚĞĐƌĞĂƐĞĚ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ /y ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ /y ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s// ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s// ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ y ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ y ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
,ǇƉŽĐŽĂŐƵůĂďůĞ ƐƚĂƚĞ
,ǇƉŽĨŝďƌŝŶŽŐĞŶĂĞŵŝĂ
,ǇƉŽƉƌŽƚŚƌŽŵďŝŶĂĞŵŝĂ
,ǇƉŽƚŚƌŽŵďŝŶĂĞŵŝĂ
,ǇƉŽƚŚƌŽŵďŽƉůĂƐƚŝŶĂĞŵŝĂ
/ŶƚĞƌŶĂƚŝŽŶĂů ŶŽƌŵĂůŝƐĞĚ ƌĂƚŝŽ ĂďŶŽƌŵĂů
/ŶƚĞƌŶĂƚŝŽŶĂů ŶŽƌŵĂůŝƐĞĚ ƌĂƚŝŽ ŝŶĐƌĞĂƐĞĚ
WƌŽƚĞŝŶ  ĚĞĐƌĞĂƐĞĚ
WƌŽƚĞŝŶ ^ ĂďŶŽƌŵĂů
WƌŽƚĞŝŶ ^ ĚĞĐƌĞĂƐĞĚ
WƌŽƚŚƌŽŵďŝŶ ůĞǀĞů ĂďŶŽƌŵĂů
WƌŽƚŚƌŽŵďŝŶ ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ĂďŶŽƌŵĂů
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ƉƌŽůŽŶŐĞĚ
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ƌĂƚŝŽ ĂďŶŽƌŵĂů
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ƌĂƚŝŽ ŝŶĐƌĞĂƐĞĚ
dŚƌŽŵďŝŶ ƚŝŵĞ ĂďŶŽƌŵĂů
dŚƌŽŵďŝŶ ƚŝŵĞ ƉƌŽůŽŶŐĞĚ
,ĞƉĂƚŝĐ ĚŝƐŽƌĚĞƌƐ ƐƉĞĐŝĨŝĐĂůůǇ ƌĞƉŽƌƚĞĚ ĂƐ ĂůĐŽŚŽůͲƌĞůĂƚĞĚ ;^DYͿ
ůĐŽŚŽůŝĐ ůŝǀĞƌ ĚŝƐĞĂƐĞ
ŝƌƌŚŽƐŝƐ ĂůĐŽŚŽůŝĐ
&ĂƚƚǇ ůŝǀĞƌ ĂůĐŽŚŽůŝĐ
,ĞƉĂƚŝƚŝƐ ĂůĐŽŚŽůŝĐ
ŝĞǀĞ ƐǇŶĚƌŽŵĞ
>ŝǀĞƌ ŝŶĨĞĐƚŝŽŶƐ ;^DYͿ
ĐƵƚĞ ŚĞƉĂƚŝƚŝƐ 
ĐƵƚĞ ŚĞƉĂƚŝƚŝƐ 
ĚĞŶŽǀŝƌĂů ŚĞƉĂƚŝƚŝƐ
ƐǇŵƉƚŽŵĂƚŝĐ ǀŝƌĂů ŚĞƉĂƚŝƚŝƐ
ŚƌŽŶŝĐ ŚĞƉĂƚŝƚŝƐ 
ŚƌŽŶŝĐ ŚĞƉĂƚŝƚŝƐ 
ŽŶŐĞŶŝƚĂů ŚĞƉĂƚŝƚŝƐ  ŝŶĨĞĐƚŝŽŶ
ǇƚŽŵĞŐĂůŽǀŝƌƵƐ ŚĞƉĂƚŝƚŝƐ
,sͲE ƉŽůǇŵĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĂŵŽĞďŝĂƐŝƐ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
,ĞƉĂƚŝĐ ĐĂŶĚŝĚŝĂƐŝƐ
,ĞƉĂƚŝĐ ĐǇƐƚ ŝŶĨĞĐƚŝŽŶ
,ĞƉĂƚŝĐ ĞĐŚŝŶŽĐŽĐĐŝĂƐŝƐ
,ĞƉĂƚŝĐ ŝŶĨĞĐƚŝŽŶ
,ĞƉĂƚŝĐ ŝŶĨĞĐƚŝŽŶ ďĂĐƚĞƌŝĂů
,ĞƉĂƚŝĐ ŝŶĨĞĐƚŝŽŶ ĨƵŶŐĂů
,ĞƉĂƚŝĐ ŝŶĨĞĐƚŝŽŶ ŚĞůŵŝŶƚŚŝĐ
,ĞƉĂƚŝƚŝƐ 
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ĂďŶŽƌŵĂů
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝŐĞŶ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ǀŝƌƵƐ ƚĞƐƚ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ 
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ĂďŶŽƌŵĂů
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ĐŽƌĞ ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ĐŽƌĞ ĂŶƚŝŐĞŶ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  E ĂƐƐĂǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  E ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŝƚŝƐ  Ğ ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  Ğ ĂŶƚŝŐĞŶ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ƐƵƌĨĂĐĞ ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ƐƵƌĨĂĐĞ ĂŶƚŝŐĞŶ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ǀŝƌƵƐ ƚĞƐƚ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ 
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ZE ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŝƚŝƐ  ZE ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ǀŝƌƵƐ ƚĞƐƚ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ 
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝŐĞŶ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ZE ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ǀŝƌƵƐ ƚĞƐƚ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ 
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ĂďŶŽƌŵĂů
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝďŽĚǇ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ĂŶƚŝŐĞŶ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ  ǀŝƌƵƐ ƚĞƐƚ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŝƚŝƐ &
,ĞƉĂƚŝƚŝƐ '
,ĞƉĂƚŝƚŝƐ ,
,ĞƉĂƚŝƚŝƐ ŝŶĨĞĐƚŝŽƵƐ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
,ĞƉĂƚŝƚŝƐ ŝŶĨĞĐƚŝŽƵƐ ŵŽŶŽŶƵĐůĞŽƐŝƐ
,ĞƉĂƚŝƚŝƐ ŵƵŵƉƐ
,ĞƉĂƚŝƚŝƐ ŶŽŶͲ ŶŽŶͲ
,ĞƉĂƚŝƚŝƐ ŶŽŶͲ ŶŽŶͲ ŶŽŶͲ
,ĞƉĂƚŝƚŝƐ ƉŽƐƚ ƚƌĂŶƐĨƵƐŝŽŶ
,ĞƉĂƚŝƚŝƐ ƐǇƉŚŝůŝƚŝĐ
,ĞƉĂƚŝƚŝƐ ƚŽǆŽƉůĂƐŵĂů
,ĞƉĂƚŝƚŝƐ ǀŝƌĂů
,ĞƉĂƚŝƚŝƐ ǀŝƌĂů ƚĞƐƚ ƉŽƐŝƚŝǀĞ
,ĞƉĂƚŽďŝůŝĂƌǇ ŝŶĨĞĐƚŝŽŶ
,ĞƉĂƚŽƐƉůĞŶŝĐ ĐĂŶĚŝĚŝĂƐŝƐ
,ĞƌƉĞƐ ƐŝŵƉůĞǆ ŚĞƉĂƚŝƚŝƐ
>ŝǀĞƌ ĂďƐĐĞƐƐ
^ĐŚŝƐƚŽƐŽŵŝĂƐŝƐ ůŝǀĞƌ
sŝƌĂů ŚĞƉĂƚŝƚŝƐ ĐĂƌƌŝĞƌ
tŝƚŚĚƌĂǁĂů ŚĞƉĂƚŝƚŝƐ
'ŝĂŶŽƚƚŝͲƌŽƐƚŝ ƐǇŶĚƌŽŵĞ
WŽƌƚĂů ƉǇĂĞŵŝĂ
tĞŝůΖƐ ĚŝƐĞĂƐĞ
WƌĞŐŶĂŶĐǇͲƌĞůĂƚĞĚ ŚĞƉĂƚŝĐ ĚŝƐŽƌĚĞƌƐ ;^DYͿ
ĐƵƚĞ ĨĂƚƚǇ ůŝǀĞƌ ŽĨ ƉƌĞŐŶĂŶĐǇ
ŚŽůĞƐƚĂƐŝƐ ŽĨ ƉƌĞŐŶĂŶĐǇ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$SSHQGL[  ,QWHUQDWLRQDO 3URVWDWH 6\PSWRP 6FRUH  TXHVWLRQQDLUH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$SSHQGL[  2YHUDFWLYH %ODGGHU 4XHVWLRQQDLUH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$SSHQGL[ D (4'/ 4XHVWLRQQDLUH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$SSHQGL[ E (4'/ ± 9LVXDO DQDORJ VFDOH
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
$VWHOODV
3DJH  RI 

$SSHQGL[  6LJQDWXUHV
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9