Conditions: Overactive Bladder (OAB)
Keywords: Urinary Incontinence Mirabegron Overactive Bladder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 888
Healthy volunteers: no

Brief summary:
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

Detailed description:

Arms:
arm 1: Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug. arm 2: Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.

Interventions: intervention 1: Mirabegron intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablet intervention 2: oral tablet

Protocol document:
Prot_000.pdf: 
A Phase 4, Double-Blind, Randomized, Placebo-
Controlled, Parallel Group, Multi-Center Study to 
Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Older Adult Subjects with Overactive 
Bladder (OAB)
ISN/Protocol 178-MA-1005
ClinicalTrials.gov Identifier: NCT02216214
Date of Protocol:
Version 3.0
10 Sep 2015
Sponsor: Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062


Sponsor APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1005
- CONFIDENTIAL -
10 Sep 2015
Astellas
Page 1 of 105
Version 3.0 Incorporating Substantial Amendment 2
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel 
Group, Multi-Center Study to Evaluate the Efficacy, Safety, and 
Tolerability of Mirabegron in Older Adult Subjects with Overactive 
Bladder (OAB)
PILLAR
Protocol for Phase 4 Study of Mirabegron
ISN/Protocol 178-MA-1005
Version 3.0 
Incorporating Substantial Amendment 2
September 10, 2015
IND 69,416
Sponsor:
Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062
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
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Astellas
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Version 3.0 Incorporating Substantial Amendment 2
Table of Contents  
I.
SIGNATURES ······················································································ 8
II.
CONTACT DETAILS OF KEY SPONSOR'S PERSONNEL····························10
III.
LIST OF ABBREVIATIONS AND KEY TERMS··········································11
IV.
SYNOPSIS··························································································16
V.
FLOW CHART AND SCHEDULE OF ASSESSMENTS·································25
1
INTRODUCTION·················································································28
1.1
Background ····················································································28
1.2
Non-clinical and Clinical Data ······························································31
1.2.1
Summary of Non-clinical Safety Data with Mirabegron ···························31
1.2.2
Summary of the Pharmacokinetics of Mirabegron ··································31
1.2.3
Summary of Clinical Data with Mirabegron ·········································32
1.3
Summary of Key Safety Information for Study Drugs ···································33
1.3.1
Summary of Key Safety Information for Mirabegron ······························33
1.4
Risk-Benefit Assessment·····································································34
2
STUDY OBJECTIVE(S), DESIGN AND VARIABLES···································35
2.1
Study Objectives ··············································································35
2.2
Study Design and Dose Rationale···························································35
2.2.1
Study Design·············································································35
2.2.2
Dose Rationale···········································································36
2.3
Variables ·······················································································36
2.3.1
Primary Variable ········································································36
2.3.2
Secondary Variables ····································································36
2.3.3
Other Variables ··········································································37
3
STUDY POPULATION··········································································37
3.1
Selection of Study Population ·······························································37
3.2
Inclusion Criteria··············································································37
3.3
Exclusion Criteria·············································································38
4
TREATMENTS····················································································39
4.1
Identification of Investigational Product(s) ················································39
4.1.1
Test Drug·················································································39
4.1.2
Placebo ···················································································40


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4.2
Packaging and Labeling······································································40
4.3
Study Drug Handling ·········································································40
4.4
Blinding ························································································41
4.4.1
Blinding Method·········································································41
4.4.2
Confirmation of the Indistinguishability of the Study Drugs ······················41
4.4.3
Retention of the Assignment Schedule and Procedures for Treatment Code 
Breaking ··················································································41
4.4.4
Breaking the Treatment Code for Emergency ·······································42
4.4.5
Breaking the Treatment Code by the Sponsor ·······································42
4.5
Assignment and Allocation ··································································42
5
TREATMENTS AND EVALUATION························································43
5.1
Dosing and Administration of Study Drugs and Other Medications····················43
5.1.1
Dose/Dose Regimen and Administration Period ····································43
5.1.2
Previous and Concomitant Medication (Drugs and Therapies)····················43
5.1.2.1
Previous Medication (Drugs and Therapies) ···································43
5.1.2.2
Concomitant Medication (Drugs and Therapies) ······························43
5.1.3
Treatment Compliance··································································44
5.1.4
Emergency Procedures and Management of Overdose ·····························44
5.2
Demographics and Baseline Characteristics ···············································44
5.2.1
Demographics············································································44
5.2.2
Medical History··········································································44
5.2.3
Diagnosis of the Target Disease, Severity, and Duration of Disease··············44
5.3
Efficacy·························································································45
5.3.1
Patient Diary - Micturition and Incontinence ········································45
5.3.2
Barthel Index of Activities of Daily Living ··········································45
5.3.3
Vulnerable Elders Survey ······························································45
5.3.4
Patient Perception of Intensity of Urgency Scale····································46
5.3.5
OAB Symptoms, Quality of Life, Bladder Health and Treatment Benefit ·······46
5.3.5.1
Overactive Bladder-questionnaire ···············································46
5.3.5.2
Patient Perception of Bladder Condition········································47
5.3.5.3
Treatment Satisfaction – Visual Analog Scale ·································47
5.3.5.4
University of Alabama,  Birmingham Life Space Assessment···············47
5.4
Safety Assessment ············································································48
5.4.1
Vital Signs················································································48


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5.4.2
Patient Diary - Subject Measurement Vital Signs ···································48
5.4.3
Montreal Cognitive Assessment·······················································49
5.4.4
Adverse Events ··········································································49
5.4.4.1
Adverse Events of Possible Hepatic Origin ····································50
5.4.5
Laboratory Assessments································································50
5.4.6
Physical Examination···································································50
5.4.7
Electrocardiogram (ECG) ······························································51
5.4.8
Post-Void Residual  Volume···························································51
5.4.9
Cough Provocation Test ································································51
5.4.10
Follow-up Phone Calls to Patient······················································51
5.5
Adverse Events and Other Safety Aspects ·················································51
5.5.1
Definition of Adverse Events (AEs) ··················································51
5.5.2
Definition of Serious Adverse Events (SAEs) ·······································52
5.5.3
Criteria for Causal Relationship to the Study Drug ·································53
5.5.4
Criteria for Defining the Severity of an Adverse Event ····························53
5.5.5
Reporting of Serious Adverse Events (SAEs) ·······································53
5.5.6
Follow-up to Adverse Events ··························································54
5.5.7
Monitoring of Common Serious Adverse Events (SAEs)··························55
5.5.8
Procedure in Case of Pregnancy·······················································55
5.5.9
Emergency Procedures and Management of Overdose ·····························55
5.5.10
Supply of New Information Affecting the Conduct of the Study··················55
5.6
Test Drug Concentration ·····································································55
5.7
Other Measurements, Assessments, or Methods ··········································55
5.8
Total Amount of Blood·······································································55
6
DISCONTINUATION············································································55
6.1
Discontinuation of Individual Subject(s)···················································55
6.2
Discontinuation of the Site···································································56
6.3
Discontinuation of the Study ································································56
7
STATISTICAL METHODOLOGY ···························································56
7.1
Sample Size····················································································57
7.2
Analysis Set····················································································58
7.2.1
Full Analysis Set - Incontinence (FAS-I)·············································58
7.2.2
Per Protocol Set (PPS)··································································59
7.2.3
Safety Analysis Set (SAF)······························································59


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7.3
Demographics and Other Baseline Characteristics········································59
7.4
Analysis of Efficacy ··········································································59
7.4.1
Analysis of Primary Variable ··························································59
7.4.1.1
Primary Analysis···································································59
7.4.1.2
Secondary Analysis································································60
7.4.2
Analysis of Secondary Variables ······················································61
7.4.3
Analysis of Other Variables····························································63
7.4.4
Exploratory Analysis····································································63
7.5
Analysis of Safety·············································································63
7.5.1
Adverse Events ··········································································64
7.5.2
Laboratory Assessments································································64
7.5.3
Vital Signs················································································65
7.5.4
Physical Examination···································································65
7.5.5
Electrocardiograms (ECG) ·····························································65
7.6
Analysis of Pharmacokinetics ·······························································65
7.7
Analysis of Pharmacodynamics ·····························································65
7.8
Protocol Deviations and Other Analysis ···················································66
7.9
Interim Analysis (and Early Discontinuation of the Clinical Study)····················66
7.10
Handling of Missing Data, Outliers, Visit Windows, and Other Information ·········66
8
OPERATIONAL AND ADMINISTRATIVE CONSIDERATIONS ····················66
8.1
Procedure for Clinical Study Quality Control ·············································66
8.1.1
Data Collection ··········································································66
8.1.2
Specification of Source Documents···················································67
8.1.3
Clinical Study Monitoring······························································67
8.1.4
Direct Access to Source Data/Documents············································68
8.1.5
Data Management ·······································································68
8.1.6
Protocol Deviations ·····································································68
8.1.7
End of Study ·············································································69
8.2
Ethics and Protection of Subject Confidentiality··········································69
8.2.1
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / 
Competent Authorities (CA) ···························································69
8.2.2
Ethical Conduct of the Study···························································69
8.2.3
Informed Consent of Subjects ·························································69
8.2.3.1
Subject Information and Consent················································69


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8.2.3.2
Supply of New and Important Information Influencing the Subject’s 
Consent and Revision of the Written Information·····························70
8.2.4
Subject Confidentiality ·································································70
8.3
Administrative Matters ·······································································70
8.3.1
Arrangement for Use of Information and Publication of the Clinical Study ·····70
8.3.2
Documents and Records Related to the Clinical Study·····························71
8.3.3
Protocol Amendment and/or Revision················································71
8.3.4
Signatory Investigator for Clinical Study Report····································71
9
QUALITY ASSURANCE········································································72
10
STUDY ORGANIZATION······································································72
10.1
Independent Data-Monitoring Committee (IDMC) | Data and Safety Monitoring 
Board (DSMB) | Monitoring Committee | Other Evaluation Committee(s) ···········72
10.2
Other Study Organization ····································································72
10.2.1
Cardiovascular Adjudication Committee·············································72
10.2.2
Neoplasm Adjudication Committee···················································72
11
REFERENCES ····················································································73
12
APPENDICES ·····················································································76
12.1
Appendix 1:  List of Prohibited and Restricted Concomitant Medications ············76
12.2
Appendix 2:  Liver Safety Monitoring and Assessment··································78
12.3
Appendix 3: Most Common Serious Adverse Events ····································80
12.4
Appendix 4: Investigator Criteria for Hypertension ······································81
12.5
Appendix 5: Investigator Criteria for Tachycardia········································82
13
ATTACHMENT 1:  SUBSTANTIAL AMENDMENT 2 ··································83
14
ATTACHMENT 2:  SPONSOR’S SIGNATURES········································ 105


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List of In-text Tables
Table 1
Schedule of Assessments·····································································26
Table 2
Adverse Events Exceeding the Placebo Rate and Reported by Greater Than or 
Equal to 1% of Mirabegron-Treated OAB Patients in the 12-Week Phase 3 
Studies··························································································34
Table 3
Laboratory Assessments······································································50
Table 4
Categories for Change from Baseline in Mean Number of Incontinence 
Episodes per 24 Hours, for North America, ≥ 65 years ··································58
List of In-text Figures
Figure 1
Flow Chart ·····················································································25


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I.
SIGNATURES
1.
SPONSOR’S SIGNATURE
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 
Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in 
Older Adult Subjects with Overactive Bladder (OAB)
ISN/Protocol 178-MA-1005 / Version 3.0 
Incorporating Substantial Amendment 2 / September 10, 2015
Required signatures (e.g., protocol authors, Sponsor’s reviewers and contributors, and
Quality Assurance) are located in Attachment 2; e-signatures (when applicable) are located at 
the end of this document.


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2.
INVESTIGATOR’S SIGNATURE
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 
Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in 
Older Adult Subjects with Overactive Bladder (OAB)
ISN/Protocol 178-MA-1005 / Version 3.0 
Incorporating Substantial Amendment 2 / September 10, 2015
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. 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
Address:




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III.
LIST OF ABBREVIATIONS AND KEY TERMS
List of Abbreviations
Abbreviation
Description of abbreviations
ADL
Activity of Daily Living
ADR
Adverse Drug Reaction
AE
Adverse Event
ALP
Alkaline Phosphatase
ALT
Alanine Aminotransferase (GPT)
ANCOVA
Analysis of Covariance
ASMA
Astellas Scientific & Medical Affairs, Inc.
AST
Aspartate Aminotransferase (GOT)
AUC
Area under the plasma 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.
β3-AR
Beta 3-adrenergic receptor
BOO
Bladder Outlet Obstruction
BP
Blood Pressure
Bpm
Beats per minute
CA
Competent Authority
cfu
Colony Forming Unit
CI
Confidence Intervals
CRCL
Creatinine Clearance
Cmax
Maximum concentration
Cmin
Minimum concentration
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
eGFR
Estimated Glomerular Filtration Rate
EDC
Electronic Data Capture
EOT
End of Treatment
ePRO
Electronic Patient Reported Outcomes
EU
Europe
FAS-I
Full Analysis Set – Incontinence
FDA
Food and Drug Administration
FWER
Family-wise error rate
GCP
Good Clinical Practice
GGT/γ-GT
γ-Glutamyl Transpeptidase (GGT)
GMP
Good Manufacturing Practice
HBPM
Home Based Blood Pressure Monitoring
HDPE
High-Density Polyethylene


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Abbreviation
Description of abbreviations
HIPAA
Health Insurance Portability and Accountability Act
ICF
Informed Consent Form
ICH
International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
IND
Investigational New Drug
INR
International Normalized Ratio
IRB
Institutional Review Board
IRT
Interactive Response Technology
ISN
International Study Number
kg
Kilogram
LA-CRF
Liver Abnormality – Case Report Form
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
MID
Minimally Important Difference
Min
Minutes
mL
Milliliter
mmHg
Millimeter of Mercury
MMSE
Mini Mental State Examination
MoCA
Montreal Cognitive Assessment
MUI
Mixed Urinary Incontinence
MVV
Mean Voided Volume
N/n
Number
NASH
Non-Alcoholic Steatohepatitis
NDA
New Drug Application
OAB
Overactive Bladder
OAB-q
Overactive Bladder – questionnaire
OAB-s
Overactive Bladder – satisfaction questionnaire
OCAS
Oral Controlled Absorption System
PBO
Placebo
PCS
Potential Clinically Significant
PHI
Personal Health Information
PPBC
Patient Perception of Bladder Condition
PPIUS
Patient Perception of Intensity of Urgency Scale
PPS
Per Protocol Set
PR
Pulse Rate
PRO
Patient Reported Outcomes
PTM
Placebo to Match
PTNS
Percutaneous Tibial Nerve Stimulation
PVR
Post-Void Residual Volume
QD
Once Daily
QoL
Quality of Life
QT
Time interval between QRS complex to end of T wave


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Abbreviation
Description of abbreviations
SAE
Serious Adverse Event
SAF
Safety Analysis Set
SAP
Statistical Analysis Plan
SBP
Systolic Blood Pressure
SD
Standard Deviation
SE
Standard Error
sec
Second
SFL
Screen Failure Log 
SOP
Standard Operating Procedure
SPC
Summary of Product Characteristics
SUSAR
Suspected Unexpected Serious Adverse Reaction
t1/2
Terminal Elimination Half-Life
TBL
Total Bilirubin
TBS
Treatment Benefit Scale
TEAE
Treatment Emergent Adverse Event
TMF
Trial Master File 
TLF
Tables, Listings and Graphs
TS-VAS
Treatment Satisfaction Visual Analog Scale
UAB-LSA
University of Alabama Birmingham Life Space Assessment
ULN
Upper Limit of Normal
UPS
Urgency Perception Scale
US
United States
UUI
Urge Urinary Incontinence
UTI
Urinary Tract Infection
YM178
Mirabegron/Myrbetriq
VES
Vulnerable Elders Survey


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List of Key Study Terms
Terms
Definition of terms
Adverse Event
An adverse event is as 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 micturition 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.
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.
Placebo Run-in 
failure
Enrolled subject who entered the placebo run-in period, but did not qualify to 
enter the double-blind treatment period, or decided not to participate anymore 
(withdrew consent) during the placebo run-in period.
Randomization
Action to allocate a subject to the treatment group or treatment cohort.
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 
starting the placebo run-in period. Subjects who are considered a screen failure 
cannot be re-screened into the study at a later date.
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 Interactive Response System after 
signature of informed consent and prior to any specific procedures.


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Terms
Definition of terms
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.
Urinary 
incontinence
The complaint of any involuntary leakage of urine.


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IV.
SYNOPSIS
Title of Study
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 
Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Older Adult Subjects with Overactive Bladder (OAB)
Planned Study 
Period
From 3Q2014 to 4Q2016
Study Objective(s)
Primary Objective:
To assess the efficacy of mirabegron versus placebo (PBO) in the treatment 
of older adult subjects with OAB.
Secondary Objective:
To assess the safety and tolerability of mirabegron versus placebo (PBO) in 
the treatment of older adult subjects with OAB.  
Planned Total 
Number of Study 
Centers and 
Location
Approximately 125 centers
North America (possibly to include South America, Europe, Australia, and/or 
Asia Pacific)
Design and 
Methodology
This is a randomized, double-blind, placebo-controlled, parallel group, 
multi-center study.
After Screening (Visit 1), subjects will enter into a 2-week placebo run-in 
period (Visit 2) prior to being randomized into the 12-week double-blind 
treatment period (Visit 3).  Subjects will be asked to complete a 3-day 
training micturition diary during the placebo run-in period (Visit 2).  If 
subjects meet all entry criteria at the end of the placebo run-in period, 
subjects will be randomized to 1 of 2 treatment groups (Mirabegron or PBO) 
for 12 weeks of treatment.  Three days before Visits 4 (Week 4), 5 (Week 8), 
and 6 (Week 12), the subject will complete a 3-day micturition diary using 
the ePRO device.  Post-void residual volume (PVR) will be assessed at 
Screening (Visit 1) and at Week 12/End of Treatment (Visit 6). Total study 
participation is approximately 20 weeks.
During the study, subject enrollment will be monitored for the percent of 
subjects ≥75 years of age. If the proportion of subjects ≥75 years of age is 
< 30%, measures may be taken to enhance enrollment of sufficient number of 
subjects ≥ 75 years of age to ensure that the percentage of subjects ≥ 75 years 
is at least 30%.
Subjects will be randomized to one of two treatment groups in a 1:1 ratio to 
either mirabegron or placebo (PBO).  Randomization will be stratified by age  
< 75 years and ≥75 years. Those subjects randomized to mirabegron will 
start at 25 mg and may increase to 50 mg after 4 weeks or 8 weeks based on 
individual subject efficacy, tolerability and Investigator discretion. Those 
subjects randomized to PBO will start blinded product matched to the 
mirabegron 25 mg tablet and may also increase to 50 mg PBO after 4 or 
8 weeks. Once a patient has increased dose, they will remain on that dose for 
the remainder of the study unless for safety reasons that require 
discontinuation of study drug.


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Number of Subjects 
Planned
Number of Subjects to be Enrolled / Randomized:
Approximately 1,150 subjects will be screened to achieve 800 randomized 
subjects. Subjects will be randomized 1:1 stratified by age (< 75 years, 
≥75 years).
400 randomized to Mirabegron;  400 randomized to PBO
Selection Criteria
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 U.S. 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.
Male or female subject greater than or equal to 65 years of age.
3.
Subject is willing and able to complete the micturition diary and 
questionnaires correctly.
4.
Subject has symptoms of wet OAB (urinary frequency and urgency with 
incontinence) for greater than or equal to 3 months prior to Screening.
5.
Subject agrees not to participate in another interventional study from the 
time of screening until the final study visit.
Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline): 
1.
Subject continues to meet all inclusion criteria of Visit 1.
2.
Subjects must experience at least one incontinence episode in the placebo 
run-in period based on the 3-day micturition diary.
3.
Subject must experience at least 3 episodes of urgency (grade 3 or 4) 
based on the 3-day micturition diary.
4.
Subject must experience an average of greater than or equal to 
8 micturitions/day based on the 3-day micturition diary.
Waivers to the inclusion criteria will NOT be allowed.
Exclusion:
Exclusion Criteria assessed at Visit 1 (Screening):
1.
Subject has ongoing symptoms suggestive of bladder outlet obstruction 
(BOO) or history of BOO that is not currently well controlled.
2.
Subject has Post-Void Residual Volume (PVR) greater than 150 mL.
3.
Subject has neurogenic bladder or neurological dysfunction or injury 
which could affect the lower urinary tract or nerve supply.
4.
Subject has significant stress incontinence or mixed stress/urgency 
incontinence where stress is the predominant factor as determined by the 
Investigator (for female subjects confirmed by a cough provocation test).
Subjects with a history of stress incontinence that is currently treated 
(e.g., remote history of surgery for stress incontinence) may be included 
as long as they pass cough provocation test. 


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5.
Subject has an indwelling catheter or practices intermittent self-
catheterization.
6.
Subject has evidence of Urinary Tract Infection (UTI) Urine culture and 
sensitivity will be performed for positive leukocytes, or 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 can be rescreened after successful treatment of the 
UTI (confirmed by a laboratory result of negative urine culture).
7.
Subject has a chronic inflammatory condition 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 and rectum in both sexes and the uterus, 
ovaries, and fallopian tubes in females; 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).
8.
Subject resides in a nursing home.
9.
Subject is likely to enter a hospital or nursing home due to medical 
instability within the next 6 months in the opinion of the Investigator. 
10. Subject has received intravesical injection in the past 12 months with 
botulinum toxin, resiniferatoxin, or capsaicin.
11. Subject has received electro-stimulation therapy for OAB (e.g., sacral 
nerve stimulation or PTNS).
12. Subject began or has changed a bladder training program or pelvic floor 
exercises less than 30 days prior to Screening.
13. Subject has moderate or severe hepatic impairment defined as 
Child-Pugh Class B or C.
14. Subject has severe renal impairment defined as estimated 
creatinine clearance less than 29 mL/min determined by Estimated 
Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD 
formulae). A subject with end stage renal disease or undergoing 
dialysis is also not a candidate for the study.
15. Subject has severe uncontrolled hypertension, which is defined as a 
sitting systolic blood pressure greater than or equal to 180 mmHg and/or 
diastolic blood pressure greater than or equal to 110 mmHg.
16. Subject has evidence of QT prolongation on ECG defined as QTc greater 
than 450 msec for males, QTc greater than 470 msec for females or a 
known history of QT prolongation.
17. Subject has a clinically significant ECG abnormality, as determined by 
the Investigator.
18. Subject has AST or ALT greater than 2x upper limit of normal (ULN), or 
γ-GT greater than 3x ULN and considered clinically significant by the 
Investigator.


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19. Subject has a hypersensitivity to any components of mirabegron, other 
β-AR agonists, or any of the inactive ingredients.
20. Subject has any clinically significant condition, which in the opinion of 
the Investigator makes the subject unsuitable for study participation.
21. 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.
22. 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.
23. Subject with current history of alcohol and/or drug abuse.
24. Subject is using prohibited medications which cannot be stopped safely 
during the period defined in Appendix 1.
25. Subject has stopped, started or changed the dose of a restricted 
medication (defined in Appendix 1) within the last 30 days prior to 
Screening.
26. 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.
27. Subject has previously received mirabegron.
Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):
1.
Subject fulfills any exclusion criteria of Visit 1 (subject does not need to 
repeat screening assessments [PVR, cough provocation test, 
chemistry/hematology/urinalysis]).
2.
Subject was non-compliant during 2-week placebo run-in period, defined 
as taking less than 80% or greater than 120% of study medication.
3.
Subject has any systolic blood pressure measurement > 180 mmHg or 
diastolic blood pressure measurement > 110 in the 3-day diary or during 
the baseline visit.
Waivers to the exclusion criteria will NOT be allowed.
Discontinuation 
Criteria
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 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 violation (e.g., subject took prohibited medication that in 
the Investigator’s opinion, after discussion with the Astellas Study 
Physician, may negatively impact the subject’s safety or 


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demonstrated lack of cooperation in following protocol-specified 
procedures/instructions)

Withdrawal of consent

Investigator and/or Sponsor feels it is in the subject’s best interest
Test Drug Dose:
Mode of 
Administration:
Duration of 
Treatment:
Mirabegron 25 mg QD with option to titrate to
Mirabegron 50 mg QD at 4 or 8 weeks post baseline
Oral
QD for 12 weeks
Reference Therapy
Dose:
Mode of 
Administration:
Duration of 
Treatment:
Placebo matched to mirabegron 25 mg with option to titrate to
Placebo matched to mirabegron 50 mg at 4 or 8 weeks post baseline
Oral
QD for 12 weeks
Drugs for Run-In 
Period:
Mode of 
Administration:
Duration of 
Treatment:
Placebo
Oral
QD for 2 weeks
Concomitant 
Medication
Prohibited Medications (Appendix 1, part A)
Medications prohibited between Screening (Visit 1) and Week 12/End 
of Treatment (Visit 6) include anticholinergics, antispasmodics, and 
CYP2D6 substrates with narrow therapeutic index (see Appendix 1, 
Part A).  These medications must have been discontinued at least
30 days prior to Screening (Visit 1). Current or previous use of 
mirabegron at any time is prohibited.
Restricted medications (Appendix 1, part B)
Medications restricted between Screening (Visit 1) and Week 12/End of 
Treatment (Visit 6) include loop diuretics, alpha blockers and 5-Alpha 
reductase inhibitors. All medications in Part B of Appendix 1 are permitted 
provided the subject has been taking this medication on a long-term basis, i.e. 
has not stopped, started or changed dose within the 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.
Restricted Non-Drug Therapy
Subjects participating in any behavioral modification therapy (i.e. pelvic floor 
exercises, Kegel exercises, biofeedback, timed voiding, etc.) or other non-
drug therapy must have started the therapy at least 30 days prior to Screening 
(Visit 1) and must continue the same schedule through Week 12/End of 


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Treatment (Visit 6).
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.  
Subject participation will last approximately 20 weeks.
Primary Endpoints
The co-primary efficacy endpoints are:

Change from baseline to the end of treatment in mean number of 
micturitions/24 hour based on a 3-day micturition diary.

Change from baseline to end of treatment in mean number of 
incontinence episodes/24 hour based on a 3-day micturition diary.
Secondary 
Endpoints
Secondary endpoints: 

Change from baseline to the end of treatment in mean volume voided 
per micturition. 

Change from baseline to the end of treatment in symptom bother and 
total health related quality of life scores as assessed by OAB-q 
questionnaire.

Change from baseline to the end of treatment in Patient Perception of 
Bladder Condition (PPBC).
Other Endpoints
Other efficacy variables are the change from Baseline (Week 0) to End 
of Treatment (Week 12) in:

Mean number of urgency episodes (grade 3 and/or 4)/24 hour

Mean number of urgency incontinence episodes/24 hour

Mean level of urgency

Mean number of nocturia episodes/24 hour

Subscale score from OAB-q scores

TS-VAS
1.
University of Alabama, Birmingham - Life Space Assessment (UAB-
LSA)
2.
Responder analysis as defined by >= 50% reduction from baseline in 
mean number of incontinence episodes/24 hours or zero incontinence 
episodes post-baseline.
Safety Variables
Safety variables include:

Adverse events (AE)s

Vital signs: sitting systolic and diastolic blood pressure and pulse rate 
(home based measurements and office measurements)

Laboratory parameters (serum chemistry, hematology, and urinalysis)

Change from baseline to end of treatment in Montreal Cognitive 
Assessment (MoCA) score 


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Statistical Methods
Sample Size Justification: 
The co-primary endpoints for this study are change from baseline to end of 
treatment in the mean number of micturitions per 24 hours based on the 3-day 
micturition diary and change from baseline to end of treatment in mean 
number of incontinence episodes per 24 hours based on the 3-day micturition 
diary.
The sample size calculation first of all evaluates the number of subjects 
needed to test the change from baseline to end of treatment in mean number 
of incontinence episodes per 24 hours based on a 3-day micturition diary and 
then assesses whether this same sample size is adequate to test the change 
from baseline to end of treatment in the mean number of micturitions per 
24 hours based on the 3-day micturition diary. The overall power is then 
calculated for the study based on these co-primary endpoints.
The sample size calculation for the change from baseline in the final visit 
mean number of incontinence episodes per 24 hours is based on 
nonparametric methods since the results from previous phase 2 and 3 studies
indicated that the assumption of normality may not be valid. The results of 
these studies showed frequent ties for the number of episodes and therefore 
the sample size calculation is based on dividing this endpoint into 
7 categories. The actual primary statistical analysis will not group the data.  
The categories are shown below together with the percentages occurring for 
placebo and mirabegron 50 mg as found in older adult subjects (≥65 years of 
age) from North American sites in studies 178-CL-047 and 178-CL-074.
Table 1 - Categories for Change from Baseline in Mean Number of 
Incontinence Episodes per 24 Hours, for North America, ≥65 years
Mean Change 
Incontinence Category
Placebo
Mirabegron 50 mg
N =185
N=187
≤ -2.67
15.68%
16.04%
[-2.67, -2.00)
7.03%
9.09%
[-2.00, -1.33)
12.43%
22.46%
[-1.33, -0.67)
13.51%
9.63%
[-0.67, -0.34)
12.43%
11.76%
[-0.34, 0.33)
17.84%
20.86%
≥ 0.33
21.08%
10.16%
Based on Table 1, the probability that a subject on mirabegron will respond 
better than a subject on placebo is 56.3% (nQuery 7.0). Based on a Wilcoxon 
(Mann-Whitney) rank-sum test that P(X<Y) = 0.5 (continuous outcome), 
340 incontinent subjects per treatment group will yield 82% power with a 
2-sided test at a significance level of 0.05.
The pivotal study showed a 0.796 mean (SD=2.7) reduction for mirabegron
50 mg compared to PBO in the mean number of micturition per 24 hours in 
North American subjects who were 65 years or older. A sample size of 
340 subjects per treatment group will yield 97% power to detect a reduction 
of .796 in mean number of micturitions per 24 hours using  a two-sided t-test 
at a significance level of 0.05 assuming a SD of 2.7 (nQuery 7.0).
Assuming ‘Change from baseline in mean number of micturitions per day’ 
and ‘Change from baseline in mean number of incontinence episodes per 


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day’ are independent the overall power would therefore be 80%.
The historical data show at least 15% of the randomized subjects will drop 
out during the double-blind period. Consequently an additional 60 subjects 
per treatment group need be enrolled. This brings the total required 
incontinent subjects per treatment group to 400. 
Based on the historical data a 20% failure rate is predicted due to lack of 
incontinence and another 10% failure due to a combination of drop out and 
placebo response during the placebo run-in period. Therefore, a 30% screen 
failure rate is expected. 
In order to randomize 800 subjects with incontinence, it is expected that 
1,150 subjects will need to be screened.
Efficacy:  
All analyses will be performed comparing two treatment groups: Mirabegron 
(regardless of dose) versus PBO.
Analysis on Co-Primary Endpoints
The primary analysis set for efficacy analyses will be the Full Analysis Set –
Incontinence (FAS-I) which comprises randomized subjects who took at 
least one dose of randomized study drug, have a micturition measurement at 
baseline, have at least one incontinence episode at baseline, and have at least 
one post-baseline micturition measurement (measurement includes 
micturition and incontinence episodes).  
Change from baseline to end of treatment in mean number of micturitions per 
24 hours will be analyzed using a stratified Analysis of Covariance 
(ANCOVA) model. The response variable will be the mean change in 
number of micturitions episodes per 24 hours from baseline to the end of 
treatment with treatment group and gender as fixed factors and baseline mean 
number of micturitions episodes per 24 hours as the covariate in the model. 
Age group (<75 years, ≥75 years) will be included as the stratification factor. 
As part of the ANCOVA results, LS means and two-sided 95% CIs for mean 
changes 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.
In order to test for statistical differences in Change from baseline to end of 
treatment in mean number of incontinence episodes per 24 hours between 
mirabegron and placebo, a stratified rank Analysis of Covariance 
(ANCOVA) will be used. The response variable is the standardized ranks of 
change from baseline to end of treatment value in mean number of 
incontinence episodes per 24 hours. Treatment group and gender will be 
added as fixed factors in the model while the standardized ranks of mean 
number of incontinence episodes per 24 hours at baseline will be included as 
a covariate. Age group (<75 years, ≥75 years) will be included as the 
stratification factor.
Responder analyses will be performed using a logistic regression model 
including the same factors as the ANCOVA model. Odds ratios that compare 
treatment effect between mirabegron and placebo will be reported with 95% 
CIs.


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Analysis on Secondary Endpoints
The change from baseline to end of treatment for other secondary endpoints 
(excluding mean voided volume [MVV]) will be analyzed using a similar 
ANCOVA model as described above for mean number of micturitions per 
24 hours.  The change from baseline to end of treatment in MVV will be 
analyzed using the Stratified Rank ANCOVA and ANCOVA model as 
described above for mean number of incontinence episodes.
Safety:  
Safety analyses will be performed on the Safety Analysis Set (SAF) defined 
as all subjects who receive at least one dose of double-blind medication.
Number and percentage of treatment-emergent adverse events reported 
during the double-blind period will be summarized by system organ class, 
preferred term, seriousness, severity, and relationship to treatment, overall 
and by treatment group. 
Statistical differences in change from baseline to end of treatment in 
cognitive assessment will be tested using a paired sample Wilcoxon test.
Changes from baseline for PVR and laboratory assessments (biochemistry 
and hematology) will be summarized in tables by treatment group and visit.
Vital sign data will be analyzed separately based on the 3-day diary and the 
site assessment at each clinic visit. Change from baseline in vital sign 
variables will be analyzed using the same ANCOVA model as described for 
the analysis of change from baseline in mean number of micturitions per 
24 hours. No p-values will be a calculated.
ECGs will be performed at Screening (Visit 1), the placebo run-in period 
(Visit 2), Baseline (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and 
Week 12/End of Treatment (Visit 6).
Interim Analysis:
N/A


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V.
FLOW CHART AND SCHEDULE OF ASSESSMENTS
Figure 1
Flow Chart


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Table 1
Schedule of Assessments
Screening
Placebo 
Run-In
Treatment Period
Follow-up 
Phone Call
Visit
1
2
3
4
5
6
7
Day
-28
-14
1
28
56
84
112
Week
-4
-2
0/Baseline
4
8
12/EOT
16
Visit Windows (Days) a
+/- 10 
+/- 3 
+/- 3 
+/- 7 
+/- 7 
+/- 7 
+/- 3
Informed Consent/HIPAA
X
Inclusion/Exclusion Criteria
X
X
Medical History and OAB History
X
Demographics
X
Enter 2-week Placebo Run-in b
X
Randomization  c
X 
Physical Exam  (including height d and weight)
X
X
Vital Signs – in office (includes pulse and blood pressure)
X
X
X
X
X
X
Cough Provocation test (Females only)
X
Serum chemistry, hematology & urinalysis e
X
X
 
12-Lead ECG
X
X
X
X
X
X
Ultrasound or Bladder Scan (PVR)
X
X
Medication History and OAB Medication History
X
X
Clinical Assessment for Dose Increase 
X
X
Concomitant Medications Assessment
X
X
X
X
X
X
X
Adverse Event Assessment
X
X
X
X
X
X
Dispense Study Drug 
X
X
X
X
Drug Accountability
X
X
X
X
Instruct Subject on 3-day Micturition Diary g
X
X
X
X
X
Complete 3-day Micturition Diary including vital sign measurements and 
PPIUS h,i
X h
X h
X h
X h
OAB-q
X
X
X
X
Patient Perception of Bladder Condition Scores (PPBC) 
X
X
X
X
TS-VAS
X
X
X
X
Montreal Cognitive Assessment Test (MoCA)
X
X
Univ Alabama Birmingham Life Space Assessment (UAB -LSA)
X
X
X
X
Table continues on next page


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Screening
Placebo 
Run-In
Treatment Period
Follow-up 
Phone Call
Visit
1
2
3
4
5
6
7
Day
-28
-14
1
28
56
84
112
Week
-4
-2
0/Baseline
4
8
12/EOT
16
Visit Windows (Days) a
+/- 10 
+/- 3 
+/- 3 
+/- 7 
+/- 7 
+/- 7 
+/- 3
Barthel ADL Assessment
X
X
Vulnerable Elders Survey 13 (VES-13)
X
X
Review Subject Diary j
X
X
X
X
a. Visits 1 and 2 are negatively scheduled from the Baseline (Visit 3) date. A subject has a combined timeframe of up to 38 days to complete both Visits 1 and 2; however, 
Baseline (Visit 3) must occur at least 18 days but no more than 38 days after Visit 1 (Screening) and at least 11 days but no more than 17 days after Visit 2 (Placebo Run-In). 
After Visit 2 (Placebo Run-In), visit windows/study days will be calculated based on the Visit 3 (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 deviation.
b. Subjects must take at least 11 days, but no more than 17 days of placebo run-in medication.
c. Randomization is to occur after confirming all eligibility criteria and after performing all other visit procedures at Visit 3.
d. Height will only be assessed at the Screening Visit.
e. Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the discretion of the PI. If a subject has a UTI, the subject can be rescreened 
after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
f.
  
g. At Visit 2 (Placebo Run-In), all subjects will be provided with an ePRO device (electronic diary) that will be used to record the date and time of each of their micturitions, 
incontinence,  urgency episodes, measure of urine volume voided, and sleep interruption (micturition diary).  Additionally, the diary will be used to record medication intake and 
home measurements of am and pm pulse rate and systolic and diastolic blood pressure. Training on device use must be done at Visit 2 (Placebo Run-In) and as necessary 
throughout the study.  Subjects will be instructed to begin completing the electronic micturition diary 3 days prior to each in-office study visit including Visits 3-6 (Treatment 
Period) and complete the diary for the full 3 days.  
h. Subjects will complete the electronic diary 3 days prior to the study visit and complete the diary for the full 3 days leading up to the visit.  
i.
During this activity, the subject will not come to the clinic for a visit. Site staff will contact the subject 3 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). The subject will need to 
complete the 3-day electronic diary at home the full 3 days leading up to Visits 3, 4, 5 & 6. 
j.
Investigator, or designee, must review the subject’s diary with the subject to ensure completion compliance and discuss data captured.


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1
INTRODUCTION
1.1
Background
Overactive bladder (OAB) is a frequent condition affecting older adults.  It is estimated that 
more than half the elderly population experience voiding dysfunction, which may be 
attributed to idiopathic, neurologic, or cognitive impairment [Nassau et al, 2014].  The 
frequency and urgency associated with OAB are often highly debilitating.  In addition, 
OAB-related urinary incontinence (UUI, MUI) has been associated with other deleterious 
health related outcomes in community dwelling seniors, including falls and fractures, urinary 
tract infections, skin infections, depression, and chronic constipation [Wagg et al, 2014;
Wagg et al, 2013; Kashyup et al, 2014].  Antimuscarinic anticholinergics in 
immediate-release and sustained-release formulations have been demonstrated to be 
efficacious in controlling urgency and incontinence episodes in older adults.  However, their 
anticholinergic properties have been shown in several studies to be especially concerning for 
the older adult patients. As a result of the combination of age-related changes in blood-brain 
barrier permeability and comorbidity-related changes in cerebrovascular status, impaired 
cognitive function has been associated with increasing anticholinergic drug burden
[Boustani et al, 2008; Cai et al, 2013; Fox et al, 2011].
Older patients are known to experience more AEs than younger patients and the AEs they 
experience with oral antimuscarinic treatment may be more pronounced [Wagg et al, 2010;
Allman et al, 2006].  Of particular concern are the potentially adverse effects of 
antimuscarinic medications caused by age-related changes in central cholinergic transmitter 
systems [Kay et al, 2005]. Indeed, immediate and extended-release formulations of 
oxybutynin have been associated with cognitive impairment in older people who are 
cognitively intact although trospium chloride, as well as other newer antimuscarinics, have 
been reported to have no adverse effects on cognition in the cognitively-intact older adult 
patients and those with mild cognitive impairment [Wagg et al, 2013; Boustani et al, 2008;
Cai et al, 2013; Fox et al, 2011; American Geriatrics Society, 2012; Kay et al, 2006; 
Holick 2008]. 
For example, a recent 12-week, double-blind, placebo-controlled trial was conducted to 
assess the efficacy and safety of fesoterodine in 794 patients aged 65 years and older with 
OAB symptoms for 3 months or longer [Wagg et al, 2013].  The trial also included patient 
reported outcome assessments [including OAB-q, Treatment Benefit Scale (TBS), PPBC, 
Urgency Perception Scale (UPS), and OAB-s] and a Mini-Mental State Examination 
(MMSE) at baseline and 12 weeks.  Although results of this study showed a statistically 
significant improvement over placebo in urgency episodes, no change in MMSE score was 
reported [Wagg et al, 2013].  There are very few data on the effects of the newer 
antimuscarinic medications using more sensitive measures of cognitive function (see for 
example Kay et al, 2006), and no data regarding their effects in combination with other 
anticholinergic medications.  Therefore, the American Geriatrics Society has cited oral 
antimuscarinics as “potentially inappropriate medications and classes to avoid in older 
adults” [American Geriatrics Society 2012].  


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Recently the first in class β3 adrenergic agonist mirabegron was approved in the US, Canada 
and many other countries around the world. The mirabegron phase 3 program has 
demonstrated it to be a safe and efficacious option for the drug treatment of symptoms of 
OAB with or without incontinence.  Mirabegron works through a different mechanism of 
action to that of antimuscarinics by stimulating the β3-AR in the detrusor muscle leading to 
bladder relaxation and increased inter-void interval.  Mirabegron also has a distinct 
tolerability profile from that of antimuscarinics.  The incidence of dry mouth and 
constipation, two of the most common and bothersome side effects with antimuscarinics, 
often a reason for discontinuation, were similar between placebo and mirabegron 50 mg 
[Herschorn et al, 2013]. 
There exists an unmet need within the community dwelling senior population for 
non-pharmacologic and pharmacologic interventions that can simultaneously demonstrate 
control of OAB symptoms and positively impact direct and indirect measures of Activities of 
Daily Living (ADL), such as life-space assessment, while at the same time not adding to the 
risk of cognitive impairment.  Life-space measures used within community dwelling older 
adult patients suggest that life-space can assess mobility-enhancing interventions as well as 
the effect of biomedical, psychological, socioeconomic, environmental, and social support 
factors on mobility [Allman et al, 2006; Abe et al, 2009; Shimada et al, 2010; Stewart et al,
2009]. Multiple studies have demonstrated both beneficial and neutral effects on social 
engagement with successful treatment of urinary incontinence among civilian and Veteran’s 
Administration long term care older adult populations [Moga et al, 2013; Ouslander et al, 
1982].
Pivotal studies with mirabegron included a significant number of older patients.  In the three 
large, placebo-controlled, randomized, 12-week phase 3 trials with mirabegron, 36–39% of 
patients were ≥65 years of age and 7–12% were ≥75 years of age. In a pre-specified 
subanalysis of these studies based on patient age, mirabegron 25 mg and 50 mg once-daily 
reduced the mean number of incontinence episodes and micturitions per 24 hours from 
baseline to final visit in these two groups of older OAB patients with no loss of efficacy with 
age [Wagg et al, 2014]. Patient Reported Outcome (PRO) measures have also been reported 
for the older adult population. In an analysis to evaluate the magnitude of PRO improvement 
stratified by age in patients enrolled in mirabegron phase 3 clinical trials, statistically 
significant improvements were observed in patients ≥65 years of age for treatment 
satisfaction (TS-VAS), PPBC and OAB-q (all p<0.001). Older patients generally perceived 
mirabegron 50 mg to be more efficacious than placebo in treating symptoms of OAB.  
Compared to the < 75 year old cohort, patients ≥75 years of age reported higher numerical 
improvement vs placebo across all PRO measures, including the OAB-q.
With regard to safety, the three most common TEAEs in patients ≥65 years of age receiving 
mirabegron 50 mg were the same as in the overall population: hypertension, nasopharyngitis 
and UTI (9.9%, 4.1%, and 3.1%, respectively).  In the ≥65 year old subgroup, the incidence 
of the most common TEAEs was similar for both doses of mirabegron and placebo over 
12 weeks, except for hypertension, UTI and dizziness which occurred with a higher incidence 


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in the mirabegron 25 mg group than the placebo or mirabegron 50 mg groups. In patients
randomized to mirabegron 50 mg in the ≥75 year old subgroup, headache, dry mouth and 
pain in extremity (each 2.6%) were more common than UTI (1.9%). In a 1-year mirabegron 
study, hypertension and UTI were still the most common TEAEs with mirabegron 50 mg in 
older subjects [Wagg et al, 2014].
While the mechanism of action of mirabegron does not suggest an effect on the brain, 
specific studies of cognitive function have not been conducted. When studied in animal 
models (rat, monkey), mirabegron was extensively distributed in organs and other tissues 
after oral and IV administration, except the brain [Astellas. Data on file. 2012]. The same 
characteristics of tissue distribution are expected in humans; however, no human studies have 
been conducted to determine if mirabegron penetrates the blood brain barrier [Astellas. Data 
on file. 2012].  The effect of mirabegron on cognitive function was also not assessed in the 
three large phase 3 pivotal trials. However, there were no adverse events reported of memory 
impairment or cognitive disorder in the mirabegron 25 mg and 50 mg treatment groups 
(n = 586 and 1,889, respectively).  Although no cognitive function assessment tools were 
utilized during these studies, the lack of any adverse events reported in the cognitive function 
domain supports the safety profile for mirabegron in older adult patients with OAB [Adapted 
from Astellas.  Myrbetriq. Integrated Summary of Safety (ISS) Final. Data on File].
There is evidence that vitamin D plays a role in the pathophysiology of OAB. Calcium is 
involved in bladder function through its role in detrusor smooth muscle contraction.  In a 
study of women with OAB, a deficiency in dietary vitamin D was found to lead to a higher 
incidence of OAB symptoms [Dallosso et al, 2004]. Another study found that treatment of 
women with a vitamin D analog improved symptoms of OAB [Digesu et al, 2012]. Although 
the elderly are at high risk of having vitamin D deficiency, there are currently no data 
evaluating the vitamin D status of patients with OAB related to efficacy on OAB oral therapy
[Holick 2008].  
In conclusion, this will be the first mirabegron OAB study to specifically evaluate the 
efficacy and safety of mirabegron in an older population of patients with OAB.  This study 
will also be the first to explore the effect of mirabegron on cognitive function in older adult 
patients.  Oral antimuscarinic agents have historically been the preferred treatment option for 
OAB; however, these agents can be suboptimal in their effect and lead to burdensome 
adverse events, as seen in previous studies in older patients.  This study is designed to 
demonstrate the reduction in frequency of incontinence episodes and micturitions in older 
adults (> 65 years) and support that mirabegron is a suitable option for the treatment of OAB 
in older patients with multiple comorbidities, not adversely affecting cognitive function in 
patients with impaired mental status, and increasing quality of life.  
 
 
 


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1.2
Non-clinical and Clinical Data
Detailed information on the non-clinical studies conducted with mirabegron can be found in 
the approved product labeling.  Summaries of findings from non-clinical and clinical studies 
with mirabegron which may have relevance for the current study are listed below.
1.2.1
Summary of Non-clinical Safety Data with Mirabegron
Mirabegron is a potent and selective agonist of the human beta-3 AR.  Mirabegron has low 
intrinsic activity for human beta-1 and beta-2 ARs.  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 
ARs.  Studies in conscious and anaesthetized 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 
repolarization in isolated dog Purkinge 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 13-week rat toxicology studies, significant 
increases in plasma alanine aminotransferase (ALT) were observed at doses of 30 mg/kg and 
above (22-fold the human area under the curve [AUC]) at the maximum recommended 
human dose.  Modest (less than 2-fold) increases in plasma 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.
1.2.2
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 mirabegron 25 mg to 45% at a dose of mirabegron 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 


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mirabegron and its metabolites following multiple oral doses in older adult subjects 
(≥65 years) were similar to 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 t1/2 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 1.73m2) 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.
1.2.3
Summary of Clinical Data with Mirabegron
The clinical development program consists of 43 completed clinical studies to date over 
approximately 10 years and is comprised of 10,552 subjects (1,812 volunteers and 
9,878 patients) including patients with OAB, type 2 diabetes mellitus, and lower urinary tract 
symptoms (LUTS)/bladder outlet obstruction (BOO).  A total of 30 phase 1 studies and 
13 phase 2 and 3 studies (10 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 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 TEAEs in the active treatment 
group is comparable with the incidence in the placebo group.  The most frequently reported 
TEAE was 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.
In the U.S. Package Insert, mirabegron has warnings and precautions for increases in blood
pressure, urinary retention in patients with bladder outlet obstruction, and in patients taking 
drugs metabolized by CYP2D6.
In the Canadian Monograph, mirabegron has contraindications for 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 


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ALT/AST, 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).
For further information, please refer to the full prescribing information for mirabegron 
[Mirabegron US Package Insert, 2012 and Myrbetriq Canadian Monograph, March 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®). On 1 October 2013, mirabegron received approval in Australia (trade name: 
Betmiga®).  Additional regulatory approvals have been obtained in countries including Hong 
Kong, Korea, Turkmenistan, and Argentina.
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 subjects 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, 2012 and Myrbetriq Canadian Monograph, March 2013].
The favorable benefit risk profile of mirabegron is not expected to change over time.
A mean change 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 the mirabegron and tolterodine treatment groups. 
In patients with OAB, categorical increases in pulse rate were noted more frequently with 
mirabegron and tolterodine than with placebo, with similar 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.


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An approximate mean increase of 1 mmHg or less 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 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).
Table 2
Adverse Events Exceeding the Placebo Rate and Reported by Greater 
Than or Equal to 1% of Mirabegron-Treated OAB Patients in the 
12-Week Phase 3 Studies
Placebo
(%)
Mirabegron 25 mg
(%)
Mirabegron 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
3.0
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
1.0
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.
Detailed information on the clinical safety profile of mirabegron can be found in the full 
prescribing information [Mirabegron US Package Insert, 2012 and Myrbetriq Canadian 
Monograph, March 2013].
According to Section 8.5 of the current mirabegron US Package Insert, there is no dose 
adjustment 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 these studies [Mirabegron US Package 
Insert, 2012]. 
1.4
Risk-Benefit Assessment 
Mirabegron is a new medication with a distinct mechanism of action (beta 3-AR agonist) 
compared with the current standard of care, primarily antimuscarinics, for the treatment of 


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symptoms of OAB. The clinical efficacy of mirabegron 25 mg and mirabegron 50 mg was 
established in the phase 3 clinical program. The effect of mirabegron has been shown to be 
superior to placebo.
Results from subjective endpoints provide evidence that the patients not only obtained 
objective evidence of improvement, but also clinically meaningful benefits from mirabegron in 
the treatment of their disease. The long-term study has demonstrated persistence of effect over 
a 1-year treatment period. The favorable benefit risk profile of mirabegron is not expected to 
change over time. The approved therapeutic dose of mirabegron in the United States 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, 2012 and Myrbetriq Canadian Monograph, 
March 2013].
Pertinent details for cardiovascular and neoplastic events, as defined in a separate charter, will 
be collected to ensure complete details are fully available to characterize these events for 
Adjudication Committee review.
Overall, the data support the acceptable safety of mirabegron in the treatment of OAB at the 
approved therapeutic doses. 
2
STUDY OBJECTIVE(S), DESIGN AND VARIABLES
2.1
Study Objectives
The primary objective is to assess the efficacy of mirabegron versus placebo (PBO) in the 
treatment of older adult subjects with OAB.
The secondary objective is to assess the safety and tolerability of mirabegron versus placebo 
(PBO) in the treatment of older adult subjects with OAB.
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.
After Screening (Visit 1), subjects will enter into a 2-week placebo run-in period (Visit 2) 
prior to being randomized into the 12-week double-blind treatment period (Visit 3).  Subjects 
will be asked to complete a 3-day training micturition diary during the placebo run-in period
(Visit 2).  If subjects meet all entry criteria at the end of the placebo run-in period, subjects 
will be randomized to 1 of 2 treatment groups (Mirabegron or PBO) for 12 weeks of 
treatment.  Three days before Visits 4 (Week 4), 5 (Week 8), and 6 (Week 12), the subject 
will complete a 3-day micturition diary using the ePRO device.  Post-void residual volume 
(PVR) will be assessed at Screening (Visit 1) and at Week 12/End of Treatment (Visit 6).  
Total study participation is approximately 20 weeks.
During the study, subject enrollment will be monitored for the percent of subjects ≥75 years 
of age. If the proportion of subjects ≥75 years of age is < 30%, measures may be taken to 
enhance enrollment of subjects ≥75 years of age.


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Subjects will be randomized to one of two treatment groups in a 1:1 ratio to either 
mirabegron or placebo (PBO).  Randomization will be stratified by age < 75 years and 
≥75 years. Those subjects randomized to mirabegron will start at 25 mg and may increase to 
50 mg after 4 weeks or 8 weeks based on individual subject efficacy, tolerability and 
Investigator discretion. Those subjects randomized to PBO will start blinded product 
matched to the mirabegron 25 mg tablet and may also increase to 50 mg PBO after 4 or 8 
weeks. Once a patient has increased dose, they will remain on that dose for the remainder of 
the study unless for safety reasons that require discontinuation of study drug.
2.2.2
Dose Rationale 
Mirabegron 25 mg, which may be increased to 50 mg based on individual efficacy and 
tolerability, is the approved dose in the treatment of overactive bladder in the United States and 
Canada [Mirabegron US Package Insert, 2012 and Myrbetriq Canadian Monograph, March 
2013]. The dosing regimen of mirabegron 25 mg increased to mirabegron 50 mg after 4 weeks 
of treatment 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. 
The study design employs an optional dose increase from 25 mg mirabegron to 50 mg 
mirabegron at either Week 4 (Visit 4) or Week 8 (Visit 5) based on the individual subject 
efficacy, tolerability, and Investigator discretion. Once a patient has increased dose, they will 
remain on that dose for the remainder of the study unless for safety reasons that require 
discontinuation of study drug.
2.3
Variables
2.3.1
Primary Variable
The co-primary efficacy endpoints are:

Change from baseline to the end of treatment in mean number of micturitions/24 hour 
based on a 3-day micturition diary.

Change from baseline to end of treatment in mean number of incontinence 
episodes/24 hour based on a 3-day micturition diary.
2.3.2
Secondary Variables
Secondary endpoints are: 

Change from baseline to the end of treatment in mean volume voided per micturition.

Change from baseline to the end of treatment in symptom bother and total health 
related quality of life scores as assessed by OAB-q questionnaire.

Change from baseline to the end of treatment in Patient Perception of Bladder 
Condition (PPBC).


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2.3.3
Other Variables
Other efficacy variables are the change from Baseline (Week 0) to End of Treatment
(Week 12) in:

Mean number of urgency episodes (grade 3 and/or 4)/24 hour

Mean number of urgency incontinence episodes/24 hour

Mean level of urgency

Mean number of nocturia episodes/24 hour

Subscale score from OAB-q scores

TS-VAS

University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)

Responder analysis as defined by >= 50% reduction from baseline in mean number of 
incontinence episodes/24 hours from baseline or zero incontinence episodes
post-baseline.
3
STUDY POPULATION
3.1
Selection of Study Population
This study will enroll male and female subjects greater than or equal to 65 years old who 
have symptoms of OAB.  Eight hundred subjects will be randomized (1:1) to either 
mirabegron or placebo, stratified by age (< 75 years, ≥ 75 years). 
3.2
Inclusion Criteria
Subject is eligible for the study if all of the following apply:
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 U.S. 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. Male or female subject greater than or equal to 65 years of age.
3. Subject is willing and able to complete the micturition diary and questionnaires correctly.
4. Subject has symptoms of OAB (urinary frequency and urgency with incontinence) for 
greater than or equal to 3 months prior to Screening.
5. Subject agrees not to participate in another interventional study from the time of 
screening until the final study visit.
Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline): 
1. Subject continues to meet all criteria of Visit 1.
2. Subjects must experience at least one incontinence episode based on the 3-day 
micturition diary.
3. Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day 
micturition diary.


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4. Subject must experience an average of greater than or equal to 8 micturitions/day based 
on the 3-day micturition diary.
Waivers to the inclusion criteria will NOT be allowed.
3.3
Exclusion Criteria
Exclusion Criteria assessed at Visit 1 (Screening):
1. Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history 
of BOO that is not currently well controlled.
2. Subject has Post-Void Residual Volume (PVR) greater than 150 mL.  
3. Subject has neurogenic bladder or neurological dysfunction or injury which could affect 
the lower urinary tract or nerve supply.
4. Subject has significant stress incontinence or mixed stress/urgency incontinence where 
stress is the predominant factor as determined by the Investigator (for female subjects 
confirmed by a cough provocation test). Subjects with a history of stress incontinence 
that is currently treated (e.g., remote history of surgery for stress incontinence) may be 
included as long as they pass cough provocation test.
5. Subject has an indwelling catheter or practices intermittent self-catheterization.
6. Subject has evidence of Urinary Tract Infection (UTI). Urine cultures and sensitivity will 
be performed for positive leukocytes, or 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 can be rescreened after successful treatment 
of the UTI (confirmed by a laboratory result of negative urine culture).
7. Subject has a chronic inflammatory condition 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 and rectum in both 
sexes and the uterus, ovaries and fallopian tubes in females; 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). 
8. Subject resides in a nursing home.
9. Subject is likely to enter a hospital or nursing home due to a medical instability within the 
next 6 months in the opinion of the Investigator. 
10. Subject has received intravesical injection in the past 12 months with botulinum toxin, 
resiniferatoxin, or capsaicin.
11. Subject has received electro-stimulation therapy for OAB (e.g., sacral nerve stimulation 
or PTNS).  
12. Subject began or has changed a bladder training program or pelvic floor exercises less 
than 30 days prior to Screening.
13. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
14. Subject has severe renal impairment defined as estimated creatinine clearance less than 
29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, 
or MDRD formulae). A subject with end stage renal disease or undergoing dialysis is also 
not a candidate for the study.


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15. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood 
pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than 
or equal to 110 mmHg.
16. Subject has evidence of QT prolongation on ECG defined as QTc greater than 450 msec 
for males, QTc greater than 470 msec for females or a known history of QT prolongation.
17. Subject has a clinically significant ECG abnormality, as determined by the Investigator.
18. Subject has AST or ALT greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x 
ULN and considered clinically significant by the Investigator.
19. Subject has a hypersensitivity to any components of mirabegron, other β-AR agonists, or 
any of the inactive ingredients.
20. Subject has any clinically significant condition, which in the opinion of the Investigator 
makes the subject unsuitable for study participation.
21. 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.
22. 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.
23. Subjects with current history of alcohol and/or drug abuse.
24. Subject is using prohibited medications which cannot be stopped safely during the period 
defined in Appendix 1.
25. Subject has stopped, started or changed the dose of a restricted medication (defined in 
Appendix 1) within the last 30 days prior to Screening.
26. 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.
27. Subject has previously received mirabegron.
Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline):
1. Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat screening 
assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]).
2. Subject was non-compliant during 2-week placebo run-in period, defined as taking less 
than 80% and greater than 120% of study medication.
3. Subject has any systolic blood pressure measurement ≥180 mmHg or diastolic blood 
pressure measurement ≥110 in the 3-day diary or during the baseline visit. 
Waivers to the exclusion criteria will NOT be allowed.
4
TREATMENTS
4.1
Identification of Investigational Product(s)
4.1.1
Test Drug
Mirabegron will be supplied as 25 mg and 50 mg OCAS (Oral Controlled Absorption System) 
modified release tablets.


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Mirabegron OCAS tablets contain the following excipients:
 
 
The mirabegron OCAS tablets are packaged in 30 cc round wide mouth white HDPE bottles 
sealed with white child resistant polypropylene caps.  Each bottle contains 30 tablets and must
be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
All investigational materials must be kept in a secure area inaccessible to unauthorized 
individuals.
4.1.2
Placebo
The placebo to match (PTM) mirabegron OCAS tablets contain 
 
 
 
The mirabegron PTM tablets are packaged in a 30 cc round wide mouth white HDPE bottles 
sealed with white child resistant polypropylene caps.  Each bottle contains 30 tablets.  The
HDPE bottles 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 under the 
responsibility of a qualified person(s) at Astellas U.S. Technologies, Inc. (AUST) in 
accordance with AUST Standard Operating Procedures (SOPs), Good Manufacturing Practice
(GMP) guidelines, ICH GCP guidelines, and applicable local laws/regulations.
4.3
Study Drug Handling
Current ICH GCP Guidelines require the Investigator to ensure that study drug deliveries from 
the Sponsor are received by a responsible person designated by the Investigator (e.g. 
pharmacist, study coordinator), and

that such deliveries are recorded

that study drug is handled and stored safely and properly

that study drug is only dispensed to study subjects in accordance with the protocol

that any unused study drug is returned to the Sponsor or standard procedures for the 
alternative disposition of unused study drug are followed and authorized by Astellas.
Drug inventory and accountability records for the study drugs will be kept by the Investigator/ 
pharmacist and in the IRT system. Study drug accountability throughout the study must be 
documented. The following guidelines are therefore pertinent:


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
The Investigator agrees not to supply study drugs to any persons except the subjects in 
this study.

The Investigator/pharmacist will keep the study drugs in a 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/pharmacist. The inventory 
will include details of material received, a clear record of when they were dispensed and 
to which subject, and when and how much was returned by each subject.

At the conclusion or termination of this study, the Investigator/pharmacist 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 returned medication. Any discrepancies must be accounted for. Appropriate 
forms of deliveries and returns must be signed by the person responsible.
4.4
Blinding
4.4.1
Blinding Method
This is a randomized, double-blind, parallel group study.  Subjects will be assigned to a 
treatment group in the order which they meet the criteria for randomization. After the 
completion of the 2-week placebo run-in period, subjects will be randomized to either 25 mg 
mirabegron or placebo for 12 weeks of treatment.  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.
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 must 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.


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4.4.4
Breaking the Treatment Code for Emergency
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. As noted in Section 4.4.3, the 
reason to break the blind must be discussed with the Astellas Study Physician prior to
unblinding.
After receiving authorization for unblinding from the Sponsor, the Investigator will utilize 
the interactive response technology (IRT) system to unblind. Unblinding through the 
interactive system may only be done by the designated individuals at the site.
If it becomes necessary to break the code during the study, the date, time and reason will be 
recorded in the subject’s Electronic Case Report Forms (eCRF).
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 Code will 
be provided to the limited staff who are empowered 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 2-week 
placebo run-in period (Visit 2).  At Visit 3 (Baseline), subjects will be randomly assigned to 
receive 25 mg mirabegron or placebo using a 1:1 randomization schedule.
To obtain the randomized 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 
the IRT. Study drug assignment will remain blinded to all staff. Study drug will be packaged 
in bottles. Each study drug bottle 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.


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5
TREATMENTS AND EVALUATION
5.1
Dosing and Administration of Study Drugs and Other Medications
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 (PBO).  Randomization will be stratified by age < 75 years and 
≥75 years.  Those subjects randomized to mirabegron will start at 25 mg and may increase to 
50 mg after 4 weeks or 8 weeks based on based on individual subject efficacy, tolerability 
and Investigator discretion. Those subjects randomized to PBO will start blinded product 
matched to the mirabegron 25 mg tablet and may also increase to 50 mg PBO after 4 or 
8 weeks. Once a patient has increased dose, they will remain on that dose for the remainder 
of the study unless for safety reasons that require discontinuation of study drug.
5.1.2
Previous and Concomitant Medication (Drugs and Therapies)
5.1.2.1 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.
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.
5.1.2.2 Concomitant Medication (Drugs and Therapies)
Concomitant medications will be captured from Screening (Visit 1) through the Follow-up 
Phone Call (Visit 7/Week 16).
Prohibited Medications
Medications prohibited between Screening (Visit 1) and Week 12/End of Treatment (Visit 6)
include anticholinergics, antispasmodics, and CYP2D6 substrates with narrow therapeutic 
index (see Appendix 1, Part A).  These medications must have been discontinued at least 
30 days prior to Screening (Visit 1). Current or previous use of mirabegron at any time is 
prohibited. This list is not inclusive of all possible prohibited medications. In case of doubt, 
the Investigator must contact the local study monitor. 
Restricted Medications
Medications restricted between Screening (Visit 1) and Week 12/End of Treatment (Visit 6) 
include loop diuretics, alpha blockers and 5-Alpha reductase inhibitors. All medications in 
Part B of Appendix 1 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 the 30 days prior to 
Screening (Visit 1), no new drug of the same class has been added to the regimen within the 


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30 days prior to Screening (Visit 1), and the subject remains on the medication at the same 
dose during the course of the study.
Restricted Non-Drug Therapy
Subjects participating in any behavioral modification therapy (i.e., pelvic floor exercises, 
Kegel exercises, biofeedback, timed voiding, etc.) or other non-drug therapy must have 
started the therapy at least 30 days prior to Screening (Visit 1) and must continue the same 
schedule through Week 12/End of Treatment (Visit 6).
5.1.3
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 
period. Compliance will be verified by the accounting of study drug at each monthly visit
after baseline. When study drug is administered at the research facility, it will be
administered under the supervision of study personnel.
Compliance of the study drug will be monitored by the accounting of unused medication
returned by the subject at visits. Compliance will be documented.
If compliance is less than 80% or more than 120%, the Investigator or designee is to counsel 
the subject and ensure steps are taken to improve compliance. Subjects who are less than 
80% or more than 120% compliant with the dosage regimen for any two consecutive visit 
periods during the study should be withdrawn from the study.
5.1.4
Emergency Procedures and Management of Overdose
Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this 
dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate 
exceeding 100 bpm (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 
10 days showed increases in pulse rate and systolic blood pressure when administered to 
healthy volunteers. Treatment for overdosage must be symptomatic and supportive. In the 
event of overdosage, pulse rate, blood pressure and ECG monitoring is recommended.
5.2
Demographics and Baseline Characteristics
5.2.1
Demographics
The subject’s date of birth, sex, race, ethnicity, height, and weight will be recorded at 
Screening (Visit 1).
5.2.2
Medical History
Medical history (other than for overactive bladder), including smoking history will be 
obtained at Screening (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 OAB history for each subject will be obtained at Screening (Visit 1).


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5.3
Efficacy
5.3.1
Patient Diary - Micturition and Incontinence
During the study, subjects will be requested to complete a ‘Subject diary’ which will be 
implemented on an electronic handheld device. This diary will collect data on micturition and 
incontinence. 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 Visit 2 (Placebo Run-In) and will be counseled on the importance of completing 
the diaries prior to the next visit. The training diary will be reviewed with the subject by the 
Investigator or designee to ensure accuracy and completion.  The diaries and questionnaires 
will be reviewed during each visit after Visit 2 (Placebo Run-In) by the Investigator or 
designee to ensure accuracy of completion.
Diaries will be completed 3 consecutive days prior to each visit: Baseline (Visit 3), Week 4 
(Visit 4), Week 8 (Visit 5), and Week 12/End of Treatment (Visit 6). During this activity, the 
subject will not come to the clinic for a visit. Site staff will contact the subject 3 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 awake with intention of staying awake, type of episode 
(urination/incontinence), time of episode, urgency severity (see Section 5.3.4), measure of 
urine volume voided, and sleep interruption will be recorded by the subject in the micturition 
diary.
At Visit 3, diary data, including the frequency of micturition (urination episodes) urgency 
episodes (grade 3 and 4) and incontinence episodes per 24 hours, will be reviewed to confirm 
inclusion criteria.
Micturitions will be counted as only urination episodes and not episodes of incontinence.
In addition to the micturition information, the electronic diary will also collect time of 
medication intake.
5.3.2
Barthel Index of Activities of Daily Living
The Barthel Index consists of 10 items that measure a person’s daily functioning; specifically 
the activities of daily living and mobility.
The Barthel Index will be completed at Baseline (Visit 3) and Week 12/End of Treatment 
(Visit 6).
5.3.3
Vulnerable Elders Survey 
The Vulnerable Elders Survey (VES-13) is a simple function-based tool for screening 
community-dwelling populations to identify older persons at risk for health deterioration.  


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The VES considers age, self-related health, limitation in physical function, and functional 
disabilities.
The Vulnerable Elders Survey will be completed at Baseline (Visit 3) and Week 12/End of 
Treatment (Visit 6).
5.3.4
Patient Perception of Intensity of Urgency Scale 
The Patient Perception of Intensity of Urgency Scale (PPIUS) is a scale that 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 categorical scale. The 
categories are recommended by the Committee for Proprietary Medicinal Products
[CPMP/EWP/18/01, Final].
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.
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 the 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 underlines the importance 
of assessing the perceptions of subjects themselves when evaluating the effects of medical or 
pharmacological treatment. This is done in QoL research, also in the OAB field [Palmtag 
2004]. In this study, the Overactive Bladder-questionnaire (OAB-q), the Patient Perception of 
Bladder Condition (PPBC), TS-VAS, and University of Alabama – Birmingham Life Space 
Assessment (UAB-LSA) will be utilized.
5.3.5.1 Overactive Bladder-questionnaire
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].


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The OAB-q will be assessed at Baseline (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and 
Week 12/End of Treatment (Visit 6).  
5.3.5.2 Patient Perception of Bladder Condition 
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 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12/End of Treatment (Visit 6). 
5.3.5.3 Treatment Satisfaction – Visual Analog Scale 
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 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12/End of Treatment (Visit 6).
5.3.5.4 University of Alabama,  Birmingham Life Space Assessment 
The University of Alabama, Birmingham (UAB) Study of Aging Life-Space Assessment 
(LSA) measures mobility in terms of the spatial extent of a person's life.  The purpose of the 
Life-Space Assessment is to determine a person's usual pattern of mobility during the month 
preceding the assessment.  Life-space is defined based upon the distance a person routinely 
travels to perform activities over this time frame.  The UAB-LSA includes determining how 
far and how often the person leaves his or her place of residence and the degree of 
independence the person has.
Each level of life-space represents a distance further from the room where one sleeps.
0 =
Mobility limited to the room where one sleeps
1 =
Mobility limited to within one's dwelling
2 =
Mobility limited to the space just proximal to one's personal living space (for 
instance, a porch, patio, or yard just outside the home or hallway outside of 
an apartment)
3 =
Mobility limited to one's neighborhood
4 =
Mobility limited to one's town
5 =
Mobility outside one's town
The UAB-LSA will be assessed at Baseline (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and 
Week 12/End of Treatment (Visit 6).  


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5.4
Safety Assessment
The safety evaluations including vital signs, cognition, adverse event recording, clinical 
laboratory assessments and physical examination will be performed according to Table 1, 
Schedule of Assessments.
Please review the requirements related to the evaluation, reporting and analysis of 
Drug-Induced Liver Injury (DILI) information 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 at all in-office visits 
according to Table 1, Schedule of Assessments.
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 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 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 3) in subjects 
who were normotensive (average systolic blood pressure < 140 mmHg and average 
diastolic blood pressure < 90 mmHg [WHO-ISH, 2003]) at Baseline (Visit 3).
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 3) in subjects with hypertension at Baseline (Visit 3).
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.
An AE of tachycardia should be considered if resting heart frequency (pulse rate) is 
> 100 bpm.
5.4.2
Patient Diary - Subject Measurement Vital Signs
During Visit 2 (Placebo Run-In), 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 him/herself with the self-measurement of BP 
and PR and recording of the data.


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Diaries for vital signs (measured at home) will be completed in both am and pm for 3 
consecutive days prior to each visit: Baseline (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), 
and Week 12/End of Treatment (Visit 6).
Validated devices for measuring BP and PR will be provided to subjects along with detailed 
operating instructions. The Investigator should measure the circumference of the upper arm 
in order to give the subject the device with the correct cuff type (Adult: 25-35 cm; Adult 
Plus: 33-40 cm arm circumference).
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 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/her BP and PR in triplicate during the 3 consecutive days 
prior to the next visit, on the arm chosen from the Screening measurements. Measurements 
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.
Three readings should be taken at every occasion, each about 2 minutes apart.
The subject should keep adequate records of the readings. Date, time, systolic and diastolic 
BP, and PR should 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.
An AE of tachycardia should be reported if the mean am or pm PR in the resting state from 
subject reported measurements at home over the last 3 diary days is >100 bpm.
5.4.3
Montreal Cognitive Assessment 
Montreal Cognitive Assessment (MoCA) will be assessed at Baseline (Visit 3) and 
Week 12/End of Treatment (Visit 6).
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction.  It 
assesses different cognitive domains: attention and concentration, executive functions, 
memory, language, visuoconstructional skills, conceptual thinking, calculations, and 
orientation. Time to administer the MoCA is approximately 10 minutes. The total possible 
score is 30 points [Nasreddine et al, 2005].
5.4.4
Adverse Events
AE collection will begin from the time of informed consent and continue through the 
Follow-up Phone Call (Visit 7/Week 16). See Section 5.5 Adverse Events and Other Safety 
Aspects for information regarding adverse event collection and data handling.


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5.4.4.1 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 a 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.
5.4.5
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 Lab will be used for all laboratory assessments.
Table 3
Laboratory Assessments
Screening (Visit 1)
Week 12/End of Treatment (Visit 6)
Hematology
CBC
Hemoglobin
Hematocrit
Screening (Visit 1)
Week 12/End of Treatment (Visit 6)
Chemistry
Sodium
Potassium
Calcium
Chloride
Glucose
Creatinine
Alkaline phosphatase
AST
ALT
GGT
Total bilirubin
Total protein
Albumin
INR
Screening (Visit 1)
Week 12/End of Treatment (Visit 6)
Urinalysis 
Protein
Glucose
pH
Blood
Urine Culture*
* Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the 
discretion of the PI.
Clinical significance of out-of-range laboratory findings is to be determined and documented 
by the Investigator/sub-Investigator who is a qualified physician.
5.4.6
Physical Examination
The subject will have a physical examination performed at Screening (Visit 1) and 
Week 12/End of Treatment (Visit 6). This includes examination of main body systems. Date 


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of physical examination and any clinically relevant adverse changes will be recorded as an 
AE in the eCRF (see Section 5.5.1).
5.4.7
Electrocardiogram (ECG)
A 12-lead ECG will be recorded at Screening (Visit 1), the Placebo Run-In (Visit 2), Baseline 
(Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12/End of Treatment (Visit 6). ECGs 
will be taken with the subject in the sitting or supine position. The patient’s sitting or supine 
position for the ECG should be consistent throughout the course of the study.
All tracings will be read locally by the Investigator to ensure patient safety and care 
management.  Any abnormalities must be evaluated in clinical context (based on subject’s 
medical history and concomitant medication) and the Investigator must determine if it is 
clinically significant. Clinically significant abnormalities must be reported as an AE.
5.4.8
Post-Void Residual  Volume
Post-Void Residual (PVR) volume will be assessed by ultrasonography or bladder scan at 
Screening (Visit 1) and Week 12/End of Treatment (Visit 6).
5.4.9
Cough Provocation Test 
The cough provocation test will be performed for female subjects at Screening (Visit 1).  
Female subjects will be asked to come to the clinic with a comfortably full bladder. With the 
subject in the supine position, the volume of urine in the bladder is measured by ultrasound. 
The bladder volume must exceed 100 mL for the assessment of stress incontinence. 
Subsequently the subject will be asked to cough vigorously in the standing position.  An 
immediate loss of urine will confirm a clinical diagnosis of stress incontinence [Wall et al, 
1993].
5.4.10
Follow-up Phone Calls to Patient
Subjects will be contacted 4 weeks after End of Treatment (Visit 6/Week 12) by telephone for 
a Follow-up Phone Call (Visit 7/Week 16) to assess concomitant medication 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. 
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:


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
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.
Due to the study objective(s), design, and variables identified in Section 2 of the protocol and 
during the conduct of the study from the time of informed consent until the final study visit, 
lack of efficacy with the study medication intended to treat overactive bladder will not be 
submitted to a Health Authority as an expedited adverse event report.
5.5.2
Definition of Serious Adverse Events (SAEs)
An AE 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 must 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, must 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.
Safety events of interest 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)

Medication error involving the medicinal product(s) (with or without subject/patient 
exposure to the Sponsor medicinal product, e.g., name confusion).


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All of the events of interest noted above should be recorded in the eCRF. Any situation 
involving these events of interest 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.
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)
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).
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 faxing, scanning or emailing of an SAE Worksheet is not possible 


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within 24 hours, the local drug safety contact should be informed by phone.  Please fax the 
SAE Worksheet to:
 
If there are any questions, or if clarification is needed regarding the SAE, please contact the 
Sponsor's Medical Director/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) as necessary.
Full details of the SAE should also be recorded on the medical records and in 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 of 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.
5.5.6
Follow-up to Adverse Events
All adverse events occurring during the study are to be followed 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 adverse event 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.


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5.5.7
Monitoring of Common Serious Adverse Events (SAEs)
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 your 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 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 makes his partner pregnant, 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.
5.8
Total Amount of Blood
Blood samples will be taken for the purposes of hematology and biochemistry analysis at 
Screening (Visit 1) and Week 12/End of Treatment (Visit 6). It is anticipated the total amount 
of blood taken will not exceed 20 mL.
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.


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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 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 violation (e.g., subject took prohibited medication that in the Investigator’s 
opinion, after discussion with the Astellas Study Physician, 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 feels 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.
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.  In addition,
specifications for tables, listings, and figures will 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.


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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 micturition diary, the 3 days of the diary recorded 
prior to the baseline visit 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 at the end of the 
double-blind treatment 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 dairy measurements within a designated visit window 
will be used.
All statistical comparisons will be made using a two-sided test at α = 0.05 significance level 
and confidence intervals will be reported with a coverage consistent with this significance 
level. Efficacy and safety variables will be summarized using descriptive statistics.  
Continuous variables will be summarized using mean, standard deviation (SD) or standard 
error (SE), minimum, median, maximum unless specified otherwise. Categorical variables 
will be described using absolute and relative frequency.
7.1
Sample Size
Sample Size Justification: 
The co-primary endpoints for this study are change from baseline to end of treatment in the 
mean number of micturitions per 24 hours based on the 3-day micturition diary and change 
from baseline to end of treatment in mean number of incontinence episodes per 24 hours
based on a 3-day micturition diary.
The sample size calculation first of all evaluates the number of subjects needed to test the 
change from baseline to end of treatment in mean number of incontinence episodes per 
24 hours based on a 3-day micturition diary and then assesses whether this same sample size 
is adequate to test the change from baseline to end of treatment in the mean number of 
micturitions per 24 hours based on the 3-day micturition diary. The overall power is then 
calculated for the study based on these co-primary endpoints.
The sample size calculation for the change from baseline in the final visit mean number of 
incontinence episodes per 24 hours is based on nonparametric methods since the results from 
previous phase 2 and 3 studies indicated that the assumption of normality may not be valid.  
The results of these studies showed frequent ties for the number of episodes and therefore the 
sample size calculation is based on dividing this endpoint into 7 categories. The actual 
primary statistical analysis will not group the data.  The categories are shown below together 
with the percentages occurring for placebo and mirabegron 50 mg as found in older adult 


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subjects (≥65 years of age) from North American sites in studies 178-CL-047 and 
178-CL-074.
Table 4
Categories for Change from Baseline in Mean Number of Incontinence 
Episodes per 24 Hours, for North America, ≥65 years
Mean Change Incontinence 
Category
Placebo
Mirabegron 50 mg
N =185
N=187
≤ -2.67
15.68%
16.04%
[-2.67, -2.00)
7.03%
9.09%
[-2.00, -1.33)
12.43%
22.46%
[-1.33, -0.67)
13.51%
9.63%
[-0.67, -0.34)
12.43%
11.76%
[-0.34, 0.33)
17.84%
20.86%
≥ 0.33
21.08%
10.16%
Based on the table above, the probability that a subject on mirabegron will respond better 
than a subject on placebo is 56.3% (nQuery 7.0). Based on a Wilcoxon (Mann-Whitney) 
rank-sum test that P(X<Y) = 0.5 (continuous outcome), 340 incontinent subjects per 
treatment group will yield 82% power with a 2-sided test at a significance level of 0.05.
The pivotal study showed a 0.796 mean (SD=2.7) reduction for mirabegron 50 mg compared 
to PBO in the mean number of micturition per 24 hours in North American subjects who 
were 65 years or older. A sample size of 340 subjects per treatment group will yield 97% 
power to detect a reduction of .796 in mean number of micturitions per 24 hours using a 
two-sided t-test at a significance level of 0.05 assuming a SD of 2.7 (nQuery 7.0).
Assuming ‘Change from baseline in mean number of micturitions per day’ and ‘Change from 
baseline in mean number of incontinence episodes per day’ are independent the overall 
power would therefore be 80%.
The historical data show at least 15% of the randomized subjects will drop out during the 
double-blind period. Consequently an additional 60 subjects per treatment group need be 
enrolled. This brings the total required incontinent subjects per treatment group to 400. 
Based on the historical data a 20% failure rate is predicted due to lack of incontinence and 
another 10% failure due to a combination of drop out and placebo response during the run in
period. Therefore a 30% screen failure rate is expected. 
In order to randomize 800 subjects with incontinence it is expected that 1,150 subjects will 
need to be screened.
7.2
Analysis Set
7.2.1
Full Analysis Set - Incontinence (FAS-I)
The FAS-I will include all subjects who meet all of the following criteria:


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
Subjects who took at least 1 dose of double-blind 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 summary of all baseline characteristics, including 
demographics, disease state data, prior medications, prior medical history and a statistical 
analysis of efficacy endpoints and QoL instruments.
7.2.2
Per Protocol Set (PPS)
The PPS will include all subjects who meet the following criteria:

Subjects in the FAS-I set,

Completed the study without major deviations of the protocol.
These criteria will be used to capture relevant non-adherence to the protocol and will be 
defined in the SAP. The PPS will be a secondary analysis set for efficacy. Selected 
demographic and baseline characteristics may also be summarized for the PPS.
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.
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
A step-down gatekeeping procedure will be performed to control the type I error rate at the 
0.05 significance level for the multiple endpoints of the co-primary efficacy variables of 
change from baseline to end of treatment in mean number of micturitions per 24 hours and 
mean number of incontinence episodes per 24 hours and the key secondary efficacy variable 
of change from baseline to end of treatment in mean volume voided per micturition. The 
hypotheses will be tested in the following order: mean number of micturitions per 24 hours, 
mean number of incontinence episodes per 24 hours and mean volume voided per 
micturition.
7.4.1
Analysis of Primary Variable
7.4.1.1 Primary Analysis
The primary analysis set for efficacy analyses will be the Full Analysis Set - Incontinence 
(FAS-I). The co-primary efficacy variables are Change from baseline to end of treatment in 
mean number of micturitions per 24 hours based on a 3-day micturition diary and Change 
from baseline to end of treatment in mean number of incontinence episodes per 24 hours 
based on a 3-day micturition diary.


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Mean number of micturitions per 24 hours
The hypothesis being tested for the mean number of micturitions per 24 hours can be stated 
as; 
H0:  Mean change from baseline in number of micturitions per 24 hours at end 
of treatment is the same for placebo and mirabegron.
H1: Mean change from baseline in number of micturitions per 24 hours at end 
of treatment is different for placebo and mirabegron.
Change from baseline to end of treatment in mean number of micturitions per 24 hours will 
be tested using a stratified Analysis of Covariance (ANCOVA) model. The response variable 
will be the mean change in number of micturitions episodes per 24 hours from baseline to the 
end of the study with treatment group and gender as fixed factors and baseline mean number 
of micturitions episodes per 24 hours as the covariate in the model. Age group (<75, ≥75) 
will be included as the stratification factor. As part of the ANCOVA results, LS means and 
two-sided 95% CIs for mean changes 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.
Mean number of incontinence episodes per 24 hours
The hypothesis being tested for the mean number of incontinence episodes per 24 hours can 
be stated as; 
H0:  Mean change from baseline in number of incontinence episodes per 
24 hours at end of treatment is the same for placebo and mirabegron.
H1: Mean change from baseline in number of incontinence episodes per 
24 hours at end of treatment is different for placebo and mirabegron.
In order to test for statistical differences in Change from baseline to end of treatment in mean 
number of incontinence episodes per 24 hours between mirabegron and placebo, a stratified
rank Analysis of Covariance (ANCOVA) will be used. The response variable is the 
standardized ranks of change from baseline to end of treatment value in mean number of 
incontinence episodes per 24 hours. Treatment group and gender will be added as fixed 
factors in the model while the standardized ranks of mean number of incontinence episodes 
per 24 hours at baseline will be included as a covariate. Age group (<75, ≥75) will be 
included as the stratification factor. LS means and two-sided 95% CIs for mean changes from 
baseline within each treatment group will be provided using an ANCOVA model with the 
same dependent and independent variables but not using the rank scale for the mean number 
of incontinence episodes data.
7.4.1.2 Secondary Analysis
Residual plots will be produced to check the assumptions of the underlying statistical models 
for mean number of micturitions per 24 hours. If the fit of the models is questionable, the 


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dependent variable may be logarithmically transformed in order to improve the fit or a 
non-parametric analysis could be applied as a secondary analysis.
An additional test will be applied to test the probability of a subject on mirabegron 
responding better than a subject on placebo. A Wilcoxon-Mann-Whitney Ordered Category 
test will be used to achieve this. The categories for responses will be the same as the 
categories in the sample size section above.
The analysis of the primary variables will be performed for Visits 3, 4 and 5. The statistical 
tests applied will be the same as the test applied to the ones described in Section 7.4.1.1
All analysis may be repeated for the PPS which is considered secondary. Additional 
sensitivity analysis may be performed to assess the robustness of the primary analysis 
findings.  Details will be included in the SAP.
Responder Analysis for Incontinence Episodes and Improvement in Patient Perception of 
Bladder Condition
Two responder analyses based on incontinence episodes will be performed using a logistic 
regression model including the same factors as the ANCOVA model. Odds ratios that 
compare treatment effect between mirabegron and placebo will be reported with 95% CIs.
The two responder definitions are as follows:

Zero Incontinence Episodes: A responder is defined as a subject with 0 incontinence 
episodes post-baseline.

Reduction in Incontinence Episodes: A responder is defined as a subject with ≥ 50% 
decrease from baseline in mean number of incontinence episodes per 24 hours.
Sub-group Analysis
Sub-group analysis of the co-primary endpoints will be conducted using ANCOVA models 
with an interaction term. The interaction term will be the treatment arm and the subgroup. 
The sub-groups to be considered for the analysis will include;

Age group 

Race

Gender
The models for the sub-group analysis will have the treatment arm, subgroup and baseline 
values as the independent variables in the model. LS means and two-sided 95% CIs for mean 
changes from baseline within each subgroup will be provided.
7.4.2
Analysis of Secondary Variables 
The key secondary efficacy variable will be the change from baseline to end of treatment in 
mean volume voided per micturition.  The other secondary variables are: 

Change from baseline to end of treatment in symptom bother and total health related 
quality of life scores as assessed by OAB-q questionnaire, and


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
Change from baseline to end of treatment in Patient Perception of Bladder Condition 
(PPBC).
Change from baseline to end of treatment in mean volume voided
Change from baseline to end of treatment in mean volume voided will be tested using a
stratified Analysis of Covariance (ANCOVA) model. The response variable will be the mean 
change in mean volume voided from baseline to the end of the study with treatment group 
and gender as fixed factors and baseline mean volume voided as the covariate in the model.
Age group (<75, ≥75) will be included as the stratification factor. As part of the ANCOVA 
results, LS means and two-sided 95% CIs for mean changes 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.
Sensitivity analysis
As a sensitivity analysis, a non-parametric test will be applied in investigating MVV. 
Differences in change from baseline to end of treatment in mean volume voided per 
micturition between mirabegron and placebo will be analyzed using a stratified rank
ANCOVA model. The response variable will be the standardized ranks of the change from 
baseline to end of treatment in mean volume voided per micturition. Treatment group and 
gender will be fixed factors in the model while the standardized ranks of the baseline mean 
volume voided per micturition will be included as covariate. Age group (<75, ≥75) will be 
included as the stratification factor. 
Change from baseline in symptom bother and total health related quality of life scores 
as assessed by OAB-q questionnaire.
Differences in change from baseline of symptom bother and total health related quality of life 
scores as assessed by OAB-q between mirabegron and placebo will be analyzed using a 
stratified ANCOVA model. The response variable will be the change from baseline in 
symptom bother and total health related quality of life scores. Treatment group and gender 
will be fixed factors in the model while the baseline symptom bother and total health related 
quality of life scores will be included as covariate. Age group (<75, ≥75) will be included as 
the stratification factor. As part of the ANCOVA results, LS means and two-sided 95% CIs 
for mean changes from baseline within each treatment group will be provided. 
Change from Baseline in Patient Perception of Bladder Condition (PPBC)
Differences in change from baseline of PPBC between mirabegron and placebo will be 
analyzed using a stratified ANCOVA model. The response variable will be the change from 
baseline in PPBC. Treatment group and gender will be fixed factors in the model while the 
baseline symptom bother and total health related quality of life scores will be included as 
covariate. Age group (<75, ≥75) will be included as the stratification factor. As part of the 
ANCOVA results, LS means and two-sided 95% CIs for mean changes from baseline within 
each treatment group will be provided.


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Responder Analysis for OAB-q and PPBC
A responder analysis will be performed for OAB-q at Week 12 or LOCF using a logistic 
regression model. This will be based on the change in percentage OAB-q from baseline. The 
definition of the categories of the response variable is based on the results of the OAB-q 
study by Coyne et al, 2007. The responder groups will be defined as follows:
A responder is a subject with a minimally important difference (MID) ≥ 10% change in 
OAB-q while a non-responder will be a subject with a MID < 10% change in OAB-q.
Two responder analyses will be performed for PPBC at Week 12 or LOCF using a logistic 
regression. Two logistic regression models will be fitted with binary response variables that 
are based on change from baseline in PPBC. The response variables will be categorized as 
follows;

Improvement: ≥1 point improvement from baseline to post-baseline for PPBC

Major improvement: ≥2 point improvement from baseline to post-baseline for PPBC
Logistic regression for the responder analysis will include treatment group, gender and 
baseline measurements as the explanatory variables.
7.4.3
Analysis of Other Variables 
The analysis of change from baseline scores for the following additional efficacy endpoints 
will be analyzed in the same way as described for the mean number of micturitions, i.e.,
using a stratified ANCOVA including treatment (placebo and mirabegron) and genders a 
fixed factor and baseline as a covariate. Age group will be used as the stratification variable.

Change from baseline in mean number of urgency episodes (grade 3 and/or 4)/24 hour

Change from baseline in mean number of urgency incontinence episodes/24 hour

Change from baseline in mean level of urgency

Change from baseline in mean number of nocturia episodes/24 hour

Change from baseline in subscale score from OAB-q scores

Change from baseline in TS-VAS

Change from baseline in University of Alabama, Birmingham - Life Space Assessment 
(UAB-LSA)
Responder analysis as defined by >= 50% reduction from baseline in mean number of 
incontinence episodes/24 hours from baseline or zero incontinence episodes post-baseline.
7.4.4
Exploratory Analysis
 
7.5
Analysis of Safety
Safety analysis will be performed for adverse events (AEs) and vital signs using the SAF. No 
inferential comparison between treatment groups will be performed for the safety analysis in 


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this study with the exception of the change from baseline in Montreal Cognitive Assessment 
Test (MoCA) and for vital signs analysis.
Differences in change from baseline of MoCA scores between mirabegron and placebo will 
be analyzed using a stratified ANCOVA model. The response variable will be the change 
from baseline in MoCA scores. Treatment group and gender will be fixed factors in the 
model while the baseline symptom bother and total health related quality of life scores will 
be included as covariate. Age group (<75, ≥75) will be included as the stratification factor.
As part of the ANCOVA results, LS means and two-sided 95% CIs for mean changes from 
baseline within each treatment group will be provided.
Vital Signs will be summarized by treatment group and by Home Based Blood Pressure 
Monitoring (HBPM) versus office based using descriptive statistics for baseline value, 
specified post-baseline time point values (Week 4, Week 8, Week 12/EOT), and change from 
baseline to each specified post-baseline time points. Office based and morning and evening 
blood pressure will be reported separately.  For HBPM the first reading from each time 
period will be discarded and the subsequent two readings for each time period will be 
averaged over the 3-day diary. HBPM and office based monitoring will be reported 
separately (See Appendix 4).  
7.5.1
Adverse Events 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA).  The number and percentage of 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 AEs by severity will also be summarized. All 
AEs will be listed.
The number and percentage of TEAEs, serious TEAEs, and discontinuations due to a TEAE
will be summarized by System Organ Class, Preferred Term, and treatment group.  In 
addition, TEAEs will be summarized by relationship to study drug as determined by the 
Investigator and by severity for each treatment group.
7.5.2
Laboratory Assessments 
Laboratory variables (biochemistry, hematology, and urinalysis) will be descriptively 
summarized for Screening and Week 12/End of Treatment and change from Screening to End 
of Treatment 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/End of Treatment
and most extreme value during the double-blind treatment period by treatment group will be 
summarized. 
Laboratory abnormalities will be evaluated based on the Potential Clinically Significant 
(PCS) laboratory criteria. For each laboratory PCS criterion, the number and percent of 
subjects who have a laboratory value meeting the PCS criteria during the double-blind 


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treatment period will be summarized by treatment group. The directions of changes (high or 
low) in PCS will be indicated in the tables.
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, specified post-baseline time point values (Week 4, Week 8, 
and Week 12/EOT), and change from baseline to each specified 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 gender as fixed factors and 
baseline vital sign value as covariate.  Vital sign data will be analyzed separately based on 
the 3-day diary and the site assessment at each clinic visit. Change from baseline in vital sign 
variables will be analyzed using the same ANCOVA model as described for the analysis of 
change from baseline in mean number of micturitions per 24 hours. No p-values will be 
calculated.
Number and percentage of subjects with more than 10/15/20 mmHg increase from baseline in 
SBP, more than 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 variables shifting between JNC-7 
defined risk categories will be summarized by treatment group. These categories are listed 
below:
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
Electrocardiograms (ECG)
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/End of Treatment, including changes from 
baseline to end of treatment. 
7.6
Analysis of Pharmacokinetics
Not applicable.
7.7
Analysis of Pharmacodynamics 
Not applicable.


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7.8
Protocol Deviations and Other Analysis 
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 the subject 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 measurements available 
for that visit. The End of Treatment analysis is a LOCF (last observation carried forward) 
approach.
Other imputation rules to account for missing data will be described in the SAP.
Subjects do not always adhere strictly to the visit timing in 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 will be 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.


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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 subject on an electronic device. The information 
completed by the subject 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 
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 signed and dated informed consent forms

Visit dates

Medical history and physical examination details

Key efficacy and safety data (as specified in the protocol)

Adverse events and concomitant medication

Results of relevant examinations (e.g., electrocardiograms (ECG), 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.  


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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 will be performed using MedDRA. 
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 the subject 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 communications to the IRB/IEC and applicable regulatory authorities will be provided to 
the Sponsor and maintained within the Trial Master File (TMF).


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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 Study
The end of study 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, the informed consent (ICF) 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 SAEs 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. 
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/her guardian or legal representative, and answer all questions regarding this study.  Prior 


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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/her 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
Individual subject medical information obtained as a result of this study is considered 
confidential and disclosure to third parties is prohibited. Such medical information may be 
given only after approval of the subject to the subject's physician or to other appropriate 
medical personnel responsible for the subject's well-being.
The Sponsor shall not disclose any confidential information on subjects obtained during the 
performance of their duties in the clinical study without justifiable reasons.
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 and other pertinent information is confidential and remains 


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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, CRFs, 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). The Sponsor will notify the
site/Investigator if the NDA/MAA/J-NDA is approved or if the IND/IMPD/CHIKEN 
TODOKE 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 on the eCRFs supplied 
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 is 
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 
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 ICF, written verification of IRB/IEC approval must be forwarded 
to the Sponsor. An approved copy of the new ICF 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 which forms part of a marketing authorization application 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 


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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 arrhythmia and 
thromboembolic events) and the specification of the event-related documents, listings, 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 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 and the specification of the event-related documents, listings, data flow, method(s) 
for data collection and data transfer.


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11
REFERENCES
Literature cited:
Abe T, Hashidate H, Shimada H, Ohnuma T, Suzuki T. The association of activity assessed 
by life-space assessment with physical function and instrumental activities of daily 
living for elderly people. Rigakuryoho Kagaku 2009;24(5):721-726.
Allman RM, Sawyer P, Roseman JM. The UAB study of aging: background and insights into 
life-space mobility among older Americans in rural and urban settings. Aging Health. 
2006;2(3):417-429. 
American Geriatrics Society. Updated Beers Criteria for potentially inappropriate medication 
use in older adults. JAGS. 2012;60:616-631.
Boustani M, Campbell N, Munger S, Maidment I, Fox C. Impact of anticholinergics on the 
aging brain: a review and practical application. Aging Health. 2008;4(3):311-320.
Cai X, Campbell N, Khan B, Callahan C, Boustani M. Long-term anticholinergic use and the 
aging brain. Alzheimer’s & Dementia. 2013;9:377–385.
Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on the Clinical 
Investigation of Medicinal Products for the Treatment of Urinary Incontinence, 
(CPMP/EWP/18/01, final).
Coyne KS, Matza LS, 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.
Coyne KS, Matza LS, Thompson C, Jumadilova Z, Bavendam T. The responsiveness of the 
OAB-q among OAB patient subgroups. Neurourology and Urodynamics. 
2007;26:196-203.
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;11:563-574.
Dallosso HM, McGrother CW, Matthews RJ, Donaldson MM, Group LMIS. Nutrient 
composition of the diet and the development of overactive bladder: a longitudinal study 
in women. Neurourology and Urodynamics. 2004;23:204-210.
Digesu G, Verdi E, Cardozo L, Olivieri L, Khullar V, Colli E. A phase IIb, multicenter, 
double-blind, randomized, placebo-controlled, parallel-group study to determine effects 
of elocalcitol in women with overactive bladder and idiopathic detrusor overactivity. 
Urology. 2012;80(1):48–54.


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Fox C, Richardson K, Maidment ID, Savva GM, Matthews FE, Smithard D, et al. 
Anticholinergic medication use and cognitive impairment in the older population: the 
Medical Research Council Cognitive Function and Ageing Study. JAGS. 
2011;59:1477–1483.
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):391-399.
Guidance for Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation. Food 
and Drug Administration, July 2009.
Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, et al.  A 
phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre 
study to assess the efficacy and safety of the β₃ adrenoceptor agonist, mirabegron, in 
patients with symptoms of overactive bladder. Urology. 2013;82:313-320.
Holick MF. The vitamin D deficiency pandemic and consequences for nonskeletal health: 
mechanisms of action. Molecular Aspects of Medicine. 2008;29:361-368.
Kashyap M, Belleville S, Mulsant B, Hilmer SN, Paquette A, Tu LM, et al. Methodological 
challenges in determining longitudinal associations between anticholinergic drug use 
and incident cognitive decline. JAGS. 2014;62:336-341.
Kay G, Crook T, Rekeda L, Lima R, Ebinger U, Arguinzoniz M, et al. Differential effects of 
the antimuscarinic agents darifenacin and oxybutynin ER on memory in older subjects. 
European Urology. 2006;50:317-326.
Kay GG, Granville LJ. Antimuscarinic agents: implications and concerns in the management 
of overactive bladder in the elderly. Clinical Therapeutics. 2005;27(1):127-138.
Moga DC, Carnahan RM, Lund BC, Pendergast JF, Wallace RB, Torner JC, et al. Risks and 
benefits of bladder antimuscarinics among elderly residents of Veterans Affairs 
community living centers. JAMDA. 2013;14(10):749-760. 
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, et al. The 
Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive 
impairment. JAGS. 2005;53:695-699.
Nassau DE, Gerber JA, Weiss JP. The prevalence and treatment of voiding dysfunction in the 
elderly. Curr Geri Rep. 2014;3:33-41.
Ouslander JG, Kane RL, Abrass IB. Urinary incontinence in elderly nursing home patients. 
JAMA. 1982;248(10):1194-1198.
Palmtag H. The patient’s perspective: redefining end points. Urology.
2004;64(Suppl 6A):17-20.


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Shimada H, Sawyer P, Harada K, Kaneya S, Nihei K, Asakawa Y, et al. Predictive validity of
the classification schema for functional mobility tests in instrumental activities of daily 
living decline among older adults. Archives of Physical Medicine and Rehabilitation. 
2010;91(2):241-246.
Stewart CM, Wheeler TL, Markland AD, Straughn JM, Richter HE. Life-space assessment in 
urogynecology and gynecological oncology surgery patients: a measure of 
perioperative mobility and function. JAGS. 2009;57:2263-2268.
The ABCD’s of Blood Pressure Measurement. American Heart Association, April 2012.
Wagg A, Cardozo L, Nitti VW, Castro-Diaz D, Auerbach S, Blauwet MB, et al. The efficacy 
and tolerability of the β3-adrenoceptor agonist mirabegron for the treatment of 
symptoms of overactive bladder in older patients. Age & Ageing. 2014;0:1-10. 
Wagg A, Khullar V, Marschall-Kehrel D, Michel MC, Oelke M, Darekar A, et al. 
Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the 
randomized, double-blind, placebo-controlled study of fesoterodine in an aging 
population trial. JAGS. 2013;61:185-193.
Wagg A, Verdejo C, Molander U. Review of cognitive impairment with antimuscarinic 
agents in elderly patients with overactive bladder. The International Journal of Clinical 
Practice. 2010;64(9):1279-1286.
Wall LL, Norton PA, DeLancey JOL. Practical Urogynecology, Baltimore, Williams & 
Wilkins, 1993.
WHO-ISH. World Health Organization/International Society of Hypertension statement on 
management of hypertension. J Hypertension. 2003;21:1983-1992. 
Company Reports:
Adapted from Astellas.  Myrbetriq.  Integrated Summary of Safety (ISS) Final.  Data on File.
Data. Astellas on file. 2012
Mirabegron (YM178) Package Insert – Astellas Global Development, Inc., 2012.
Myrbetriq Canadian Product Monograph, March 2013.


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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 12/End of Treatment (Visit 6).  This list is not exhaustive.  In case of doubt, the 
Investigator must contact the local study monitor. These medications must have been 
discontinued at least 30 days prior to Screening (Visit 1). Current or previous use of 
mirabegron at any time is prohibited.
Anticholinergics/Antispasmodics
Atropine
Baclofen
Biperiden
Bentropine/Benzatropine
Clomipramine
Cyclobenzaprine
Darifenacin
Dicyclomine/Dicycloverine
Emepronium
Glycopyrronium/Glycopyrrolate
Fesoterodine
Flavoxate
Glycopyrolate
Hyoscine
Hyoscyamine
Ipratropium
Isopropamide
Meclozine
Orphenadrine
Otilonium
Oxybutynin
Oxyphencyclimine
Procyclidine
Propantheline
Propiverine
Scopolamine/(Butyl)hyoscine
Solifenacin
Tiotropium
Tolterodine
Trospium
CYP2D6 Substrates with Narrow Therapeutic Index
Aripiprazole (neuroleptic)
Desipramine (TCA)
Donepezil (Acetylcholinesterase 
inhibitor)
Thioridazine (anti-psychotic)
Flecainide (anti-arrhythmic)
Propafenone (anti-arrhythmic)
Imipramine (TCA)
Tramadol (analgesic)
Venlafaxin (SNRI)
OAB Medications
Mirabegron
Other medication if used to 
treat OAB
Medications to Treat Dementia
Donepezil
Rivastigmine
Galantamine
Memantine
Other medication if used to 
treat dementia
Part B - Medications Permitted With Restrictions
Medications restricted between Screening (Visit 1) and Week 12/End of Treatment (Visit 6) 
include loop diuretics, alpha blockers and 5-Alpha reductase inhibitors.  All medications in 
Part B of Appendix 1 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 the 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.


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Loop Diuretics
Furosemide
Bumetanide
Piretanide
Alpha Blockers
Alfuzosin
Doxazosin
Prazosin
Phenoxybenzamine
Phentolamine
Tamsulosin
Terazosin
5-alpha Reductase Inhibitors
Dutasteride
Finasteride


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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 
of serum aminotransferases (AT) to > 3X ULN, or bilirubin > 2X ULN, at least all four of the 
usual serum hepatic measures (ALT, AST, ALP, and TBL) must be repeated. Testing must be 
repeated within 48-72 hours of notification of the test results. For studies for which a central 
laboratory is used, alerts will be generated by the central lab regarding moderate and marked 
liver abnormality to inform the Investigator, study monitor and study team. Subjects must be 
asked if they have any symptoms suggestive of hepatobiliary dysfunction.
Definition of Liver Abnormalities
Confirmed abnormalities will be characterized as moderate and marked where ULN:
ALT or AST
Total Bilirubin
Moderate
> 3 x ULN
or
> 2 x ULN
Marked (Hy’s Law)
> 3 x ULN
and
> 2 x ULN
In addition, the subject must be considered to have marked hepatic abnormalities for any of 
the following:

ALT or AST > 8X ULN

ALT or AST > 5X ULN for more than 2 weeks

ALT or AST > 3X ULN and INR > 1.5

ALT or AST > 3X ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (> 5%).
The Investigator will determine if abnormal liver function results, other than as described 
above, qualify as moderate or marked abnormalities and require additional monitoring and 
follow-up.
Follow-up Procedures
Confirmed moderate and marked abnormalities in hepatic functions must be thoroughly 
characterized by obtaining appropriate expert consultations, detailed pertinent history, physical 
examination and laboratory tests. The site must complete the Liver Abnormality Case Report 
Form (LA-CRF) or an appropriate document. Subjects with confirmed abnormal liver function 
testing must be followed as described below.
Confirmed moderately abnormal LFTs must 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.
Marked hepatic liver function abnormalities, in the absence of another etiology, may be 
considered an important medical event and reported as a Serious Adverse Event (SAE). The 
Astellas Study Physician must be contacted and informed of all subjects for whom marked 
hepatic liver function abnormalities possibly attributable to study drug are observed.


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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 must be recorded as adverse events on the AE page of eCRFs. 
Illnesses and conditions such as hypotensive events, and decompensated cardiac disease 
that may lead to secondary liver abnormalities must 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 must 
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, must be entered on the concomitant 
medication page of the eCRFs.  Information on alcohol, other substance use, and diet 
must 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
o
substance abuse testing

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 LFTs, 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 must occur if:

ALT or AST > 8X ULN

ALT or AST > 5X ULN for more than 2 weeks

ALT or AST > 3X ULN and (TBL > 2X ULN or INR > 1.5)

ALT or AST > 3X 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.


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12.3
Appendix 3: Most Common Serious Adverse Events
The following is a list of serious adverse events that the Sponsor considers to be associated 
with the disease state being studied. The list does NOT change your reporting obligations or 
prevent the need to report an adverse event meeting the definition of an SAE as detailed in 
Section 5.5.2 Definition of Serious Adverse Events (SAEs). 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”. You are required 
to follow the requirements detailed in Section 5.5.5 Reporting of Serious Adverse Events
(SAEs).
For IND safety reporting, single occurrences of the following events may be excluded from 
expedited reporting to the FDA. If aggregate analysis of these events indicate they occur 
more frequently with study drug, an expedited IND safety report may be submitted to the 
FDA.
Most Common SAEs for Mirabegron:
Serious adverse events reported by at least 2 patients and exceeding active control included 
cerebrovascular accident (0.4%) and osteoarthritis (0.2%). Serum ALT/AST increased from 
baseline by greater than 10-fold in 2 patients (0.3%) taking Mirabegron 50 mg, and these 
markers subsequently returned to baseline while both patients continued Mirabegron. In one 
study, serious adverse events of neoplasm were reported by 0.1%, 1.3%, and 0.5% of patients 
treated with Mirabegron 50 mg, Mirabegron 100 mg and active control once daily, 
respectively. Neoplasms reported by 2 patients treated with Mirabegron 100 mg included 
breast cancer, lung neoplasm malignant and prostate cancer.


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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 and Home 
Based Blood Pressure Monitoring results will be reviewed.
Home-Based Blood Pressure Monitoring is to consist of three readings approximately 
2 minutes apart with the at home blood pressure device. The average for each vital sign 
parameter using the last 2 of the 3 readings from each measurement will be calculated 
programmatically as follows: 
Average of self-measurement device (AVGSM) = (measurement 2 + measurement 3)/2
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 3) in subjects 
who were normotensive (average systolic blood pressure < 140 mmHg and average diastolic 
blood pressure < 90 mmHg [WHO-ISH, 2003]) at Baseline (Visit 3).
2.
If the average systolic blood pressure is increased >20mmHg AND/OR the average 
diastolic blood pressure is increased > 10 mmHg at two consecutive visits as compared to 
Baseline (Visit 3) in subjects with hypertension at Baseline (Visit 3).
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. 


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12.5
Appendix 5: Investigator Criteria for Tachycardia
Investigator Criteria for Determing TEAE of Tachycardia
Tachycardia is defined as a rest heart frequency > 100 beats per minute (bpm) measured as 
pulse rate. Based on pulse rate measurements taken by the subject with the self-measurement 
device and recorded in the 3-day diary, if the mean am and/or pm pulse rate in the resting 
state was > 100 bpm over the prior 3 days, 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 not be recorded. 
  


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13
ATTACHMENT 1:  SUBSTANTIAL AMENDMENT 2
I.  The purpose of this amendment is:
Substantial Change
1.  Addition of home based vital sign measurements.
DESCRIPTION OF CHANGE:
The addition of home based vital signs (sitting systolic and diastolic blood pressure and pulse 
rate) will be measured in the am and pm and recorded into the 3-day diary.
RATIONALE:
The addition of home based vital sign measurement provides additional safety data to be 
collected regarding effects of mirabegron and hypertension.
Non-Substantial Changes
1.  Updated Sponsor Name
DESCRIPTION OF CHANGE:
The sponsor affiliation of Astellas Scientific & Medical Affairs (ASMA) was updated to 
Astellas Pharma Global Development, Inc. (APGD), Medical Affairs, Americas.
RATIONALE:
Astellas Scientific & Medical Affairs is now called Astellas Pharma Global Development, 
Inc., Medical Affairs, Americas.
2.  Edited the definition for the exclusion criteria #1 of bladder outlet obstruction 
(BOO).
DESCRIPTION OF CHANGE:
Clarification for the exclusion criteria #1 of subjects with BOO was updated to be subjects 
who have ongoing symptoms of BOO or have a history of BOO, that is not well-controlled.
RATIONALE:
These statements were added to provide further clarification to the sites regarding exclusion 
of BOO.
3. Edited the exclusion criteria #4 for stress incontinence.
DESCRIPTION OF CHANGE:
Clarification for the exclusion criteria #4 of subjects with a history of stress incontinence 
may be included as long as they pass the cough provocation test.
RATIONALE:
This statement was added to provide further clarification to sites regarding exclusion of 
subjects with regards to stress incontinence.


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4. Updated urinary tract infection (UTI), urine cultures and sensitivity (exclusion criteria #6).
DESCRIPTION OF CHANGE:
Clarification of the determination of UTI and when urine cultures and sensitivity would be 
conducted.
RATIONALE:
Additional urinalysis criteria were necessary to trigger appropriate urine culture and 
sensitivity procedures.
5. Updated the definition of creatinine clearance (exclusion criteria #14).
DESCRIPTION OF CHANGE:
Clarified renal impairment is defined as estimated creatinine clearance (determined by 
Estimated Glomerular Filtration Rate [eGFR] or Cockroft-Gault or MDRD formulae) less 
than 29 mL/min.
RATIONALE:
These statements were added to provide further clarification to the sites that a 24-hour urine 
was not required to measure creatinine clearance.
6. Edited QTcF to QTc (exclusion criteria #16).
DESCRIPTION OF CHANGE:
Removed the requirement to use QTcF to calculate QT prolongation (exclusion criteria #16).
RATIONALE:
Local ECG machines are used for the study and most sites were unable to provide the 
correction factor used on their machines. Some use Bazetts, not all sites will utilize the QTc 
corrected by the Fredericia method.
7. Removed exclusion criteria for completion of all 3-day micturition diaries.
DESCRIPTION OF CHANGE:
Exclusion criteria 3. Subject did not complete all 3 days of the 3-day micturition diary.
RATIONALE:
Subjects will be asked to complete 3-day micturition diaries, but the completion of all 3 days 
as an inclusion criterion will no longer be be required. This will be consistent with other 
previous Astellas mirabegron clinical trials.
8. Updated Identification of Investigational Product(s)
DESCRIPTION OF CHANGE:
Manufacturing of test and placebo by Astellas Pharma Technologies, Inc. and packaging of 
aluminum blisters have been removed.
RATIONALE:
The information provided in the protocol is not correct- it had been carried over from another 
protocol. Astellas Pharma Technologies, Inc. is not manufacturing the test or placebo drugs. 


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In addition, the study product is only being provided in bottles and not with aluminum 
blisters. There is no change to the IP supply, just correction of the wording.
9. Updated Study Drug Handling
DESCRIPTION OF CHANGE:
The addition that any study drug handling procedures is authorized by Astellas.
RATIONALE:
This was an omission in the original protocol and provides additional clarification of the 
study drug handling.
10. Updated Prohibited Medications
DESCRIPTION OF CHANGE:
Current or previous use of mirabegron at any time was added to Prohibited Medication 
Appendix 1, part A.
RATIONALE:
Mirabegron was previously listed in Appendix A but adding the statement  provides further 
clarification to the sites that current or previous use of mirabegron at any time is prohibited.
11. Updated Section V. Table 1.
DESCRIPTION OF CHANGE:

Edited Baseline Visit Windows (Days)

Edited Visit Windows (Days) footnote

Added footnote for urine cultures and sensitivity

Added footnote for ultrasound or bladder scan measurement

Updated footnote to include measure of urine volume voided and sleep interruption will 
be recorded in the 3-day micturition diary.
RATIONALE:
These edits, additions and updates provide further clarification of study procedures that are 
elsewhere described in the protocol for the sites to provide easier scheduling, proper subject 
care, and necessary data collection. There is no change to the originally planned data 
collection.
12. Included measure of urine volume voided to be collected with the electronic diary.
DESCRIPTION OF CHANGE:
Table 1 Schedule of Assessments was updated to provide more specific information the 
ePRO device will record that in oversight left out of the original table. The addition included 
measure of urine volume voided and sleep interruption.
RATIONALE:
Addition of measure of urine volume voided is required to obtain data for the following 
secondary endpoint:

Change from baseline to the end of treatment in mean volume voided per micturition.


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13. Added subjects to be contacted 3 days prior to visit in Patient Diary Instructions.
DESCRIPTION OF CHANGE:
Clarification was included in the Patient Diary description to include the subject is to be 
contacted 3 days prior to the scheduled Visit to remind the subject to complete the electronic 
diary, review completion instruction and review changes to concomitant medications and 
adverse events (if applicable).
RATIONALE:
The exact wording is extracted from the footnote of Table 1 Schedule of Assessments. There 
was an oversight to include it in Section 5.3.1 Patient Diary – Micturition and Incontinence.
14. Updated definition of an adverse event of hypertension.
DESCRIPTION OF CHANGE:
The definition that an adverse event of hypertension was updated to include that hypertension 
criteria needs to be met on 2 or more separate/consecutive visits.
RATIONALE:
This statement was added to provide further clarification and to the sites make it consistent 
throughout the protocol that the criteria of hypertension needed to be on consecutive visits 
and not any 2 visits throughout the course of the study.
15. Addition of INR in Table 3 Laboratory Assessment.
DESCRIPTION OF CHANGE:
Addition of INR in Table 3 Laboratory Assessment under Chemistry for Visit 1 and Visit 6.
RATIONALE:
Omission of INR in Table 3 was overlooked. INR is being analyzed and is specified in 12.2 
Appendix 2: Liver Safety Monitoring and Assessment. It is already being collected and no 
increase in laboratory work is required.
16. Edited the positioning requirement for ECG measurement.
DESCRIPTION OF CHANGE:
Changed the positioning from sitting to either sitting or supine.
RATIONALE:
Subjects may not be able to be in the sitting position for an ECG due to anatomical or 
physical constraints. It is acceptable to have an ECG reading in either a sitting or supine 
position as long as the position is consistent throughout the study.


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II.  Amendment Summary of Changes:
Substantial Changes:
1. Addition of home based vital sign measurements.
III. List of Abbreviations and Key Terms, Page 11
ADDED:
HBPM   Home based blood pressure monitoring
PR    Pulse Rate
1. Addition of home based vital sign measurements.
IV. Synopsis, Exclusion Criteria assessed after placebo run-in period at Visit 3 
(Baseline), Page 18
3.3 Exclusion Criteria, Exclusion Criteria assess after placebo run-in period at Visit 3 
(Baseline), Page 38
ADDED:
3.
Subject has any systolic blood pressure measurement > 180 mmHg or 
diastolic blood pressure measurement > 110 in the 3-day diary or during the 
baseline visit.
1. Addition of home based vital sign measurements.
IV. Synopsis, Safety Variables, Page 20
ADDED:

Vital Signs: sitting systolic and diastolic blood pressure and pulse rate (home 
based measurements and office measurements
1. Addition of home based vital sign measurements.
IV. Synopsis, Analysis on Secondary Endpoints, Page 24
7.5.3 Vital Signs, Page 65
ADDED:

Vital sign data will be analyzed separately based on the 3-day diary and the 
site assessment at each clinic visit. Change from baseline in vital sign 
variables will be analyzed using the same ANCOVA model as described for 
the analysis of change from baseline in mean number of micturitions per 24 
hours. No p-values will be calculated.
1. Addition of home based vital sign measurements.
V. Flow Chart and Schedule of Assessments – Table 1 Schedule of Assessments –
Footnote, Page 26
WAS:
Visit
Day
Week
Visit Windows (Days) a




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home the full 3 days leading up to Visits 3, 4, 5 & 6. 
i.
Investigator, or designee, must review the subject’s diary with the subject to ensure completion 
compliance and discuss data captured.
IS AMENDED TO:
Visit
Day
Week
Visit Windows (Days) a
Informed Consent/HIPAA
Inclusion/Exclusion Criteria
Medical History and OAB History
Demographics
Enter 2-week Placebo Run-in b
Randomization  c
Physical Exam  (including height d and weight)
Vital Signs – in office (includes pulse and blood pressure)
Cough Provocation test (Females only)
Serum chemistry, hematology & urinalysis e
 
12-Lead ECG
Ultrasound or Bladder Scan (PVR)
Medication History and OAB Medication History
Clinical Assessment for Dose Increase 
Concomitant Medications Assessment
Adverse Event Assessment
Dispense Study Drug 
Drug Accountability
Instruct Subject on 3-day Micturition Diary g
Complete 3-day Micturition Diary including Vital Sign measurements and PPIUS h,i
OAB-q
Patient Perception of Bladder Condition Scores (PPBC) 
TS-VAS
Montreal Cognitive Assessment Test (MoCA)
Univ Alabama Birmingham Life Space Assessment (UAB -LSA)
Table continues on next page
Barthel ADL Assessment
Vulnerable Elders Survey 13 (VES-13)
Review Subject Diary j
a. Visits 1 and 2 are negatively scheduled from the Baseline (Visit 3) date. A subject has a 
combined timeframe of up to 38 days to complete both Visits 1 and 2; however, Baseline (Visit 
3) must occur at least 18 days but no more than 38 days after Visit 1 (Screening) and at least 11 
days but no more than 17 days after Visit 2 (Placebo Run-In). After Visit 2 (Placebo Run-In), 
visit windows/study days will be calculated based on the Visit 3 (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 deviation.
b. Subjects must take at least 11 days, but no more than 17 days of placebo run-in medication.




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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.
Three readings should be taken at every occasion, each about 2 minutes apart.
The subject should keep adequate records of the readings. Date, time, systolic and 
diastolic BP, and PR should 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.
An AE of tachycardia should be reported if the mean am or pm PR in the resting 
state from subject reported measurements at home over the last 3 days is >100 bpm.
1. Addition of home base vital sign measurements.
5.4.1 Vital Signs, Page 48
WAS:
An AE of hypertension will be recorded if one of the following criteria is met on >= 2 
separate/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 3) in 
subjects who were normotensive (average systolic blood pressure < 140 mmHg and 
average diastolic blood pressure < 90 mmHg [WHO-ISH, 2003]) at Baseline (Visit 
3).
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 3) in subjects with hypertension at Baseline (Visit 3).
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 tachycardia should be considered if resting heart frequency (pulse rate) is > 
100 bpm.
IS AMENDED TO:
An AE of hypertension will be recorded if one of the following criteria is met on > 2  or 
more separate/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 3) in 
subjects who were normotensive (average systolic blood pressure < 140 mmHg and 
average diastolic blood pressure < 90 mmHg [WHO-ISH, 2003]) at Baseline (Visit 
3).
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 3) in subjects with hypertension at Baseline (Visit 3).
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.


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An AE of “increased” Blood Pressure should be considered if the above conditions 
are not met, but a high blood pressure is recorded."
An AE of tachycardia should be considered if resting heart frequency (pulse rate) is 
> 100 bpm.
1. Addition of home based vital sign measurements.
7.5 Analysis of Safety, Page 63
WAS:
Safety analysis will be performed for adverse events (AEs) and vital signs using the SAF. 
No inferential comparison between treatment groups will be performed for the safety 
analysis in this study with the exception of the change from baseline in Montreal 
Cognitive Assessment Test (MoCA).
IS AMENDED TO:
Safety analysis will be performed for adverse events (AEs) and vital signs using the SAF. 
No inferential comparison between treatment groups will be performed for the safety 
analysis in this study with the exception of the change from baseline in Montreal 
Cognitive Assessment Test (MoCA) and for vital signs analysis.
1. Addition of home based vital sign measurements.
7.5 Analysis of Safety, Page 63
WAS:
Vital signs will be summarized by treatment group using descriptive statistics for baseline 
value, specific post-baseline time point values (Week 4, Week 8, Week 12/EOT), and 
change from baseline to each specified post-baseline time points.
IS AMENDED TO:
Vital signs will be summarized by treatment group and by Home Based Blood Pressure 
Monitoring (HBPM) versus office based using descriptive statistics for baseline value, 
specific post-baseline time point values (Week 4, Week 8, Week 12/EOT), and change 
from baseline to each specified post-baseline time points. Office based and morning 
and evening blood pressure will be reported separately. For HBPM the first reading 
from each time period will be discarded and the subsequent two readings for each 
time period will be averaged over the 3-day diary. HBPM and office based 
monitoring will be reported separately (See Appendix 4).
1. Addition of home based vital sign measurements. 
7.5.3 Vital Signs, Page 64
ADDED:
Details on the averaging of the multiple vital sign measurements are located in 
Appendix 4. Vital sign data will be analyzed separately based on the 3-day diary and 
the site assessment at each clinic visit. Change from baseline in vital sign variables 
will be analyzed using the same ANCOVA model as described for the analysis of 








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incontinence that is currently treated (e.g. remote history of surgery for stress 
incontinence may be included as long as they pass cough provocation test.
4. Updated urinary tract infection (UTI), urine cultures and sensitivity (exclusion 
criteria #6).
IV. Synopsis – Selection Criteria – Exclusion: Exclusion Criteria assessed at Visit 1 
(Screening)
Section 3.3 – Exclusion Criteria: Exclusion Criteria assessed at Visit 1 (Screening), Page 
37
WAS:
6. Subject has evidence of Urinary Tract Infection (UTI) (positive leukocyte esterase will 
be confirmed with a urine culture greater than 100,000 cfu/mL) as assessed at Screening 
(Visit 1). The subject can be rescreened after successful treatment of the UTI (confirmed 
by a laboratory result of negative urine culture).
IS AMENDED TO:
6. Subject has evidence of Urinary Tract Infection (UTI). (positive leukocyte esterase will 
be confirmed with a urine culture greater than 100,000 cfu/mL) as assessed at Screening 
(Visit 1).Urine culture and sensitivity will be performed for positive leukocytes, or 
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 can be rescreened after successful treatment of the UTI (confirmed by a 
laboratory result of negative urine culture). 
4. Updated urinary tract infection (UTI), urine cultures and sensitivity (exclusion 
criteria #6).
V. Flow Chart and Schedule of Assessments – Table 1 Schedule of Assessments –
footnote, Page 26
ADDED:
e. Urine cultures and sensitivity will be performed for positive leukocytes, or 
nitrites, or turbidity, or at the discretion of the PI. If a subject has a UTI, the subject 
can be rescreened after successful treatment of the UTI (confirmed by a laboratory 
result of negative urine culture).
4. Updated urinary tract infection (UTI), urine cultures and sensitivity (exclusion 
criteria #6).
5.4.4 Laboratory Assessments – Table 3 Laboratory Assessments footnote, Page 49
WAS:
*Urine culture will be done only for subjects with positive leukocyte esterase.
IS AMENDED TO:
*Urine culture will be done only for subjects with positive leukocyte esterase.and 
sensitivity will be done only for subjects performed for positive leukocytes, or nitrites, 
or turbidity, or at the discretion of the PI.


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5. Updated the definition of creatinine clearance (exclusion criter1a #14).
IV. Synopsis – Selection Criteria – Exclusion: Exclusion Criteria assessed at Visit 1 
(Screening)
Section 3.3 – Exclusion Criteria: Exclusion Criteria assessed at Visit 1 (Screening), Page 
38
WAS:
14. Subject has severe renal impairment defined as creatinine clearance less than 29 
mL/min. A subject with end stage renal disease or undergoing dialysis is also not a 
candidate for the study.
IS AMENDED TO:
14. Subject has severe renal impairment defined as estimated creatinine clearance less 
than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, 
Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or 
undergoing dialysis is also not a candidate for the study.
6. Edited QTcF to QTc (exclusion criteria #16).
IV. Synopsis – Selection Criteria – Exclusion: Exclusion Criteria assessed at Visit 1 
(Screening)
Section 3.3 – Exclusion Criteria: Exclusion Criteria assessed at Visit 1 (Screening), Page 
38
WAS:
16. Subject has evidence of QT prolongation on ECG defined at QTcF greater than 450 
msec for males, QTcF greater than 470 msec for females or known history of QT 
prolongation.
IS AMENDED TO:
16. Subject has evidence of QT prolongation on ECG defined as QTcF greater than 450 
msec for males, QTcF interval greater than 470 msec for females or a known history of 
QT prolongation.
6. Edited QTcF to QTc (exclusion criteria #16).
7.5.5 Electrocardiograms (ECG), Page 64
WAS:
ECG variable (heart rate, PR interval, RR interval, QRS interval, QT interval and QTcF
interval) will be summarized using frequency tables and percentages for each treatment 
group at Baseline, Week 4, Week 8, and Week 12/End of Treatment, including changes 
from baseline to end of treatment.
IS AMENDED TO:
ECG variable (heart rate, PR interval, RR interval, QRS interval, QT interval and QTcF
interval) will be summarized using frequency tables and percentages for each treatment 
group at Baseline, Week 4, Week 8, and Week 12/End of Treatment, including changes 
from baseline to end of treatment.


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7. Removed exclusion criteria for completion of all 3-day micturition diaries.
IV. Synopsis – Selection Criteria – Exclusion: Exclusion Criteria assessed after placebo 
run-in period at Visit 3 (Baseline)
Section 3.3 – Exclusion Criteria: Exclusion Criteria assessed after placebo run-in period 
at Visit 3 (Baseline), Page 38
DELETED:
3. Subject did not complete all 3 days of the 3 day micturition diary.
8. Updated Identification of Investigational Product(s)
4.1.1 Test Drug, Paragraph 4, Page 39
DELETED:
The clinical trial material of mirabegron OCAS tablets have been manufactured for 
Astellas by Astellas Pharma Technologies, Inc.
8. Updated Identification of Investigational Product(s)
4.1.2 Placebo, Paragraph 2, Page 39
DELETED:
The PTM mirabegron OCAS tablets have been manufactured for Astellas by Astellas 
Pharma Technologies, Inc.
8. Updated Identification of Investigational Products(s)
4.1.2 Placebo, Paragraph 3, Page 39
WAS:
The mirabegron PTM tablets are package in a 30 cc round wide mouth white HDPE 
bottles sealed with white child resistant polypropylene caps. Each bottle contains 30 
tablets. Both the aluminum blisters and HDPE bottles must be stored at room 
temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
IS AMENDED TO:
The mirabegron PTM tablets are package in a 30 cc round wide mouth white HDPE 
bottles sealed with white child resistant polypropylene caps. Each bottle contains 30 
tablets. Both the aluminum blisters and The HDPE bottles must be stored at room 
temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
9. Updated Study Drug Handling
4.3 Study Drug Handling, Paragraph 1, Bullet 4, Page 40
WAS:

that any unused study drug is returned to the Sponsor or standard procedures for the 
alternative disposition of unused study drug are followed.
IS AMENDED TO:

that any unused study drug is returned to the Sponsor or standard procedures for the 
alternative disposition of unused study drug are followed and authorized by 


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Astellas.
10. Updated Prohibited Medications
IV. Synopsis – Concomitant Medication – Prohibited Medications (Appendix 1, part A)
5.1.2.2 Concomitant Medications (Drugs and Therapies) – Prohibited Medications, Page 
43
12.1 Appendix 1: List of Prohibited and Restricted Medications, Page 75
ADDED:
Current or previous use of mirabegron at any time is prohibited.
11. Updated Section V. Table 1.
V. Flow Chart and Schedule of Assessments – Table 1 Schedule of Assessments –
Footnote, Page 26
WAS:
Visit
Day
Week
Visit Windows (Days) a
Informed Consent/HIPAA
Inclusion/Exclusion Criteria
Medical History and OAB History
Demographics
Enter 2-week Placebo Run-in b
Randomization  c
Physical Exam  (including height d and weight)
Vital Signs (includes pulse and blood pressure)
Cough Provocation test (Females only)
Serum chemistry, hematology & urinalysis
 
12-Lead ECG
Ultrasound or Bladder Scan (PVR)
Medication History and OAB Medication History
Clinical Assessment for Dose Increase 
Concomitant Medications Assessment
Adverse Event Assessment
Dispense Study Drug 
Drug Accountability
Instruct Subject on 3-day Micturition Diary f
Complete 3-day Micturition Diary including PPIUS g
OAB-q
Patient Perception of Bladder Condition Scores (PPBC) 
TS-VAS
Montreal Cognitive Assessment Test (MoCA)
Univ Alabama Birmingham Life Space Assessment (UAB -LSA)
Table continues on next page
Barthel ADL Assessment






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(electronic diary) that will be used to record the date and time of each of their 
micturitions, incontinence, and urgency episodes (micturition diary). Additionally, the 
diary will be used to record medication intake. Training on device use must be done at 
Visit 2 (Placebo Run-In) and as necessary throughout the study. Subjects will be 
instructed to begin completing the electronic micturition diary 3 days prior to each in-
office study visit including Visits 3-6 (Treatment Period) and complete the diary for the 
full 3 days.
IS AMENDED TO:
g. At Visit 2 (Placebo Run-In), all subjects will be provided with an ePRO device 
(electronic diary) that will be used to record the date and time of each of their 
micturitions, incontinence, urgency episodes, measure of urine volume voided, and 
sleep interruption (micturition diary). Additionally, the diary will be used to record 
medication intake. Training on device use must be done at Visit 2 (Placebo Run-In) and 
as necessary throughout the study. Subjects will be instructed to begin completing the 
electronic micturition diary 3 days prior to each in-office study visit including Visits 3-6 
(Treatment Period) and complete the diary for the full 3 days.
12. Included measure of urine volume voided to be collected with electronic diary.
5.3.1 Patient Diary – Micturition and Incontinence, Paragraph 3, Page 44
WAS:
A diary day starts at midnight and ends at midnight the following day. Time to bed with 
intention to sleep, time to awake with intention of staying awake, type of episode 
(urinary/incontinence), time of episode, urgency severity (see Section 5.3.4) and sleep 
interruption will be recorded by the subject in the micturition diary.
IS AMENDED TO:
A diary day starts at midnight and ends at midnight the following day. Time to bed with 
intention to sleep, time to awake with intention of staying awake, type of episode 
(urinary/incontinence), time of episode, urgency severity (see Section 5.3.4), measure of 
urine volume voided and sleep interruption will be recorded by the subject in the 
micturition diary.
13. Added subjects to be contacted 3 days prior to visit in Patient Diary Instructions.
5.3.1 Patient Diary – Micturition and Incontinence, Paragraph 2, Page 44
ADDED:
During this activity, the subject will not come to the clinic for a visit. Site staff will 
contact the subject 3 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).
14. Updated definition of an adverse event of hypertension.
5.4.1 Vital Signs – Paragraph 3, Page 47
WAS:


Sponsor APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1005
- CONFIDENTIAL -
10 Sep 2015
Astellas
Page 103 of 105
Version 3.0 Incorporating Substantial Amendment 2
An AE of hypertension will be recorded if one of the following criteria is met on >2 
separate visits:
IS AMENDED TO:
An AE of hypertension will be recorded if one of the following criteria is met on 2 
separate, consecutive visits:
15. Addition of INR in Table 3 Laboratory Assessment.
5.4.4 Laboratory Assessments – Table 3 Laboratory Assessments, Page 49
WAS:
Table 5
Laboratory Assessments
Screening (Visit 1)
Week 12/End of Treatment (Visit 
6)
Hematology
CBC
Hemoglobin
Hematocrit
Screening (Visit 1)
Week 12/End of Treatment (Visit 
6)
Chemistry
Sodium
Potassium
Calcium
Chloride
Glucose
Creatinine
Alkaline phosphatase
AST
ALT
GGT
Total bilirubin
Total protein
Albumin
Screening (Visit 1)
Week 12/End of Treatment (Visit 
6)
Urinalysis 
Protein
Glucose
pH
Blood
Urine Culture *
* Urine culture will be done only for subjects with positive leukocyte esterase.
IS AMENDED TO:
Table 6
Laboratory Assessments
Screening (Visit 1)
Week 12/End of Treatment (Visit 
6)
Hematology
CBC
Hemoglobin
Hematocrit
Screening (Visit 1)
Week 12/End of Treatment (Visit 
6)
Chemistry
Sodium
Potassium
Calcium
Chloride
Glucose
Creatinine
Alkaline phosphatase
AST


Sponsor APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1005
- CONFIDENTIAL -
10 Sep 2015
Astellas
Page 104 of 105
Version 3.0 Incorporating Substantial Amendment 2
ALT
GGT
Total bilirubin
Total protein
Albumin
INR
Screening (Visit 1)
Week 12/End of Treatment (Visit 
6)
Urinalysis 
Protein
Glucose
pH
Blood
Urine Culture *
*Urine culture will be done only for subjects with positive leukocyte esterase.and sensitivity will be done 
only for subjects performed for positive leukocytes, or nitrites, or turbidity, or at the discretion of the 
PI.
16. Edited the positioning requirement for ECG measurement.
5.4.6 Electrocardiogram (ECG), Paragraph 1, Page 49
WAS:
A 12-lead ECG will be recorded at Screening (Visit 1), the placebo run-in (Visit 2), 
Baseline (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12/End of Treatment 
9Visit 6). ECGs will be taken with the subject in the sitting position.
IS AMENDED TO:
A 12-lead ECG will be recorded at Screening (Visit 1), the Placebo Run-In (Visit 2), 
Baseline (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), Week 12/End of Treatment (Visit 
6). ECGs will be taken with the subject in the sitting position. ECGs will be taken with 
the subject in the sitting or supine position. The patient’s sitting or supine position 
for the ECG should be consistent throughout the course of the study.


Sponsor APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1005
- CONFIDENTIAL -
10 Sep 2015
Astellas
Page 105 of 105
Version 3.0 Incorporating Substantial Amendment 2
14
ATTACHMENT 2:  SPONSOR’S SIGNATURES



SAP_001.pdf: 
A Phase 4, Double-Blind, Randomized, Placebo-
Controlled, Parallel Group, Multi-Center Study to 
Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Older Adult Subjects with Overactive 
Bladder (OAB)
ISN/Protocol 178-MA-1005
ClinicalTrials.gov Identifier: NCT02216214
Date of Statistical Analysis Plan: Sep 2017
Sponsor: Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062


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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
  
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ŚƌŽŶŝĐ ŚĞƉĂƚŝƚŝƐ
'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
  
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ůĂŶŝŶĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
ŵŵŽŶŝĂ ĂďŶŽƌŵĂů
ŵŵŽŶŝĂ ŝŶĐƌĞĂƐĞĚ
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
  
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<ĂǇƐĞƌͲ&ůĞŝƐĐŚĞƌ ƌŝŶŐ
>ŝǀĞƌ ĨƵŶĐƚŝŽŶ ƚĞƐƚ ĂďŶŽƌŵĂů
>ŝǀĞƌ ŝŶĚƵƌĂƚŝŽŶ
>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
  
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ůŽŽĚ ƚŚƌŽŵďŽƉůĂƐƚŝŶ ĚĞĐƌĞĂƐĞĚ
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ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ /y ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ /y ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
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ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ y ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ y ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
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/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
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ůĐŽŚŽůŝĐ ůŝǀĞƌ ĚŝƐĞĂƐĞ
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