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Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER (RANGER)

Primary Purpose

Pulmonary Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bardoxolone methyl
Sponsored by
Reata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Arterial Hypertension, Pulmonary Hypertension, PH, PAH, Bardoxolone methyl, 6-minute walk distance, CDDO-ME, RTA 402, LARIAT, CATALYST, RANGER

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl

Exclusion Criteria:

  • Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication;
  • Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
  • Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug;
  • Women who are pregnant or breastfeeding;
  • Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
  • Known hypersensitivity to any component of the study drug

Sites / Locations

  • Banner University Medical Center, Phoenix Advanced Lung Disease Institute
  • Arizona Pulmonary Specialists
  • Cedars Sinai Medical Center
  • University of California San Diego
  • VA Healthcare System of Greater Los Angeles
  • David Geffen School of Medicine UCLA
  • University of California Davis Medical Center - Division of Pulmonary and Critical Care
  • Harbor - UCLA Medical Center
  • University of Colorado Denver - Division of Pulmonary Sciences
  • Georgetown University Medical Center - Department of Rheumatology
  • University of Miami Miller School of Medicine
  • Cleveland Clinic of Florida
  • Augusta University
  • Piedmont-Georgia Lung
  • Northwestern Memorial Hospital
  • University of Illinois at Chicago
  • University of Chicago
  • Kentuckiana Pulmonary Associates
  • Maine Medical Center - Division of Pulmonary and Critical Care Medicine
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Boston University School of Medicine
  • University of Michigan
  • Washington University School of Medicine
  • University of New Mexico Health Sciences Center
  • Winthrop University Hospital
  • NYU Langone Medical Center
  • University of Rochester - University of Rochester Medical Center
  • Duke University Medical Center
  • The Lindner Clinical Trial Center
  • University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
  • Cleveland Clinic
  • The Ohio State University Wexner Medical Center
  • Oklahoma Heart Hospital
  • Oregon Health & Science University
  • University of Pennsylvania
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • University of Texas Southwestern Medical Center
  • The Methodist Hospital Research Institute
  • The University of Texas - Health Science Center & Medical School at Houston
  • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
  • University of Utah
  • Aurora Health Care
  • Centro Médico Dra de Salvo
  • Instituto de Investigaciones Clínicas Mar Del Plata
  • Hospital Privado Centro Médico de Córdoba
  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral
  • Instituto Cardiovascular de Rosario
  • Hospital Provincial Dr Jose Maria Cullen
  • St Vincent's Hospital Sydney
  • John Hunter Hospital
  • Princess Alexandra Hospital
  • Royal Hobart Hospital
  • UZ Leuven
  • Hospital Erasme
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre
  • Hospital Dia do Pulmão
  • Instituto do Coração - HCFMUSP
  • Peter Lougheed Centre
  • Vancouver General Hospital
  • London Health Sciences Centre
  • Centre Hospitalier de l'Université Laval
  • Vseobecna fakultni nemocnice v Praze
  • Institut klinicke a experimentalni mediciny
  • Universitatsklinkum Carl Gustav Carus an der Tu
  • Universitatsklinikum Hamburg Eppendorf
  • Thorax Klinik
  • Hadassah University Hospital Ein Kerem
  • Rabin Medical Center
  • Nippon Medical School Hospital
  • Kobe University Hospital
  • Kitasato University Hospital
  • Kyorin University Hospital
  • National Hospital Organization Okayama Medical Center
  • Chiba University Hospital
  • Hokkaido University Hospital
  • Kurume University Medical Center
  • National Cerebral and Cardiovascular Center
  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Unidad de Investigación Clínica En Medicina SC
  • Vrije Universiteit Amsterdam
  • Philippine Heart Center
  • Makati Medical Center
  • Philippine General Hospital (PGH)
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro
  • Hospital Virgen de La Salud
  • Golden Jubilee National Hospital
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bardoxolone methyl 10 mg

Arm Description

Bardoxolone methyl will be administered orally once daily at 10 mg until it becomes commercially available. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

Outcomes

Primary Outcome Measures

Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2017
Last Updated
October 10, 2023
Sponsor
Reata Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03068130
Brief Title
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Acronym
RANGER
Official Title
An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The company determined that continued exposure of these high-risk PH patients to clinic or in-person visits during the COVID pandemic presented an unacceptable risk.
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reata Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Detailed Description
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl. Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Arterial Hypertension, Pulmonary Hypertension, PH, PAH, Bardoxolone methyl, 6-minute walk distance, CDDO-ME, RTA 402, LARIAT, CATALYST, RANGER

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bardoxolone methyl 10 mg
Arm Type
Experimental
Arm Description
Bardoxolone methyl will be administered orally once daily at 10 mg until it becomes commercially available. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.
Intervention Type
Drug
Intervention Name(s)
Bardoxolone methyl
Other Intervention Name(s)
RTA 402
Intervention Description
Capsules of Bardoxolone methyl
Primary Outcome Measure Information:
Title
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
Description
Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities.
Time Frame
From time of first dose until the final visit, up to 172 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl Exclusion Criteria: Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication; Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl; Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug; Women who are pregnant or breastfeeding; Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason; Known hypersensitivity to any component of the study drug
Facility Information:
Facility Name
Banner University Medical Center, Phoenix Advanced Lung Disease Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Arizona Pulmonary Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
VA Healthcare System of Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
David Geffen School of Medicine UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis Medical Center - Division of Pulmonary and Critical Care
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Harbor - UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Denver - Division of Pulmonary Sciences
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Medical Center - Department of Rheumatology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cleveland Clinic of Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Piedmont-Georgia Lung
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maine Medical Center - Division of Pulmonary and Critical Care Medicine
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester - University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas - Health Science Center & Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Centro Médico Dra de Salvo
City
Buenos Aires
State/Province
Ciudad Autónoma De BuenosAires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Mar Del Plata
City
Buenos Aires
State/Province
Mar Del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Hospital Privado Centro Médico de Córdoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Instituto Cardiovascular de Rosario
City
Rosario
ZIP/Postal Code
S2000DSR
Country
Argentina
Facility Name
Hospital Provincial Dr Jose Maria Cullen
City
Santa Fe
ZIP/Postal Code
S3000EPV
Country
Argentina
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Irmandade Da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Hospital Dia do Pulmão
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-000
Country
Brazil
Facility Name
Instituto do Coração - HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Centre Hospitalier de l'Université Laval
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Prague
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Institut klinicke a experimentalni mediciny
City
Prague
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Universitatsklinkum Carl Gustav Carus an der Tu
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Thorax Klinik
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Nippon Medical School Hospital
City
Tokyo
State/Province
Bunkyo-ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo
State/Province
Mitaka-shi
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Kurume University Medical Center
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
ZIP/Postal Code
5658565
Country
Japan
Facility Name
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Nuevo León
State/Province
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Unidad de Investigación Clínica En Medicina SC
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Vrije Universiteit Amsterdam
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Philippine Heart Center
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Makati Medical Center
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Philippine General Hospital (PGH)
City
Manila
Country
Philippines
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
Country
Spain
Facility Name
Hospital Virgen de La Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4HX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

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