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  • Clinical Expertise with Cardiovascular Drugs

Clinical Expertise with Cardiovascular Drugs

Clinical Expertise with Cardiovascular Drugs

by IHC research / Thursday, 20 February 2014 / Published in History of Expertise

… And The Disorders They Treat

IHC has had extensive experience and expertise designing, conducting and analyzing drugs used in the treatment of various cardiovascular disorders.  We have presented below some details of the studies we conducted and managed with the goal to show the complexity of these programs and through the success of these studies our competency and breadth of expertise.Examples are:

  • Anticoagulants/antiplatelets – International HealthCare has managed a number of clinical programs evaluating several drugs in this category.  One large clinical program assessed patients undergoing percutaneous coronary intervention, and in patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI.

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Further details of these studies will provide you with the scope of our experience and the breadth of our capabilities:

  • One program was conducted to evaluate the ability of the drug to reduce clinical events following PCI.  IHC managed this entire program of over 6600 patients in over 200 cardiovascular centers in the US and several European and Middle East countries;
  • Another very large study to determine the ability of the drug to reduce major bleeding compared to heparin + glycoprotein (GP) IIb/IIIa inhibitors, was conducted in over 13,000 patients and over 350 cardiovascular centers in the US alone.  IHC participated in the design of the protocol and monitored this successful study.
  • Another study designed to assess the effect on platelet count compared to baseline and the change in renal function from baseline as measured by change in serum creatinine
  • A study to assess the safety of replacing heparin with an anticoagulant in patients undergoing percutaneous peripheral (non-cardiac) interventional procedures
  • Adding to the breadth of our experience and expertise we successfully completed on-time and within budget constraints an entire CABG (Coronary Artery Bypass Grafting) program. The anticoagulant program consisted of several trials evaluating several drugs including Heparin in Off-Pump/On-Pump/All Comers/HITs study arms.
    • A Phase III Study in patients with HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
    • Another Phase III Study in Patients with Heparin-Induced Thrombocytopenia Type II (HIT) and Heparin-Induced Thrombocytopenia Thrombosis Syndrome (HITTS) Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
    • An open-label, prospective, multicenter, single-arm study using an historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the previous 12 months
    • Another significant study was conducted to evaluate an anticoagulant to heparin plus protamine in patients undergoing CABG or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery).  This study was designed to assess a number of important aspects of treating patients undergoing these procedures.  In this study we evaluated the test product’s capability by assessing whether the test drugs were comparable in the number of in-hospital acute procedures, such as:
      • Repeat operation for coronary revascularization or catheterization
      • The incidence and number of transfusions,
      • The incidence of hemorrhage necessitating repeat exploratory operation,
      • The incidence of other major bleeding events, defined as intracranial, intraocular, retroperitoneal, gastro-intestinal, and other major hemorrhage and other new thromboembolic events;
      • Assessment of the Bleeding Index to account for the impact of transfusion in the calculation of hemoglobin drops

 

Although we focused on our extensive experience with antiplatelets drugs, this knowledge and capability of working with the largest, well-known and respected research institutions in the US and throughout the world provides us with the most important attribute in a successful study – picking the right Institution, Investigator and Study Coordinator that will complete your study on-time and within budget.  We add to this capability by delivering the most experienced Project Managers and importantly well-experienced CRAs who have long-term expertise monitoring cardiovascular studies.  Whether it is a large antiplatelets study in patients undergoing a PCI or the evaluation of a vasoactive drug that reduces blood flow in the splanchnic area, and thereby lowering portal blood pressure and thereby assisting the liver in its clearance of toxins, our experience in this area is very extensive.

The ability to successfully Conduct, Manage and Complete a clinical program is, in part (a very significant part), due to the studies the CRO (IHC) has conducted, as well as, the experience and relationship the CRAs have with the leading cardiovascular centers throughout the US.  Towards this end, we have listed (~300 Cardiovascular centers) with which we have conducted studies.  Our staff and project managers have a good working relationship with these Institutions, and specifically the Investigators, Study Coordinators, IRBs and their Legal contract group.  All of these contacts play an important role assuring your clinical studies will start on time, have more complete and accurate data with fewer queries, achieve good enrollment and complete the study on time.

We also have experience facilitating the creation and management of DSMBs and CEC Committees that serve to identify potential issues before they become major problems.

It is important to note that – of all the centers in the US that conduct cardiovascular research – IHC has had direct clinical monitoring experience with those institutions that account for over 70% of all patients that participated in Cardiovascular research in the US.

 

IHC Experience with the following Cardiovascular Centers:



Site Name

City

State

Russell Medical Center

Alexander City

AL

University of Alabama at Birmingham

Birmingham

AL

The Heart Center, PC –   Oracle Research

Huntsville

AL

Sparks Regional Medical Center

Fort Smith

AR

Cardiology Associates of NEA

Jonesboro

AR

Arkansas Heart Hospital

Little Rock

AR

Cardiology & Medicine Clinic, P.A.

Little Rock

AR

Central Arkansas Veterans Healthcare System (John L. McClellan Memorial VA Hospital)

Little Rock

AR

University of Arkansas For Medical Science

Little Rock

AR

Advanced Cardiac Specialists/Mesa General Hospital

Apache Junction

AZ

Chandler Regional Hospital

Chandler

AZ

Desert Banner Medical Center

Mesa

AZ

Arizona Heart Hospital

Phoenix

AZ

Good Samaritan

Phoenix

AZ

Good Samaritan Regional Medical Center/Banner Health Research Inst

Phoenix

AZ

Mayo Clinic Hospital and Medical Ctr

Phoenix

AZ

Scottsdale Health Care – Shea

Scottsdale

AZ

Scottsdale-Osborn

Scottsdale

AZ

Central Cardiology

Bakersfield

CA

Providence St. Joseph’s Medical Ctr

Burbank

CA

Bay Area Cardiology Medical Group

Concord

CA

Escondido Cardiology Associates Inc

Escondido

CA

Washington Hospital

Fremont

CA

St. Agnes Medical Center

Fresno

CA

Glendale Adventist Hospital/Heart & Vascular Institute

Glendale

CA

Scripps Hospital – will be UIC Cardiology

La Jolla

CA

Marin General Hospital

Larkspur

CA

Loma Linda University Medical Center

Loma Linda

CA

Long Beach Memorial Medical Center Heart & Vascular Institute

Long Beach

CA

West Los Angeles VA

Los Angeles

CA

Providence Holy Cross Medical Center

Mission Hills

CA

Memorial Medical Center

Modesto

CA

Northridge Hospital Medical Center

Northridge

CA

Cardiology Associates Medical Group

Oxnard

CA

Eisenhower Medical Center

Rancho Mirage

CA

Sequoia Hospital

Redwood City

CA

Mercy Heart Institute

Sacramento

CA

San Bernardino Hospital

San Bernadino

CA

Scripps Mercy Hospital

San Diego

CA

Sharp Memorial Hospital/Sharp, Reese, Stealy Medical Group

San Diego

CA

UCSD Medical Center

San Diego

CA

VA San Diego Health Care System

San Diego

CA

California Pacific Medical Center

San Francisco

CA

Western Medical CenterSanta Ana

Santa Ana

CA

Cottage Hospital

Santa Barbara

CA

Kaiser Permanente

Santa Cruz

CA

St. Joseph’s Medical Center

Stockton

CA

Harbor-UCLA Medical Center

Torrance

CA

St. Lukes Cardiovascular Medical Gp

Windomar

CA

University of Southern California Division of Cardiovascular Medicine

Los Angeles

CA

St. Anthony Central Hospital/Centura Health Research Center

Denver

CO

South Denver Cardiology Associates PC, Swedish Medical Center.

Littleton

CO

St. Vincent’s Medical Center

Bridgeport

CT

University of Connecticut Health Ctr

Farmington

CT

Hospital of St. Raphael

New Haven

CT

Yale University

New Haven

CT

WHC

Washington

DC

Christiana Care Hospital

Newark

DE

Bay Pines VAMC

Bay Pines

FL

St. Luke’s Heart Institute

Brooksville

FL

Clearwater Cardiovascular Consultants

Clearwater

FL

North Ridge Medical Center

Fort Lauderdale

FL

Cardiovascular Center at Shands UF

Gainesville

FL

Memorial Regional Hospital

Hollywood

FL

Pasco Cardiology Center

Hudson

FL

Baker & Gilmour Cardiovascular Inst

Jacksonville

FL

Watson Clinic Center for Research

Lakeland

FL

Florida Medical Center

Lauderdale Lakes

FL

Princeton Research Associates, Inc.

Lauderdale Lakes

FL

Holmes Regional Medical Center

Melbourne

FL

Brevard Cardiology Physicians, PA

Merritt Island

FL

Baptist Cardiac and Vascular Institute/Baptist Hospital of Miami

Miami

FL

Cedars Medical Center

Miami

FL

Jackson Memorial Hospital

Miami

FL

Mercy Hospital

Miami

FL

Miami Research & Education Foundation, Baptist Hosp

Miami

FL

Miami International Cardiology Consultants/Miami Heart Institute

Miami Beach

FL

MediQuest Research group, Inc.

Ocala

FL

Florida Hospital

Orlando

FL

Palm Beach Gardens Medical Center/Palm Beach Cardiology

Palm Beach Gardens

FL

Sacred Heart Hospital of Pensacola Fl

Pensacola

FL

All Children’s Hospital

St. Petersburg

FL

Tallahassee Research Institute

Tallahassee

FL

University Community Hospital

Tampa

FL

James A. Haley VA Hospital

Tampa

FL

Leesburg Regional/Florida Waterman Hospital

Tavares

FL

Crawford Long Hospital

Atlanta

GA

Emory University at Grady Health System

Atlanta

GA

Emory University Hospital

Atlanta

GA

Piedmont Medical Center- Fuqua Heart Center of Atlanta

Atlanta

GA

The Atlanta Heart and Vascular Research Group

Atlanta

GA

Southeast Georgia Health System- Brunswick GA

Brunswick

GA

Northeast Georgia Heart Center, PC

Gainesville

GA

Mercer University School of Medicine

Macon

GA

Harbin Clinic

Rome

GA

St. Joseph’s Candler Health System

Savannah

GA

Kaiser Permanente Medical Center Hawaii

Honolulu

HI

Mary Greeley Medical Center/ McFarland Clinic

Ames

IA

 Genesis Medical Center

Davenport

IA

Iowa Heart Center

Des Moines

IA

University of Iowa Hospitals and Clinics

Iowa City

IA

St. Luke’s Medical Center

Boise

ID

Heart Care Research Foundation

Blue Island

IL

Macpheal Hospital

Blue Island

IL

John H. Stroger Jr. Hospital of Cook County

Chicago

IL

Mercy Hospital & Medical Center

Chicago

IL

Northwestern Memorial Hospital

Chicago

IL

Rush-Presbyterian-St. Luke Medical Center

Chicago

IL

Swedish Covenant Hospital

Chicago

IL

University of Illinois at Chicago

Chicago

IL

Alexian Brothers Medical Center

Elk Grove Village

IL

St. Francis Hospital

Evanston

IL

St. Alexias Medical Center

Hoffman Estate

IL

Provena St. Joseph Medical Center

Joliet

IL

West Suburban Cardiologists

LaGrange

IL

Gottilieb Hospital

Melrose Park

IL

St. Francis Medical Center

Peoria

IL

Midwest Heart Specialists- Cardiology

Rockford

IL

Prairie Education and Research Cooperative, Memorial Medical

Springfield

IL

Prairie Education and Research Cooperative, St. John’s

Springfield

IL

DuPage Medical Group

Winfield

IL

Indiana Heart Hospital (Community hospitals of Indianapolis)

Indianapolis

IN

Krannert Institute of Cardiology

Indianapolis

IN

Methodist Hospital/Clarian Health Partners

Indianapolis

IN

St. Vincent Hospital, Indianapolis

Indianapolis

IN

Heart Center of Indiana

Indianapolis,

IN

St. Mary Medical Center

Merrillville

IN

The Methodist Hospital/Cardiovascular Clinic, PC

Merrillville

IN

Community Hospital

Munster

IN

Midwest Medical Group

South Bend

IN

Olathe Medical Center/Cardiology Services

Olathe

KS

Shawnee Mission Medical Center

Shawnee Mission

KS

Kansas Heart Hospital

Wichita

KS

Kings Daughters Hospital/Cumberland Cardiology

Ashland

KY

Central Cardiology Associates/ Hardin Memorial Hospital

Elizabethtown

KY

Central Baptist Hospital

Lexington

KY

University of Kentucky/Gill Heart Inst.

Lexington

KY

Louisville Cardiology Medical Group, PSC

Louisville

KY

University of Louisville Cardiology

Louisville

KY

Alexandria Cardiology Clinic

Alexandria

LA

Lake Charles Medical & Surgical

Lake Charles

LA

Medical Center of Louisiana in NO

New Orleans

LA

Ochsner Clinic Foundation

New Orleans

LA

Tulane University Affiliated Hospitals

New Orleans

LA

VA Medical Center of New Orleans

New Orleans

LA

Louisiana State University Health Sciences Center- Shreveport

Shreveport

LA

Overton Brooks VA Medical Center

Shreveport

LA

Cardiovascular Consultants, LLP- Willis Knighton – North Medical Ctr

Shreveport

LA

Beth Israel Deaconess Medical Ctr

Boston

MA

St. Elizabeth’s Medical Center of Boston

Boston

MA

Falmouth Hospital

Falmouth

MA

Cape Cod Research Institute

Hyannis

MA

Baystate M.C.

Springfield

MA

St. Vincent Hopsital @ Worcester Medical Center

Worcester

MA

Good Samaritan Hospital

Baltimore

MD

Johns Hopkins School of Medicine

Baltimore

MD

University Of Maryland

Baltimore

MD

Shady Grove Hospital

Rockville

MD

Delmarva heart Research Foundation

Salisbury

MD

Washington Adventist Hospital

Takoma Park

MD

Eastern Maine Med

Bangor

ME

Central Maine Medical Center / Central Maine Heart and Vascular Institute

Lewiston

ME

Maine Medical Center

Portland

ME

University Of Michigan Medical Ctr

Ann Arbor

MI

Sinai-Grace Hospital

Detroit

MI

Borgess Research Institute

Kalamazoo

MI

Sparrow Edward Hospital

Lansing

MI

Thoracic & Cardiovascular Healthcare Foundation

Lansing

MI

Covenant Medical Center

Saginaw

MI

Providence Hospital

Southfield

MI

Michigan Heart PC

Ypsilanti

MI

Metropolitan Cardiology Consulting

Coon Rapids

MN

St. Mary’s Medical Center, Duluth Clinic

Duluth

MN

Abbott Northwestern Hospital/ Minneapolis Heart Inst Foundation

Minneapolis

MN

Veterans Affairs Medical Center

Minneapolis

MN

Central Minnesota Heart Center

St. Cloud

MN

John Nasseff Heart/St. Paul Heart Clinic

St. Paul

MN

Regions Hospital

St. Paul

MN

University of Missouri Hospital, The Curators of the Univ. of Columbia

Columbia

MO

St. John’s Regional Medical Center

Joplin

MO

St. Luke’s Hospital/ Mid America Heart Institute

Kansas City

MO

St. John’s Hospital

Springfield

MO

St. Joseph Health Center

St. Charles

MO

Heartland Regional Medical Center

St. Joseph

MO

St. Louis University Health System

St. Louis

MO

New Coast Cardiology Center

Golf Port

MS

Forrest General Hospital/Southern Heart Center

Hattiesburg

MS

Cardiology Associates of North Mississippi

Tupelo

MS

Mission St. Joseph Hospital (Asheville Cardiology)

Asheville

NC

The University of North Carolina at Chapel Hill

Chapel Hill

NC

Carolinas Heart Institute, Sanger Clinic

Charlotte

NC

Mid Carolina Cardiology

Charlotte

NC

LeBauer CV Research Foundation

Greensboro

NC

Carolina Cardiology Associates

High Point

NC

WakeMed

Raleigh

NC

Forsyth Medical Center

Winston-Salem

NC

Wake Forest University

Winston-Salem

NC

Dakota Clinic, Innovis Health

Fargo

ND

Trinity Hospitals

Minot

ND

Bryan LGH Heart Institute

Lincoln

NE

University of Nebraska Medical Center

Omaha

Ne

Nebraska Heart Institute

Papillion

NE

Exeter Hospital

Exeter

NH

Dartmouth Cardiology

Lebanon

NH

Belle Mead

NJ

Cooper University Hospital

Camden

NJ

St. Michael’s Medical Center

Newark

NJ

St. Joseph’s Regional Medical Center

Paterson

NJ

New Mexico Heart Institute

Albuquerque

NM

Sunrise Hospital Cardiovascular Consultants of Nevada

Las Vegas

NV

Montefiore Medical Center

Bronx

NY

Buffalo Heart Group

Buffalo

NY

Arnot Odgen Medical Center

Elmira

NY

United Health Services Hospital, Inc.

Johnson City

NY

Winthrop University Hosp

Mineola

NY

Bellevue Hospital

New York

NY

Cardiovascular Research Foundation

New York

NY

Lenox Hill Hospital

New York

NY

Mt Sinai Medical Center

New York

NY

New York Presbyterian Hospital, Weill Medical College of Cornell

New York

NY

New York University Medical Center

New York

NY

NYU – Downtown Hospital

New York

NY

Roosevelt Center

New York

NY

St. Lukes Hospital

New York

NY

St. Vincent Catholic Medical Centers

New York

NY

Community Cardiology Associates

Pittsford

NY

Valley Hospital

Pomona

NY

Hudson Valley Heart Center

Poughkeepsie

NY

Staten Island University Hospital

Staten Island

NY

Westchester Medical Center

Valhalla

NY

South Buffalo Mercy Hospital

Williamsville

NY

Aultman Hosptial

Canton

OH

Comprehensive Cardiology

Cincinnati

OH

Cleveland Clinic Foundation

Cleveland

OH

MetroHealth Medical Center
Heart and Vascular Center

Cleveland

OH

University Hospital Of Cleveland

Cleveland

OH

Grant Medical Center

Columbus

OH

MidWest Cardiology Research Foundation

Columbus

OH

The Ohio State University Medical Center

Columbus

OH

Good Samaritan Hospital

Dayton

OH

The Dayton Heart Center

Dayton

OH

MedCentral Health System Mansfield

Mansfield

OH

North Ohio Heart Center

Sandusky

OH

Flowers Hospital

Toledo

OH

The Toledo Hospital

Toledo

OH

The Toledo Hospital

Toledo

OH

Cardiology Associates of Southeastern Ohio, Genesis Healthcare System

Zanesville

OH

Cardiovascular Disease Specialists and Clinical Research

Oklahoma City

OK

University of OK Health Sciences Center

Oklahoma City

OK

Veterans Affairs Medical Center, Oklahoma City

Oklahoma City

OK

Heart Center of Tulsa, Inc.

Tulsa

OK

Oklahoma Heart Institute/Hillcrest Medical Center

Tulsa

OK

St. Francis Hospital

Tulsa

OK

Cascarde Medical Associates

Eugene

OR

Portland VA Medical Center

Portland

OR

Abington Road Memorial Hospital

Abington

PA

Lehigh Valley Hospital

Allentown

PA

Tri-State Cardiology

Beaver

PA

Bryn Mawr Hospital

Bryn Mawr

PA

Doylestown Hospital

Doylestown

PA

St. Vincent Health Center

Erie

PA

Oxford Valley Cardiology

Langhorne

PA

St. Mary’s Langhorne Hospital

Langhorne

PA

Lehigh Valley Cardiology

Leetsdale

PA

Albert Einstein Medical Center

Philadelphia

PA

Presbyterian Medical Ctr, U of PA

Philadelphia

PA

University of PA Health Systems

Philadelphia

PA

UPMC Shadyside

Phittsburgh

PA

Allegheny General Hospital

Pittsburgh

PA

West Penn Hospital

Pittsburgh

PA

Guthrie Clinic

Sayre

PA

Pinnacle Health at Harrisburg, Moffit Heart and Vascular

Wormleysburg

PA

Lankenau Hospital

Wynnewood

PA

York Hospital

York

PA

Chester County Hospital

West Chester

PA

Rhode Island Hospital

Providence

RI

Anderson Area Medical Center

Anderson

SC

Medical University of South Carolina

Charleston

SC

Ralph H. Johnson VAMC

Charleston

SC

WJBD VA Medical Center

Columbia

SC

Spartanburg Regional Medical Center

Spartanburg

SC

Black Hills Cardiovascular Research

Rapid City

SD

Chattanooga Heart Institute

Chattanooga

TN

Chattanooga Heart Institute – Erlanger

Chattanooga

TN

Wellmont Holston Valley Medical Ctr

Kingsport

TN

East Tennessee Heart Consultants

Knoxville

TN

Fort Sanders Regional Medical Center

Knoxville

TN

University Of Tennessee Medical Center/Knoxille Cardio Group

Knoxville

TN

Discovery Alliance International, INC.

Nashville

TN

Heart & Vascular Clinic/Centennial Medical Center/Access Clinical Trials,

Nashville

TN

St. Thomas Hospital/Thomas Hospital Research Institute

Nashville

TN

Vanderbilt University Medical Center

Nashville

TN

Amarillo Heart Group (Clinic) / North West Texas Hospital (Interventions)

Amarillo

TX

Baptist St. Anthony’s Health System

Amarillo

TX

Heart Hospital of Austin

Austin

TX

TCC1 –  Seton Medical

Austin

TX

TCC2 – North Austin Medical Center

Austin

TX

Southeast Texas Cardiology Associates II, L.L.P.

Beaumont

TX

Cardilogy Assoc. of Corpus Christi

Corpus Christi

TX

Christus Spohn Shoreline Hospital/Coastal Cardiology

Corpus Christi

TX

Baylor Heart and Vascular Hospital

Dallas

TX

Cardiology Research Institute of Dallas, Inc.

Dallas

TX

Medical City – Dallas

Dallas

TX

Presbyterian Hospital of Dallas

Dallas

TX

Providence Memorial Center

El Paso

TX

Sierra Medical Center

El Paso

TX

Valley Diagnostic Clinic

Harlingen

TX

Baylor College of Medicine, VA Medical Center

Houston

TX

Methodist Hospital

Houston

TX

North Houston Heart Center

Houston

TX

Spectra Clinical Research Management Group

Mission

TX

Baptists Health Systems

San Antonio

TX

Christus Santa Rosa Health Care/ Cardiology of San Antonio

San Antonio

TX

South Texas VA/ San Antonio

San Antonio

TX

Southwest Texas Methodist Hospital

San Antonio

TX

The Texsan Heart Hospital

San Antonio

TX

University Hospital/ U.T. Health Science Center @ San Antonio

San Antonio

TX

Cardiovascular Assoc. of East Texas

Tyler

TX

Trinity Mother Francis Hospital/East Texas Medical Center

Tyler

TX

Victoria Heart and Vascular Center

Victoria

TX

Citizens Hospital

Victoria,

TX

McKay-Dee Hospital Center

Ogden

UT

Columbia St. Mark’s Hospital, Heart Center

Salt Lake City

UT

University of Utah Health Science Ctr

Salt Lake City

UT

Danville Rgional Medical  Center

Danville

VA

Inova Fairfax Hospital

Falls Church

VA

Advanced Health Institute

Galax

VA

Rockingham Memorial Hospital/Harrisonburg Medical Assoc.

Harrisonburg

VA

Maryview Medical Center/ Portsmouth Cardiology, Inc.

Portsmouth

VA

Cardiovascular Associates of VA, Henrico Doctor’s Hospital

Richmond

VA

Cardiovascular Associates of Virginia

Richmond

VA

McGuire VA Medical Center

Richmond

VA

Medical College of Virginia, Virginia Commonwealth University

Richmond

VA

Sentara Norfolk General

Suffolk

VA

Cardiovascular Associates, LTD

Virginia Beach

VA

Chesapeake General Hospital

Virginia Beach

VA

Winchester Cardiology

Winchester

VA

Overlake Hospital- Seattle Cardiovascular Research

Bellevue

WA

Madigan Army Medical Center

Fort Lewis

WA

Cardiology Associates

Olympia

WA

Multicare Health System/Cardiac Study Center

Puyallup

WA

 

 

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