Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

NCT ID: NCT00248170

Last Updated: 2016-04-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2014-09-30

Brief Summary

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Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole

2.5 mg by mouth (p.o.) once daily

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

2.5 mg tablets

Anastrozole

1 mg p.o. once daily

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1 mg tablets

Interventions

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Letrozole

2.5 mg tablets

Intervention Type DRUG

Anastrozole

1 mg tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recent primary surgery for breast cancer
* Early stage breast cancer
* Postmenopausal
* Hormone receptor positive
* Positive lymph node involvement

Exclusion Criteria

* Metastatic disease
* Presence of contralateral breast cancer including DCIS
* Progression
Minimum Eligible Age

33 Years

Maximum Eligible Age

96 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Birmingham Hematology and Oncology Associates

Birmingham, Alabama, United States

Site Status

Comprehensive Cancer Institute

Huntsville, Alabama, United States

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Northern Arizona Hematology/Oncology Associates, P.C.

Flagstaff, Arizona, United States

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Oncology & Hematology Associates, PC

New London, Connecticut, United States

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Florida Cancer Specialists

Fort Meyers, Florida, United States

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Sarah Cannon Research Institute

Jacksonville, Florida, United States

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Cancer Centers of Florida PA

Ocoee, Florida, United States

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Florida Cancer Institute

Orlando, Florida, United States

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Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

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University Cancer & Blood Center, LLC

Athens, Georgia, United States

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Central Indiana Cancer Centers

Indianapolis, Indiana, United States

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Kansas City Cancer Center

Overland Park, Kansas, United States

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Wichita Community Clinical Oncology Program

Wichita, Kansas, United States

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Center for Cancer & Blood Disorders

Bethesda, Maryland, United States

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St. Louis Cancer & Breast Institute

St Louis, Missouri, United States

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New York Oncology Hematology, P.C. NYOH Latham

Troy, New York, United States

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Raleigh Hematology Oncology Associates

Cary, North Carolina, United States

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Aultman Cancer Center

Canton, Ohio, United States

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Sarah Cannon Oncology Hematology Care, Inc

Cincinnati, Ohio, United States

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Oncology Associates of Oregon, PC

Eugene, Oregon, United States

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Medical Oncology Associates of Wyorning Valley, PC

Kingston, Pennsylvania, United States

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Chattanooga Oncology and Hematology Assoicates, PC

Chattanooga, Tennessee, United States

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Sarah Cannon Research Institute

Nashville, Tennessee, United States

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Texas Oncology, P.A.

Bedford, Texas, United States

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Center for Oncology Research and Treatment, PA

Dallas, Texas, United States

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Texas Cancer Center ( Medical City Dallas Hospital)

Dallas, Texas, United States

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Texas Oncology Presbyterian Hospital

Dallas, Texas, United States

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Texas Oncology Sammons Cancer Center

Dallas, Texas, United States

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Texas Oncology Texas Oncology PA

Dallas, Texas, United States

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Texas Cancer Center Denton

Denton, Texas, United States

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El Paso Cancer Treatment Ctr-East

El Paso, Texas, United States

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Texas Oncology, P.A.

Fort Worth, Texas, United States

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San Antonio Tumor and Blood Clinic

Fredericksburg, Texas, United States

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MD Anderson Cancer Center/University of Texas

Houston, Texas, United States

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Longview Cancer Center

Longview, Texas, United States

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South Texas Cancer Center- McAllen

McAllen, Texas, United States

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Allison Cancer Center

Midland, Texas, United States

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Texas Cancer Center- Sherman

Sherman, Texas, United States

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Tyler Cancer Center

Tyler, Texas, United States

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Waco Cancer and Research Center

Waco, Texas, United States

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Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

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Northwest Cancer Specialists, P.C.

Vancover, Washington, United States

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Novartis Investigative Site

Garran, Australian Capital Territory, Australia

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Port Macquarie, New South Wales, Australia

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Randwick, New South Wales, Australia

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Sydney, New South Wales, Australia

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Tweed Heads, New South Wales, Australia

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Waratah, New South Wales, Australia

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Nambour, Queensland, Australia

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Redcliff, Queensland, Australia

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Adelaide, South Australia, Australia

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Toorak Gardens, South Australia, Australia

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Box Hill, Victoria, Australia

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East Bentleigh, Victoria, Australia

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Epping, Victoria, Australia

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Footscray, Victoria, Australia

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Franston, Victoria, Australia

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Malvern, Victoria, Australia

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Parkville, Victoria, Australia

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Wodonga, Victoria, Australia

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Nedlands, Western Australia, Australia

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Perth, Western Australia, Australia

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Perth, Western Australia, Australia

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Auckland, , Australia

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Dunedin, , Australia

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Hamilton, , Australia

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Graz, Austria, Austria

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Vienna, Austria, Austria

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Wels, Austria, Austria

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Feldkirch, , Austria

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Friesach, , Austria

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Graz, , Austria

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Güssing, , Austria

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Innsbruck, , Austria

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Leoben, , Austria

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Linz, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Villach, , Austria

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Wiener Neustadt, , Austria

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Aalst, , Belgium

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Antwerp, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Libramont, , Belgium

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Liège, , Belgium

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Turnhout, , Belgium

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Verviers, , Belgium

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Wilrijk, , Belgium

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Tianjin, Tianjin Municipality, China

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Beijing, , China

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Guangzhou, , China

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Shanghai, , China

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Aalborg, Denmark, Denmark

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Copenhagen, , Denmark

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Herlev, , Denmark

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Herning, , Denmark

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Hillerød, , Denmark

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Næstved, , Denmark

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Odense C, , Denmark

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Roskilde, , Denmark

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Vejle, , Denmark

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Viborg, , Denmark

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Angers, , France

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Caen, , France

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Créteil, , France

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Le Chesnay, , France

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Lyon, , France

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Marseille, , France

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Montbéliard, , France

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Montpellier, , France

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Nice, , France

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Perpignan, , France

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Périgueux Cédex, , France

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Rennes, , France

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Strasbourg, , France

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Toulouse, , France

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Kiel, Germany, Germany

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Amberg, , Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bremen, , Germany

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Düsseldorf, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Freiburg im Breisgau, , Germany

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Halle, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Homburg, , Germany

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Jena, , Germany

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Lübeck, , Germany

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Lüneburg, , Germany

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Magdeburg, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Offenbach, , Germany

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Regensburg, , Germany

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Trier, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Wiesbaden, , Germany

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Wiesbaden, , Germany

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Witten, , Germany

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Galway, Ireland, Ireland

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Cork, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Letterkenny, , Ireland

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Limerick, , Ireland

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Jerusalem, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Montevarchi, AR, Italy

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Bari, BA, Italy

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Biella, BI, Italy

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Bologna, BO, Italy

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Chieti, CH, Italy

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Catania, CT, Italy

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Antella - Bagno A Ripoli, FI, Italy

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Forlì, FO, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Modena, MO, Italy

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Aviano, PN, Italy

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Parma, PR, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Castelfranco Veneto, TV, Italy

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Udine, UD, Italy

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Verona, VR, Italy

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Fermo, , Italy

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Nagoya, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Isehara, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kyoto, Kyoto, Japan

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Osaka, Osaka, Japan

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Suita, Osaka, Japan

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Kitaadachi-gun, Saitama, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuke, Tochigi, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Koto, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Eindhoven, , Netherlands

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Enschede, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Veldhoven, , Netherlands

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Skien, , Norway

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Goyang-si, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, , South Korea

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Alicante, Alicante, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Sabadell, Barcelona, Spain

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Santander, Cantabria, Spain

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A Coruña, Galicia, Spain

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A Coruña, Galicia, Spain

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Madrid, Madrid, Spain

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Valencia, Valencia, Spain

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Zaragoza, Zaragoza, Spain

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Lund, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Chur, , Switzerland

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Lucerne, , Switzerland

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Schaffhausen, , Switzerland

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Winterthur, , Switzerland

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Hull, East Yorkshire, United Kingdom

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Glasgow, Glasgow, United Kingdom

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Northwood, Middlesex, United Kingdom

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Belfast, , United Kingdom

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Bournemouth, , United Kingdom

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Bristol, , United Kingdom

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Chelmsford, , United Kingdom

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Colchester, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Merseyside, , United Kingdom

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Plymouth, , United Kingdom

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Rhyl, , United Kingdom

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Sheffiled, , United Kingdom

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Shrewsbury, , United Kingdom

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Surrey, , United Kingdom

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Countries

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United States Australia Austria Belgium Canada China Denmark France Germany Ireland Israel Italy Japan Netherlands Norway South Korea Spain Sweden Switzerland United Kingdom

Other Identifiers

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2005-004263-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EUDRACT number 2005-004263-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

CFEM345D2411

Identifier Type: -

Identifier Source: org_study_id

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