BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

NCT ID: NCT00097357

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.

Detailed Description

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Conditions

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Venous Thrombosis Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Apixaban: 2.5 mg, BID

PLUS

Enoxaparin Placebo

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Tablets, Oral, 12 +/- 2 days

Enoxaparin Placebo

Intervention Type DRUG

Injection, SQ, BID, 12 +/- 2 days

A2

Apixaban: 5 mg, BID

PLUS

Enoxaparin Placebo

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Tablets, Oral, 12 +/- 2 days

Enoxaparin Placebo

Intervention Type DRUG

Injection, SQ, BID, 12 +/- 2 days

A3

Apixaban: 10 mg, BID

PLUS

Enoxaparin Placebo

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Tablets, Oral, 12 +/- 2 days

Enoxaparin Placebo

Intervention Type DRUG

Injection, SQ, BID, 12 +/- 2 days

A4

Apixaban: 5 mg, QD

PLUS

Enoxaparin Placebo

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Tablets, Oral, 12 +/- 2 days

Enoxaparin Placebo

Intervention Type DRUG

Injection, SQ, BID, 12 +/- 2 days

A5

Apixaban: 10 mg, QD

PLUS

Enoxaparin Placebo

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Tablets, Oral, 12 +/- 2 days

Enoxaparin Placebo

Intervention Type DRUG

Injection, SQ, BID, 12 +/- 2 days

A6

Apixaban: 20 mg, QD

PLUS

Enoxaparin Placebo

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Tablets, Oral, 12 +/- 2 days

Enoxaparin Placebo

Intervention Type DRUG

Injection, SQ, BID, 12 +/- 2 days

E1

Enoxaparin: 30 mg

PLUS

Apixaban Placebo

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Injection, SQ, Q12H, 12 +/- 2 days

Apixaban Placebo

Intervention Type DRUG

Tablets, Oral, BID, 12 +/- 2 days

W1

Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Tablets, Oral, QD, 12 +/- 2 days

Interventions

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Apixaban

Tablets, Oral, 12 +/- 2 days

Intervention Type DRUG

Enoxaparin

Injection, SQ, Q12H, 12 +/- 2 days

Intervention Type DRUG

Warfarin

Tablets, Oral, QD, 12 +/- 2 days

Intervention Type DRUG

Enoxaparin Placebo

Injection, SQ, BID, 12 +/- 2 days

Intervention Type DRUG

Apixaban Placebo

Tablets, Oral, BID, 12 +/- 2 days

Intervention Type DRUG

Other Intervention Names

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BMS-562247

Eligibility Criteria

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Inclusion Criteria

* Undergoing elective unilateral total knee replacement surgery.
* Willing and able to undergo bilateral ascending contrast venography.
* Able to inject (by self or caregiver) study medication subcutaneously.

Exclusion Criteria

* Women of childbearing potential.
* Women who are pregnant or breastfeeding.
* Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) \>=35 kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Locations

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Local Institution

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Northport, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Encinitas, California, United States

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Fountain Valley, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Montclair, California, United States

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Oakland, California, United States

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Pasadena, California, United States

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Sacramento, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Torrance, California, United States

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Wildomar, California, United States

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Yuba City, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Bay Pines, Florida, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Melbourne, Florida, United States

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Pensacola, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Cumming, Georgia, United States

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Decatur, Georgia, United States

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Suwanee, Georgia, United States

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Boise, Idaho, United States

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Meridian, Idaho, United States

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Galesburg, Illinois, United States

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Springfield, Illinois, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Madisonville, Kentucky, United States

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Covington, Louisiana, United States

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Baltimore, Maryland, United States

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Newton, Massachusetts, United States

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Port Huron, Michigan, United States

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Jackson, Mississippi, United States

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Buffalo, New York, United States

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Charlotte, North Carolina, United States

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Monroe, North Carolina, United States

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Cincinnati, Ohio, United States

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Youngstown, Ohio, United States

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Tulsa, Oklahoma, United States

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Havertown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Newport News, Virginia, United States

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Seattle, Washington, United States

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Marshfield, Wisconsin, United States

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Buenos Aires, Buenos Aires, Argentina

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Capital fEDERAL, Buenos Aires, Argentina

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Prov. Buenos Aires, Buenos Aires, Argentina

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Godoy Cruz, Mendoza Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Camperdown, New South Wales, Australia

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Chermside, Queensland, Australia

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Gold Coast, Queensland, Australia

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Herston, Queensland, Australia

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Bedford Park, South Australia, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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East Ringwood, Victoria, Australia

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Geelong, Victoria, Australia

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Windsor, Victoria, Australia

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Dartmouth, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Burlington, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Newmarket, Ontario, Canada

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Niagara Falls, Ontario, Canada

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Oakville, Ontario, Canada

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Richmond Hill, Ontario, Canada

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St. Catharines, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Welland, Ontario, Canada

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Weston, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Ste-foy, Quebec, Canada

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Victoriaville, Quebec, Canada

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Frederiksberg, , Denmark

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Herlev, , Denmark

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Hørsholm, , Denmark

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Silkeborg, , Denmark

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Slagelse, , Denmark

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Haifa, , Israel

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Holon, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Ẕerifin, , Israel

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Aguascalientes, Aguascalientes, Mexico

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Tijuana, Baja California Sur, Mexico

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Chihuahua City, Chihuahua, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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Hermosillo, Sonora, Mexico

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México, State of Mexico, Mexico

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Tampico, Tamps, Tamaulipas, Mexico

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Jalapa, Veracruz, Mexico

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Veracruz, Veracruz, Mexico

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Mérida, Yucatán, Mexico

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Bialystock, , Poland

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Gdansk, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Piekary Śląskie, , Poland

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Radom, , Poland

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Sosnowiec, , Poland

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Szczecin, , Poland

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Szczecin Zdunowo, , Poland

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Warsaw, , Poland

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Ponce, , Puerto Rico

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Countries

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United States Argentina Australia Canada Denmark Israel Mexico Poland Puerto Rico

Other Identifiers

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CV185-010

Identifier Type: -

Identifier Source: org_study_id

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