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NCT06283966PHASE3Recruiting

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

AstraZeneca

Start Date

2/21/2024

Completion Date

12/3/2027

Summary

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Detailed Description

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

Eligibility Criteria

Age Range: 40 years to 80 years

Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% at V1. 4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking; defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to V1. 5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory 6. A CAT score of ≥ 10 at Visit 1. 7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b), (c), or (d)\]: 1. : Established CV Disease 2. : Combination of CV risk factors: * Hypertension * Diabetes Mellitus * Chronic Kidney Disease * Dyslipidemia * Obesity 3. : High risk of CV disease determined using an established CV risk assessment tool. 4. : CT coronary Artery Calcification 8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol. 9. Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments. 10. A female is eligible to enter and participate in the study if the female is of: * Non-childbearing potential: either permanently sterilized or who are post-menopausal. * Childbearing potential: has a negative serum pregnancy test at V1 and must use one highly effective form of birth control. 11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Exclusion Criteria: 1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension. 2. End-stage renal disease requiring renal replacement therapy 3. History of heart or lung transplant or actively listed for heart or lung transplant. 4. Implanted left ventricular assist device or implant anticipated in \< 3 months. 5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1. 6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded: 1. An MI or unstable angina in the last 8 weeks 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks. NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event. 7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1 8. Any life-threatening condition, including malignancy, with a life expectancy \< 5 years, other than CV disease or COPD, that might prevent the participant from completing the study. 9. Use of maintenance ICS treatment within the past 12 months. 10. Unable to abstain from protocol-defined prohibited medications 11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study). 12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI. 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 15. Previous randomization in the present study. 16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

Interventions

DRUG

BGF MDI 320/14.4/9.6 μg

DRUG

GFF MDI 14.4/9.6 μg

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Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Locations

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Athens, Alabama 35611

United States

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Cullman, Alabama 35058

United States

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Fairhope, Alabama 36532

United States

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Huntsville, Alabama 35801

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Mobile, Alabama 36608

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Sheffield, Alabama 35660

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Gilbert, Arizona 85296

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Glendale, Arizona 85308

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Mesa, Arizona 85206

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Mesa, Arizona 85213

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Phoenix, Arizona 85006

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Tempe, Arizona 85281

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Tempe, Arizona 85283

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Tucson, Arizona 85710

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Tucson, Arizona 85715

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Apple Valley, California 92307

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Canoga Park, California 91303

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Castroville, California 95012

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Garden Grove, California 92844

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Gardena, California 90247

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Inglewood, California 90301

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La Mesa, California 91942

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La Palma, California 90623

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Lomita, California 90717

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Long Beach, California 90815

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Los Alamitos, California 90720

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Mission Viejo, California 92691

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Newport Beach, California 92663

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North Hollywood, California 91602

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Pomona, California 91768

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Sacramento, California 95823

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Sacramento, California 95831

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San Bernardino, California 92408

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San Diego, California 92111

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San Dimas, California 91773

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Santa Ana, California 92704

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Tarzana, California 91356

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Thousand Oaks, California 91360

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Van Nuys, California 91405

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Vista, California 92081

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Westminster, California 92683

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Aurora, Colorado 80012

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Denver, Colorado 80228

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Englewood, Colorado 80110

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Washington D.C., District of Columbia 20016

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Boynton Beach, Florida 33435

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Bradenton, Florida 34209

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Cape Coral, Florida 33990

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Clearwater, Florida 33756

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Clearwater, Florida 33765

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Crystal River, Florida 34429

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Cutler Bay, Florida 33189

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Edgewater, Florida 32132

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Fort Lauderdale, Florida 33308

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Fort Myers, Florida 33912

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Hialeah, Florida 33012

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Hialeah, Florida 33013

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Hollywood, Florida 33024

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Homestead, Florida 33033

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Kissimmee, Florida 34741

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Kissimmee, Florida 34746

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Lake City, Florida 32055

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Lake City, Florida 32055

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Lake Worth, Florida 33467

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Lakeland, Florida 33805

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Lakeland, Florida 33813

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Loxahatchee Groves, Florida 33470

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Miami, Florida 33155

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Miami, Florida 33175

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Miami, Florida 33175

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Miami Lakes, Florida 33014

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Naples, Florida 34102

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Ocala, Florida 34470

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Orlando, Florida 32807

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Orlando, Florida 32819

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Orlando, Florida 32825

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Ormond Beach, Florida 32174

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Pembroke Pines, Florida 33024

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Plantation, Florida 33324

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St. Petersburg, Florida 33713

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St. Petersburg, Florida 33713

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Sun City Center, Florida 33573

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Tamarac, Florida 33321

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Tamarac, Florida 33321

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Tampa, Florida 33606

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Tampa, Florida 33607

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Tampa, Florida 33625

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Fayetteville, Georgia 30214

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Peachtree Corners, Georgia 30092

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Savannah, Georgia 31406

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Tucker, Georgia 30084

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Boise, Idaho 83706

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Chicago, Illinois 60607

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Winfield, Illinois 60190

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Valparaiso, Indiana 46383

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Sioux City, Iowa 51106

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Newton, Kansas 67114

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Wichita, Kansas 67218

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Lexington, Kentucky 40503

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Paducah, Kentucky 42001

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Lafayette, Louisiana 70508

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Monroe, Louisiana 71201

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Shreveport, Louisiana 71105

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Zachary, Louisiana 70791

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Glen Burnie, Maryland 21061

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Oxon Hill, Maryland 20745

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Potomac, Maryland 20854

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Boston, Massachusetts 02115

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Ann Arbor, Michigan 48109

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Flint, Michigan 48504

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Southfield, Michigan 48034

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Southfield, Michigan 48075

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Gulfport, Mississippi 39503

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Olive Branch, Mississippi 38654

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Kansas City, Missouri 64116

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Liberty, Missouri 64068

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St Louis, Missouri 63104

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St Louis, Missouri 63136

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Missoula, Montana 59808

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Fremont, Nebraska 68025

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Grand Island, Nebraska 68803

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Lincoln, Nebraska 68510

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Omaha, Nebraska 68134

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Las Vegas, Nevada 89101

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Las Vegas, Nevada 89102

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Las Vegas, Nevada 89119

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Las Vegas, Nevada 89121

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Lawrence, New Jersey 08648

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Mullica Hill, New Jersey 08062

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Toms River, New Jersey 08755

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Union City, New Jersey 07087

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Albuquerque, New Mexico 87109

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Albany, New York 12205

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Albany, New York 12208

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Bronxville, New York 10708

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Brooklyn, New York 11220

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Massapequa, New York 11758

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New Windsor, New York 12553

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New York, New York 10036

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New York, New York 10065

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The Bronx, New York 10455

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Vestal, New York 13850

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Fayetteville, North Carolina 28303

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Greensboro, North Carolina 27405

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Greenville, North Carolina 27834

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Huntersville, North Carolina 28078

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Morehead City, North Carolina 28557

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Raleigh, North Carolina 27612

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Salisbury, North Carolina 28144

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Statesville, North Carolina 28625

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Statesville, North Carolina 28677

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Wilmington, North Carolina 28412

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Winston-Salem, North Carolina 27104

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Beavercreek, Ohio 45431

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Blue Ash, Ohio 45242

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Cleveland, Ohio 44130

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Columbus, Ohio 43215

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Columbus, Ohio 43235

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Marion, Ohio 43302

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Toledo, Ohio 43617

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Norman, Oklahoma 73071

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Oklahoma City, Oklahoma 73134

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Tulsa, Oklahoma 74133

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Grants Pass, Oregon 97527

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Medford, Oregon 97504

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Roseburg, Oregon 97471

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Camp Hill, Pennsylvania 17011

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DuBois, Pennsylvania 15801

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Exton, Pennsylvania 19341

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Philadelphia, Pennsylvania 19107

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Philadelphia, Pennsylvania 19140

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Anderson, South Carolina 29621

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Charleston, South Carolina 29414

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Charleston, South Carolina 29414

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Columbia, South Carolina 29201

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Gaffney, South Carolina 29340

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Spartanburg, South Carolina 29303

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Union, South Carolina 29379

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Pierre, South Dakota 57501

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Rapid City, South Dakota 57701

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Sioux Falls, South Dakota 57104

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Chattanooga, Tennessee 37421

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Elizabethton, Tennessee 37643

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Franklin, Tennessee 37067

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Morristown, Tennessee 37813

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Tullahoma, Tennessee 37388

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Abilene, Texas 79606

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Amarillo, Texas 79106

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Austin, Texas 78704

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Brownsville, Texas 78520

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Dallas, Texas 75225

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Dallas, Texas 75235

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Dallas, Texas 75254

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El Paso, Texas 79902

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El Paso, Texas 79902

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Forney, Texas 75126

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Georgetown, Texas 78633

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Houston, Texas 77002

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Houston, Texas 77008

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Houston, Texas 77024

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Houston, Texas 77025

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Houston, Texas 77074

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Houston, Texas 77079

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Houston, Texas 77084

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Houston, Texas 77089

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Houston, Texas 77207

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Katy, Texas 77450

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Katy, Texas 77493

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Kerrville, Texas 78028

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Kingwood, Texas 77339

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Lewisville, Texas 75057

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McAllen, Texas 78504

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McKinney, Texas 75069

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Paris, Texas 75462

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Plano, Texas 75024

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Plano, Texas 75093

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Victoria, Texas 77901

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Waco, Texas 76708

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Wichita Falls, Texas 76308

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Wylie, Texas 75098

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Bountiful, Utah 84010

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Ogden, Utah 84405

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Salt Lake City, Utah 84107

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West Jordan, Utah 84088

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West Valley City, Utah 84120

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Newport News, Virginia 23606

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Norfolk, Virginia 23504

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Richmond, Virginia 23219

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Richmond, Virginia 23226

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Suffolk, Virginia 23435

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Spokane, Washington 99218

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Morgantown, West Virginia 26505

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Cudahy, Wisconsin 53110

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Milwaukee, Wisconsin 53228

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Milwaukee, Wisconsin 53295

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Buenos Aires, 1425

Argentina

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Buenos Aires, C1012AAR

Argentina

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Buenos Aires, C1425BEN

Argentina

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CABA, C1019ABS

Argentina

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Capital Federal, C1060ABN

Argentina

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Ciudad de Buenos Aires, C1414AIF

Argentina

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Ciudad de Buenos Aires, C1425AGC

Argentina

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Florida, B1602DQD

Argentina

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Mar del Plata, B7600GWV

Argentina

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Mendoza, M5500CCG

Argentina

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Ranelagh, 1886

Argentina

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Rosario, 2000

Argentina

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San Fernando, B1646EBJ

Argentina

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San Juan Bautista, 1888

Argentina

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San Miguel de Tucumán, 4000

Argentina

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San Miguel de Tucumán, T4000CBC

Argentina

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Birtinya, 4575

Australia

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Cairns, 4870

Australia

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Chermside, 4032

Australia

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Coffs Harbour, 02450

Australia

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Dubbo, 2830

Australia

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Nedlands, 6009

Australia

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Port Macquarie, 2444

Australia

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Spearwood, 6163

Australia

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St Albans, 3021

Australia

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St Albans, 3021

Australia

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Waitara, 2077

Australia

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Wangaratta, 3677

Australia

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Bad Ischl, 4820

Austria

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Braunau am Inn, 5280

Austria

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Feldbach, 8330

Austria

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Graz, 8036

Austria

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Vienna, 1090

Austria

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Belo Horizonte, 30110-934

Brazil

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Belo Horizonte, 30150-221

Brazil

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Belo Horizonte, 30220-140

Brazil

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Blumenau, 89030-101

Brazil

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Brasília, 70200-730

Brazil

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Brasília, 70390-700

Brazil

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Brasília, 70712-903

Brazil

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Brasília, 71681-603

Brazil

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Campina Grande do Sul, 83.430-000

Brazil

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Campinas, 13060-080

Brazil

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Caxias do Sul, 95070-560

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Curitiba, 80030-110

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Curitiba, 80230-130

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Curitiba, 80810-050

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Fortaleza, 60125-000

Brazil

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Ijuí, 98700-000

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Juiz de Fora, 36033-318

Brazil

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Mossoró, 59603-020

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Natal, 59020-035

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Niterói, 24020-096

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Passo Fundo, 99010-120

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Porto Alegre, 90035-903

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Porto Alegre, 90035074

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Porto Alegre, 9061-000

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Porto Alegre, 91350-200

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Recife, 50740-465

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Rio de Janeiro, 20551-030

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Rio de Janeiro, 22281-100

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Salvador, 40170-130

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Santo André, 09080-110

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São Bernardo do Campo, 09715090

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São Bernardo do Campo, 09750-420

Brazil

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São José do Rio Preto, 15090-000

Brazil

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São Paulo, 04012-180

Brazil

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São Paulo, 05403-000

Brazil

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Serra, 29160-750

Brazil

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Sorocaba, 18040-425

Brazil

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Volta Redonda, 27258-000

Brazil

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Votuporanga, 15501-405

Brazil

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Burgas, 8000

Bulgaria

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Dobrich, 9300

Bulgaria

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Dupnitsa, 2600

Bulgaria

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Dupnitsa, 2602

Bulgaria

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Haskovo, 6300

Bulgaria

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Kozloduy, 3320

Bulgaria

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Montana, 3400

Bulgaria

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Panagyurishte, 4500

Bulgaria

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Pazardzhik, 4400

Bulgaria

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Pernik, 2300

Bulgaria

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Pleven, 5800

Bulgaria

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Pleven, 5800

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Plovdiv, 4002

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Plovdiv, 4003

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Plovdiv, 4004

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Plovdiv, 4023

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Rousse, 7000

Bulgaria

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Rousse, 7002

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Sandanski, 2800

Bulgaria

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Sevlievo, 5403

Bulgaria

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Sliven, 8800

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Sliven, 8800

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Sofia, 1000

Bulgaria

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Sofia, 1000

Bulgaria

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Sofia, 1202

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Sofia, 1618

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Sofia, 1756

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Stara Zagora, 6003

Bulgaria

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Varna, 9000

Bulgaria

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Varna, 9000

Bulgaria

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Vidin, 3700

Bulgaria

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Vratsa, 3000

Bulgaria

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Yambol, 8600

Bulgaria

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Calgary, Alberta T3R 1W7

Canada

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Sherwood Park, Alberta T8L 0N2

Canada

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Kelowna, British Columbia V1Y 1Z9

Canada

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Richmond, British Columbia V6V 2L1

Canada

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Winnipeg, Manitoba R3L 1Z5

Canada

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Sydney, Nova Scotia B1M 0A1

Canada

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Ajax, Ontario L1S 2J5

Canada

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Guelph, Ontario N1H 1B1

Canada

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Hamilton, Ontario L8L 5G4

Canada

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Kingston, Ontario K7L 2V7

Canada

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Kingston, Ontario K7M 4E7

Canada

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Thunder Bay, Ontario P7B 7C7

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Toronto, Ontario M5T 3A9

Canada

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Montreal, Quebec H4A 3J1

Canada

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Québec, Quebec G1G 5X1

Canada

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Québec, Quebec G1V 4G5

Canada

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Québec, Quebec G1W 4R4

Canada

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Québec, Quebec G3K 2P8

Canada

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Saint-Charles-Borromée, Quebec J6E 2B4

Canada

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Trois-Rivières, Quebec G8T 7A1

Canada

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Trois-Rivières, Quebec G9A 4P3

Canada

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Saskatoon, Saskatchewan S7N 0W8

Canada

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Curicó, 3341643

Chile

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Quillota, 2260000

Chile

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Santiago, 7500691

Chile

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Santiago, 7691236

Chile

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Santiago, 7750495

Chile

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Talca, 3465584

Chile

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Temuco, 4810345

Chile

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Victoria, 4720097

Chile

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Viña del Mar, 2540488

Chile

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Vitacura, 7630226

Chile

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Anning, 650000

China

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Anyang, 455001

China

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Baotou, 014040

China

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Baotou, 14010

China

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Beijing, 101100

China

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Beijing, 10730

China

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Changsha, 410004

China

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Changsha, 410005

China

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Changsha, 410015

China

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Changsha, 430033

China

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Changzhi, 46000

China

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Chengdu, 610031

China

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Chengdu, 610072

China

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Chengdu, 610500

China

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Chengdu, 611130

China

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Chifeng, 024000

China

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Chizhou, 247099

China

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Chongqing, 400010

China

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Chongqing, 401320

China

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Chongqing, 408400

China

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Daqing, 163000

China

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Dazhou, 635000

China

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Foshan, 528000

China

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Fuzhou, 350001

China

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Guangzhou, 510000

China

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Guangzhou, 510120

China

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Guangzhou, 510145

China

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Guangzhou, 510163

China

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Guangzhou, 510530

China

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Haikou, 570311

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Ukraine

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Vinnytsia, 21009

Ukraine

Research Site

Vinnytsia, 21029

Ukraine

Research Site

Bicester, OX26 6AT

United Kingdom

Research Site

Bollington, SK10 5JH

United Kingdom

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Bradford, BD13 2GD

United Kingdom

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Cardiff, CF37 2DR

United Kingdom

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Chesterfield, S40 4AA

United Kingdom

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Corby, NN17 2UR

United Kingdom

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Cottingham, HU16 5JQ

United Kingdom

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Fowey, PL23 1DT

United Kingdom

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Glasgow, G4 0SF

United Kingdom

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Hounslow, TW4 7NR

United Kingdom

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Liverpool, L14 3PE

United Kingdom

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London, EC1M 6BQ

United Kingdom

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London, NW3 2QG

United Kingdom

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London, SW1P 2PF

United Kingdom

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Manchester, M8 5RB

United Kingdom

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Newquay, TR7 1RU

United Kingdom

Research Site

North Somerset, BS23 3HQ

United Kingdom

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Northallerton, DL7 8AW

United Kingdom

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Norwich, NR1 1RB

United Kingdom

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Nottingham, NG9 6DX

United Kingdom

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Perth, PH1 1NX

United Kingdom

Research Site

Poole, BH16 5PW

United Kingdom

Research Site

Sheffield, S7 1NF

United Kingdom

Research Site

Torbay, TQ1 4QX

United Kingdom

Research Site

Whitney, OX29 4QB

United Kingdom

Research Site

Witney, OX28 6JS

United Kingdom