Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
NCT ID: NCT00858364
Last Updated: 2022-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2549 participants
INTERVENTIONAL
2009-07-17
2017-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo
Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
Placebo
Administered subcutaneously once every 3 weeks
Darbepoetin alfa
Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first.
Darbepoetin alfa
Administered subcutaneously once every 3 weeks
Interventions
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Darbepoetin alfa
Administered subcutaneously once every 3 weeks
Placebo
Administered subcutaneously once every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
* Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
* 18 years of age or older at screening.
* Life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.
* Hemoglobin level less than or equal to 11.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomization (retest in screening is acceptable).
* Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
* Subjects must have had a baseline scan (computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography-computer tomography \[PET/CT\]) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
* Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative.
Exclusion Criteria
* History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
* Received any prior adjuvant or neoadjuvant therapy for NSCLC.
* Subjects with a history of brain metastasis.
* Uncontrolled hypertension (systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg), or as determined by the investigator during screening.
* History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
* Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
* Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
* Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
* Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of acquired immunodeficiency syndrome (AIDS), positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
* History of pure red cell aplasia
* History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
* Transferrin saturation \< 20% and ferritin \< 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
* Abnormal renal function (serum creatinine level \> 2X upper limit of normal \[ULN\]) as assessed by the central laboratory during screening.
* Abnormal liver function (total bilirubin \> 2X ULN or liver enzymes alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 2.5X ULN for subjects without liver metastasis or ≥ 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
* Received any red blood cell (RBC) transfusion within 28 days prior to randomization.
* Plan to receive any RBC transfusion between randomization and study day 1.
* Known previous treatment failure to erythropoiesis stimulating agents (ESAs) (eg, rHuEPO, darbepoetin alfa).
* ESA therapy within the 28 days prior to randomization.
* Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
* Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
* Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
* Previously randomized to this study.
* Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits).
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Anchorage, Alaska, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Arcadia, California, United States
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Berkeley, California, United States
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Burbank, California, United States
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Downey, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Fresno, California, United States
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La Verne, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Merced, California, United States
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Mission Hills, California, United States
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Montebello, California, United States
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Oxnard, California, United States
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Palm Springs, California, United States
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Pismo Beach, California, United States
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Pomona, California, United States
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Redlands, California, United States
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Salinas, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Simi Valley, California, United States
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Soquel, California, United States
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St. Helena, California, United States
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Torrance, California, United States
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Vallejo, California, United States
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West Covina, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Bridgeport, Connecticut, United States
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Southington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Boynton Beach, Florida, United States
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Coral Springs, Florida, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Holiday, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Lake Worth, Florida, United States
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Lakeland, Florida, United States
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Lecanto, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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New Port Richey, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Rockledge, Florida, United States
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Tamarac, Florida, United States
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The Villages, Florida, United States
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Titusville, Florida, United States
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Weston, Florida, United States
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Albany, Georgia, United States
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Augusta, Georgia, United States
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Stockbridge, Georgia, United States
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Thomasville, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Galesburg, Illinois, United States
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Gurnee, Illinois, United States
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Mount Vernon, Illinois, United States
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Skokie, Illinois, United States
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Indianapolis, Indiana, United States
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Michigan City, Indiana, United States
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Muncie, Indiana, United States
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Council Bluffs, Iowa, United States
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Dubuque, Iowa, United States
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Iowa City, Iowa, United States
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Sioux City, Iowa, United States
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Waterloo, Iowa, United States
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Hutchinson, Kansas, United States
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Wichita, Kansas, United States
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Ashland, Kentucky, United States
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Hazard, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Morehead, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Paducah, Kentucky, United States
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Paducah, Kentucky, United States
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Alexandria, Louisiana, United States
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Lafayette, Louisiana, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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Ruston, Louisiana, United States
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Shreveport, Louisiana, United States
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Lewiston, Maine, United States
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Rockport, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Chevy Chase, Maryland, United States
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Cumberland, Maryland, United States
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Frederick, Maryland, United States
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Hagerstown, Maryland, United States
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Towson, Maryland, United States
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Westminster, Maryland, United States
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Attleboro, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Cambridge, Massachusetts, United States
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Worcester, Massachusetts, United States
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Clarkston, Michigan, United States
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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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Southfield, Michigan, United States
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Southgate, Michigan, United States
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Willmar, Minnesota, United States
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Biloxi, Mississippi, United States
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Hattiesburg, Mississippi, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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Columbia, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Kalispell, Montana, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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North Las Vegas, Nevada, United States
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Manchester, New Hampshire, United States
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Sparta, New Jersey, United States
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Teaneck, New Jersey, United States
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Vineland, New Jersey, United States
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Albuquerque, New Mexico, United States
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Santa Fe, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Glens Falls, New York, United States
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Goshen, New York, United States
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Lake Success, New York, United States
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Latham, New York, United States
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Nyack, New York, United States
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Poughkeepsie, New York, United States
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Staten Island, New York, United States
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Staten Island, New York, United States
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Syracuse, New York, United States
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Valhalla, New York, United States
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Asheboro, North Carolina, United States
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Asheville, North Carolina, United States
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Burlington, North Carolina, United States
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Concord, North Carolina, United States
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Durham, North Carolina, United States
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Goldsboro, North Carolina, United States
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Greenville, North Carolina, United States
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Hendersonville, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Huntersville, North Carolina, United States
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Kinston, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, North Carolina, United States
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Washington, North Carolina, United States
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Bismarck, North Dakota, United States
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Akron, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Massillon, Ohio, United States
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Middletown, Ohio, United States
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Port Clinton, Ohio, United States
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Sylvania, Ohio, United States
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Wooster, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Gettysburg, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Providence, Rhode Island, United States
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Woonsocket, Rhode Island, United States
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Aiken, South Carolina, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Hilton Head Island, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Sumter, South Carolina, United States
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Aberdeen, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Watertown, South Dakota, United States
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Johnson City, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bedford, Texas, United States
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Bryan, Texas, United States
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Corpus Christi, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Garland, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Longview, Texas, United States
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McAllen, Texas, United States
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Mesquite, Texas, United States
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Midland, Texas, United States
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Paris, Texas, United States
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Richardson, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Southlake, Texas, United States
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Sugar Land, Texas, United States
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Temple, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Webster, Texas, United States
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Wichita Falls, Texas, United States
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Ogden, Utah, United States
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White River Junction, Vermont, United States
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Christiansburg, Virginia, United States
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Fairfax, Virginia, United States
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Lynchburg, Virginia, United States
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Newport News, Virginia, United States
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Portsmouth, Virginia, United States
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Bremerton, Washington, United States
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Burien, Washington, United States
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Edmonds, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Vancouver, Washington, United States
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Yakima, Washington, United States
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Green Bay, Wisconsin, United States
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Janesville, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Quilmes, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, Distrito Federal, Argentina
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Buenos Aires, Distrito Federal, Argentina
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San Salvador de Jujuy, Jujuy Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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La Rioja, , Argentina
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Santa Fe, , Argentina
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Steyr, , Austria
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Vienna, , Austria
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Ieper, , Belgium
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Libramont, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Ottignies, , Belgium
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Fortaleza, Ceará, Brazil
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Fortaleza, Ceará, Brazil
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Cachoeiro de Itapemirim, Espírito Santo, Brazil
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Salvador, Estado de Bahia, Brazil
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Brasília, Federal District, Brazil
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Campo Grande, Mato Grosso do Sul, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Londrina, Paraná, Brazil
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Belém, Pará, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Pelotas, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Itajaí, Santa Catarina, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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São José dos Campos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Moncton, New Brunswick, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Temuco, Cautín, Chile
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Reñaca, Región de Valparaíso, Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
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Fuzhou, Fujian, China
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Lanzhou, Gansu, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Zhongshan, Guangdong, China
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Haikou, Hainan, China
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Haikou, Hainan, China
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Shijiazhuang, Hebei, China
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Harbin, Heilongjiang, China
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Wuhan, Hubei, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Changchun, Jilin, China
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Dalian, Liaoning, China
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Shenyang, Liaoning, China
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Shenyang, Liaoning, China
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Xi'an, Shaanxi, China
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Jinan, Shandong, China
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Chengdu, Sichuan, China
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Chengdu, Sichuan, China
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Ürümqi, Xinjiang, China
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Kunming, Yunnan, China
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Kunming, Yunnan, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Chongqing, , China
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Chongqing, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Rijeka, , Croatia
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Zagreb, , Croatia
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Benesov U Prahy, , Czechia
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Hořovice, , Czechia
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Kutná Hora, , Czechia
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Kyjov, , Czechia
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Nová Ves pod Pleší, , Czechia
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Ostrava-Poruba, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Příbram, , Czechia
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Bad Berka, , Germany
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Köln-Merheim, , Germany
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Moers, , Germany
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München, , Germany
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Münster, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Chania, , Greece
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Larissa, , Greece
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Nea Kifissia, Athens, , Greece
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Piraeus, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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New Territories, , Hong Kong
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Panjim, Goa, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Kochi, Kerala, India
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Bhopal, Madhya Pradesh, India
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Ahilyanagar, Maharashtra, India
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Aurangabad, Maharashtra, India
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Thāne, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Jaipur, Rajasthan, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Kolkata, West Bengal, India
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Bangalore, , India
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Dublin, , Ireland
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Dublin, , Ireland
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Poria Eylit, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Catania, , Italy
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Faenza RA, , Italy
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Grosseto, , Italy
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Lecce, , Italy
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Legnago VR, , Italy
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Lugo RA, , Italy
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Meldola FC, , Italy
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Messina, , Italy
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Milan, , Italy
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Napoli, , Italy
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Ravenna, , Italy
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Reggio Calabria, , Italy
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San Giovanni Rotondo FG, , Italy
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Nagoya, Aichi-ken, Japan
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Fukui-shi, Fukui, Japan
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Chikushino-shi, Fukuoka, Japan
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Kurume-shi, Fukuoka, Japan
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Amagasaki-shi, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Kanazawa, Ishikawa-ken, Japan
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Okayama, Okayama-ken, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Bunkyo-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Yonago-shi, Tottori, Japan
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Kyoto, , Japan
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Esch-sur-Alzette, , Luxembourg
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Luxembourg, , Luxembourg
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Kota Bharu, Kelantan, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuantan, Pahang, Malaysia
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George Town, Pulau Pinang, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Saltillo, Coahuila, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Querétaro City, Querétaro, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Mérida, Yucatán, Mexico
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Chihuahua City, , Mexico
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Colima, , Mexico
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Oaxaca City, , Mexico
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Puebla City, , Mexico
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Davao City, Davao Region, Philippines
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Krakow, , Poland
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Olsztyn, , Poland
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Olsztyn, , Poland
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Rzeszów, , Poland
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San Juan, , Puerto Rico
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San Juan, , Puerto Rico
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Sibiu, , Romania
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Arkhangelsk, , Russia
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Barnaul, , Russia
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Belgorod, , Russia
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Ivanovo, , Russia
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Kirov, , Russia
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Krasnodar, , Russia
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Kursk, , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Obninsk, , Russia
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Omsk, , Russia
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Orenburg, , Russia
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Penza, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Saratov, , Russia
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Stavropol, , Russia
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Tula, , Russia
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Tver', , Russia
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Ufa, , Russia
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Ulyanovsk, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Belgrade, , Serbia
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Gornji Matejevac, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Golnik, , Slovenia
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Pohorje, , Slovenia
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Umhlanga, KwaZulu-Natal, South Africa
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Bloemfontein, , South Africa
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Johannesburg, , South Africa
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Overport, , South Africa
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Polokwane, , South Africa
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Gwangju, , South Korea
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Seongnam-si, Gyeonggido, , South Korea
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Seoul, , South Korea
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Granada, Andalusia, Spain
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Las Palmas de Gran Canaria, Canary Islands, Spain
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Barcelona, Catalonia, Spain
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Pontevedra, Galicia, Spain
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Alicante, Valencia, Spain
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Benidorm, Valencia, Spain
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Valencia, Valencia, Spain
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Aarau, , Switzerland
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Aarau, , Switzerland
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Chur, , Switzerland
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Sursee, , Switzerland
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Zurich, , Switzerland
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Kirovograd, , Ukraine
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Bebington, , United Kingdom
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Dorechester, , United Kingdom
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Dorset, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Gascon P, Nagarkar R, Smakal M, Syrigos KN, Barrios CH, Sanchez JC, Zhang L, Henry DH, Gordon D, Hirsh V, Kubota K, Orlov S, Thomas G, Steinmetz T, Kang JH, Tomita DK, Fleishman AN, Park JK, De Oliveira Brandao C. A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC. J Thorac Oncol. 2020 Feb;15(2):190-202. doi: 10.1016/j.jtho.2019.10.005. Epub 2019 Oct 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2007-005792-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20070782
Identifier Type: -
Identifier Source: org_study_id
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