NCT00358215

Brief Summary

The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
2,278

participants targeted

Target at P75+ for phase_3 heart-failure

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3 heart-failure

Geographic Reach
34 countries

743 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 13, 2013

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6.4 years

First QC Date

July 27, 2006

Results QC Date

October 23, 2013

Last Update Submit

November 4, 2022

Conditions

Keywords

Survival studymorbidity and mortalityheart failure hospitalizationall-cause deathpatient-reported outcomesKansas City Cardiomyopathy questionnaireanemia treatment

Outcome Measures

Primary Outcomes (1)

  • Time to All Cause Death or First Hospitalization for Worsening Heart Failure

    Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

    From randomization to the end of study; maximum time on study was 73 months

Secondary Outcomes (4)

  • Time to Death From Any Cause

    From randomization to the end of study; maximum time on study was 73 months

  • Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure

    From randomization to the end of study; maximum time on study was 73 months

  • Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    Baseline and Month 6

  • Change From Baseline to Month 6 in KCCQ Symptom Frequency Score

    Baseline and Month 6

Study Arms (2)

Darbepoetin alfa

EXPERIMENTAL

Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.

Drug: Darbepoetin alfa

Placebo

PLACEBO COMPARATOR

Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.

Drug: Placebo

Interventions

Administered by subcutaneous injection

Also known as: Aranesp®
Darbepoetin alfa

Placebo subcutaneous injection

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure of at least 3 months duration and of New York Heart Association (NYHA) class II, III, or IV
  • hemoglobin between 9.0 g/dL and 12.0 g/dL
  • left ventricular ejection fraction equal to or less than 40%

You may not qualify if:

  • Transferrin saturation (Tsat) \< 15%
  • Blood pressure \> 160/100 mm Hg
  • Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
  • Recipient of a major organ transplant or receiving renal replacement therapy
  • Serum creatinine \> 3.0 mg/dL (\> 265 µmol/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (754)

Research Site

Birmingham, Alabama, 35211, United States

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Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Gilbert, Arizona, 85296, United States

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Mesa, Arizona, 85206, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85723, United States

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Little Rock, Arkansas, 72204, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92801, United States

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Buena Park, California, 90621, United States

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Corona, California, 92879, United States

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Culver City, California, 90232, United States

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Downey, California, 90241, United States

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La Jolla, California, 92037, United States

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Lancaster, California, 93534, United States

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Larkspur, California, 94939, United States

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Loma Linda, California, 92354, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90024, United States

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Los Angeles, California, 90033-1026, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90073, United States

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Modesto, California, 95355, United States

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Oakland, California, 94609, United States

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Pasadena, California, 91105, United States

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Redondo Beach, California, 90277, United States

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Sacramento, California, 95819, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92120, United States

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San Francisco, California, 94115, United States

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San Francisco, California, 94118, United States

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Santa Monica, California, 90404, United States

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Santa Rosa, California, 95405, United States

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Sylmar, California, 91342, United States

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Walnut Creek, California, 94598, United States

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Westlake Village, California, 91361, United States

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Aurora, Colorado, 80012, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80218, United States

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Littleton, Colorado, 80120, United States

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Loveland, Colorado, 80538, United States

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Bridgeport, Connecticut, 06606, United States

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Fairfield, Connecticut, 06430, United States

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Washington D.C., District of Columbia, 20010, United States

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Washington D.C., District of Columbia, 20422, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32209, United States

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Jacksonville, Florida, 32258, United States

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Jacksonville Beach, Florida, 32250, United States

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Jupiter, Florida, 33458, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33133, United States

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Miami Beach, Florida, 33140, United States

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Orlando, Florida, 32803, United States

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Port Charlotte, Florida, 33952, United States

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Safety Harbor, Florida, 34695, United States

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Sarasota, Florida, 34239, United States

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St. Petersburg, Florida, 33701, United States

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St. Petersburg, Florida, 33705, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33609, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30901, United States

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Covington, Georgia, 30014, United States

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Rome, Georgia, 30165, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60611, United States

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Elk Grove Village, Illinois, 60007, United States

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Evanston, Illinois, 60202, United States

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Hinsdale, Illinois, 60521, United States

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Maywood, Illinois, 60153, United States

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Melrose Park, Illinois, 60160, United States

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Oak Lawn, Illinois, 60453, United States

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Oakbrook Terrace, Illinois, 60181, United States

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Peoria, Illinois, 61606, United States

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Rockford, Illinois, 61107, United States

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Springfield, Illinois, 62701, United States

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Springfield, Illinois, 62702, United States

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Anderson, Indiana, 46011, United States

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Fort Wayne, Indiana, 46805, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46250, United States

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Indianapolis, Indiana, 46260, United States

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Jeffersonville, Indiana, 47130, United States

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Valparaiso, Indiana, 46383, United States

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Des Moines, Iowa, 50314, United States

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Iowa City, Iowa, 52242, United States

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Iowa City, Iowa, 52245, United States

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Kansas City, Kansas, 66160, United States

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Olathe, Kansas, 66061, United States

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Wichita, Kansas, 67214, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Madisonville, Kentucky, 42431, United States

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Alexandria, Louisiana, 71301, United States

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Covington, Louisiana, 70433, United States

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Lake Charles, Louisiana, 70601, United States

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Marrero, Louisiana, 70072, United States

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Slidell, Louisiana, 70458, United States

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South Portland, Maine, 04106, United States

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Annapolis, Maryland, 21401, United States

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Baltimore, Maryland, 21287, United States

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Salisbury, Maryland, 21804, United States

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Ayer, Massachusetts, 01432, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02118, United States

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Haverhill, Massachusetts, 01830, United States

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Natick, Massachusetts, 01760, United States

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North Dartmouth, Massachusetts, 02747, United States

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West Roxbury, Massachusetts, 02132, United States

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Whitman, Massachusetts, 02382, United States

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Worcester, Massachusetts, 01604, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Grand Rapids, Michigan, 49503, United States

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Lansing, Michigan, 48910, United States

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Muskegon, Michigan, 49444, United States

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Petoskey, Michigan, 49770, United States

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Saginaw, Michigan, 48601, United States

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Southfield, Michigan, 48075, United States

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Duluth, Minnesota, 55805, United States

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Minneapolis, Minnesota, 55304, United States

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Minneapolis, Minnesota, 55417, United States

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Minneapolis, Minnesota, 55455, United States

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Saint Louis Park, Minnesota, 55426, United States

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Saint Paul, Minnesota, 55102, United States

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Columbia, Missouri, 65201, United States

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Kansas City, Missouri, 64108, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63122, United States

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Kalispell, Montana, 59901, United States

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Missoula, Montana, 59802, United States

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Grand Island, Nebraska, 68803, United States

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Lincoln, Nebraska, 68506, United States

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Lincoln, Nebraska, 68526, United States

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Lebanon, New Hampshire, 03756, United States

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Hackensack, New Jersey, 07601, United States

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Morristown, New Jersey, 07962, United States

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Newark, New Jersey, 07103, United States

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Newark, New Jersey, 07112, United States

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Summit, New Jersey, 07902, United States

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Westwood, New Jersey, 07675, United States

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Albuquerque, New Mexico, 87131, United States

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Buffalo, New York, 14221, United States

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Cortlandt Manor, New York, 10567, United States

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Flushing, New York, 11355, United States

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Garden City, New York, 11530, United States

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Johnson City, New York, 13790, United States

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Kingston, New York, 12401, United States

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New York, New York, 10001, United States

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New York, New York, 10016, United States

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New York, New York, 10019, United States

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New York, New York, 10021, United States

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New York, New York, 10029, United States

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New York, New York, 10032, United States

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Rochester, New York, 14618, United States

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Staten Island, New York, 10305, United States

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Syracuse, New York, 13210, United States

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The Bronx, New York, 10461, United States

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The Bronx, New York, 10467, United States

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Troy, New York, 12180, United States

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West Islip, New York, 11795, United States

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Williamsville, New York, 14221, United States

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Asheville, North Carolina, 28803, United States

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Burlington, North Carolina, 27215, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28204, United States

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Durham, North Carolina, 27705, United States

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Gastonia, North Carolina, 28054, United States

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Greensboro, North Carolina, 27403, United States

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New Bern, North Carolina, 28562, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27157, United States

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Akron, Ohio, 44307, United States

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Canton, Ohio, 44710, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44109, United States

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Cleveland, Ohio, 44195, United States

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Dayton, Ohio, 45414, United States

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Garfield Heights, Ohio, 44125, United States

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Mayfield Heights, Ohio, 44124, United States

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Sandusky, Ohio, 44870, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73109, United States

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Oklahoma City, Oklahoma, 73112, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74104, United States

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Bend, Oregon, 97701, United States

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Hillsboro, Oregon, 97123, United States

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Portland, Oregon, 97213, United States

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Allentown, Pennsylvania, 18106, United States

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Hershey, Pennsylvania, 17033, United States

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Lancaster, Pennsylvania, 17603, United States

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Philadelphia, Pennsylvania, 19102, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19140, United States

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Philadelphia, Pennsylvania, 19141, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15224, United States

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Sayre, Pennsylvania, 18840, United States

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Wyomissing, Pennsylvania, 19610, United States

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Pawtucket, Rhode Island, 02860, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29401, United States

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Charleston, South Carolina, 29403, United States

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Columbia, South Carolina, 29204, United States

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Orangeburg, South Carolina, 29115, United States

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Spartanburg, South Carolina, 29303, United States

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Chattanooga, Tennessee, 37404, United States

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Germantown, Tennessee, 38138, United States

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Jackson, Tennessee, 38305, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37232-8802, United States

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Tullahoma, Tennessee, 37388, United States

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Beaumont, Texas, 77702, United States

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Dallas, Texas, 75216, United States

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Dallas, Texas, 75226, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75390, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77074, United States

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Lubbock, Texas, 79410, United States

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Odessa, Texas, 79763, United States

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San Antonio, Texas, 78217, United States

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Tyler, Texas, 75708, United States

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Salt Lake City, Utah, 84148, United States

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Annandale, Virginia, 22003, United States

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Midlothian, Virginia, 23114, United States

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Richmond, Virginia, 23249, United States

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Roanoke, Virginia, 24014, United States

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Bellingham, Washington, 98225, United States

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Kirkland, Washington, 98034, United States

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Seattle, Washington, 98195, United States

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Tacoma, Washington, 98405, United States

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Beloit, Wisconsin, 53511, United States

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Madison, Wisconsin, 53707, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53215, United States

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Adrogué, Buenos Aires, 1836, Argentina

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Bahía Blanca, Buenos Aires, 8000, Argentina

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Capital Federal, Buenos Aires, C1408INH, Argentina

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Capital Federal, Buenos Aires, C1426ANZ, Argentina

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Ciudad Autónoma de Buenos Aires, Buenos Aires, 1118, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425, Argentina

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Coronel Suárez, Buenos Aires, 7540, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Quilmes, Buenos Aires, B1878GEG, Argentina

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San Martín, Buenos Aires, 1650, Argentina

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Córdoba, Córdoba, X5016KEH, Argentina

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Cipolletti, RÃ-o Negro, R8324EMD, Argentina

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Rosario, Santa Fe Province, S2000CVD, Argentina

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Buenos Aires, 1155, Argentina

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Buenos Aires, B1708KCH, Argentina

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Buenos Aires, C1181ACH, Argentina

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Buenos Aires, C1280AEB, Argentina

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Buenos Aires, C1405BCH, Argentina

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Buenos Aires, C1416DRJ, Argentina

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Capital Federal, C1221ADC, Argentina

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Corrientes, W3400AMZ, Argentina

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Córdoba, 5000, Argentina

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Córdoba, X5004CDT, Argentina

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Mendoza, 5500, Argentina

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Salta, A4406CLA, Argentina

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Santa Fe, 3000, Argentina

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Camperdown, New South Wales, 2050, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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Concord, New South Wales, 2139, Australia

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Gosford, New South Wales, 2250, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Randwick, New South Wales, 2031, Australia

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Chermside, Queensland, 4032, Australia

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Kippa-Ring, Queensland, 4021, Australia

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Woolloongabba, Queensland, 4102, Australia

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Bedford Park, South Australia, 5042, Australia

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Geelong, Victoria, 3220, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3052, Australia

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Prahran, Victoria, 3181, Australia

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Nedlands, Western Australia, 6009, Australia

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Linz, 4021, Austria

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Vienna, 1150, Austria

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Wels, 4600, Austria

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Aalst, 9300, Belgium

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Antwerp, 2020, Belgium

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Antwerp, 2060, Belgium

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Bonheiden, 2820, Belgium

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Bruges, 8000, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Huy, 4500, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Turnhout, 2300, Belgium

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Fortaleza, Ceará, 60864-194, Brazil

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Salvador, Estado de Bahia, 40144-900, Brazil

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Goiânia, Goiás, 74605-050, Brazil

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Belo Horizonte, Minas Gerais, 30110-908, Brazil

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Curitiba, Paraná, 80010-030, Brazil

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Recife, Pernambuco, 50100-060, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

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Campinas, São Paulo, 13059-740, Brazil

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Riberão Preto, São Paulo, 14048-900, Brazil

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São Paulo, São Paulo, 04012-909, Brazil

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São Paulo, São Paulo, 05403-900, Brazil

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São José Do Rio Preto, São Paulo, 15090-000, Brazil

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São Paulo, São Paulo, 04025-002, Brazil

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Rio de Janeiro, 20020-020, Brazil

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Rio de Janeiro, 20551-030, Brazil

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Rio de Janeiro, 22271-100, Brazil

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Dimitrovgrad, 6400, Bulgaria

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Haskovo, 6300, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Plovdiv, 4003, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Sofia, 1606, Bulgaria

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Varna, 9010, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Calgary, Alberta, T2E 7C5, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Edmonton, Alberta, T6K 4C1, Canada

Location

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Campbell River, British Columbia, V9W 5Y4, Canada

Location

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Surrey, British Columbia, V3V 1Z2, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Winnipeg, Manitoba, R3T 2E8, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Ajax, Ontario, L1S 7K8, Canada

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Cambridge, Ontario, N1R 7R1, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Kingston, Ontario, K7L 1C2, Canada

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London, Ontario, N6A 5A5, Canada

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Mississauga, Ontario, L5B 4A2, Canada

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North York, Ontario, M2K 2W2, Canada

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Ottawa, Ontario, K1Y 4W7, Canada

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Scarborough Village, Ontario, M1E 5E9, Canada

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Scarborough Village, Ontario, M1P 2V5, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2W 1T7, Canada

Location

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Montreal, Quebec, H2W 1T8, Canada

Location

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Montreal, Quebec, H3A 1A1, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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St-Jérôme, Quebec, J7Z 5T3, Canada

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Regina, Saskatchewan, S4P 3X3, Canada

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Research Site

Saskatoon, Saskatchewan, S7H 5H9, Canada

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Rancagua, Cachapoal, 2841959, Chile

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La Serena, Elqui, 1731295, Chile

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San Miguel, Santiago Metropolitan, 8900085, Chile

Location

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Osorno, Chile

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Research Site

Santiago, 7500922, Chile

Location

Research Site

Santiago, 8320000, Chile

Location

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Santiago, 8330032, Chile

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Santiago, Chile

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Temuco, 4781151, Chile

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Viña del Mar, Chile

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Benešov, 256 01, Czechia

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Brno, 656 91, Czechia

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České Budějovice, 370 87, Czechia

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Jihlava, 586 01, Czechia

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Karlovy Vary, 360 01, Czechia

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Pardubice, 530 02, Czechia

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Prague, 100 34, Czechia

Location

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Prague, 108 00, Czechia

Location

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Prague, 110 00, Czechia

Location

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Prague, 120 00, Czechia

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Prague, 128 08, Czechia

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Příbram, 261 01, Czechia

Location

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Tábor, 390 03, Czechia

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Ústí nad Labem, 401 13, Czechia

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Fredericia, 7000, Denmark

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Research Site

Frederiksberg, 2000, Denmark

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Research Site

Frederikshavn, 9900, Denmark

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Research Site

Glostrup Municipality, 2600, Denmark

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Hellerup, 2900, Denmark

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Herlev, 2730, Denmark

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Research Site

Horsens, 8700, Denmark

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Research Site

Hvidovre, 2650, Denmark

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København Ø, 2011, Denmark

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København S, 2300, Denmark

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Køge, 4600, Denmark

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Odense, 5000, Denmark

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Roskilde, 4000, Denmark

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Svendborg, 5700, Denmark

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Pärnu, 80010, Estonia

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Tallinn, 10138, Estonia

Location

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Tallinn, 10617, Estonia

Location

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Tallinn, 13419, Estonia

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Espoo, 00029, Finland

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Helsinki, 00260, Finland

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Lahti, 15110, Finland

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Seinäjoki, 60100, Finland

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Bron, 69500, France

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Caen, 14033, France

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Cholet, 49325, France

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Créteil Cedex, 94010, France

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Douai, 59507, France

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Grenoble, 38043, France

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Lille, 59037, France

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Montfermeil, 93370, France

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Montpellier, 34295, France

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Nice, 06002, France

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Paris, 75010, France

Location

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Paris, 75651, France

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Pessac, 33604, France

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Poitiers, 86000, France

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Pontoise, 95301, France

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Rouen, 76031, France

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Saint-Herblain, 44800, France

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Strasbourg, 67091, France

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Toulouse, 31403, France

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Vandœuvre-lès-Nancy, 54511, France

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Bad Tölz, 83646, Germany

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Berlin, 10787, Germany

Location

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Berlin, 12200, Germany

Location

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Berlin, 13353, Germany

Location

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Bochum, 44789, Germany

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Bremen, 28277, Germany

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Frankfurt, 60594, Germany

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Göttingen, 37075, Germany

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Georgsmarienhütte, 49124, Germany

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Hamburg, 20148, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Heidelberg, 69115, Germany

Location

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Heidelberg, 69120, Germany

Location

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Homburg, 66421, Germany

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Ingelheim, 55218, Germany

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Köln, 50924, Germany

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Lahr, 77933, Germany

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Leipzig, 04289, Germany

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Mainz, 55131, Germany

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Marburg, 35037, Germany

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Nürnberg, 90402, Germany

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Schwedt, 16303, Germany

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Stuttgart, 70376, Germany

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Witten, 58455, Germany

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Hong Kong, Hong Kong

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New Territories, 00000, Hong Kong

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Békéscsaba, 5600, Hungary

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Budapest, 1027, Hungary

Location

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Budapest, 1075, Hungary

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Budapest, 1096, Hungary

Location

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Budapest, 1106, Hungary

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Budapest, 1115, Hungary

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Budapest, 1135, Hungary

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Debrecen, 4032, Hungary

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Győr, 9023, Hungary

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Kalocsa, 6300, Hungary

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Kecskemét, 6000, Hungary

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Sopron, 9400, Hungary

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Szeged, 6720, Hungary

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Szekszárd, 7100, Hungary

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Székesfehérvár, 8000, Hungary

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Szolnok, 5000, Hungary

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Veszprém, 8200, Hungary

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Zalaegerszeg, 8900, Hungary

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Hyderabad, Andhra Pradesh, 500 001, India

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Hyderabad, Andhra Pradesh, 500 033, India

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Hyderabad, Andhra Pradesh, 500 063, India

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Ahmedabad, Gujarat, 380 006, India

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Ahmedabad, Gujarat, 380 060, India

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Ahmedabad, Gujarat, 382 428, India

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Gurgaon, Haryana, 122 001, India

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Bangalore, Karnataka, 560 034, India

Location

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Bangalore, Karnataka, 560 054, India

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Mumbai, Maharashtra, 400 022, India

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Nagpur, Maharashtra, 400 012, India

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Nashik, Maharashtra, 422 005, India

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Pune, Maharashtra, 411 001, India

Location

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Pune, Maharashtra, 411 004, India

Location

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Pune, Maharashtra, 411 006, India

Location

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Pune, Maharashtra, 411 011, India

Location

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Pune, Maharashtra, 411 016, India

Location

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Pune, Maharashtra, 411 033, India

Location

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New Delhi, National Capital Territory of Delhi, 110 025, India

Location

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New Delhi, National Capital Territory of Delhi, 110 029, India

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Ludhiana, Punjab, 141 001, India

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Bikaner, Rajasthan, 334 003, India

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Chennai, Tamil Nadu, 600 006, India

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Chennai, Tamil Nadu, 600 037, India

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Chennai, Tamil Nadu, 600 081, India

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Coimbatore, Tamil Nadu, 641 004, India

Location

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Coimbatore, Tamil Nadu, 641 014, India

Location

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Madurai, Tamil Nadu, 625 020, India

Location

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Lucknow, Uttar Pradesh, 226 014, India

Location

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Mumbai, 400 020, India

Location

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Askelon, 78278, Israel

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Beer Yaakov, 70300, Israel

Location

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Beersheba, 84101, Israel

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Giv‘atayim, 53583, Israel

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Hadera, 38100, Israel

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Haifa, 34362, Israel

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Holon, 58100, Israel

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Jerusalem, 91031, Israel

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Jerusalem, 91200, Israel

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Kfar Saba, 44281, Israel

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Safed, 13100, Israel

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Tel Aviv, 64239, Israel

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Arezzo, 52100, Italy

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Bergamo, 24128, Italy

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Cesenatico (FC), 47042, Italy

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Cetraro CS, 87022, Italy

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Cortona AR, 52044, Italy

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Eboli, 84025, Italy

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Ferrara, 44100, Italy

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Forlì, 47100, Italy

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Milan, 20138, Italy

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Napoli, 80131, Italy

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Oliveto Citra SA, 84020, Italy

Location

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Palermo, 90126, Italy

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Palmanova UD, 33057, Italy

Location

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Pavia, 27100, Italy

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Roma, 00152, Italy

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Roma, 00184, Italy

Location

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Rozzano MI, 20089, Italy

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San Bonifacio VR, 37047, Italy

Location

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Torino, 10126, Italy

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Trento, 38100, Italy

Location

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Udine, 33100, Italy

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Daugavpils, 5417, Latvia

Location

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Ogre, 5001, Latvia

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Rēzekne, 4600, Latvia

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Riga, 1002, Latvia

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Riga, 1006, Latvia

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Riga, 1012, Latvia

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Riga, 1038, Latvia

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Alytus, 62114, Lithuania

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Kaunas, 44320, Lithuania

Location

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Kaunas, 49155, Lithuania

Location

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Kaunas, 50009, Lithuania

Location

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Klaipėda, 92288, Lithuania

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Šiauliai, 76231, Lithuania

Location

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Vilnius, 01113, Lithuania

Location

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Vilnius, 08314, Lithuania

Location

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Vilnius, 08661, Lithuania

Location

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Vilnius, 10309, Lithuania

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Guadajalara, Jalisco, 44100, Mexico

Location

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Guadalajara, Jalisco, 44340, Mexico

Location

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Guadalajara, Jalisco, 44380, Mexico

Location

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Mexico City, Mexico City, 14080, Mexico

Location

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Monterrey, Nuevo León, 64000, Mexico

Location

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San Luis Potosí City, San Luis PotosÃ-, 78240, Mexico

Location

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Xalapa, Veracruz, 91140, Mexico

Location

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Mérida, Yucatán, 97000, Mexico

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Baja California, 21397, Mexico

Location

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Distrito Federal, 06760, Mexico

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's-Hertogenbosch, 5211 RW, Netherlands

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Alkmaar, 1815 JD, Netherlands

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Almelo, 7609 PP, Netherlands

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Amsterdam, 1091 AC, Netherlands

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Arnhem, 6815 AD, Netherlands

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Assen, 9401 RK, Netherlands

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Blaricum, 1261 AN, Netherlands

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Breda, 4818 CK, Netherlands

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Delft, 2625 AD, Netherlands

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Deventer, 7416 SE, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7513 ER, Netherlands

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Groningen, 9713 GZ, Netherlands

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Haarlem, 2035 RC, Netherlands

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Harderwijk, 3844 DG, Netherlands

Location

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Heerlen, 6419 PC, Netherlands

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Hilversum, 1213 XZ, Netherlands

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Hoorn, 1625 HV, Netherlands

Location

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Nijmegen, 6532 SZ, Netherlands

Location

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Rotterdam, 3045 PM, Netherlands

Location

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Rotterdam, 3083 AN, Netherlands

Location

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Sneek, 8601 ZK, Netherlands

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The Hague, 2512 VA, Netherlands

Location

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Tiel, 4002 WP, Netherlands

Location

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Tilburg, 5042 AD, Netherlands

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Zwijndrecht, 3331 LZ, Netherlands

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Arendal, 4809, Norway

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Ã…lesund, 6026, Norway

Location

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Gjettum, 1309, Norway

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Kristiansand, 4604, Norway

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Oslo, 0407, Norway

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Skien, 3710, Norway

Location

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Stavanger, 4095, Norway

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Bialystok, 15-276, Poland

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Gdansk, 80-952, Poland

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Gdynia, 81-423, Poland

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Gdynia, 81-519, Poland

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Katowice, 40-635, Poland

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Krakow, 30-092, Poland

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Krakow, 31-202, Poland

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Lublin, 20-954, Poland

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Stalowa Wola, 37-450, Poland

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Tarnów, 33-100, Poland

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Warsaw, 01-211, Poland

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Warsaw, 01-809, Poland

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Warsaw, 03-242, Poland

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Warsaw, 04-238, Poland

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Warsaw, 04-628, Poland

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Wałbrzych, 58-309, Poland

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Wroclaw, 50-981, Poland

Location

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Zabrze, 41-800, Poland

Location

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Zielona Góra, 65-046, Poland

Location

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Coimbra, 3000-075, Portugal

Location

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Faro, 8000-386, Portugal

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Lisbon, 1169-024, Portugal

Location

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Lisbon, 1449-005, Portugal

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San Juan, 00935, Puerto Rico

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Arad, 310031, Romania

Location

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Bacau, 600114, Romania

Location

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Brasov, 500157, Romania

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Bucharest, 011461, Romania

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Bucharest, 021659, Romania

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Bucharest, 022328, Romania

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Bucharest, 030171, Romania

Location

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Iași, 700111, Romania

Location

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Oradea, 410169, Romania

Location

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Sibiu, 550245, Romania

Location

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Târgu Mureş, 540103, Romania

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Târgu Mureş, 540136, Romania

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Timișoara, 300041, Romania

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Timișoara, 300310, Romania

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Moscow, 107014, Russia

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Moscow, 109263, Russia

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Moscow, 115093, Russia

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Moscow, 115516, Russia

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Moscow, 117292, Russia

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Moscow, 117513, Russia

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Moscow, 119435, Russia

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Moscow, 119620, Russia

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Moscow, 119992, Russia

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Moscow, 121359, Russia

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Moscow, 121552, Russia

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Moscow, 125206, Russia

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Moscow, 125315, Russia

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Moscow, 127018, Russia

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Moscow, 127473, Russia

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Moscow, 127644, Russia

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Moscow, 129090, Russia

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Saint Petersburg, 192242, Russia

Location

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Saint Petersburg, 194017, Russia

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Saint Petersburg, 194156, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 198205, Russia

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Saint Petersburg, 199106, Russia

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Volgograd, 400008, Russia

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Bardejov, 085 01, Slovakia

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Bratislava, 811 00, Slovakia

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Košice, 040 22, Slovakia

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Levice, 934 48, Slovakia

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Lučenec, 984 01, Slovakia

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Nitra, 949 01, Slovakia

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Nitra, 950 01, Slovakia

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Prešov, 080 01, Slovakia

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Žilina, 012 07, Slovakia

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Boksburg, Gauteng, 1459, South Africa

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Johannesburg, Gauteng, 2157, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Soweto, Gauteng, 2013, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Durban, KwaZulu-Natal, 4052, South Africa

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Durban, KwaZulu-Natal, 4068, South Africa

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Parow, Western Cape, 7505, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Worcester, Western Cape, 6850, South Africa

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Cape Town, 7405, South Africa

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Cape Town, 7530, South Africa

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Córdoba, AndalucÃ-a, 14004, Spain

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Granada, AndalucÃ-a, 18014, Spain

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Málaga, AndalucÃ-a, 29010, Spain

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Santander, Cantabria, 39008, Spain

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Badalona, Cataluña, 08916, Spain

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Barcelona, Cataluña, 08003, Spain

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Barcelona, Cataluña, 08035, Spain

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Barcelona, Cataluña, 08036, Spain

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Barcelona, Cataluña, 08041, Spain

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Sabadell, Cataluña, 08208, Spain

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Tarragona, Cataluña, 43007, Spain

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Santiago de Compostela, Galicia, 15706, Spain

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Majadhonda, Madrid, 28222, Spain

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El Palmar, Murcia, 30120, Spain

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Galdakao, PaÃ-s Vasco, 48960, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Valencia, Valencia, 46014, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Ã-rebro, 701 85, Sweden

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Danderyd, 182 88, Sweden

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Göteborg, 413 45, Sweden

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Göteborg, 416 85, Sweden

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Linköping, 581 85, Sweden

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Malmö, 205 02, Sweden

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Mölndal, 431 80, Sweden

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Stockholm, 112 81, Sweden

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Sundsvall, 851 56, Sweden

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Umeå, 901 85, Sweden

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Uppsala, 751 85, Sweden

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Lugano, 6900, Switzerland

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Sankt Gallen, 9007, Switzerland

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Barnet, EN5 3DJ, United Kingdom

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Belfast, BT12 6BA, United Kingdom

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Birmingham, B757RR, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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Bridlington, YO164QP, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Glasgow, G12 8TA, United Kingdom

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Glasgow, G51 4TF, United Kingdom

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Harrow, HA1 3UJ, United Kingdom

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Kirkcaldy, KY2 5AH, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Leicester, LE3 9QP, United Kingdom

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Livingston, EH54 6PP, United Kingdom

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London, SE1 7EH, United Kingdom

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Manchester, M8 5RB, United Kingdom

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Romford, RM7 0AG, United Kingdom

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Stockport, SK2 7JE, United Kingdom

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Worcester, WR5 1DD, United Kingdom

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Worthing, BN11 2DH, United Kingdom

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York, YO31 8HE, United Kingdom

Location

Related Publications (5)

  • McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098.

    PMID: 19633103BACKGROUND
  • Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.

    PMID: 23473338BACKGROUND
  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  • Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.

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Related Links

MeSH Terms

Conditions

Heart FailureAnemiaCardiovascular DiseasesVentricular Dysfunction

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Heart DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

June 1, 2006

Primary Completion

October 11, 2012

Study Completion

October 11, 2012

Last Updated

November 8, 2022

Results First Posted

December 13, 2013

Record last verified: 2022-11

Locations