A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
BORA
A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)
2 other identifiers
interventional
2,133
24 countries
429
Brief Summary
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Nov 2014
Longer than P75 for phase_3 asthma
429 active sites
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
First Submitted
Initial submission to the registry
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 7, 2014
CompletedStudy Start
First participant enrolled
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedResults Posted
Study results publicly available
February 6, 2019
CompletedAugust 21, 2019
July 1, 2019
2.9 years
September 1, 2014
October 18, 2018
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Basophils.
Week 56
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Basophils.
Week 108
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Leukocytes.
Week 56
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Leukocytes.
Week 108
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Lymphocytes.
Week 56
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Lymphocytes.
Week 108
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Neutrophils.
Week 56
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Neutrophils.
Week 108
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in hematologic lab parameter of Eosinophils.
Week 56
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Eosinophils.
Week 108
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry tests ALT.
Week 56
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of ALT.
Week 108
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry tests AST.
Week 56
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of AST.
Week 108
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Change from baseline in chemistry test Bilirubin.
Week 56
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Change from baseline in hematologic lab parameter of Bilirubin.
Week 108
Secondary Outcomes (26)
Number of Overall Patients With Asthma Exacerbations During Study Period
From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
Change From Baseline in Pre-bronchodilator FEV1 (L)
Week 56
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Week 108
Change From Baseline in Post-bronchodilator FEV1 (L)
Week 56
- +21 more secondary outcomes
Study Arms (2)
Benralizumab Arm A
EXPERIMENTALBenralizumab administered subcutaneously
Benralizumab Arm B
EXPERIMENTALBenralizumab administered subcutaneously
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
- Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
- Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP).
- For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
- All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
You may not qualify if:
- Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
- A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
- Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient's ability to complete the entire duration of the study
- Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
- Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product
- Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
- Planned major surgical procedures during the conduct of the study
- Previous participation in the present study
- Concurrent enrolment in another clinical trial
- AstraZeneca staff involved in the planning and/or conduct of the study
- Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
- Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (429)
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Andalusia, Alabama, 36420, United States
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Birmingham, Alabama, 35209, United States
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Scottsboro, Alabama, 35768, United States
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Glendale, Arizona, 85306, United States
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Phoenix, Arizona, 85012, United States
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Alhambra, California, 91801, United States
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Bakersfield, California, 93301, United States
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Newport Beach, California, 92663, United States
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Redondo Beach, California, 90277, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95825, United States
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San Jose, California, 95117, United States
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Stockton, California, 95204, United States
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Walnut Creek, California, 94598, United States
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Westminster, California, 92683, United States
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Woodland, California, 95695, United States
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Colorado Springs, Colorado, 80907, United States
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Denver, Colorado, 80206, United States
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Wheat Ridge, Colorado, 80033, United States
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New Haven, Connecticut, 06520, United States
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Brandon, Florida, 33511, United States
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Clearwater, Florida, 33765, United States
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Cutler Bay, Florida, 33189, United States
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Doral, Florida, 33172, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33013, United States
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Homestead, Florida, 33030, United States
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Miami, Florida, 33015, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33176, United States
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Ocala, Florida, 34471-4463, United States
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Orlando, Florida, 32819, United States
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Orlando, Florida, 32825, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789, United States
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Albany, Georgia, 31707, United States
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Gainesville, Georgia, 30501, United States
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Lawrenceville, Georgia, 30046, United States
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Gurnee, Illinois, 60031, United States
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Normal, Illinois, 61761, United States
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Iowa City, Iowa, 52242, United States
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Fort Mitchell, Kentucky, 41017, United States
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Louisville, Kentucky, 40215, United States
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Covington, Louisiana, 70433, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21236, United States
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Quincy, Massachusetts, 02169, United States
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Farmington Hills, Michigan, 48334, United States
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Farmington Hills, Michigan, 48336, United States
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Flint, Michigan, 48504, United States
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Traverse City, Michigan, 49684, United States
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Rochester, Minnesota, 55905, United States
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Saint Paul, Minnesota, 55130, United States
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St Louis, Missouri, 63143, United States
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Northfield, New Jersey, 08225, United States
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Union, New Jersey, 07083, United States
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Albuquerque, New Mexico, 87131, United States
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New York, New York, 10016, United States
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Staten Island, New York, 10305, United States
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The Bronx, New York, 10461, United States
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Durham, North Carolina, 27705, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27104, United States
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Cincinnati, Ohio, 45231, United States
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Middleburg Heights, Ohio, 44130, United States
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Oklahoma City, Oklahoma, 73103, 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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Oklahoma City, Oklahoma, 73131, United States
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Tulsa, Oklahoma, 74136, United States
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Jefferson Hills, Pennsylvania, 15025, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Warwick, Rhode Island, 02886, United States
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Hodges, South Carolina, 29653, United States
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Rapid City, South Dakota, 57702, United States
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Arlington, Texas, 76018, United States
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Boerne, Texas, 78006, United States
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Dallas, Texas, 75225, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77058, United States
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Houston, Texas, 77081, United States
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Houston, Texas, 77083, United States
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Houston, Texas, 77099, United States
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McAllen, Texas, 78504, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78229, United States
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Splendora, Texas, 77372, United States
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Provo, Utah, 84604, United States
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Salt Lake City, Utah, 84112, United States
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Abingdon, Virginia, 24210, United States
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Falls Church, Virginia, 22044, United States
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Greenfield, Wisconsin, 53228, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Buenos Aires, 1121, Argentina
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Buenos Aires, C1414AIF, Argentina
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CABA, C1056ABJ, Argentina
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CABA, C1425BEN, Argentina
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CABA, C1431FWO, Argentina
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Ciudad Autónoma de Bs. As., 1426, Argentina
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Concepción del Uruguay, 3260, Argentina
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Corrientes, 3400, Argentina
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Córdoba, X5003DCE, Argentina
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Florida, 1138, Argentina
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Godoy Cruz, Argentina
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La Plata, B1902COS, Argentina
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Mar del Plata, B7600GNY, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500GIP, Argentina
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Nueve de Julio, B6500EZL, Argentina
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Ranelagh, 1886, Argentina
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Rosario, S2000DEJ, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Bedford Park, 5042, Australia
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Box Hill, 3128, Australia
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Clayton, 3168, Australia
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Concord, 2139, Australia
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Frankston, 3199, Australia
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Nedlands, 6009, Australia
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New Lambton Heights, 2305, Australia
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Parkville, 3050, Australia
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Prahran, 3004, Australia
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Randwick, 2031, Australia
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Woolloongabba, 4102, Australia
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Santo André, 09080-110, Brazil
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São Paulo, 04323-062, Brazil
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São Paulo, 05403-000, Brazil
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Sorocaba, 18040-425, Brazil
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Dupnitsa, 2600, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pernik, 2300, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7002, Bulgaria
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Samokov, 2000, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1002, Bulgaria
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Sofia, 1152, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Velingrad, 4600, Bulgaria
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Vratsa, 3000, Bulgaria
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Yambol, 8600, Bulgaria
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Calgary, Alberta, T2N 4Z6, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Ottawa, Ontario, K1G 6C6, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Quillota, 2260000, Chile
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Santiago, 8207257, Chile
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Talcahuano, 4270918, Chile
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Valparaíso, 2341131, Chile
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Viña del Mar, 2520594, Chile
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Jindřichův Hradec, 377 01, Czechia
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Karlovy Vary, 360 17, Czechia
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Ostrava, 728 80, Czechia
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Pilsen, 30460, Czechia
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Prague, 130 00, Czechia
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Rokycany, 337 22, Czechia
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Strakonice, 38601, Czechia
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Teplice, 415 01, Czechia
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Brest, 29609, France
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Dijon, 21079, France
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Le Kremlin-Bicêtre, 94275, France
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Le Mans, 72037, France
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Lyon, 69317, France
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Marseille, 13015, France
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Montpellier, 34295, France
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Paris, 75018, France
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Pau, 64046, France
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Pringy, 74374, France
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Saint-Pierre, 97448, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Aschaffenburg, 63739, Germany
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Bamberg, 96049, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 12203, Germany
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Bonn, 53123, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Frankfurt am Main, 60596, Germany
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Geesthacht, 21502, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 22299, Germany
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Hanover, 30167, Germany
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Hanover, 30625, Germany
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Hanover, D-30173, Germany
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Herford, 32049, Germany
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Leipzig, 04103, Germany
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Leipzig, 04207, Germany
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Leipzig, 04275, Germany
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Mainz Am Rhein, 55131, Germany
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München, 80539, Germany
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München, 80639, Germany
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Neu-Isenburg, 63263, Germany
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Rostock, 18057, Germany
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Rüdersdorf, 15562, Germany
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Witten, 58452, Germany
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Asahi-shi, 289-2511, Japan
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Chiyoda-ku, 102-0083, Japan
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Chūōku, 103-0022, Japan
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Fukuoka, 811-1394, Japan
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Hiroshima, 732-0052, Japan
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Itabashi-ku, 173-8610, Japan
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Itabashi-ku, 174-0065, Japan
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Kagoshima, 890-0064, Japan
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Kishiwada-shi, 596-8501, Japan
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Kobe, 653-0013, Japan
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Kokubunji-shi, 185-0014, Japan
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Matsue, 690-8556, Japan
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Minatoku, 105-0003, Japan
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Mizunami-shi, 509-6134, Japan
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Niigata, 950-2085, Japan
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Obihiro-shi, 080-0013, Japan
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Ota-shi, 373-0807, Japan
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Ōita, 870-0021, Japan
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Sagamihara-shi, 252-0315, Japan
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Sakaide-shi, 762-8550, Japan
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Sakaishi, 591-8037, Japan
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Sapporo, 060-0033, Japan
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Sapporo, 064-0807, Japan
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Sendai, 983-8520, Japan
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Setagaya-ku, 158-0097, Japan
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Shibuya-ku, 150-0013, Japan
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Shinagawa-ku, 142-8666, Japan
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Sumida-ku, 130-8587, Japan
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Takamatsu, 761-7073, Japan
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Toshima-ku, 170-0003, Japan
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Tsukubo-gun, 701-0304, Japan
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Yokohama, 231-8682, Japan
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Yokohama, 234-0054, Japan
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Yokohama, 236-0024, Japan
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Cusco, Peru
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Lima, 15102, Peru
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Lima, 41, Peru
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Lima, L41, Peru
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Lima, Lima 18, Peru
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Lima, LIMA 1, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 33, Peru
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Iloilo City, 5000, Philippines
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Lipa City, 4217, Philippines
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Quezon City, 1101, Philippines
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Aleksandrów Łódzki, 95-070, Poland
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Bialystok, 15-044, Poland
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Bialystok, 15-276, Poland
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Bialystok, 15-430, Poland
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Bialystok, 15-879, Poland
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Bielsko-Biala, 43-316, Poland
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Bydgoszcz, 85-168, Poland
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Bystra, 43-360, Poland
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Dobre Miasto, 11-040, Poland
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Gdansk, 80-433, Poland
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Gdansk, 80-952, Poland
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Giżycko, 11-500, Poland
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Gorzów Wlkp, 66-400, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Karczew, 05-480, Poland
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Katowice, 40-081, Poland
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Koszalin, 75-679, Poland
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Kościan, 64-000, Poland
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Krakow, 31-011, Poland
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Krakow, 31-033, Poland
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Krakow, 31-159, Poland
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Krakow, 31-455, Poland
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Lodz, 90-141, Poland
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Lodz, 90-242, Poland
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Lodz, 91-103, Poland
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Lubin, 59-300, Poland
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Lublin, 20-089, Poland
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Lublin, 20-552, Poland
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Lublin, 20-718, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Poznan, 60-214, Poland
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Poznan, 60-685, Poland
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Poznan, 60-693, Poland
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Poznan, 60-823, Poland
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Proszowice, 32-100, Poland
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Ruda Śląska, 41-709, Poland
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Rzeszów, 35-205, Poland
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Rzeszów, 35-612, Poland
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Skierniewice, 96-100, Poland
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Sosnowiec, 41-200, Poland
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Szczecin, 70-111, Poland
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Tarnów, 33-100, Poland
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Trzebnica, 55-100, Poland
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Warsaw, 01-138, Poland
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Warsaw, 01-868, Poland
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Wieluń, 98-300, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 50-220, Poland
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Wroclaw, 51-162, Poland
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Wroclaw, 53-201, Poland
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Wroclaw, 53-301, Poland
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Żnin, 88-400, Poland
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Bragadiru, 077025, Romania
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Bucharest, 030303, Romania
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Bucharest, 71593, Romania
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Constanța, 900002, Romania
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Deva, 330061, Romania
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Iași, 700115, Romania
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Chelyabinsk, 454106, Russia
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Ivanovo, 153005, Russia
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Izhevsk, 426063, Russia
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Kazan', 420012, Russia
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Moscow, 109240, Russia
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Moscow, 115682, Russia
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Moscow, 121309, Russia
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Moscow, 123995, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630084, Russia
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Pyatigorsk, 357500, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 194356, Russia
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Saint Petersburg, 195257, Russia
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Saint Petersburg, 196084, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 196657, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 410053, Russia
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Smolensk, 214019, Russia
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StPetersburg, 193312, Russia
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Tomsk, 634063, Russia
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Vladikavkaz, 362007, Russia
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Vladimir, 600023, Russia
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Volgograd, 400001, Russia
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Volgograd, 400131, Russia
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Yekaterinburg, 620039, Russia
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Yekaterinburg, 620109, Russia
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Yekaterinburg, 620149, Russia
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Cape Town, 7764, South Africa
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Durban, 4092, South Africa
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KwaDukuza, 4450, South Africa
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Mowbray, 7700, South Africa
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Anyang-si, 14068, South Korea
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Bucheon-si, 14584, South Korea
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Busan, 49201, South Korea
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Busan, 602-702, South Korea
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Cheongju-si, 362-804, South Korea
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Gwangju, 61469, South Korea
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Incheon, 21431, South Korea
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Incheon, 405-760, South Korea
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Jeju City, 690-767, South Korea
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Seoul, 03080, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05030, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 07985, South Korea
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Seoul, 08308, South Korea
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Seoul, 135-710, South Korea
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Seoul, 150-713, South Korea
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Suwon, 16499, South Korea
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Barcelona, 08025, Spain
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Barcelona, 08036, Spain
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Lugo, 27004, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Palma de Mallorca, 07010, Spain
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Sagunto(Valencia), 46520, Spain
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Salamanca, 37007, Spain
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Valencia, 46015, Spain
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Valencia, 46017, Spain
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Gothenburg, Sweden
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Lund, 22185, Sweden
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34844, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Chernivtsi, 58000, Ukraine
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Dnipropetrovsk, 49007, Ukraine
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Ivano-Frankivsk, 76012, Ukraine
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Kharkiv, 61022, Ukraine
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Kharkiv, 61035, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61058, Ukraine
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Kharkiv, 61106, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04201, Ukraine
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Lutsk, 43000, Ukraine
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Uzhhorod, 88000, Ukraine
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Vinnytsia, 21029, Ukraine
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Birmingham, B9 5SS, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Chertsey, KT16 0PZ, United Kingdom
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Chester, CH2 1UL, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Darlington, DL3 6HX, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Soham, CB7 5JD, United Kingdom
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Somerset, BS26 2BJ, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
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Stockton, TS19 8PE, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Related Publications (2)
Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.
PMID: 33609624DERIVEDBusse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8.
PMID: 30416083DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Patients in this study had to complete treatment in predecessor studies. Therefore selection bias may exist. Baseline is defined for this study's entry value, not all values are prior to active treatment due to some patients being treated previously.
Results Point of Contact
- Title
- Ubaldo Martin, Global Clinical Lead Benralizumab
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
William W. Busse, M.D., Professor of Medicine
Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2014
First Posted
October 7, 2014
Study Start
November 19, 2014
Primary Completion
October 18, 2017
Study Completion
July 2, 2018
Last Updated
August 21, 2019
Results First Posted
February 6, 2019
Record last verified: 2019-07