A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
THARROS
A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)
2 other identifiers
interventional
5,000
35 countries
895
Brief Summary
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2024
Typical duration for phase_3
895 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
February 21, 2024
CompletedStudy Start
First participant enrolled
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 7, 2028
March 4, 2026
March 1, 2026
4 years
February 21, 2024
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first severe cardiac or COPD event
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
Up to 3 years
Secondary Outcomes (6)
Time to first severe COPD exacerbation event
Up to 3 years
Time to first severe cardiac event
Up to 3 years
Time to cardiopulmonary death
Up to 3 years
Moderate/severe COPD exacerbation rate
Over time, up 3 years
Time to Myocardial Infarction (MI) hospitalization or cardiac death
Up to 3 years
- +1 more secondary outcomes
Other Outcomes (1)
Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death
Up to 3 years
Study Arms (2)
BGF arm
EXPERIMENTALBGF MDI 320/14.4/9.6 μg BID
GFF arm
EXPERIMENTALGFF MDI 14.4/9.6 μg BID
Interventions
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Eligibility Criteria
You may qualify if:
- Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
- the ICF.
- Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
- A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70%
- at V1.
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
- defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6
- months prior to V1.
- A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by
- the central laboratory
- A CAT score of ≥ 10 at Visit 1.
- Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b),
- (c), or (d)\]:
- : Established CV Disease
- : Combination of CV risk factors:
- +17 more criteria
You may not qualify if:
- Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
- End-stage renal disease requiring renal replacement therapy
- History of heart or lung transplant or actively listed for heart or lung transplant.
- Implanted left ventricular assist device or implant anticipated in \< 3 months.
- History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
- Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:
- An MI or unstable angina in the last 8 weeks
- Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.
- NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event.
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
- Any life-threatening condition, including malignancy, with a life expectancy \< 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.
- Use of maintenance ICS treatment within the past 12 months.
- Unable to abstain from protocol-defined prohibited medications
- Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).
- Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (917)
Research Site
Athens, Alabama, 35611, United States
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Cullman, Alabama, 35058, United States
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Fairhope, Alabama, 36532, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Sheffield, Alabama, 35660, United States
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Gilbert, Arizona, 85296, United States
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Glendale, Arizona, 85308, United States
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Mesa, Arizona, 85206, United States
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Mesa, Arizona, 85213, United States
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Phoenix, Arizona, 85006, United States
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Tempe, Arizona, 85281, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85710, United States
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Tucson, Arizona, 85715, United States
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Apple Valley, California, 92307, United States
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Canoga Park, California, 91303, United States
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Castroville, California, 95012, United States
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Garden Grove, California, 92844, United States
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Gardena, California, 90247, United States
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Inglewood, California, 90301, United States
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La Mesa, California, 91942, United States
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La Palma, California, 90623, United States
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Lomita, California, 90717, United States
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Long Beach, California, 90815, United States
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Los Alamitos, California, 90720, United States
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Newport Beach, California, 92660, United States
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Newport Beach, California, 92663, United States
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North Hollywood, California, 91602, United States
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Pomona, California, 91768, United States
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Sacramento, California, 95823, United States
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Sacramento, California, 95831, United States
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San Bernardino, California, 92408, United States
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San Diego, California, 92111, United States
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San Dimas, California, 91773, United States
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Santa Ana, California, 92704, United States
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Tarzana, California, 91356, United States
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Thousand Oaks, California, 91360, United States
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Van Nuys, California, 91405, United States
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Vista, California, 92081, United States
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Westminster, California, 92683, United States
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Aurora, Colorado, 80012, United States
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Denver, Colorado, 80228, United States
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Englewood, Colorado, 80110, United States
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Washington D.C., District of Columbia, 20016, United States
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Boynton Beach, Florida, 33435, United States
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Bradenton, Florida, 34209, United States
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Cape Coral, Florida, 33990, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Crystal River, Florida, 34429, United States
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Cutler Bay, Florida, 33189, United States
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Edgewater, Florida, 32132, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Myers, Florida, 33912, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33013, United States
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Hollywood, Florida, 33024, United States
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Homestead, Florida, 33032, United States
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Kissimmee, Florida, 34741, United States
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Kissimmee, Florida, 34746, United States
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Lake City, Florida, 32055, United States
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Lake City, Florida, 32055, United States
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Lake Worth, Florida, 33467, United States
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Lakeland, Florida, 33805, United States
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Lakeland, Florida, 33813, United States
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Loxahatchee Groves, Florida, 33470, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33175, United States
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Miami Lakes, Florida, 33014, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34470, United States
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Orlando, Florida, 32807, United States
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Orlando, Florida, 32819, United States
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Orlando, Florida, 32825, United States
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Ormond Beach, Florida, 32174, United States
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Pembroke Pines, Florida, 33024, United States
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Plantation, Florida, 33324, United States
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St. Petersburg, Florida, 33713, United States
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Sun City Center, Florida, 33573, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33606, United States
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Tampa, Florida, 33607, United States
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Tampa, Florida, 33625, United States
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Fayetteville, Georgia, 30214, United States
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Peachtree Corners, Georgia, 30092, United States
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Savannah, Georgia, 31406, United States
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Tucker, Georgia, 30084, United States
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Boise, Idaho, 83706, United States
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Chicago, Illinois, 60607, United States
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Winfield, Illinois, 60190, United States
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Valparaiso, Indiana, 46383, United States
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Sioux City, Iowa, 51106, United States
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Newton, Kansas, 67114, United States
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Wichita, Kansas, 67218, United States
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Lexington, Kentucky, 40503, United States
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Paducah, Kentucky, 42001, United States
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Lafayette, Louisiana, 70508, United States
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Monroe, Louisiana, 71201, United States
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Shreveport, Louisiana, 71105, United States
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Zachary, Louisiana, 70791, United States
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Glen Burnie, Maryland, 21061, United States
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Oxon Hill, Maryland, 20745, United States
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Potomac, Maryland, 20854, United States
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Boston, Massachusetts, 02115, United States
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Ann Arbor, Michigan, 48109, United States
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Flint, Michigan, 48504, United States
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Southfield, Michigan, 48034, United States
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Southfield, Michigan, 48075, United States
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Gulfport, Mississippi, 39503, United States
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Olive Branch, Mississippi, 38654, United States
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Kansas City, Missouri, 64116, United States
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Liberty, Missouri, 64068, United States
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St Louis, Missouri, 63104, United States
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St Louis, Missouri, 63136, United States
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Missoula, Montana, 59808, United States
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Fremont, Nebraska, 68025, United States
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Grand Island, Nebraska, 68803, United States
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Lincoln, Nebraska, 68510, United States
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Omaha, Nebraska, 68134, United States
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Las Vegas, Nevada, 89101, United States
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Las Vegas, Nevada, 89102, United States
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Las Vegas, Nevada, 89119, United States
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Las Vegas, Nevada, 89121, United States
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Lawrence, New Jersey, 08648, United States
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Mullica Hill, New Jersey, 08062, United States
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Toms River, New Jersey, 08755, United States
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Union City, New Jersey, 07087, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12205, United States
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Albany, New York, 12208, United States
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Bronxville, New York, 10708, United States
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Brooklyn, New York, 11220, United States
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Massapequa, New York, 11758, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10036, United States
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New York, New York, 10065, United States
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The Bronx, New York, 10455, United States
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Vestal, New York, 13850, United States
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Fayetteville, North Carolina, 28303, United States
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Greensboro, North Carolina, 27405, United States
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Greenville, North Carolina, 27834, United States
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Huntersville, North Carolina, 28078, United States
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Morehead City, North Carolina, 28557, United States
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Raleigh, North Carolina, 27612, United States
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Salisbury, North Carolina, 28144, United States
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Statesville, North Carolina, 28625, United States
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Statesville, North Carolina, 28677, United States
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Wilmington, North Carolina, 28412, United States
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Winston-Salem, North Carolina, 27104, United States
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Beavercreek, Ohio, 45431, United States
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Blue Ash, Ohio, 45242, United States
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Cleveland, Ohio, 44130, United States
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Columbus, Ohio, 43215, United States
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Columbus, Ohio, 43235, United States
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Marion, Ohio, 43302, United States
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Toledo, Ohio, 43617, United States
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Norman, Oklahoma, 73071, United States
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Oklahoma City, Oklahoma, 73134, United States
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Tulsa, Oklahoma, 74133, United States
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Grants Pass, Oregon, 97527, United States
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Medford, Oregon, 97504, United States
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Roseburg, Oregon, 97471, United States
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Camp Hill, Pennsylvania, 17011, United States
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DuBois, Pennsylvania, 15801, United States
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Exton, Pennsylvania, 19341, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19140, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29414, United States
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Charleston, South Carolina, 29414, United States
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Columbia, South Carolina, 29201, United States
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Gaffney, South Carolina, 29340, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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Pierre, South Dakota, 57501, United States
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Rapid City, South Dakota, 57701, United States
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Sioux Falls, South Dakota, 57104, United States
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Chattanooga, Tennessee, 37421, United States
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Elizabethton, Tennessee, 37643, United States
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Franklin, Tennessee, 37067, United States
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Morristown, Tennessee, 37813, United States
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Tullahoma, Tennessee, 37388, United States
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Abilene, Texas, 79606, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78704, United States
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Brownsville, Texas, 78520, United States
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Dallas, Texas, 75225, United States
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Dallas, Texas, 75235, United States
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Dallas, Texas, 75254, United States
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El Paso, Texas, 79902, United States
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El Paso, Texas, 79902, United States
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Forney, Texas, 75126, United States
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Georgetown, Texas, 78633, United States
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Houston, Texas, 77002, United States
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Houston, Texas, 77008, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77025, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77079, United States
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Houston, Texas, 77084, United States
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Houston, Texas, 77089, United States
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Houston, Texas, 77207, United States
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Katy, Texas, 77450, United States
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Katy, Texas, 77493, United States
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Kerrville, Texas, 78028, United States
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Kingwood, Texas, 77339, United States
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Lewisville, Texas, 75057, United States
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McAllen, Texas, 78504, United States
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McKinney, Texas, 75069, United States
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Paris, Texas, 75462, United States
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Plano, Texas, 75024, United States
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Plano, Texas, 75093, United States
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Victoria, Texas, 77901, United States
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Waco, Texas, 76708, United States
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Wichita Falls, Texas, 76308, United States
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Wylie, Texas, 75098, United States
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Bountiful, Utah, 84010, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84107, United States
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West Jordan, Utah, 84088, United States
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West Valley City, Utah, 84120, United States
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Newport News, Virginia, 23606, United States
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Norfolk, Virginia, 23504, United States
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Richmond, Virginia, 23219, United States
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Richmond, Virginia, 23226, United States
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Suffolk, Virginia, 23435, United States
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Spokane, Washington, 99218, United States
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Morgantown, West Virginia, 26505, United States
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Cudahy, Wisconsin, 53110, United States
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Milwaukee, Wisconsin, 53228, United States
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Milwaukee, Wisconsin, 53295, United States
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Buenos Aires, 1425, Argentina
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Buenos Aires, C1012AAR, Argentina
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Buenos Aires, C1425BEN, Argentina
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CABA, C1019ABS, Argentina
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Capital Federal, C1060ABN, Argentina
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Ciudad de Buenos Aires, C1414AIF, Argentina
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Ciudad de Buenos Aires, C1425AGC, Argentina
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Florida, B1602DQD, Argentina
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Mar del Plata, B7600GWV, Argentina
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Mendoza, M5500CCG, Argentina
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Ranelagh, 1886, Argentina
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Rosario, 2000, Argentina
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San Fernando, B1646EBJ, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, T4000CBC, Argentina
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Birtinya, 4575, Australia
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Chermside, 4032, Australia
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Coffs Harbour, 02450, Australia
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Dubbo, 2830, Australia
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Nedlands, 6009, Australia
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Port Macquarie, 2444, Australia
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Spearwood, 6163, Australia
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St Albans, 3021, Australia
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Waitara, 2077, Australia
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Wangaratta, 3677, Australia
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Bad Ischl, 4820, Austria
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Braunau am Inn, 5280, Austria
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Feldbach, 8330, Austria
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Belo Horizonte, 30110-934, Brazil
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Belo Horizonte, 30150-221, Brazil
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Belo Horizonte, 30220-140, Brazil
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Blumenau, 89030-101, Brazil
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Brasília, 70200-730, Brazil
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Brasília, 70390-700, Brazil
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Brasília, 70712-903, Brazil
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Brasília, 71681-603, Brazil
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Campina Grande do Sul, 83.430-000, Brazil
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Campinas, 13060-080, Brazil
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Caxias do Sul, 95070-560, Brazil
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Curitiba, 80030-110, Brazil
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Curitiba, 80230-130, Brazil
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Curitiba, 80810-050, Brazil
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Fortaleza, 60125-000, Brazil
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Ijuí, 98700-000, Brazil
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Juiz de Fora, 36033-318, Brazil
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Mossoró, 59603-020, Brazil
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Natal, 59020-035, Brazil
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Niterói, 24020-096, Brazil
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Passo Fundo, 99010-120, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 9061-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Recife, 50740-465, Brazil
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Rio de Janeiro, 20551-030, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Salvador, 40170-130, Brazil
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Santo André, 09080-110, Brazil
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São Bernardo do Campo, 09715090, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 04012-180, Brazil
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São Paulo, 05403-000, Brazil
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Serra, 29160-750, Brazil
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Sorocaba, 18040-425, Brazil
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Volta Redonda, 27258-000, Brazil
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Votuporanga, 15501-405, Brazil
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Burgas, 8000, Bulgaria
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Dobrich, 9300, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Dupnitsa, 2602, Bulgaria
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Haskovo, 6300, Bulgaria
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Kozloduy, 3320, Bulgaria
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Montana, 3400, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pernik, 2300, Bulgaria
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Pleven, 5800, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Plovdiv, 4003, Bulgaria
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Plovdiv, 4004, Bulgaria
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Plovdiv, 4023, Bulgaria
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Rousse, 7000, Bulgaria
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Rousse, 7002, Bulgaria
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Sandanski, 2800, Bulgaria
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Sevlievo, 5403, Bulgaria
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Sliven, 8800, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1756, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Varna, 9000, Bulgaria
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Vidin, 3700, Bulgaria
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Vratsa, 3000, Bulgaria
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Yambol, 8600, Bulgaria
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Calgary, Alberta, T3R 1W7, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Kelowna, British Columbia, V1Y 1Z9, Canada
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Richmond, British Columbia, V6V 2L1, Canada
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Winnipeg, Manitoba, R3L 1Z5, Canada
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Sydney, Nova Scotia, B1M 0A1, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Hamilton, Ontario, L8L 5G4, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Kingston, Ontario, K7M 4E7, Canada
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Thunder Bay, Ontario, P7B 7C7, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1G 5X1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G1W 4R4, Canada
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Québec, Quebec, G3K 2P8, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Trois-Rivières, Quebec, G9A 4P3, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Curicó, 3341643, Chile
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Quillota, 2260000, Chile
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Santiago, 7500691, Chile
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Santiago, 7691236, Chile
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Santiago, 7750495, Chile
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Talca, 3465584, Chile
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Temuco, 4810345, Chile
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Victoria, 4720097, Chile
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Viña del Mar, 2540488, Chile
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Vitacura, 7630226, Chile
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Anning, 650000, China
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Anyang, 455001, China
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Baotou, 014040, China
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Baotou, 14010, China
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Beijing, 101100, China
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Beijing, 10730, China
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Changsha, 410004, China
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Changsha, 410005, China
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Changsha, 410015, China
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Changsha, 430033, China
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Changzhi, 46000, China
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Chengdu, 610031, China
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Chengdu, 610072, China
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Chengdu, 610500, China
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Chengdu, 611130, China
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Chifeng, 024000, China
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Chizhou, 247099, China
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Chongqing, 400010, China
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Chongqing, 401320, China
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Chongqing, 408400, China
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Daqing, 163000, China
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Dazhou, 635000, China
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Foshan, 528000, China
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Fuzhou, 350001, China
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Guangzhou, 510000, China
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Guangzhou, 510120, China
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Guangzhou, 510145, China
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Guangzhou, 510163, China
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Guangzhou, 510530, China
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Haikou, 570311, China
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Hangzhou, 310006, China
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Hefei, 230000, China
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Hefei, 230061, China
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Bialystok, 15-044, Poland
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Uzhhorod, 88002, Ukraine
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Uzhhorod, 88018, Ukraine
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Bicester, OX26 6AT, United Kingdom
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Bollington, SK10 5JH, United Kingdom
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Bradford, BD13 2GD, United Kingdom
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Cardiff, CF37 2DR, United Kingdom
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Chesterfield, S40 4AA, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Fowey, PL23 1DT, United Kingdom
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Glasgow, G4 0SF, United Kingdom
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Hounslow, TW4 7NR, United Kingdom
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Liverpool, L14 3PE, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW1P 2PF, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Newquay, TR7 1RU, United Kingdom
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North Somerset, BS23 3HQ, United Kingdom
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Northallerton, DL7 8AW, United Kingdom
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Norwich, NR1 1RB, United Kingdom
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Nottingham, NG9 6DX, United Kingdom
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Perth, PH1 1NX, United Kingdom
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Poole, BH16 5PW, United Kingdom
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Sheffield, S7 1NF, United Kingdom
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Torbay, TQ1 4QX, United Kingdom
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Whitney, OX29 4QB, United Kingdom
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Witney, OX28 6JS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
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
February 21, 2024
First Posted
February 28, 2024
Study Start
February 21, 2024
Primary Completion (Estimated)
March 7, 2028
Study Completion (Estimated)
March 7, 2028
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.