Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
9,463
28 countries
607
Brief Summary
Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus
Started Jul 2015
Typical duration for phase_4 diabetes-mellitus
607 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
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2018
CompletedResults Posted
Study results publicly available
March 6, 2019
CompletedMarch 6, 2019
February 1, 2019
2.6 years
June 4, 2015
February 11, 2019
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period
Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction \[MI\] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent.
Median of 1.65 person years for CV follow-up time period
Secondary Outcomes (20)
Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina
Median of 1.65 person years for CV follow-up time period
Time to Adjudicated CV Death
Median of 1.65 person years for the CV follow-up time period
Time to First Occurrence of Adjudicated MI
Median of 1.65 person years for CV follow-up time period
Time to First Occurrence of Adjudicated Stroke
Median of 1.65 person years for CV follow-up time period
Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)
Median of 1.65 person years for CV follow-up time period
- +15 more secondary outcomes
Study Arms (2)
Albiglutide
EXPERIMENTALAlbiglutide once weekly by subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed. Albiglutide will be administered in addition to standard therapy for diabetes and cardiovascular health.
Placebo
PLACEBO COMPARATORPlacebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health.
Interventions
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
Eligibility Criteria
You may qualify if:
- Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- Diagnosis of type 2 diabetes.
- Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
- HbA1c \>7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
- Able and willing to provide informed consent.
You may not qualify if:
- Severely reduced kidney function: eGFR \<30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
- Use of a GLP-1 receptor agonist at Screening.
- Severe gastroparesis
- History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
- Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
- Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
- Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
- Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
- Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
- Any other reason the investigator deems the subject to be unsuitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- Duke Clinical Research Institutecollaborator
Study Sites (607)
GSK Investigational Site
Birmingham, Alabama, 35211, United States
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
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Chandler, Arizona, 85284, United States
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Glendale, Arizona, 85308, United States
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Goodyear, Arizona, 85395, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85741, United States
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Tucson, Arizona, 85745, United States
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Little Rock, Arkansas, 72209, United States
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Searcy, Arkansas, 72143, United States
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Chula Vista, California, 91910, United States
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Lancaster, California, 93534, United States
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Lomita, California, 90717, United States
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Long Beach, California, 90807, United States
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Long Beach, California, 90822, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90073, United States
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Moreno Valley, California, 92555, United States
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Northridge, California, 91325, United States
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Oakland, California, 94607, United States
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San Diego, California, 92103, United States
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San Diego, California, 92117, United States
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San Marino, California, 91108, United States
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San Ramon, California, 94583, United States
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Simi Valley, California, 93065, United States
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Stanford, California, 94305, United States
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Torrance, California, 90502, United States
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Denver, Colorado, 80220, United States
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Littleton, Colorado, 80120, United States
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Littleton, Colorado, 80127, United States
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New Haven, Connecticut, 06511, United States
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Belle Glade, Florida, 33430, United States
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Bradenton, Florida, 34201, United States
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Bradenton, Florida, 34209, United States
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Coral Gables, Florida, 33134, United States
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Coral Springs, Florida, 33065, United States
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Fleming Island, Florida, 32003, United States
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Inverness, Florida, 34452, United States
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Jacksonville, Florida, 32216, 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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Miami, Florida, 33174, United States
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Ocala, Florida, 34471, United States
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Ponte Vedra, Florida, 32081, United States
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Port Charlotte, Florida, 33952, United States
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Port Orange, Florida, 32127, United States
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St. Petersburg, Florida, 33713, United States
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Vero Beach, Florida, 32960, United States
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Wellington, Florida, 33449, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30342, United States
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Conyers, Georgia, 30094, United States
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Cumming, Georgia, 30041, United States
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Decatur, Georgia, 30033, United States
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Dunwoody, Georgia, 30338, United States
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Snellville, Georgia, 30078, United States
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Tucker, Georgia, 30084, United States
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Aurora, Illinois, 60504, United States
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Champaign, Illinois, 61820, United States
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Gurnee, Illinois, 60031, United States
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Moline, Illinois, 61265, United States
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Avon, Indiana, 46123, United States
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Franklin, Indiana, 46131, United States
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Greenfield, Indiana, 46140, United States
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Muncie, Indiana, 47304-, United States
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Munster, Indiana, 46321, United States
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West Des Moines, Iowa, 50265, United States
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Topeka, Kansas, 66606, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40213, United States
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New Orleans, Louisiana, 70115, United States
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Lewiston, Maine, 04240, United States
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Annapolis, Maryland, 21401, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Paul, Minnesota, 55102, United States
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St Louis, Missouri, 63136, United States
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Omaha, Nebraska, 68124, United States
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Las Vegas, Nevada, 89086, United States
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Camden, New Jersey, 08103, United States
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Haddon Heights, New Jersey, 08035, United States
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Albuquerque, New Mexico, 87102, United States
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Brooklyn, New York, 11215, United States
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North Massapequa, New York, 11758, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28209, United States
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Charlotte, North Carolina, 28277, United States
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Hickory, North Carolina, 28601, United States
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Rocky Mount, North Carolina, 27804, 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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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27157, United States
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Fargo, North Dakota, 58103, United States
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Cleveland, Ohio, 44122, United States
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Columbus, Ohio, 43210, United States
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Sandusky, Ohio, 44870, United States
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Springfield, Ohio, 45504, United States
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Toledo, Ohio, 43614, United States
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Camp Hill, Pennsylvania, 17011, United States
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Feasterville, Pennsylvania, 19053, United States
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Harleysville, Pennsylvania, 19438, United States
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Jersey Shore, Pennsylvania, 17740, United States
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Lansdale, Pennsylvania, 19446, United States
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Newport, Pennsylvania, 17074, United States
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Penndel, Pennsylvania, 19047, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15240, United States
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Sellersville, Pennsylvania, 18960, United States
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Pawtucket, Rhode Island, 02860, United States
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Anderson, South Carolina, 29621, United States
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Columbia, South Carolina, 29223, United States
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Myrtle Beach, South Carolina, 29572, United States
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Rapid City, South Dakota, 57701, United States
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Rapid City, South Dakota, 57702, United States
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Bristol, Tennessee, 37620, United States
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Kingsport, Tennessee, 37660, United States
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Memphis, Tennessee, 38104, United States
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Memphis, Tennessee, 38119, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37212, United States
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Arlington, Texas, 76014, United States
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Austin, Texas, 78731, United States
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Bellaire, Texas, 77401, United States
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Dallas, Texas, 75216, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75234, United States
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Dallas, Texas, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
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Georgetown, Texas, 78626, United States
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Houston, Texas, 77070, United States
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Huntsville, Texas, 77340, United States
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Kingwood, Texas, 77339, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Schertz, Texas, 78154, United States
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Suite 101, Texas, 76132, United States
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Tyler, Texas, 75708, United States
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Layton, Utah, 84401, United States
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Manassas, Virginia, 20109, United States
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Federal Way, Washington, 98003, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Madison, Wisconsin, 53713, United States
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Adrogué, Buenos Aires, B1846DSK, Argentina
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Bahía Blanca, Buenos Aires, B8000FTD, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1205, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1179AAB, Argentina
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Ciudad Autónoma de Buenos Aires, Buenos Aires, C141AH, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Pergamino, Buenos Aires, B2700CPM, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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Godoy Cruz, Mendoza Province, M5501ARP, Argentina
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San Rafael, Mendoza Province, 5600, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2000C, Argentina
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Berazategui, 1886, Argentina
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Buenos Aires, 1093, Argentina
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Buenos Aires, 1407, Argentina
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Buenos Aires, C1056ABJ, Argentina
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Buenos Aires, C1061ABD, Argentina
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Buenos Aires, C1128A, Argentina
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Buenos Aires, C1180A, Argentina
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Buenos Aires, C1406BOA, Argentina
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Buenos Aires, C1425AGC, Argentina
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Buenos Aires, C1426A, Argentina
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Buenos Aires, C1428D, Argentina
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Buenos Aires, Argentina
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Córdoba, 5016, Argentina
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La Plata, B1902C, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500CCE, Argentina
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Mendoza, M5500C, Argentina
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Santa Fe, 3000, Argentina
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Bonheiden, 2820, Belgium
GSK Investigational Site
Brussels, 1070, Belgium
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Brussels, 1090, Belgium
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
GSK Investigational Site
Byala, 7100, Bulgaria
GSK Investigational Site
Gabrovo, 5300, Bulgaria
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Montana, Bulgaria
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Sevlievo, 5400, Bulgaria
GSK Investigational Site
Sofia, 1202, Bulgaria
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Sofia, 1407, Bulgaria
GSK Investigational Site
Sofia, 1632, Bulgaria
GSK Investigational Site
Stara Zagora, 6000, Bulgaria
GSK Investigational Site
Kelowna, British Columbia, V1Y 1V6, Canada
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Surrey, British Columbia, V3V 0C6, Canada
GSK Investigational Site
Victoria, British Columbia, V8R 4R2, Canada
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Victoria, British Columbia, V8V 4A, Canada
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Winnipeg, Manitoba, 3P, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Brampton, Ontario, L6Z 4N5, Canada
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Burlington, Ontario, L7M 4Y, Canada
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Cambridge, Ontario, N1R 7R1, Canada
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Cornwall, Ontario, K6H4M4, Canada
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Corunna, Ontario, N0N 1G, Canada
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Greater Sudbury, Ontario, P3A 5H, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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London, Ontario, N5W 6A, Canada
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London, Ontario, N6A 4V2, Canada
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Sarnia, Ontario, N7T 4X, Canada
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Smiths Falls, Ontario, K7A 4W8, Canada
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Toronto, Ontario, M9V 4B, Canada
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Brossard, Quebec, J4Z 2K, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Greenfield Park, Quebec, J4V 2G, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Laval, Quebec, H7T 2P5, Canada
GSK Investigational Site
Lévis, Quebec, G6V 4Z5, Canada
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Montreal, Quebec, H4N 2W, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Saint-Lambert, Quebec, J4P 2J, Canada
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Sherbrooke, Quebec, J1J 2E3, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Beroun, 266 01, Czechia
GSK Investigational Site
Krnov, 794 01, Czechia
GSK Investigational Site
Olomouc, 772 00, Czechia
GSK Investigational Site
Ostrava, 702 00, Czechia
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Prague, 100 00, Czechia
GSK Investigational Site
Prague, 116 94, Czechia
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Prague, 128 08, Czechia
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Prague, 149 00, Czechia
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Prague, 150 00, Czechia
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Příbram, 261 01, Czechia
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Uherské Hradiště, 686 01, Czechia
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Ústí nad Labem, 401 13, Czechia
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Zlín, 760 01, Czechia
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Copenhagen, 2100, Denmark
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Esbjerg, 6700, Denmark
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Frederikssund, DK-3600, Denmark
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Hellerup, 2900, Denmark
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Herlev, DK-273, Denmark
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Holbæk, DK-430, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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København S, DK-230, Denmark
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Roskilde, DK-400, Denmark
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Amiens, 80054, France
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Broglie, 27270, France
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Corbeil-Essonnes, 91106, France
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La Rochelle, 17019, France
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Nantes, 44277, France
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Narbonne, 11100, France
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Paris, 75010, France
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Pau, 64046, France
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Pierre-Bénite, 69310, France
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Strasbourg, 67091, France
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Vandœuvre-lès-Nancy, 54511, France
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Deggingen, Baden-Wurttemberg, 73326, Germany
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Güglingen, Baden-Wurttemberg, 74363, Germany
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Karlsruhe, Baden-Wurttemberg, 76199, Germany
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Ludwigsburg, Baden-Wurttemberg, 71640, Germany
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Stuttgart, Baden-Wurttemberg, 70199, Germany
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Stuttgart, Baden-Wurttemberg, 70378, Germany
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Villingen-Schwenningen, Baden-Wurttemberg, 78048, Germany
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Wangen, Baden-Wurttemberg, 88239, Germany
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Aschaffenburg, Bavaria, 63739, Germany
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Dachau, Bavaria, 85221, Germany
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Haag, Bavaria, 83527, Germany
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Künzing, Bavaria, 94550, Germany
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Rednitzhembach, Bavaria, 91126, Germany
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Wallerfing, Bavaria, 94574, Germany
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Elsterwerda, Brandenburg, 04910, Germany
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Falkensee, Brandenburg, 14612, Germany
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Potsdam, Brandenburg, 14469, Germany
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Flörsheim, Hesse, 65439, Germany
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Gelnhausen, Hesse, 63571, Germany
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Hildesheim, Lower Saxony, 31139, Germany
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Stuhr, Lower Saxony, 28816, Germany
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Wardenburg, Lower Saxony, 26203, Germany
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Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
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Bochum, North Rhine-Westphalia, 44791, Germany
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Bochum, North Rhine-Westphalia, 44869, Germany
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Cologne, North Rhine-Westphalia, 51069, Germany
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Essen, North Rhine-Westphalia, 45136, Germany
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Essen, North Rhine-Westphalia, 45329, Germany
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Essen, North Rhine-Westphalia, 45359, Germany
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Kleve, North Rhine-Westphalia, 47533, Germany
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Münster, North Rhine-Westphalia, 48145, Germany
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Witten, North Rhine-Westphalia, 58455, Germany
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Bad Kreuznach, Rhineland-Palatinate, 55545, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany
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Mainz, Rhineland-Palatinate, 55116, Germany
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Sankt Ingbert, Saarland, 66386, Germany
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Chemnitz, Saxony, 09113, Germany
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Delitzsch, Saxony, 04509, Germany
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Dresden, Saxony, 01069, Germany
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Dresden, Saxony, 01219, Germany
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Dresden, Saxony, 01279, Germany
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Dresden, Saxony, 01307, Germany
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Leipzg, Saxony, 04109, Germany
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Leipzig, Saxony, 04109, Germany
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Leipzig, Saxony, 04249, Germany
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Oschatz, Saxony, 04758, Germany
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Pirna, Saxony, 01796, Germany
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Riesa, Saxony, 01587, Germany
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Schkeuditz, Saxony, 04435, Germany
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Hohenmölsen, Saxony-Anhalt, 06679, Germany
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Jerichow, Saxony-Anhalt, 39319, Germany
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Magdeburg, Saxony-Anhalt, 39112, Germany
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Berlin, 10117, Germany
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Berlin, 10409, Germany
GSK Investigational Site
Berlin, 10789, Germany
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Berlin, 12157, Germany
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Berlin, 13405, Germany
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Dortmund, 44137, Germany
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Hamburg, 20099, Germany
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Hamburg, 21073, Germany
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Hamburg, 22041, Germany
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Mannheim, 68163, Germany
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München, 80809, Germany
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Alexandroupoli, 68 100, Greece
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Athens, 11 527, Greece
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Athens, 11521, Greece
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Athens, 11528, Greece
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Haidari, Athens, 12462, Greece
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Heraklion, Crete, 71409, Greece
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Ioannina, 45500, Greece
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Lamia, 35100, Greece
GSK Investigational Site
Nikaia Piraeus, 184 54, Greece
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Piraeus, 18536, Greece
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Thessaloniki, 546 36, Greece
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Thessaloniki, 546 42, Greece
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Thessaloniki, 54642, Greece
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Thessaloniki, 564 29, Greece
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Thessaloniki, 570 01, Greece
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Thessaloniki, 570 10, Greece
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Baja, 6500, Hungary
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Budapest, 1036, Hungary
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Budapest, 1135, Hungary
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Debrecen, 4031, Hungary
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Eger, 3300, Hungary
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Rome, Lazio, 00168, Italy
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Rome, Lazio, 00186, Italy
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Arenzano (GE), Liguria, 16011, Italy
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Bergamo, Lombardy, 24127, Italy
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Milan, Lombardy, 20122, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20142, Italy
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Vigevano (PV), Lombardy, 27029, Italy
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Olbia (OT), Sardinia, 07026, Italy
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Ancona, The Marches, 60131, Italy
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Siena, Tuscany, 53100, Italy
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S.Andrea Delle Fratte - S. Sisto (PG), Umbria, 06132, Italy
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Padua, Veneto, 35128, Italy
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Aguascalientes, Ags, Aguascalientes, 20127, Mexico
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Guadalajara, Jalisco, 44150, Mexico
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Guadalajara, Jalisco, 44600, Mexico
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Guadalajara, Jalisco, 45116, Mexico
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Tlaquepaque, Jalisco, 45510, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Monterrey NL, Nuevo León, 64718, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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Mazatlán, Sinaloa, 82126, Mexico
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Mazatlán, Sinaloa, Mexico
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Mérida, Yucatán, 97129, Mexico
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Aguascalientes, 20230, Mexico
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Mexico City, 11650, Mexico
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Alkmaar, 1815 JD, Netherlands
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Amsterdam, 1061 A, Netherlands
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Eindhoven, 5631 BM, Netherlands
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Gouda, 2803 H, Netherlands
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Hardenberg, 7772 SE, Netherlands
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Heerlen, 6419 PC, Netherlands
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Hoogeveen, 7909 A, Netherlands
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Meppel, 7943 K, Netherlands
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Rotterdam, 3051 G, Netherlands
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Sneek, 8601 Z, Netherlands
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Hoenefoss, 3513, Norway
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Kolbjørnsvik, 4816, Norway
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Oslo, 0319, Norway
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Oslo, 0586, Norway
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Stavanger, 4011, Norway
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Trujillo, La Libertad, 13001, Peru
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San Martín de Porres, Lima region, Lima 33, Peru
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Callao, Lima, Callao 2, Peru
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Arequipa, Peru
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Lima, 01, Peru
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Lima, 17, Peru
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Lima, Lima 14, Peru
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Lima, Lima 29, Peru
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Lima, Lima 32, Peru
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Piura, 20001, Peru
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Cebu City, 6000, Philippines
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Iloilo City, 5000, Philippines
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Laoag, 2900, Philippines
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Bialystok, 15-435, Poland
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Bydgoszcz, 85-231, Poland
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Bydgoszcz, 85-863, Poland
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Gdansk, 80-858, Poland
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Gniewkowo, 88-140, Poland
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Katowice, 40-081, Poland
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Katowice, 40-772, Poland
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Krakow, 30-539, Poland
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Krakow, 31-261, Poland
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Krakow, 31-530, Poland
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Lublin, 20-538, Poland
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Poznan, 60-111, Poland
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Poznan, 61-655, Poland
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Sopot, 81- 71, Poland
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Warsaw, 00-465, Poland
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Wierzchosławice, 33-122, Poland
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Wroclaw, 50-127, Poland
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Wroclaw, 50-981, Poland
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Wroclaw, 54-239, Poland
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Arkhangelsk, 163045, Russia
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Barnaul, 656 045, Russia
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Chelyabinsk, 454021, Russia
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Chelyabinsk, 454047, Russia
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Ivanovo, 153005, Russia
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Kemerovo, 650000, Russia
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Kemerovo, 650002, Russia
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Krasnodar, 350086, Russia
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Moscow, 117 036, Russia
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Moscow, 117 03, Russia
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Moscow, 117292, Russia
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Moscow, 119435, Russia
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Moscow, 119992, Russia
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Moscow, 127411, Russia
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Moscow, 129110, Russia
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Nizhny Novgorod, 603003, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630047, Russia
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Novosibirsk, 630091, Russia
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Perm, 614097, Russia
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Rostov-on-Don, 344022, Russia
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Ryazan, 390039, Russia
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Saint Petersburg, 195257, Russia
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Samara, 443067, Russia
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Saratov, 410053, Russia
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Tomsk, 634012, Russia
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Tomsk, 634041, Russia
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Tomsk, 634050, Russia
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Voronezh, 394018, Russia
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Yaroslavl, 150000, Russia
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Yaroslavl, 150003, Russia
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Yaroslavl, 150010, Russia
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Yaroslavl, 150030, Russia
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Yekaterinburg, 620039, Russia
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Yekaterinburg, 620149, Russia
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Bloemfontein, Free State, 9301, South Africa
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Tongaat, KwaZulu-Natal, 4400, South Africa
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Bloemfontein, 9301, South Africa
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Cape Town, 7500, South Africa
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Houghton Estate, 2198, South Africa
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Kuilsrivier, 7580, South Africa
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Paarl, 7646, South Africa
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Pinelands, 7405, South Africa
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Umhlanga, 4319, South Africa
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Daegu, 42415, South Korea
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Daegu, 700-71, South Korea
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Gyeonggi-do, 463-70, South Korea
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Gyeonggido, 420-717, South Korea
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Kangwondo, 220-701, South Korea
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Pusan, 602-73, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 134-72, South Korea
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Seoul, 135-71, South Korea
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Seoul, 135-72, South Korea
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Seoul, 137-70, South Korea
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Seoul, 150-95, South Korea
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Seoul, 152-703, South Korea
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Seoul, 411-70, South Korea
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Suwon, 442-723, South Korea
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Suwon, Kyonggi-do, 443-72, South Korea
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A Coruña, 15006, Spain
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Alicante, 03004, Spain
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Almería, 4001, Spain
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Alzira/Valencia, 46600, Spain
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Badalona, 08916, Spain
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Badalona / Barcelona, 08917, Spain
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Barcelona, 08003, Spain
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Barcelona, 08006, Spain
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Barcelona, 08026, Spain
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Barcelona, 08907, Spain
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Boadilla Del Monte (Madrid), 28660, Spain
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Canet de Mar - Barcelona, 08360, Spain
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Cangas Del Narcea/Asturias, 33800, Spain
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Centelles (Barcelona), 08540, Spain
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Córdoba, 14004, Spain
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Elche, 03293, Spain
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Granada, 18012, Spain
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León, 24071, Spain
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Madrid, 28006, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Palma de Mallorca, 07198, Spain
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Pontevedra, 36071, Spain
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Pozuelo de Alarcón/Madrid, 28223, Spain
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Sagunto/Valencia, 46520, Spain
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San Juan (Alicante), 03550, Spain
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Sanlucar de Barrameda - Cádiz, 11540, Spain
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Santa Coloma de Gramanet (Barcelona), 08923, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41014, Spain
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Tarrasa, Barcelona, 08221, Spain
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Valencia, 46010, Spain
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Valencia, 46017, Spain
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Valencia, 46026, Spain
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Vigo-Pontevedra, 36312, Spain
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Borås, SE-506, Sweden
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Eksjö, SE-575 35, Sweden
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Gothenburg, SE-413 45, Sweden
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Härnösand, SE-871, Sweden
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Helsingborg, SE-252, Sweden
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Karlskrona, SE-371 41, Sweden
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Kristianstad, SE-291 85, Sweden
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Linköping, SE-587 58, Sweden
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Ljungby, SE-341, Sweden
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Malmo, SE-205 02, Sweden
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Örebro, SE-703 62, Sweden
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Rättvik, SE-795 30, Sweden
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Stockholm, SE-111, Sweden
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Stockholm, SE-113 61, Sweden
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Stockholm, SE-182 88, Sweden
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Umeå, SE-901 85, Sweden
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Uppsala, SE-752, Sweden
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Changhua, 500, Taiwan
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Hualien City, 970, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 433, Taiwan
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Tainan, 71004, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Pathum Thani, 12120, Thailand
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Songkhla, 90110, Thailand
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Chernivtsi, 58022, Ukraine
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Dnipropetrovsk, 49038, Ukraine
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Kharkiv, 61058, Ukraine
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Kharkiv, 61070, Ukraine
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Kherson, 73000, Ukraine
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Kyiv, 01004, Ukraine
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Kyiv, 01021, Ukraine
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Kyiv, 02091, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04114, Ukraine
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Mykolaiv, 54003, Ukraine
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Odesa, 65025, Ukraine
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Poltava, 36011, Ukraine
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Uzhhorod, 88000, Ukraine
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Vinnytsia, 21010, Ukraine
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Zaporizhzhya, 69001, Ukraine
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Soham, Cambridgeshire, CB7 5J, United Kingdom
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Chesterfield, Derbyshire, S40 4AAA, United Kingdom
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Romford, Essex, RM1 3P, United Kingdom
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Edinburgh, Midlothian, EH4 2XU, United Kingdom
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Trowbridge, Wiltshire, BA14 8, United Kingdom
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Aberdeen, AB25 2, United Kingdom
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Axbridge, Somerset, BS26 2, United Kingdom
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Ayr, KA6 6D, United Kingdom
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Blackpool, FY3 8NR, United Kingdom
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Bristol, BS10 5, United Kingdom
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Dumfries, DG1 4AP, United Kingdom
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Related Publications (7)
John McMurray, Stefano Del Prato, Adrian Hernandez, Larry Leiter, Chris Granger, Ralph D'Agostino, Jennifer Green, Kristina Sigmon, Anne Rosenberg Nigel Jones, Karl Thorpe, Matt Somerville, Salim Janmohamed. Albiglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Cardiovascular Disease. Lancet. 2018
BACKGROUNDNatale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PMID: 39963952DERIVEDGilbert MP, Skelly J, Hernandez AF, Green JB, Krychtiuk KA, Granger CB, Leiter LA, McMurray JJV, Del Prato S, Pratley RE. Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial. Diabetes Obes Metab. 2024 May;26(5):1714-1722. doi: 10.1111/dom.15479. Epub 2024 Feb 6.
PMID: 38317618DERIVEDO'Brien EC, Raman SR, Ellis A, Hammill BG, Berdan LG, Rorick T, Janmohamed S, Lampron Z, Hernandez AF, Curtis LH. The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study. Trials. 2021 Jul 19;22(1):465. doi: 10.1186/s13063-021-05397-0.
PMID: 34281607DERIVEDHernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.
PMID: 30291013DERIVEDGreen JB, Hernandez AF, D'Agostino RB, Granger CB, Janmohamed S, Jones NP, Leiter LA, Noronha D, Russell R, Sigmon K, Del Prato S, McMurray JJV. Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus-Rationale, design, and baseline characteristics. Am Heart J. 2018 Sep;203:30-38. doi: 10.1016/j.ahj.2018.03.030. Epub 2018 Jun 12.
PMID: 30015066DERIVEDWittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
PMID: 29693361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
June 4, 2015
First Posted
June 8, 2015
Study Start
July 1, 2015
Primary Completion
February 20, 2018
Study Completion
March 14, 2018
Last Updated
March 6, 2019
Results First Posted
March 6, 2019
Record last verified: 2019-02