Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
NCT ID: NCT02876835
Last Updated: 2024-04-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
3872 participants
INTERVENTIONAL
2016-09-27
2021-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daprodustat
Participants will receive oral daprodustat once daily.
Daprodustat
The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.
Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Iron Therapy
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
Darbepoetin alfa
Participants will be administered darbepoetin alfa subcutaneously (SC).
Darbepoetin alfa
The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.
Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Iron Therapy
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
Interventions
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Daprodustat
The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.
Darbepoetin alfa
The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.
Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Iron Therapy
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
Eligibility Criteria
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Inclusion Criteria
* CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
* Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.
* For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
* \>=80% and \<=120% compliance with placebo during run-in period.
* Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Exclusion Criteria
* Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
* Ferritin: \<=100 nanograms (ng)/milliliter (mL) (\<=100 micrograms/liter \[L\]) at screening.
* Transferrin saturation (TSAT) (screening only): \<=20%.
* Aplasias: History of bone marrow aplasia or pure red cell aplasia.
* Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
* Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding \<=4 weeks prior to screening through to randomization (Day 1).
* MI or acute coronary syndrome: \<=4 weeks prior to screening through to randomization (Day 1).
* Stroke or transient ischemic attack: \<=4 weeks prior to screening through to randomization (Day 1).
* Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
* Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator.
* Bazett's corrected QT interval (QTcB) (Day 1): QTcB \>500 millisecond (msec), or QTcB \>530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
* Alanine transaminase (ALT): \>2x upper limit of normal (ULN) at screening.
* Bilirubin: \>1.5xULN at screening.
* Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example \[e.g.\] Bosniak Category II F, III or IV) \> 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated \>=4 weeks prior to screening.
* Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or darbepoetin alfa.
* Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
* Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).
* Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of \>30 days.
* Females only: Subject is pregnant \[as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options.
* Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin alfa) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
18 Years
99 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Andalusia, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Azusa, California, United States
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Bakersfield, California, United States
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Bakersfield, California, United States
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Chula Vista, California, United States
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Cudahy, California, United States
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El Centro, California, United States
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Escondido, California, United States
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Glendale, California, United States
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Granada Hills, California, United States
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La Mesa, California, United States
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La Palma, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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National City, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Simi Valley, California, United States
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Tarzana, California, United States
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Whittier, California, United States
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Middlebury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Coral Gables, Florida, United States
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Cutler Bay, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
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Homestead, Florida, United States
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Hudson, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Miami Lakes, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Port Charlotte, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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Temple Terrace, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Augusta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Nampa, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Crystal Lake, Illinois, United States
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Mount Prospect, Illinois, United States
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Quincy, Illinois, United States
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Springfield, Illinois, United States
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Fort Wayne, Indiana, United States
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Jeffersonville, Indiana, United States
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Michigan City, Indiana, United States
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Hutchinson, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Potomac, Maryland, United States
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Takoma Park, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Pontiac, Michigan, United States
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Minneapolis, Minnesota, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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North Platte, Nebraska, United States
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Las Vegas, Nevada, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Flushing, New York, United States
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Laurelton, New York, United States
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New York, New York, United States
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New York, New York, United States
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Ridgewood, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Yonkers, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Grand Forks, North Dakota, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Mentor, Ohio, United States
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Lawton, Oklahoma, United States
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Portland, Oregon, United States
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Roseburg, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Sumter, South Carolina, United States
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Cordova, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lufkin, Texas, United States
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McAllen, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Waxahachie, Texas, United States
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Alexandria, Virginia, United States
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Fairfax, Virginia, United States
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Hampton, Virginia, United States
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Salem, Virginia, United States
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Bluefield, West Virginia, United States
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Ciudad Evita, Buenos Aires, Argentina
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Coronel Suárez, Buenos Aires, Argentina
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Junín, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Pergamino, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Corrientes, , Argentina
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Formosa, , Argentina
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La Plata, , Argentina
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Mendoza, , Argentina
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Morón, , Argentina
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San Miguel de Tucumán, , Argentina
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Garran, Australian Capital Territory, Australia
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Concord, New South Wales, Australia
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Gosford, New South Wales, Australia
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Kingswood, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Nambour, Queensland, Australia
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Melbourne, Victoria, Australia
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Reservoir, Victoria, Australia
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St Albans, Victoria, Australia
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Nedlands, Western Australia, Australia
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Liverpool, , Australia
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Aalst, , Belgium
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Baudour, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Ieper, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Ronse, , Belgium
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Sint-Niklaas, , Belgium
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Salvador, Estado de Bahia, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São José do Rio Preto, São Paulo, Brazil
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Votuporanga, São Paulo, Brazil
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Belo Horizonte, , Brazil
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Brasília, , Brazil
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Feira de Santana, , Brazil
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Joinville, , Brazil
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Juiz de Fora, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Blagoevgrad, , Bulgaria
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Burgas, , Bulgaria
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Dobrich, , Bulgaria
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Gabrovo, , Bulgaria
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Lom, , Bulgaria
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Pazardzhik, , Bulgaria
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Plovdiv, , Bulgaria
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Sliven, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Floridablanca, , Colombia
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Medellín, , Colombia
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Beroun, , Czechia
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Český Krumlov, , Czechia
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Ivančice, , Czechia
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Jilemnice, , Czechia
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Mariánské Lázně, , Czechia
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Nový Jičín, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Sokolov, , Czechia
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Aalborg, , Denmark
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Holstebro, , Denmark
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Kolding, , Denmark
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Odense C, , Denmark
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Jämejala Village, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Annonay, , France
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Boulogne-Billancourt, , France
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Caen, , France
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Clermont-Ferrand, , France
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Lyon, , France
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Montpellier, , France
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Mulhouse, , France
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Poitiers, , France
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Saint-Ouen, , France
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Mannheim, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Cloppenburg, Lower Saxony, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Kaiserslautern, Rhineland-Palatinate, Germany
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Leipzig, Saxony, Germany
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Cologne, , Germany
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Wiesbaden, , Germany
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Alexandroupoli, , Greece
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Arta, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Efkarpia, , Greece
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Heraklion-Crete, , Greece
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Ioannina, , Greece
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Ioannina, , Greece
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Komotini, , Greece
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Larissa, , Greece
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Melíssia, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Lai Chi Kok, , Hong Kong
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New Territories, , Hong Kong
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Tsuen Wan, , Hong Kong
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Baja, , Hungary
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Balatonfüred, , Hungary
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Esztergom, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Salgótarján, , Hungary
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Szigetvár, , Hungary
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Ahmedabad, , India
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Ahmedabad, , India
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Bangalore, , India
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Bangalore, , India
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Calicut, , India
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Chandigarh, , India
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Chennai, , India
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Chennai, Tamil Nadu, , India
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Delhi, , India
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Ghaziabad, , India
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Gurgaon, , India
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Hyderabad, , India
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Hyderabad, , India
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Jaipur, , India
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Jaipur, , India
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Lucknow, , India
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Manipal, , India
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Mumbai, , India
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Mumbai, , India
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Nadiād, , India
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Nagpur, , India
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New Delhi, , India
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New Delhi, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Pune, , India
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Secunderabad, , India
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Trivandrum, , India
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Ashkelon, , Israel
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Hadera, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Nazareth, , Israel
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Poria – Neve Oved, , Israel
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Ẕerifin, , Israel
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Foggia, Apulia, Italy
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Catanzaro, Calabria, Italy
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Napoli, Campania, Italy
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Piacenza, Emilia-Romagna, Italy
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Reggio Emilia, Emilia-Romagna, Italy
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Genoa, Liguria, Italy
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Lecco, Lombardy, Italy
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Milan, Lombardy, Italy
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Pavia, Lombardy, Italy
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Turin, Piedmont, Italy
GSK Investigational Site
Cagliari, Sardinia, Italy
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Imola, , Italy
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Mestre, , Italy
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Alor Star, , Malaysia
GSK Investigational Site
George Town, , Malaysia
GSK Investigational Site
Ipoh, , Malaysia
GSK Investigational Site
Kuala Lumpur, , Malaysia
GSK Investigational Site
Kuala Pahang, , Malaysia
GSK Investigational Site
Kuantan, , Malaysia
GSK Investigational Site
Lumut, , Malaysia
GSK Investigational Site
Saltillo, Coahuila, Mexico
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Torreón, Coahuila, Mexico
GSK Investigational Site
Durango, Durango, Mexico
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León, Guanajuato, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Querétaro City, Querétaro, Mexico
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Culiacán, Sinaloa, Mexico
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Culiacán, Sinaloa, Mexico
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Mazatlán, Sinaloa, Mexico
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Ciudad de Mexico, State of Mexico, Mexico
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Mérida, Yucatán, Mexico
GSK Investigational Site
Mérida, Yucatán, Mexico
GSK Investigational Site
Aguascalientes, , Mexico
GSK Investigational Site
Chihuahua City, , Mexico
GSK Investigational Site
Chihuahua City, , Mexico
GSK Investigational Site
Culiacán, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Tlalnepantla, , Mexico
GSK Investigational Site
Veracruz, , Mexico
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Zapopan, Jalisco, , Mexico
GSK Investigational Site
Amsterdam, , Netherlands
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Deventer, , Netherlands
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Rotterdam, , Netherlands
GSK Investigational Site
Dunedin, , New Zealand
GSK Investigational Site
Hamilton, , New Zealand
GSK Investigational Site
Hastings, , New Zealand
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Otahuhu, , New Zealand
GSK Investigational Site
Takapuna, Auckland, , New Zealand
GSK Investigational Site
Baguio City, Benguet, , Philippines
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Cebu City, , Philippines
GSK Investigational Site
Dasmariñas, , Philippines
GSK Investigational Site
Iloilo City, , Philippines
GSK Investigational Site
Manila, , Philippines
GSK Investigational Site
Pasig, , Philippines
GSK Investigational Site
Quezon City, , Philippines
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San Juan City, , Philippines
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Sto Tomas, , Philippines
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Brzeg, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Kielce, , Poland
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Kołobrzeg, , Poland
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Lodz, , Poland
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Radom, , Poland
GSK Investigational Site
Szczecin, , Poland
GSK Investigational Site
Żyrardów, , Poland
GSK Investigational Site
Amadora, , Portugal
GSK Investigational Site
Aveiro, , Portugal
GSK Investigational Site
Covilha, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Torres Novas, , Portugal
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Constanța, , Romania
GSK Investigational Site
Oradea, , Romania
GSK Investigational Site
Timișoara, , Romania
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Irkutsk, , Russia
GSK Investigational Site
Kemerovo, , Russia
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Krasnodar, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Mytischi, , Russia
GSK Investigational Site
Omsk, , Russia
GSK Investigational Site
Podolsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Ulyanovsk, , Russia
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Volzhsky, , Russia
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Yaroslavl, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Port Elizabeth, Eastern Cape, South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Somerset West, , South Africa
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Anyang-Si, Gyeonggi-do, , South Korea
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Bucheon-si, , South Korea
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Busan, , South Korea
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Daejeon, , South Korea
GSK Investigational Site
Goyang-si, , South Korea
GSK Investigational Site
Ilsanseo-gu, Goyang-si,, , South Korea
GSK Investigational Site
Incheon, , South Korea
GSK Investigational Site
Incheon, , South Korea
GSK Investigational Site
Jeonju, , South Korea
GSK Investigational Site
Seongnam, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon, , South Korea
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Suwon, , South Korea
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Uijeongbu-si, , South Korea
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Wŏnju, , South Korea
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Majadahonda, Madrid, Spain
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Badalona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Burela de Cabo, , Spain
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Cáceres, , Spain
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Ciudad Real, , Spain
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Girona, , Spain
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Guadalajara, , Spain
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L'Hospitalet de Llobregat, , Spain
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Mollet del Vallès, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Örebro, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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New Taipei City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan Hsien, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkoknoi, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Pathum Thani, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Eskişehir, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
GSK Investigational Site
Istanbul, , Turkey (Türkiye)
GSK Investigational Site
Istanbul, , Turkey (Türkiye)
GSK Investigational Site
Kayseri, , Turkey (Türkiye)
GSK Investigational Site
Cherkasy, , Ukraine
GSK Investigational Site
Chernihiv, , Ukraine
GSK Investigational Site
Chernivtsi, , Ukraine
GSK Investigational Site
Ivano-Frankivsk, , Ukraine
GSK Investigational Site
Kharkiv, , Ukraine
GSK Investigational Site
Kherson, , Ukraine
GSK Investigational Site
Kiev, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Lutsk, , Ukraine
GSK Investigational Site
Mykolaiv, , Ukraine
GSK Investigational Site
Poltava, , Ukraine
GSK Investigational Site
Ternopil, , Ukraine
GSK Investigational Site
Zaporizhzhia, , Ukraine
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Zaporizhzhia, , Ukraine
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Zhytomyr, , Ukraine
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Stevenage, Hertfordshire, United Kingdom
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Preston, Lancashire, United Kingdom
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Hampstead, London, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Wolverhampton, West Midlands, United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Cambridge, , United Kingdom
GSK Investigational Site
Cardiff, , United Kingdom
GSK Investigational Site
Derby, , United Kingdom
GSK Investigational Site
Doncaster, , United Kingdom
GSK Investigational Site
Fife, , United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
Hull, , United Kingdom
GSK Investigational Site
Leeds, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Middlesbrough, , United Kingdom
GSK Investigational Site
Oxford, , United Kingdom
GSK Investigational Site
Salford, , United Kingdom
GSK Investigational Site
York, , United Kingdom
GSK Investigational Site
Haiphong, , Vietnam
GSK Investigational Site
Hanoi, , Vietnam
GSK Investigational Site
Hà Nội, , Vietnam
GSK Investigational Site
Ho Chi Minh City, , Vietnam
Countries
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References
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Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196
Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.
Cunningham JW, Claggett BL, Lopes RD, McMurray JJV, Perkovic V, Carroll K, Hiemstra T, Khavandi K, Lukas MA, Ranganathan P, Shannon J, van Adelsberg J, Singh AK, Solomon SD. Daprodustat and Heart Failure in CKD. J Am Soc Nephrol. 2024 May 1;35(5):607-617. doi: 10.1681/ASN.0000000000000321. Epub 2024 Feb 22.
Singh AK, McCausland FR, Claggett BL, Wanner C, Wiecek A, Atkins MB, Carroll K, Perkovic V, McMurray JJV, Wittes J, Snapinn S, Blackorby A, Meadowcroft A, Barker T, DiMino T, Mallett S, Cobitz AR, Solomon SD. Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents-post hoc analyses of the ASCEND-ND and ASCEND-D trials. Nephrol Dial Transplant. 2023 Jul 31;38(8):1890-1897. doi: 10.1093/ndt/gfac342.
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000542-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
200808
Identifier Type: -
Identifier Source: org_study_id
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