A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
Study Purpose
The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years - 99 Years |
| Gender | All |
Inclusion Criteria:
1. Signed informed consent form and assent form, as appropriate. 2. Male or female ≥12 years of age at Screening Visit 1. Sites in Poland will only include participants aged ≥18 years. Asthma-related criteria. 3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1. 4. Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Note: In Poland, this will instead include participants requiring a minimum daily medium dose ICS (≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021). Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks prior to Screening Visit 1. 5. Pre-BD FEV1 ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2. 6. Bronchodilator reversibility, at Screening Visit 2, as evidenced by ≥12% and ≥200 mL improvement in FEV1, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17).Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening Period, at an unscheduled visit at least 7 days prior to baseline. 7. ACQ-6 ≥1.5 at Screening Visit 2. 8. Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2). General medical history. 9. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening and Baseline visits. 10. WOCBP must use either of the following methods of birth control, from Screening Visit 1 through the End of Study Visit: 1. A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system (IUS), Levonorgestrel Intrauterine system, or oral contraceptive. Or. 2. Two protocol acceptable methods of contraception in tandem.- - Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
Exclusion Criteria:
Asthma-related criteria. 1. A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization prior to the Screening Visit 1 up to and including the Baseline Visit. Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status. 2. Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, or hypereosinophilic syndrome, or lung diseases (eg, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis). 3. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1. Prohibited medications/procedures. 4. Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long acting anti-interleukin-5) in the past 12 months. 5. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab. 6. Treatment with pramipexole (Mirapex®) within 30 days of Baseline. 7. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1. 8. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the study period. General medical history. 9. Weight <40 kg at Screening Visit 2. 10. Current smoking within 12 months prior to Screening Visit 1 or a smoking history of >10 packyears. Smoking includes tobacco, vaping, and/or marijuana use. 11. Known or suspected alcohol or drug abuse. 12. Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to the Baseline Visit despite antihypertensive therapy. 13. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 5 years prior to the Baseline Visit. 14. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C. 15. A helminth parasitic infection diagnosed within 24 weeks prior to Screening Visit 1, that has not been treated with or has failed to respond to standard of care therapy. 16. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements. 17. Known or suspected noncompliance with medication. 18. Unwillingness or inability to follow the procedures outlined in the protocol. Clinical safety labs. 19. Absolute neutrophil count <2.000x10⁹/L at Screening Visit 1 or Screening Visit 2.. 20. Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 at Screening Visit 2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [Levey et al, 2009] for age ≥18 years at screening; using the Bedside Schwartz [Schwartz and Work, 2009] eGFR formula for age <18). 21. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin >2x ULN at Screening Visit 2 confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart. Cardiac safety. 22. History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction <25%. 23. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit. 24. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation. 25. History of long QT syndrome. 26. Corrected QT interval by Fridericia (QTcF) interval >450 ms for males and >470 ms for females at Screening Visit 2 or QTcF ≥480 ms for participants with bundle branch block. 27. Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval changes at Screening Visit 2, including resting heart rate <45 beats per minute (bpm) or >100 bpm. Pregnancy/Lactation. 28. Pregnant women or women breastfeeding. 29. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide). For this study, rescreening may only be permitted under specific circumstances and only after contact with a Sponsor Clinical representative.Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05748600 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Areteia Therapeutics |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Mona Bafadhel, MD |
| Principal Investigator Affiliation | Guy's and St Thomas' NHS Foundation Trust |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Brazil, Canada, Israel, Korea, Republic of, Poland, Puerto Rico, Romania, South Africa, Taiwan, Turkey, Ukraine, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Eosinophilic Asthma, Asthma; Eosinophilic, Asthma Attack |
Arms
Experimental: 150 mg BID
Dexpramipexole 150 mg oral tablet taken twice a day
Experimental: 75 mg BID
Dexpramipexole 75 mg oral tablet taken twice a day
Placebo Comparator: Placebo
Placebo oral tablet taken twice a day
Interventions
Drug: - Dexpramipexole Dihydrochloride
administration of dexpramipexole tablet
Drug: - Placebo
administration of placebo tablet
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Research Site 40001-462
Peoria, Arizona, 85381
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Surprise, Arizona, 85378
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Bakersfield, California, 93301
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Encinitas, California, 92024
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La Palma, California, 90623
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Lancaster, California, 93534
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Mission Viejo, California, 92691
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Newport Beach, California, 92660
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Newport Beach, California, 92663
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Redding, California, 96001
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San Diego, California, 92123
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San Jose, California, 95117
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Upland, California, 91756
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West Covina, California, 91790
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Westminster, California, 92683
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Aurora, Colorado, 80014
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Colorado Springs, Colorado, 80907
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Wheat Ridge, Colorado, 80033
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Research Site 40001-048
Aventura, Florida, 33180
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Research Site 40001-005
Brandon, Florida, 33511
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Brandon, Florida, 33511
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Research Site 40001-029
Coral Gables, Florida, 33134
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Gainesville, Florida, 32607
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Greenacres City, Florida, 33467
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Hialeah, Florida, 33012
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Hialeah, Florida, 33016
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Homestead, Florida, 33030
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Kissimmee, Florida, 34744
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Kissimmee, Florida, 34746
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Loxahatchee Groves, Florida, 33470
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Maitland, Florida, 32751
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Miami Beach, Florida, 33169
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Research Site 40001-066
Miami, Florida, 33126
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Miami, Florida, 33135
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Miami, Florida, 33144
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Miami, Florida, 33155
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Miami, Florida, 33165
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Miami, Florida, 33173
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Miami, Florida, 33184
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Ocala, Florida, 34471
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Orlando, Florida, 32819
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Plantation, Florida, 33317
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Saint Petersburg, Florida, 33713
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Tallahassee, Florida, 32308
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Tampa, Florida, 33607
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Viera, Florida, 32940
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Adairsville, Georgia, 30103
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Augusta, Georgia, 30909
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Columbus, Georgia, 31904
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Dunwoody, Georgia, 30350
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Lilburn, Georgia, 30047
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Savannah, Georgia, 31406
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Berwyn, Illinois, 60402
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Chicago, Illinois, 60607
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Normal, Illinois, 61761
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River Forest, Illinois, 60305
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Skokie, Illinois, 60077
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Elwood, Indiana, 46036
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Louisville, Kentucky, 40202
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Owensboro, Kentucky, 42301
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Alexandria, Louisiana, 71303
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Marrero, Louisiana, 70072
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Zachary, Louisiana, 70791
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Annapolis, Maryland, 21401
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Takoma Park, Maryland, 20912
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White Marsh, Maryland, 21162
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Dearborn, Michigan, 48126
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Flint, Michigan, 48504
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Flint, Michigan, 48507
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Rochester Hills, Michigan, 48307
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Warren, Michigan, 48088
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Mankato, Minnesota, 56001
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Columbia, Missouri, 65203
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Saint Charles, Missouri, 63301
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Saint Louis, Missouri, 63110
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Missoula, Montana, 59808
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Lincoln, Nebraska, 68510
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Brick, New Jersey, 08724
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Edison, New Jersey, 08817
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Jersey City, New Jersey, 07304
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Toms River, New Jersey, 08755
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E. Amherst, New York, 14051
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Great Neck, New York, 11021
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Hawthorne, New York, 10532
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New York, New York, 10029
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Charlotte, North Carolina, 28277
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Gastonia, North Carolina, 28054
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Greenville, North Carolina, 17834
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Huntersville, North Carolina, 28078
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Raleigh, North Carolina, 27610
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Winston-Salem, North Carolina, 21704
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Cincinnati, Ohio, 45215
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Cincinnati, Ohio, 45236
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Dayton, Ohio, 45424
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Toledo, Ohio, 43617
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Research Site US-40001-038
Edmond, Oklahoma, 73034
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Oklahoma City, Oklahoma, 73102
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Oklahoma City, Oklahoma, 73120
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Grants Pass, Oregon, 97527
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Grants Pass, Oregon, 97527
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Portland, Oregon, 97202
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Philadelphia, Pennsylvania, 19140
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Columbia, South Carolina, 29204
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Greenville, South Carolina, 29651
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Rock Hill, South Carolina, 29732
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Spartanburg, South Carolina, 29303
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Franklin, Tennessee, 37067
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Allen, Texas, 75013
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Amarillo, Texas, 79124
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Dallas, Texas, 75230
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Dallas, Texas, 75235
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DeSoto, Texas, 75115
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Frisco, Texas, 75034
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Houston, Texas, 77074
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Houston, Texas, 77099
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Kerrville, Texas, 78028
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McKinney, Texas, 75069
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Red Oak, Texas, 75154
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San Antonio, Texas, 78258
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Sugar Land, Texas, 77479
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Murray, Utah, 84107
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Pleasant View, Utah, 84404
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Burke, Virginia, 22015
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Williamsburg, Virginia, 23188
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Greenfield, Wisconsin, 53228
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La Crosse, Wisconsin, 54601
International Sites
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Research Site 40054-015
Caba, , C1121ABE
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Rio de Janeiro, , 22061-080
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Santos, , 11075-900
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Ajax, Ontario, L1S 2J5
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Ajax, Ontario, L1Z 0M1
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Burlington, Ontario, L7N
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Ottawa, Ontario, K1H 1E4
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Windsor, Ontario, N8X 2G1
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Windsor, Ontario, N8X 5A6
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Québec, Quebec, G1G 3Y8
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Trois-Rivières, Quebec, G9A 4P3
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Kfar Saba, , 4428164
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Ramat Gan, , 5262000
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Anyang-Si, , 14068
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Busan, , 48108
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Incheon, , 21565
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Jeonju, , 54907
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Seoul, , 04763
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Seoul, , 06591
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Seoul, , 07061
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Suwon-si, , 16499
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Bialystok, , 15-430
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Białystok, , 15-044
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Będzin, , 42-500
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Giżycko, , 11-500
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Katowice, , 40-081
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Krakow, , 31-864
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Kraków, , 30-033
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Kraków, , 31-011
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Kraków, , 31-159
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Lublin, , 20-089
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Maków Podhalański, , 34-220
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Ostrowiec Świętokrzyski, , 27-400
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Piaseczno, , 05-500
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Poznań, , 61-578
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Rzeszow, , 35-205
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Skierniewice, , 96-100
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Trzebnica, , 55-100
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Wrocław, , 51-162
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Łódź, , 90-302
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Łódź, , 90-549
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Guaynabo, , 00968
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Ponce, , 00717
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San Juan, , 00907
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San Juan, , 00918
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San Juan, , 00927
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Braşov, Brasov, 50366
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Cluj-Napoca, Cluj, 400371
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Braşov, , 500051
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Cluj-Napoca, , 400371
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Constanţa, , 900002
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Sangeorgiu de Mures, , 547365
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Timişoara, , 300310
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Benoni, , 1500
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Cape Town, , 7570
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Durban, , 7570
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Johannesburg, , 2193
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KwaZulu, , 4001
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KwaZulu, , 4092
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KwaZulu, , 4301
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KwaZulu, , 4301
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KwaZulu, , 4450
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Mpumalanga, , 1050
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Pretoria, , 0002
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Vereeniging, , 1935
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Welkom, , 9460
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Kaohsiung, , 807
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New Taipei City, , 220
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New Taipei City, , 23561
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Taichung, , 40403
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Taipei, , 100
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Taipei, , 11217
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Taipei, , 11240
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Ankara, , 06230
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Ankara, , 06560
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Ankara, , 06560
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Konak, , 35110
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Tekirdag, , 59100
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Chernivtsi, , 58001
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Chernivtsi, , 58022
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Ivano-Frankivs'k, , 76008
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Ivano-Frankivs'k, , 76018
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Ivano-Frankivs'k, , 76018
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Ivano-Frankivs'k, , 76019
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Kyiv, , 02002
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Kyiv, , 03037
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Kyiv, , 03038
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Kyiv, , 03038
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Kyiv, , 03038
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Kyiv, , 03049
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Kyiv, , 03057
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Kyiv, , 03115
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Luts'k, , 45634
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Ternopil, , 46023
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Vinnytsia, , 21001
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Vinnytsia, , 21018
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Vinnytsia, , 21029
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Vinnytsia, , 21029
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Zhytomyr, , 10002
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Research Site 40044-018
Bellshill, , ML4 3NJ
Status
Address
Research Site 40044-021
Birmingham, , B15 2SQ
Status
Address
Research Site 40044-017
Chorley, , PR7 7NA
Status
Address
Research Site 40044-022
Enfield Town, , EN3 4GS
Status
Address
Research Site 40044-019
Liverpool, , L22 0LG
Status
Address
Research Site 40044-001
Manchester, , BL9 0NJ
Status
Address
Research Site 40044-020
Manchester, , M15 6SE
Status
Address
Research Site 40044-013
Manchester, , M22 4DH
Status
Address
Research Site 40044-009
Manchester, , M24 4DZ
Status
Address
Research Site 40044-036
Manchester, , M27 0EW
Status
Address
Research Site 40044-006
Manchester, , M33 4BR
Status
Address
Research Site 40044-024
Preston, , PR2 9RB
Status
Address
Research Site 40044-026
Rochdale, , OL11 4AU
Status
Address
Research Site 40044-008
Salford, , M6 5WW
Status
Address
Research Site 40044-034
Stockport, , SK8 5LL
Status
Address
Research Site 40044-078
Wythenshawe, , M23 9QZ
