A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

NCT ID: NCT05763121

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1061 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2025-12-08

Brief Summary

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This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

Detailed Description

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This is a multicenter, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of dexpramipexole in adults and adolescents with severe, inadequately controlled asthma with eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS )and at least one additional asthma controller medication with or without oral corticosteroids (OCS). Approximately 1400 participants will be randomized globally. Participants will receive dexpramipexole, or placebo, administered orally, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 4 weeks.

Conditions

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Eosinophilic Asthma Asthma; Eosinophilic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo oral tablet taken twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral administration of placebo tablet

150 mg BID

Dexpramipexole 150 mg oral tablet taken twice a day

Group Type EXPERIMENTAL

Dexpramipexole Dihydrochloride

Intervention Type DRUG

oral administration of dexpramipexole tablet

75 mg BID

Dexpramipexole 75 mg oral tablet taken twice a day

Group Type EXPERIMENTAL

Dexpramipexole Dihydrochloride

Intervention Type DRUG

oral administration of dexpramipexole tablet

Interventions

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Dexpramipexole Dihydrochloride

oral administration of dexpramipexole tablet

Intervention Type DRUG

Placebo

oral administration of placebo tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent form and assent form, as appropriate
2. Male or female ≥12 years of age at Screening Visit 1

Asthma-related criteria
3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
4. Treatment of asthma, participants must satisfy all the below (items a to c):

1. Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS; ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
2. Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Screening Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1.
3. Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to Screening Visit 1.
5. Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
6. Variable airflow obstruction documented with at least one of the following criteria:

1. 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 to17). 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.
2. Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1.
3. Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1.
4. Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1.
5. Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV₁ of methacholine \<8 mg/mL) documented in the past past 24 months prior to Screening Visit 1.
7. ACQ-6 ≥1.5 at Screening Visit 2.
8. Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) within the past 12-month period prior to Screening Visit 1.

General medical history
9. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening Visit 2 and Baseline Visit.
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. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit without an alternative medical cause. The following age specific requirements apply:
3. Women \<50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range.
4. Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.

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 due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening 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, hypereosinophilic syndrome, 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.
4. For participants aged 12 to 17 years old, AEC of \<0.15x10⁹/L at Screening Visit 1.

Prohibited medications/procedures
5. 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-IL-5) in the past 12 months.
6. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline Visit: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
7. Treatment with pramipexole (Mirapex®) within 30 days of Baseline Visit.
8. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.
9. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the coming year.

General medical history
10. Weight \<40 kg at Screening Visit 2.
11. Current smoking within the 12 months prior to Screening Visit 1 or a smoking history of \>10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use.
12. Known or suspected alcohol or drug abuse
13. Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to the Baseline Visit despite antihypertensive therapy.
14. 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.
15. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C.
16. 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 (SoC) therapy.
17. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements.
18. Known or suspected noncompliance with medication.
19. Unwillingness or inability to follow the procedures outlined in the protocol.

Clinical safety labs
20. Absolute neutrophil count (ANC) \<2.000x10⁹/L at Screening Visit 1 or Screening Visit 2.
21. 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 for age ≥18 years at screening; using the Bedside Schwartz eGFR formula).
22. 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
23. History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction \<25%.
24. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit.
25. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation.
26. History of long QT syndrome.
27. 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.
28. Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTcF interval changes at Screening Visit 2, including heart rate \<45 beats per minute (bpm) or \>100 bpm.

Pregnancy/Lactation
29. Pregnant women or women breastfeeding
30. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Areteia Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salman Siddiqui, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust (via Imperial Consultants)

Locations

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Research Site 20001-374

Bakersfield, California, United States

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Research Site 20001-440

La Palma, California, United States

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Research Site 20001-062

Newport Beach, California, United States

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Research Site 20001-043

Newport Beach, California, United States

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Research Site 20001-380

Redding, California, United States

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Research Site US-20001-488

San Diego, California, United States

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Research Site 20001-003

West Covina, California, United States

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Research Site 20001-419

Westminster, California, United States

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Research Site 20001-048

Aventura, Florida, United States

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Research Site 20001-005

Brandon, Florida, United States

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Research Site 20001-051

Brandon, Florida, United States

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Research Site 20001-029

Coral Gables, Florida, United States

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Research Site 20001-350

Gainesville, Florida, United States

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Research Site 20001-014

Green Acres, Florida, United States

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Research Site 20001-054

Hialeah, Florida, United States

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Research Site 20001-067

Hialeah, Florida, United States

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Research Site 20001-020

Homestead, Florida, United States

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Research Site 20001-015

Kissimmee, Florida, United States

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Research Site 20001-002

Kissimmee, Florida, United States

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Research Site 20001-086

Loxahatchee Groves, Florida, United States

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Research Site 20001-066

Miami, Florida, United States

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Research Site 20001-001

Miami, Florida, United States

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Research Site 20001-059

Miami, Florida, United States

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Research Site 20001-026

Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Research Site 20001-069

St. Petersburg, Florida, United States

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Research Site 20001-004

Tampa, Florida, United States

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Augusta, Georgia, United States

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Research Site 20001-018

Columbus, Georgia, United States

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Research Site 20001-459

Sugar Hill, Georgia, United States

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Research Site 20001-090

Berwyn, Illinois, United States

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Research Site 20001-476

Chicago, Illinois, United States

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Research Site 20001-358

Normal, Illinois, United States

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Research Site 20001-135

River Forest, Illinois, United States

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Skokie, Illinois, United States

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Elwood, Indiana, United States

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Research Site 20001-044

Evansville, Indiana, United States

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Iowa City, Iowa, United States

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Owensboro, Kentucky, United States

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Research Site 20001-466

Baltimore, Maryland, United States

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Research Site 20001-456

Takoma Park, Maryland, United States

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White Marsh, Maryland, United States

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Fall River, Massachusetts, United States

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Flint, Michigan, United States

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Flint, Michigan, United States

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Rochester Hills, Michigan, United States

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Chesterfield, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Highland Park, New Jersey, United States

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Jersey City, New Jersey, United States

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New Brunswick, New Jersey, United States

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East Amherst, New York, United States

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Hawthorne, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Edmond, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Hershey, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Dickson, Tennessee, United States

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Amarillo, 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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Plano, Texas, United States

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The Woodlands, Texas, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Vienna, Virginia, United States

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Barboursville, West Virginia, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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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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Buenos Aires, , 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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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Mendoza, , Argentina

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Mendoza, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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San Miguel de Tucumán, , Argentina

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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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Ribeirão Preto, São Paulo, Brazil

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Santos, São Paulo, Brazil

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São Bernardo do Campo, São Paulo, Brazil

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Sorocaba, São Paulo, Brazil

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Blumenau, , Brazil

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Campo Largo, , Brazil

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Porto Alegre, , Brazil

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Santo André, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Dimitrovgrad, , Bulgaria

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Kozloduy, , Bulgaria

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Lovech, , Bulgaria

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Montana, , Bulgaria

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Montana, , Bulgaria

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Pernik, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sliven, , 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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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Stara Zagora, , Bulgaria

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Velingrad, , Bulgaria

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Vidin, , Bulgaria

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Research Site 20011-011

Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Ajax, Ontario, Canada

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Ajax, Ontario, Canada

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Burlington, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Guelph, , Canada

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Research Site 20086-071

Jilin, Jilin, China

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Taizhou, Zhejang, China

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Baoding, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Chengdu, , China

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Guandong, , China

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Guangdong, , China

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Guangxi, , China

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Guangzhou, , China

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Guizhou, , China

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Hangzhou, , China

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Hangzhou, , China

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Hangzhou, , China

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Hangzhou, , China

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Jinan, , China

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Luoyang, , China

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Nanchang, , China

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Nanchang, , China

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Research Site 20086-040

Ningbo, , China

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Pudong, , China

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Qingdao, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shenyang, , China

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Taiyuan, , China

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Weifang, , China

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Weifang, , China

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Wuxi, , China

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Zhejiang, , China

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Research Site 20057-008

Barranquilla, , Colombia

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Bogotá, , Colombia

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Ibagué, , Colombia

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Santander, , Colombia

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Research Site 20057-001

Zipaquirá, , Colombia

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Research Site 20995-007

Batumi, , Georgia

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Research Site 20995-001

Kutaisi, , Georgia

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Research Site 20995-005

Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Research Site 20081-080

Asahikawa, , Japan

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Research Site 20081-046

Fukuoka, , Japan

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Research Site 20081-003

Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Himeji, , Japan

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Research Site 20081-078

Hiroshima, , Japan

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Hokkaido, , Japan

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Ibaraki, , Japan

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Research Site 20081-069

Isehara, , Japan

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Kagoshima, , Japan

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Kobe, , Japan

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Kobe, , Japan

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Kochi, , Japan

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Kochi, , Japan

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Maebashi, , Japan

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Matsusaka, , Japan

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Miura, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Ono, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Saga, , Japan

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Saitama, , Japan

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Shibuya-ku, , Japan

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Shimane, , Japan

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Shizuoka, , Japan

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Shizuoka, , Japan

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Tarumi, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Research Site 20081-026

Tokyo, , Japan

Site Status

Research Site 20081-066

Tokyo, , Japan

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Research Site 20081-019

Tokyo, , Japan

Site Status

Research Site 20081-074

Tokyo, , Japan

Site Status

Research Site 20081-065

Tokyo, , Japan

Site Status

Research Site 20081-029

Tokyo, , Japan

Site Status

Research Site 20081-062

Toyama, , Japan

Site Status

Research Site 20081-038

Toyama, , Japan

Site Status

Research Site 20081-049

Tsuchiura, , Japan

Site Status

Research Site 20081-016

Yamaguchi, , Japan

Site Status

Research Site 20081-011

Yokohama, , Japan

Site Status

Research Site 20081-051

Yokohama, , Japan

Site Status

Research Site 20081-087

Yonago, , Japan

Site Status

Research Site 20081-043

Yoshida, , Japan

Site Status

Research Site 20961-007

Aïn Ouzaïn, , Lebanon

Site Status

Research Site 20961-003

Beirut, , Lebanon

Site Status

Research Site 20961-004

Beirut, , Lebanon

Site Status

Research Site 20961-009

Beirut, , Lebanon

Site Status

Research Site 20961-010

Beirut, , Lebanon

Site Status

Research Site 20961-012

Beirut, , Lebanon

Site Status

Research Site 20961-005

Tripoli, , Lebanon

Site Status

Research Site 20052-011

Benito Juárez, , Mexico

Site Status

Research Site 20052-008

Córdoba, , Mexico

Site Status

Research Site 20052-035

Cuernavaca, , Mexico

Site Status

Research Site 20052-002

Guadalajara, , Mexico

Site Status

Research Site 20052-034

Guadalajara, , Mexico

Site Status

Research Site 20052-013

Mérida, , Mexico

Site Status

Research Site 20052-004

Mérida, , Mexico

Site Status

Research Site 20052-012

San Juan del Río, , Mexico

Site Status

Research Site 20052-037

San Nicolás de los Garza, , Mexico

Site Status

Research Site 20052-006

Veracruz, , Mexico

Site Status

Research Site 20052-009

Zapopan, , Mexico

Site Status

Research Site 20389-006

Shtip, , North Macedonia

Site Status

Research Site 20389-003

Skopje, , North Macedonia

Site Status

Research Site 20389-004

Skopje, , North Macedonia

Site Status

Research Site 20389-007

Skopje, , North Macedonia

Site Status

Research Site 20389-005

Strumica, , North Macedonia

Site Status

Research Site 20389-001

Veles, , North Macedonia

Site Status

Research Site 20051-009

Lima, , Peru

Site Status

Researcdh Site 20051-014

Lima, , Peru

Site Status

Research Site 20051-012

Lima, , Peru

Site Status

Research Site 20051-013

Lima, , Peru

Site Status

Research Site 20051-030

Lima, , Peru

Site Status

Research Site 20051-003

Lima, , Peru

Site Status

Research Site 20051-007

Lima, , Peru

Site Status

Research Site 20051-006

Lima, , Peru

Site Status

Research Site 20051-010

Lima, , Peru

Site Status

Research Site 20051-001

Lima, , Peru

Site Status

Research Site20051-002

Lima, , Peru

Site Status

Research Site 20051-008

Piura, , Peru

Site Status

Research Site 20048-001

Będzin, , Poland

Site Status

Research Site 20048-018

Bialystok, , Poland

Site Status

Research Site 20048-032

Bialystok, , Poland

Site Status

Research Site 20048-006

Giżycko, , Poland

Site Status

Research Site 20048-021

Katowice, , Poland

Site Status

Research Site 20048-002

Katowice, , Poland

Site Status

Research Site 20048-036

Kielce, , Poland

Site Status

Research Site 20048-027

Krakow, , Poland

Site Status

Research Site 20048-033

Krakow, , Poland

Site Status

Research Site 20048-008

Krakow, , Poland

Site Status

Research Site 20048-040

Krakow, , Poland

Site Status

Research Site 20048-005

Lodz, , Poland

Site Status

Research Site 20048-009

Lodz, , Poland

Site Status

Research Site 20048-015

Lodz, , Poland

Site Status

Research Site 20048-022

Lublin, , Poland

Site Status

Research Site 20048-024

Maków Podhalański, , Poland

Site Status

Research Site 20048-031

Ostrowiec Świętokrzyski, , Poland

Site Status

Research Site 20048-010

Piaseczno, , Poland

Site Status

Research Site 20048-028

Poznan, , Poland

Site Status

Research Site 20048-016

Poznan, , Poland

Site Status

Research Site 20048-039

Rzeszów, , Poland

Site Status

Research Site 20048-014

Skierniewice, , Poland

Site Status

Research Site 20048-037

Torun, , Poland

Site Status

Research Site 20048-012

Trzebnica, , Poland

Site Status

Research Site 20048-034

Warsaw, , Poland

Site Status

Research Site 20048-019

Wroclaw, , Poland

Site Status

Research Site 20048-029

Wroclaw, , Poland

Site Status

Research Site 20787-365

Guaynabo, , Puerto Rico

Site Status

Research Site 20787-390

Ponce, , Puerto Rico

Site Status

Research Site 20040-004

Brasov, Brașov County, Romania

Site Status

Research Site 20040-006

Cluj-Napoca, Cluj, Romania

Site Status

Research Site 20040-008

Bragadiru, , Romania

Site Status

Research Site 20040-002

Brasov, , Romania

Site Status

Research Site 20040-004

Brasov, , Romania

Site Status

Research Site 20040-011

Timișoara, , Romania

Site Status

Research Site 20381-002

Belgrade, , Serbia

Site Status

Research Site 20381-007

Belgrade, , Serbia

Site Status

Research Site 20381-010

Belgrade, , Serbia

Site Status

Research Site 20381-012

Belgrade, , Serbia

Site Status

Research Site 20381-005

Belgrade, , Serbia

Site Status

Research Site 20381-006

Belgrade, , Serbia

Site Status

Research Site 20381-008

Kamenitz, , Serbia

Site Status

Research Site 20381-001

Kragujevac, , Serbia

Site Status

Research Site 20381-004

Niš, , Serbia

Site Status

Research Site 20381-009

Novi Sad, , Serbia

Site Status

Research Site 20381-011

Užice, , Serbia

Site Status

Research Site 20381-003

Valjevo, , Serbia

Site Status

Research Site 20082-003

Anyang, , South Korea

Site Status

Research Site 20082-007

Busan, , South Korea

Site Status

Research Site 20082-009

Daegu, , South Korea

Site Status

Research Site 20381-009

Incheon, , South Korea

Site Status

Research Site 20082-006

Jeonju, , South Korea

Site Status

Research Site 20082-013

Seoul, , South Korea

Site Status

Research Site 20082-019

Seoul, , South Korea

Site Status

Research Site 20082-008

Seoul, , South Korea

Site Status

Research Site 20082-004

Seoul, , South Korea

Site Status

Research Site 20082-014

Seoul, , South Korea

Site Status

Research Site 20082-011

Seoul, , South Korea

Site Status

Research Site 20082-010

Suwon, , South Korea

Site Status

Research Site 20380-002

Chernivtsi, , Ukraine

Site Status

Research Site 20380-021

Chernivtsi, , Ukraine

Site Status

Research Site 20380-017

Ivano-Frankivsk, , Ukraine

Site Status

Research Site 20380-004

Ivano-Frankivsk, , Ukraine

Site Status

Research Site 20380-009

Ivano-Frankivsk, , Ukraine

Site Status

Research Site 20380-014

Ivano-Frankivsk, , Ukraine

Site Status

Research Site 20380-015

Kyiv, , Ukraine

Site Status

Research Site 20380-019

Kyiv, , Ukraine

Site Status

Research Site 20380-007

Kyiv, , Ukraine

Site Status

Research Site 20380-010

Kyiv, , Ukraine

Site Status

Research Site 20380-012

Kyiv, , Ukraine

Site Status

Research Site 20380-011

Kyiv, , Ukraine

Site Status

Research Site 20380-013

Kyiv, , Ukraine

Site Status

Research Site 20380-018

Kyiv, , Ukraine

Site Status

Research Site 20380-016

Lutsk, , Ukraine

Site Status

Research Site 20380-001

Ternopil, , Ukraine

Site Status

Research Site 20380-003

Vinnytsia, , Ukraine

Site Status

Research Site 20380-020

Vinnytsia, , Ukraine

Site Status

Research Site 20380-022

Vinnytsia, , Ukraine

Site Status

Research Site 20380-008

Vinnytsia, , Ukraine

Site Status

Research Site 20380-005

Zhytomyr, , Ukraine

Site Status

Research Site 20044-001

Manchester, Greater Manchester, United Kingdom

Site Status

Research Site 20044-033

Manchester, Greater Manchester, United Kingdom

Site Status

Research Site 20044-046

Manchester, Greater Manchester, United Kingdom

Site Status

Research Site 20044-013

Manchester, Greater Manchester, United Kingdom

Site Status

Research Site 20044-008

Salford, Greater Manchester, United Kingdom

Site Status

Research Site 20044-010

Altrincham, , United Kingdom

Site Status

Research Site 20044-079

Bedford, , United Kingdom

Site Status

Research Site 20044-018

Bellshill, , United Kingdom

Site Status

Research Site 20044-083

Birmingham, , United Kingdom

Site Status

Research Site 20044-021

Birmingham, , United Kingdom

Site Status

Research Site 20044-077

Bollington, , United Kingdom

Site Status

Research Site 20044-017

Chorley, , United Kingdom

Site Status

Research Site 20044-022

Enfield, , United Kingdom

Site Status

Research Site 20044-019

Liverpool, , United Kingdom

Site Status

Research Site 20044-084

London, , United Kingdom

Site Status

Research Site 20044-081

London, , United Kingdom

Site Status

Research Site 20044-036

London, , United Kingdom

Site Status

Research Site 20044-042

London, , United Kingdom

Site Status

Research Site 20044-020

Manchester, , United Kingdom

Site Status

Research Site 20044-031

Manchester, , United Kingdom

Site Status

Research Site 20044-032

Manchester, , United Kingdom

Site Status

Research Site 20044-009

Manchester, , United Kingdom

Site Status

Research Site 20044-005

Manchester, , United Kingdom

Site Status

Research Site 20044-030

Manchester, , United Kingdom

Site Status

Research Site 20044-012

Manchester, , United Kingdom

Site Status

Research Site 20044-004

Manchester, , United Kingdom

Site Status

Research Site 20044-082

Nottingham, , United Kingdom

Site Status

Research Site 20044-024

Preston, , United Kingdom

Site Status

Research Site 20044-026

Rochdale, , United Kingdom

Site Status

Research Site 20044-029

Stockport, , United Kingdom

Site Status

Research Site 20044-034

Stockport, , United Kingdom

Site Status

Research Site 20044-078

Wythenshawe, , United Kingdom

Site Status

Countries

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United States Argentina Brazil Bulgaria Canada China Colombia Georgia Japan Lebanon Mexico North Macedonia Peru Poland Puerto Rico Romania Serbia South Korea Ukraine United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-003004-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023049491

Identifier Type: REGISTRY

Identifier Source: secondary_id

AR-DEX-22-01

Identifier Type: -

Identifier Source: org_study_id

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