RecruitingPhase 3NCT06878261

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Sponsor

AstraZeneca

Enrollment

990 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests tezepelumab, a biologic drug that blocks an inflammatory protein, in people with moderate to very severe COPD (chronic obstructive pulmonary disease). Tezepelumab is already approved for severe asthma, and researchers want to know if it can also reduce flare-ups and improve lung function in COPD patients. **You may be eligible if:** - You are between 40 and 80 years old - You have been diagnosed with COPD for at least 1 year - Your lung function tests show moderate to very severe airflow limitation - You have been on triple or dual inhaled COPD therapy for at least 3 months - You have had 2 or more moderate flare-ups or 1 severe flare-up requiring hospitalization in the past year **You may NOT be eligible if:** - Your COPD is mild - You are a current smoker (some trials require smoking cessation) - You have a diagnosis of asthma or another major lung condition - You are pregnant or planning to become pregnant - You have a serious heart or immune condition that could make the drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTezepelumab

Tezepelumab subcutaneous injection

OTHERPlacebo

Placebo subcutaneous injection

Locations(268)

Research Site

Cullman, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Inglewood, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Redding, California, United States

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San Diego, California, United States

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New Britain, Connecticut, United States

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Wilmington, Delaware, United States

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Bay Pines, Florida, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Fleming Island, Florida, United States

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Jacksonville, Florida, United States

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Leesburg, Florida, United States

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Margate, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Ocala, Florida, United States

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Palmetto Bay, Florida, United States

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Winter Park, Florida, United States

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Adairsville, Georgia, United States

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Atlanta, Georgia, United States

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Cordele, Georgia, United States

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Decatur, Georgia, United States

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Fort Eisenhower, Georgia, United States

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Savannah, Georgia, United States

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Evanston, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Bowling Green, Kentucky, United States

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Owensboro, Kentucky, United States

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Baltimore, Maryland, United States

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Potomac, Maryland, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Hannibal, Missouri, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Grants Pass, Oregon, United States

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Sayre, Pennsylvania, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Gaffney, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Rapid City, South Dakota, United States

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Knoxville, Tennessee, United States

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Boerne, Texas, United States

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El Paso, 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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Lewisville, Texas, United States

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McKinney, Texas, United States

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Mesquite, Texas, United States

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San Antonio, Texas, United States

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Colchester, Vermont, United States

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Williamsburg, Virginia, United States

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Everett, Washington, United States

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Alberdi, Argentina

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Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Florida, Argentina

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La Plata, Argentina

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La Plata, Argentina

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Mar del Plata, Argentina

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Mendoza, Argentina

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Quilmes, Argentina

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Rosario, Argentina

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San Fernando, Argentina

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San Juan Bautista, Argentina

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Coffs Harbour, Australia

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Frankston, Australia

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Garran, Australia

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Nedlands, Australia

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New Lambton, Australia

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Spearwood, Australia

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Wollongong, Australia

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Woodville South, Australia

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Genk, Belgium

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Ghent, Belgium

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Jette, Belgium

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Leuven, Belgium

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Mechelen, Belgium

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Namur, Belgium

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Dupnitsa, Bulgaria

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Haskovo, Bulgaria

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Lovech, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Rousse, 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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Varna, Bulgaria

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Veliko Tanovo, Bulgaria

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Veliko Tarnovo, Bulgaria

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Vidin, Bulgaria

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Yambol, Bulgaria

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Armenia, Colombia

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Barranquilla, Colombia

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Bogotá, Colombia

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Cali, Colombia

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Ibague, Colombia

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Manizales, Colombia

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Medellín, Colombia

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Medellín, Colombia

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Aalborg, Denmark

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Hvidovre, Denmark

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Næstved, Denmark

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Odense C, Denmark

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Vejle, Denmark

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Brest, France

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Lyon, France

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Marseille, France

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Montpellier, France

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Paris, France

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Paris, France

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Pessac, France

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Saint-Herblain, France

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Heraklion, Greece

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Ioannina, Greece

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Pátrai, 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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Hong Kong, Hong Kong

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Budapest, Hungary

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Debrecen, Hungary

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Edelény, Hungary

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Gödöllő, Hungary

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Hatvan, Hungary

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Mosonmagyaróvár, Hungary

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Nyíregyháza-Sóstóhegy, Hungary

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Törökbálint, Hungary

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Ashkelon, Israel

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Akashi-shi, Japan

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Chikushino-shi, Japan

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Chiyoda-ku, Japan

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Fukui-shi, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Gifu, Japan

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Iruma-Gun, Japan

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Ishinomaki, Japan

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Kasuga-shi, Japan

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Kitakyushu-shi, Japan

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Kiyose-shi, Japan

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Kiyose-shi, Japan

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Kobe, Japan

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Komatsu-shi, Japan

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Kure-shi, Japan

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Kyoto, Japan

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Matsusaka-shi, Japan

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Meguro-ku, Japan

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Minatoku, Japan

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Minatoku, Japan

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Miyazaki, Japan

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Mizunami-shi, Japan

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Nagaoka-shi, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Nagoya, Japan

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Nagoya, Japan

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Nerima-ku, Japan

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Ohta-ku, Japan

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Okayama, Japan

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Okayama, Japan

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Osaka, Japan

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Sapporo, Japan

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Sendai, Japan

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Sendai, Japan

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Shinjuku-ku, Japan

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Shinjuku-ku, Japan

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Shinjuku-ku, Japan

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Shiogama, Japan

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Takamatsu, Japan

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Takatsuiki-shi, Japan

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Tanabe-shi, Japan

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Toshima-ku, Japan

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Ube, Japan

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Yokohama, Japan

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Yokohama, Japan

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Eindhoven, Netherlands

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Maastricht, Netherlands

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Rotterdam, Netherlands

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Rotterdam, Netherlands

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Zutphen, Netherlands

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Auckland, New Zealand

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Auckland, New Zealand

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Auckland, New Zealand

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Hamilton West, New Zealand

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Tauranga, New Zealand

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Cusco, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Piura, Peru

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Bucharest, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Cluj-Napoca, Romania

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Oradea, Romania

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Timișoara, Romania

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Timișoara, Romania

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Bellville, South Africa

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Benoni, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Durban, South Africa

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eMkhomazi, South Africa

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Kimberley, South Africa

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Somerset West, South Africa

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Gothenburg, Sweden

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Karlskrona, Sweden

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Lund, Sweden

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Örebro, Sweden

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Stockholm, Sweden

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Stockholm, Sweden

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Bang Kra So, Thailand

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Bangkok, Thailand

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Hat Yai, Thailand

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Muang, Thailand

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Muang, Thailand

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Mueang, Thailand

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Rayong, Thailand

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Kocaeli, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Can Tho, Vietnam

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Da Nang, Vietnam

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Haiphong, Vietnam

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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Ho Chi Minh City, Vietnam

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Ho Chi Minh City, Vietnam

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Hồ Chí Minh, Vietnam

Research Site

Huế, Vietnam

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NCT06878261

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