New biologic drug aims to cut COPD attacks in half

NCT ID NCT06883305

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This Phase 3 study tests whether tezepelumab, a biologic drug, can reduce moderate to severe COPD flare-ups in adults aged 40-80. About 990 participants will receive either tezepelumab or a placebo as a shot under the skin. The main goal is to see if the drug lowers the number of flare-ups over 76 weeks and improves lung function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tezepelumab (a biologic drug given as a shot under the skin)
What this could lead to: If it works, this could provide a new treatment option to reduce COPD flare-ups and help people breathe better.
What could go wrong: This is a Phase 3 trial, but tezepelumab has not yet been proven effective for COPD. It may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 990 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥40 to ≤80 years old 2. COPD diagnosis ≥1 year, 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1 5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years Exclusion Criteria: 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD 2. Asthma, incl. pediatric, or ACOS 3. Any unstable disorder that can impact participants safety or study outcomes 4. Tuberculosis requiring treatment within 12 months prior V2 5. Malignancies current or past Concomitant therapies: * Macrolides (less than 6 months) * Systemic immuno-suppressive, -modulating medications 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic obstructive pulmonary disease (COPD) are added.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease (COPD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

275 sites in 18 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Foley, Alabama, 36535, United States
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Mobile, Alabama, 36609, United States
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Sheffield, Alabama, 35660, United States
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Phoenix, Arizona, 85012, United States
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Phoenix, Arizona, 85027, United States
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Tucson, Arizona, 85704, United States
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Garden Grove, California, 92844, United States
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Newport Beach, California, 92663, United States
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Torrance, California, 90502, United States
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Clearwater, Florida, 33765, United States
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Cutler Bay, Florida, 33157, United States
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Cutler Bay, Florida, 33189, United States
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DeBary, Florida, 32713, United States
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Gainesville, Florida, 32608, United States
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Homestead, Florida, 33032, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33175, United States
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Orlando, Florida, 32807, United States
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Tampa, Florida, 33606, United States
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Tampa, Florida, 33607, United States
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Atlanta, Georgia, 30344, United States
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Lithonia, Georgia, 30038, United States
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Rincon, Georgia, 31326, United States
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Meridian, Idaho, 83646, United States
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Chicago, Illinois, 60611, United States
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Palos Hills, Illinois, 60465, United States
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Winfield, Illinois, 60190, United States
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Munster, Indiana, 46321, United States
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Baltimore, Maryland, 21201, United States
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Columbia, Maryland, 21045, United States
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North Dartmouth, Massachusetts, 02747, United States
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Farmington Hills, Michigan, 48336, United States
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Saint Cloud, Minnesota, 56303, United States
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St Louis, Missouri, 63103, United States
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St Louis, Missouri, 63103, United States
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Missoula, Montana, 59808, United States
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Papillion, Nebraska, 68046, United States
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Las Vegas, Nevada, 89106, United States
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Millville, New Jersey, 08332, United States
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Sewell, New Jersey, 08080, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87102, United States
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Buffalo, New York, 14203, United States
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Buffalo, New York, 14215, United States
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Cortland, New York, 13045, United States
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Horseheads, New York, 14845, United States
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NOT_YET_RECRUITING

Massapequa, New York, 11758, United States
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The Bronx, New York, 10455, United States
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High Point, North Carolina, 27260, United States
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Kings Mountain, North Carolina, 28086, United States
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New Bern, North Carolina, 28562, United States
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COMPLETED

Wilmington, North Carolina, 28412, United States
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Winston-Salem, North Carolina, 27103, United States
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Columbus, Ohio, 43213, United States
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Oklahoma City, Oklahoma, 73120, United States
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DuBois, Pennsylvania, 15801, United States
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Philadelphia, Pennsylvania, 19140, United States
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Rock Hill, South Carolina, 29732, United States
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Franklin, Tennessee, 37067, United States
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Johnson City, Tennessee, 37604, United States
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Dallas, Texas, 75254, United States
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Forney, Texas, 75126, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77084, United States
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Houston, Texas, 77090, United States
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Humble, Texas, 77338, United States
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Kerrville, Texas, 78028, United States
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Mansfield, Texas, 76063, United States
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Clearfield, Utah, 84015, United States
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Morgantown, West Virginia, 26501, United States
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Cudahy, Wisconsin, 53110, United States
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NOT_YET_RECRUITING

Milwaukee, Wisconsin, 53295, United States
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Bragança Paulista, 12916-542, Brazil
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Brasília, 70200-730, Brazil
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Campinas, 13060-080, Brazil
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Chapecó, 89812-210, Brazil
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Curitiba, 80030-110, Brazil
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Jaú, 17201-130, Brazil
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Mossoró, 59603-020, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90480-000, Brazil
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Porto Alegre, 90560-003, Brazil
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Porto Alegre, 9061-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40050-410, Brazil
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São José do Rio Preto, 15090-000, Brazil
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Vitória, 29062-110, Brazil
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Calgary, Alberta, T3R 1W7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Scarborough Village, Ontario, M1P 2V5, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Winchester, Ontario, K0C 2K0, Canada
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Windsor, Ontario, N8X-5A6, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Saint-Laurent, Quebec, H4R3C8, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Chile, 7770484, Chile
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Concepción, 4070094, Chile
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Curicó, 3341643, Chile
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Quillota, 2260000, Chile
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Santiago, 7500010, Chile
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Santiago, 7501126, Chile
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Santiago, 7750495, Chile
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Santiago, 8380453, Chile
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Talca, 3481349, Chile
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Anyang, 455099, China
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Beijing, 100020, China
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Beijing, 100191, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410015, China
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Changsha, 430033, China
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Chengdu, 610072, China
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Chengdu, 611130, China
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Chongqing, 400042, China
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Chongqing, 401320, China
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Fuzhou, 350031, China
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Guangzhou, 510000, China
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Guangzhou, 510150, China
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Guangzhou, 510163, China
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Guangzhou, 510515, China
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Haikou, 570311, China
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Hangzhou, 310005, China
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Hefei, 230061, China
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Hengyang, 421001, China
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Heze, 274099, China
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Hohhot, 750306, China
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Huizhou, 516002, China
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Jinan, 250013, China
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Jinan, 250021, China
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Jinhua, 321000, China
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Linhai, 317000, China
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Loudi, 417099, China
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Nanchang, 330006, China
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Nanchong, 637000, China
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Nanjing, 2100008, China
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Nanjing, 211100, China
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Nanning, 530000, China
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Nanning, 530021, China
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Pingxiang, 337055, China
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Qingdao, 266011, China
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Qingyuan, 511518, China
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Sanya, 572000, China
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Shanghai, 200040, China
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Shanghai, 200120, China
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Shanghai, 201199, China
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Shanghai, 310000, China
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Shantou, 515041, China
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Shenyang, 110004, China
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Shenzhen, 518020, China
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Shijiazhuang, 50051, China
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Suining Shi, 629000, China
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Taiyuan, 030001, China
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Taiyuan, 030032, China
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Taizhou, 318000, China
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Tianjin, 300050, China
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Wenzhou, 325027, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xinxiang, 453100, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Yichang, 443003, China
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Yinchuan, 750001, China
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Yinchuan, 750004, China
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Zhangzhou, 363000, China
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Brandýs nad Labem, 250 01, Czechia
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Brno, 625 00, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Lovosice, 410 02, Czechia
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Pilsen, 301 00, Czechia
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Prague, 110 00, Czechia
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Prague, 15300, Czechia
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Teplice, 415 01, Czechia
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Varnsdorf, 407 47, Czechia
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København NV, 2400, Denmark
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Bendorf, 56170, Germany
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Berlin, 10787, Germany
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Haltern am See, 45721, Germany
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Hanover, D-30173, Germany
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Immenhausen, 34376, Germany
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Lübeck, 23552, Germany
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Marburg, 35037, Germany
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Rosenheim, 83022, Germany
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Wiesbaden, 65183, Germany
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Ahmedabad, 380053, India
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Ahmedabad, 380054, India
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NOT_YET_RECRUITING

Aligarh, 202002, India
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Belagavi, 590010, India
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Coimbatore, 641028, India
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Dehradun, 248001, India
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Delhi, 110029, India
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Dwārka, 110075, India
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Faridabad, 121012, India
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Gurgaon, 122001, India
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SUSPENDED

Kochi, 682027, India
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SUSPENDED

Kolkata, 700053, India
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Kozhikode, 673008, India
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TERMINATED

Lucknow, 226003, India
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Madurai, 625107, India
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Mysuru, 570002, India
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Nagpur, 440012, India
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Nagpur, 441108, India
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Pune, 411 018, India
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Telangana, 500004, India
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Vadodara, 391760, India
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Cona, 44124, Italy
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Florence, 50134, Italy
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Milan, 20122, Italy
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Montebelluna, 31044, Italy
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Naples, 80131, Italy
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Pavia, 27100, Italy
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Roma, 00128, Italy
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Sassari, 07100, Italy
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Telese Terme, 82037, Italy
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Tradate, 21049, Italy
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Alor Star, 5460, Malaysia
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Kajang, 43000, Malaysia
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Kota Kinabalu, 88200, Malaysia
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Kuala Lumpur, 50603, Malaysia
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Kuala Terengganu, 20400, Malaysia
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Kuantan, 25100, Malaysia
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Kuching, 93586, Malaysia
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Benito Juárez, 03650, Mexico
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Chihuahua City, 31000, Mexico
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WITHDRAWN

Cuauhtémoc, 06700, Mexico
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RECRUITING

Cuernavaca, 62290, Mexico
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NOT_YET_RECRUITING

Guadalajara, 44130, Mexico
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Mérida, 97130, Mexico
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NOT_YET_RECRUITING

Monterrey, 64310, Mexico
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NOT_YET_RECRUITING

Monterrey, 64460, Mexico
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RECRUITING

Monterrey, 64465, Mexico
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Morelia, 58000, Mexico
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Oaxaca City, 68020, Mexico
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San Juan del Río, 76800, Mexico
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Tijuna, 22010, Mexico
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RECRUITING

Veracruz, 91900, Mexico
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NOT_YET_RECRUITING

Zapopan, 45070, Mexico
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Zapopan, 45138, Mexico
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Iloilo City, 5000, Philippines
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Las Piñas, 1742, Philippines
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Manadaluyong City, 1552, Philippines
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Manila, 1000, Philippines
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Marilao, 3019, Philippines
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Quezon City, 1100, Philippines
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Tondo, 1012, Philippines
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Bialystok, 15-044, Poland
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Bydgoszcz, 85-231, Poland
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Bydgoszcz, 85-796, Poland
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Chrzanów, 32-500, Poland
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Karczew, 05-480, Poland
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Katowice, 40-648, Poland
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Kielce, 25-426, Poland
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Krakow, 31-513, Poland
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Lodz, 91-211, Poland
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Lublin, 20-011, Poland
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Ostróda, 14-100, Poland
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Piaseczno, 05-500, Poland
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Poznan, 60-693, Poland
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Pruszków, 05-800, Poland
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Płock, 09-407, Poland
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Humenné, 066 01, Slovakia
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Košice, 04011, Slovakia
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Levice, 93401, Slovakia
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Martin, 03659, Slovakia
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WITHDRAWN

Trnava, 91701, Slovakia
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RECRUITING

Anyang-si, 14068, South Korea
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Daegu, 42415, South Korea
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Iksan-si, 54538, South Korea
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Jeonju, 54907, South Korea
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Seoul, 06591, South Korea
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Seoul, 06973, South Korea
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WITHDRAWN

Seoul, 08308, South Korea
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Seoul, 135-710, South Korea
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Seoul, 143-729, South Korea
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Seoul, 150-713, South Korea
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Uijeongbu-si, 11765, South Korea
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Wŏnju, 26426, South Korea
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Barakaldo, 48903, Spain
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Barcelona, 08036, Spain
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Granada, 18014, Spain
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Madrid, 28007, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Pamplona, 31008, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Bradford, BD9 6RJ, United Kingdom
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Brighton, BN2 1ES, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Halifax, HX3 0PW, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Tyne and Wear, NE29 8NH, United Kingdom
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Wakefield, WF1 4DG, United Kingdom

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