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New hope for endometrial cancer: immunotherapy and targeted drug combo tested
NCT ID NCT04269200
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether adding the immunotherapy drug durvalumab and the targeted therapy olaparib to standard chemotherapy can help women with newly diagnosed advanced or recurrent endometrial cancer live longer without their cancer growing. About 805 participants will receive either chemotherapy alone or chemotherapy plus durvalumab, followed by maintenance durvalumab with or without olaparib. The study aims to see if these combinations improve progression-free survival and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (an immunotherapy drug) and olaparib (a targeted therapy drug), given alongside standard chemotherapy (carboplatin and paclitaxel)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option that delays cancer progression and improves survival for women with advanced or recurrent endometrial cancer.
- What could go wrong
- This is a Phase 3 trial, but results are not yet final. The added drugs may cause more side effects, and not all patients may benefit. The study is also specific to certain cancer types and stages.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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805 people
The number who actually took part.
- Started
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May 2020
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 150 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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: * Age ≥18 years at the time of screening and female. * Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. * Patient must have endometrial cancer in one of the following categories: 1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), 2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) 3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. * Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse * FPPE tumor sample must be available for MMR evaluation. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment. Exclusion Criteria: * History of leptomeningeal carcinomatosis. * Brain metastases or spinal cord compression. * Prior treatment with PARP inhibitors. * Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Get updates
Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tucson, Arizona, 85719, United States
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Concord, California, 94520-2278, United States
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La Jolla, California, 92093, United States
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San Francisco, California, 94158, United States
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Santa Barbara, California, 93105, United States
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Aurora, Colorado, 80012, United States
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Fort Lauderdale, Florida, 33316, United States
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Tampa, Florida, 33612, United States
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Savannah, Georgia, 31404, United States
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Honolulu, Hawaii, 96826, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60637, United States
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Indianapolis, Indiana, 46237, United States
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Louisville, Kentucky, 40207, United States
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Baton Rouge, Louisiana, 70817, United States
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Boston, Massachusetts, 02111, United States
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Saint Paul, Minnesota, 55125, United States
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Jackson, Mississippi, 39216, United States
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Lebanon, New Hampshire, 03756, United States
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Camden, New Jersey, 08103, United States
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Paramus, New Jersey, 07652, United States
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New York, New York, 10011, United States
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New York, New York, 10029, United States
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Pinehurst, North Carolina, 28374, United States
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Cleveland, Ohio, 44109, United States
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Cleveland, Ohio, 44124, United States
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Dayton, Ohio, 45459, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74134, United States
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Eugene, Oregon, 97401, United States
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Tigard, Oregon, 97223, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Providence, Rhode Island, 02905, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37403, United States
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Germantown, Tennessee, 38138, United States
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Knoxville, Tennessee, 37920, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Sugar Land, Texas, 77479, United States
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Tyler, Texas, 75702, United States
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Webster, Texas, 77598, United States
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Fairfax, Virginia, 22031, United States
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Norfolk, Virginia, 23502, United States
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Seattle, Washington, 98195, United States
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Morgantown, West Virginia, 26505, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Clayton, 3168, Australia
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Malvern, 3144, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Sydney, NSW 2145, Australia
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Bruges, 8000, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Libramont-Chevigny, 6800, Belgium
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Liège, 4000, Belgium
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Belo Horizonte, 30130-090, Brazil
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Belo Horizonte, 30150-274, Brazil
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Curitiba, 80520-174, Brazil
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Passo Fundo, 99010-080, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90110-270, Brazil
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Rio de Janeiro, 20231-050, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-001, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100034, China
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Beijing, 100142, China
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Changchun, 130012, China
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Changchun, 130021, China
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Changsha, 410003, China
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Changsha, 410008, China
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Chengdu, 610041, China
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Chongqing, 400038, China
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Chongqing, 408099, China
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Dalian, 116001, China
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Dalian, 116027, China
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Guangdong, China
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Guangzhou, 510060, China
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Haikou, 570311, China
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Harbin, 150081, China
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Hefei, 230031, China
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Nanning, 530021, China
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Shanghai, 200032, China
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Shenyang, 110042, China
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Taiyuan, 030001, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Zhanjiang, 524001, China
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Zhengzhou, 450008, China
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Zhengzhou, China
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Barranquilla, 80020, Colombia
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Bogotá, 110321, Colombia
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Bogotá, 111321, Colombia
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Bogotá, 111511, Colombia
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Cali, 760043, Colombia
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Medellín, 50025, Colombia
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Medellín, 50030, Colombia
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Montería, 23001, Colombia
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Pereira, 660001, Colombia
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Tallinn, 1131, Estonia
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Tartu, 50406, Estonia
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Bonn, 53127, Germany
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Chemnitz, 09116, Germany
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Dresden, 01307, Germany
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Leipzig, 4103, Germany
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Athens, 11528, Greece
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Chaïdári, 124 62, Greece
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Thessaloniki, 54645, Greece
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Hong Kong, Hong Kong
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Szolnok, 5004, Hungary
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Hisar, 125005, India
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Mumbai, 400012, India
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Be’er Ya‘aqov, 70300, Israel
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Hadera, 3810101, Israel
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Jerusalem, 91031, Israel
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Nahariya, 22100, Israel
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Tel Aviv, 6423906, Israel
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Chūōku, 104-0045, Japan
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Kashiwa-shi, 277-8567, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Minatoku, 105-8471, Japan
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Nagoya, 464-8681, Japan
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Nakagami-gun, 903-0215, Japan
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Niigata, 951-8520, Japan
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Osaka, 541-8567, Japan
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Osaka, 637086, Japan
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Sapporo, 003-0804, Japan
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Shinjuku-ku, 160-8582, Japan
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Sunto-gun, 411-8777, Japan
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Toon-Shi, 791-0295, Japan
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Tsu, 514-8507, Japan
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Yokohama, 236-0004, Japan
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Kaunas, 50161, Lithuania
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Vilnius, 08661, Lithuania
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Vilnius, 8660, Lithuania
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Aguascalientes, 20116, Mexico
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México, 06700, Mexico
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Monterrey, 64000, Mexico
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Oaxaca City, 68000, Mexico
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Querétaro, 76090, Mexico
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San Luis Potosí City, 78200, Mexico
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Veracruz, 91910, Mexico
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Gdansk, 80-214, Poland
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Lodz, 93-513, Poland
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Lublin, 20-081, Poland
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Olsztyn, 10-228, Poland
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Olsztyn, 10-560, Poland
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Anzorey, 361350, Russia
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Kazan, Tatarstan, 420029, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Saint Petersburg, 198255, Russia
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Saransk, 430032, Russia
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Sochi, 354000, Russia
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Singapore, 258499, Singapore
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Goyang-si, 10408, South Korea
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Seoul, 01812, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 138-736, South Korea
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Suwon, 443380, South Korea
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Yangsan, 50612, South Korea
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Barcelona, 08208, Spain
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Barcelona, 08907, Spain
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El Palmar, 30120, Spain
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Girona, 17007, Spain
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Jaén, 23007, Spain
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Madrid, 28046, Spain
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Mallorca, 07120, Spain
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Other studies related to the condition(s) this trial covers.
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