New drug shows promise in slowing spread of aggressive prostate cancer

NCT ID NCT06952803

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests whether adding the drug saruparib to standard radiation and hormone therapy can delay the spread of cancer in 700 men with high-risk prostate cancer that has a BRCA gene mutation. Participants will receive either saruparib or a placebo alongside their usual treatment. The main goal is to see if the drug helps keep cancer from spreading to other parts of the body.

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 700 people

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

Started

Aug 2025

Expected to finish

Apr 2036

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

18 years and older

Sex

Male participants only

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: * Male participants with a histologically documented diagnosis of prostate adenocarcinoma. * Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy. * Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample. * Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment. * Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0). * Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization. * Minimum life expectancy of 12 months. * Adequate organ and bone marrow function as described in study protocol. * All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis. * All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue. * Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention. * Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners. Exclusion Criteria: * Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML. * Participants with any known predisposition to bleeding \[e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy\]. * Any history of persisting (\> 2 weeks) severe cytopenia due to any cause. * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone. * History of another primary malignancy, with exceptions. * Persistent toxicities \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\] caused by previous anticancer therapy. * Cardiac criteria, including history of arrhythmia and cardiovascular disease. * Evidence of active and uncontrolled hepatitis B and/or hepatitis C. * Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection. * Active tuberculosis infection. * Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor. * Prior treatment within 14 days with blood product support or growth factor support. * Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization. * Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP). * Participants with a known hypersensitivity to saruparib or any excipients of these products.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer

How to take part

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

The places running it

294 sites in 24 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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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85741, United States
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La Jolla, California, 92037, United States
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La Jolla, California, 92093, United States
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Los Angeles, California, 90048, United States
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San Diego, California, 92123, United States
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San Luis Obispo, California, 93401, United States
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Lakewood, Colorado, 80215, United States
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Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32224, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33612, United States
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Newnan, Georgia, 30265, United States
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Chicago, Illinois, 60611, United States
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Chicago Ridge, Illinois, 60415, United States
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Lake Barrington, Illinois, 60010, United States
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Greenwood, Indiana, 46143, United States
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Jeffersonville, Indiana, 47130, United States
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Bethesda, Maryland, 20817, United States
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Towson, Maryland, 21204, United States
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Plymouth, Massachusetts, 02360, United States
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Rochester, Minnesota, 55905, United States
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Hackensack, New Jersey, 07601, United States
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Voorhees Township, New Jersey, 08043, United States
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Albany, New York, 12206, United States
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New York, New York, 10065, United States
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Syracuse, New York, 13210, United States
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Columbus, Ohio, 43230, United States
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Springfield, Oregon, 97477, United States
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Hershey, Pennsylvania, 17033, United States
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Lancaster, Pennsylvania, 17601, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Providence, Rhode Island, 02903, United States
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Myrtle Beach, South Carolina, 29572, United States
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Nashville, Tennessee, 37209, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78745, United States
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Houston, Texas, 77074, United States
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San Antonio, Texas, 78229, United States
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Spring, Texas, 77380, United States
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Salt Lake City, Utah, 84112, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24014, United States
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Virginia Beach, Virginia, 23462, United States
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Seattle, Washington, 98109, United States
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CABA, 1426, Argentina
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CABA, C1113AAE, Argentina
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Ciudad de Buenos Aires, 1181, Argentina
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Ciudad de Buenos Aires, 1426, Argentina
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Ciudad de Buenos Aires, C1419AHL, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5008HHW, Argentina
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Cuidad Autónoma de Buenos Aire, C1426ANZ, Argentina
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La Plata, 1900, Argentina
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Pergamino, B2700CPM, Argentina
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Rosario, S2000KZE, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Viedma, R8500ACE, Argentina
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Kingswood, 2747, Australia
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Murdoch, 6150, Australia
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Orange, 2800, Australia
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South Brisbane, 4101, Australia
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St Leonards, 2065, Australia
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Waratah, 2298, Australia
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Woolloongabba, 4102, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Vienna, 1020, Austria
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Vienna, 1090, Austria
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Jette, 1090, 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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Roeselare, 8800, Belgium
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Wilrijk, 2610, Belgium
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Barretos, 14784-400, Brazil
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Cachoeiro de Itapemirim, 29308-014, Brazil
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Curitiba, 80810-050, Brazil
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Curitiba, Brazil
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Jaú, 17210-120, Brazil
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Londrina, 86015-520, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 91350200, Brazil
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Recife, 50070-460, Brazil
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Rio de Janeiro, 22.250-905, Brazil
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Rio de Janeiro, 22775-001, Brazil
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Salvador, 41950640, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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Calgary, Alberta, T2V 1P9, Canada
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Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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London, Ontario, N6A 5A5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Toronto, M4N 3M5, Canada
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Concepción, 4070196, Chile
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La Serena, 1720430, Chile
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Temuco, 4781156, Chile
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Beijing, 100020, China
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Beijing, 100021, China
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Beijing, 100176, China
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Changchun, 130012, China
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Changsha, 410013, China
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Chongqing, 400016, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510180, China
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Guangzhou, 510280, China
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Hangzhou, 31000, China
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Hangzhou, 310022, China
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Jinan, 250021, China
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Jinhua, 322100, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Ningbo, 315010, China
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Shanghai, 200025, China
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Shanghai, 20032, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Sichuan, 610041, China
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Suining, 629018, China
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Tianjin, 300201, China
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Wuhan, 430022, China
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Wuhan, 430060, China
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Wuhu, 241000, China
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Xiamen, 361003, China
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Yangzhou, 225001, China
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Zhuhai, 519099, China
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Helsinki, 00290, Finland
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Helsinki, FI-00180, Finland
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Kuopio, 70210, Finland
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Oulu, 90029, Finland
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Tampere, FI-33521, Finland
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Turku, 20520, Finland
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Angers, 49100, France
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Bordeaux, 33000, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Le Mans, 72000, France
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Marseille, 13273, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Nice, 06100, France
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Nîmes, 30029, France
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Paris, 75020, France
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Paris, 75674, France
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Paris, 75970, France
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Pierre-Bénite, 69310, France
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Rennes, 35000, France
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Saint-Herblain, 44805, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67200, France
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Suresnes, 92151, France
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Tours, 37044, France
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Vandœuvre-lès-Nancy, 54511, France
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Villejuif, 94805, France
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Augsburg, 86156, Germany
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Berlin, 10117, Germany
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Braunschweig, 38126, Germany
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Cologne, 50937, Germany
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Dresden, 1307, Germany
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Duisburg, 47169, Germany
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Düsseldorf, 40226, Germany
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Essen, 45147, Germany
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Giessen, 35392, Germany
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Göttingen, 37075, Germany
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Gronau, 48599, Germany
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Hamburg, 20246, Germany
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Herne, 44625, Germany
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Kiel, 24105, Germany
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Lübeck, 23538, Germany
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Marburg, 35043, Germany
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Münster, 48149, Germany
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Nuremberg, 90419, Germany
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Nürtingen, 72622, Germany
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Regensburg, 93053, Germany
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Schwerin, 19049, Germany
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Trier, 54292, Germany
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Ulm, 89081, Germany
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Würzburg, 97080, Germany
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Budapest, H-1145, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Zalaegerszeg, 8900, Hungary
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Ansārinagar, 110 029, India
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Babgalore, 560069, India
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Calicut, 673601, India
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Delhi, 110085, India
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Hyderabad, 500019, India
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Kannur, 670103, India
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Kanpur, 208005, India
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Mumbai, 400012, India
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Nagpur, 440001, India
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Varanasi, 221005, India
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Afula, 18101, Israel
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Beersheba, 8410101, Israel
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Hadera, 38100, Israel
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Haifa, 31096, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 6423906, Israel
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Arezzo, 52100, Italy
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Bari, 70124, Italy
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Bergamo, 24125, Italy
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Bergamo, 24127, Italy
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Chieti, 66100, Italy
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Genoa, 16132, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Palermo, 90127, Italy
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Pisa, 56126, Italy
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Roma, 00144, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Torino, 10126, Italy
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Varese, 21100, Italy
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Verona, 37134, Italy
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Bunkyō City, 113-8431, Japan
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Fukuoka, 812-8582, Japan
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Kamakura-shi, 247-8533, Japan
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Kawagoe-shi, 350-8550, Japan
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Kawasaki-shi, 216-8511, Japan
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Kisarazu-shi, 292-8535, Japan
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Kumamoto, 860-8556, Japan
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Kyoto, 606-8507, Japan
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Maebashi, 371-8511, Japan
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Miyazaki, 889-1692, Japan
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Ōta-ku, 373-8550, Japan
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Sagamihara-shi, 252-0375, Japan
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Shimotsuke-shi, 329-0498, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Batu Caves, 68100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Pulau Pinang, 10450, Malaysia
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Hilversum, 1213 XZ, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Roosendaal, 4708 AE, Netherlands
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Lima, 15036, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 34, Peru
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Trujillo, 13008, Peru
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Gdynia, 81-519, Poland
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Gliwice, 44-101, Poland
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Koszalin, 75-581, Poland
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Krakow, 30-727, Poland
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Piotrkow Trybunalski, 97-300, Poland
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Poznan, 61-731, Poland
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Rzeszów, 35-001, Poland
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Warsaw, 04-073, Poland
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Busan, 49241, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Barcelona, 08041, Spain
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Barcelona, 8035, Spain
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Girona, 17007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Málaga, 29009, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Sabadell, 08208, Spain
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Santander, 39008, Spain
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Valencia, 46009, Spain
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Valencia, 46014, Spain
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Gothenburg, 413 45, Sweden
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Malmö, 205 02, Sweden
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Stockholm, 112 81, Sweden
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Stockholm, 141 86, Sweden
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Umeå, 901 85, Sweden
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Uppsala, 75185, Sweden
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Kaohsiung City, 83301, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 43503, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10055, Taiwan
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RECRUITING

Taipei, 110, Taiwan
Research Site
RECRUITING

Taipei, 112, Taiwan
Research Site
RECRUITING

Taoyuan, 333, Taiwan
Research Site
RECRUITING

Bangkok, 10210, Thailand
Research Site
RECRUITING

Bangkok, 10400, Thailand
Research Site
RECRUITING

Bangkok, 10700, Thailand
Research Site
RECRUITING

Khon Kaen, 40002, Thailand
Research Site
RECRUITING

Muang, 50200, Thailand
Research Site
RECRUITING

Pathum Thani, 12120, Thailand
Research Site
RECRUITING

Songkhla, 90110, Thailand
Research Site
RECRUITING

Ankara, 06010, Turkey (Türkiye)
Research Site
RECRUITING

Ankara, 06520, Turkey (Türkiye)
Research Site
RECRUITING

Ankara, 06620, Turkey (Türkiye)
Research Site
RECRUITING

Ankara, 06800, Turkey (Türkiye)
Research Site
RECRUITING

Cordaleo, 35575, Turkey (Türkiye)
Research Site
RECRUITING

Diyarbakır, 21280, Turkey (Türkiye)
Research Site
RECRUITING

Istanbul, 34010, Turkey (Türkiye)
Research Site
RECRUITING

Istanbul, 34098, Turkey (Türkiye)
Research Site
RECRUITING

Istanbul, 34722, Turkey (Türkiye)
Research Site
RECRUITING

Izmir, 35040, Turkey (Türkiye)
Research Site
RECRUITING

Sakarya, 54290, Turkey (Türkiye)
Research Site
WITHDRAWN

Seyhan, 01130, Turkey (Türkiye)
Research Site
RECRUITING

Şahinbey, 27310, Turkey (Türkiye)
Research Site
RECRUITING

Aberdeen, AB25 2ZN, United Kingdom
Research Site
RECRUITING

Bristol, BS2 8ED, United Kingdom
Research Site
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Research Site
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Research Site
RECRUITING

Exeter, EX2 5DW, United Kingdom
Research Site
RECRUITING

Glasgow, G12 0YN, United Kingdom
Research Site
RECRUITING

Greater London, SW3 6JJ, United Kingdom
Research Site
RECRUITING

Guildford, GU2 7XX, United Kingdom
Research Site
WITHDRAWN

London, EC1M6BQ, United Kingdom
Research Site
RECRUITING

London, NW3 2QG, United Kingdom
Research Site
RECRUITING

London, WC1N 3BG, United Kingdom
Research Site
RECRUITING

Manchester, M20 4BX, United Kingdom
Research Site
WITHDRAWN

Newcastle, NE7 7DN, United Kingdom
Research Site
RECRUITING

Plymouth, PL6 8DH, United Kingdom
Research Site
WITHDRAWN

Preston, PR2 9HT, United Kingdom
Research Site
RECRUITING

Romford, RM7 0AG, United Kingdom

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