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New hope for advanced endometrial cancer: targeted drug takes on chemo

NCT ID NCT07044336

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This Phase 3 trial is testing a new drug called puxitatug samrotecan against standard chemotherapy in 800 people with advanced endometrial cancer that has worsened after platinum-based chemo and immunotherapy. The goal is to see if the new drug can delay cancer growth or improve survival. Participants are randomly assigned to receive either the experimental drug or one of two chemotherapies.

What this could mean

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

Active substance: puxitatug samrotecan (a targeted antibody-drug conjugate)
What this could lead to: If it works, this could offer a new treatment option for people with advanced endometrial cancer that has stopped responding to standard therapies.
What could go wrong: This is a Phase 3 trial, but the drug is still experimental. It may not work better than chemotherapy, and side effects are possible. Results may not apply to all patients.

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 800 people

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

Started

Aug 2025

Expected to finish

Jul 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

18 years and older

Sex

Female 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.

The main inclusion criteria include but are not limited to the following: * Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma. * Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression. * Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination. * A WHO/ECOG performance status of 0 or 1 at Screening. * Has radiographically measurable disease by RECIST 1.1 The main exclusion criteria include but are not limited to the following: * Had uterine sarcomas or uterine neuroendocrine carcinoma. * Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \> 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. * Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs . * Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent. * History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Active or previously documented autoimmune or inflammatory disorders

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cancer carcinosarcoma endometrial cancer endometrial carcinoma endometrium neoplasm Neoplasm Metastasis uterine cancer

As listed by the trial registrant

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

Endometrial cancer Malignant solid tumour

How to take part

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

The places running it

308 sites in 28 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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Innsbruck, 6020, 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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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Belém, 66073-005, Brazil
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Belo Horizonte, 30360-680, Brazil
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Bento Gonçalves, 95700-084, Brazil
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Blumenau, 89010-340, Brazil
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Curitiba, 80510-130, Brazil
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Curitiba, 80810-050, Brazil
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Florianópolis, 88020-210, Brazil
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Joinville, 89201-260, Brazil
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Natal, 59062-000, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90470-340, Brazil
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Porto Alegre, 90610-001, Brazil
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Recife, 50040-000, Brazil
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Recife, 50070-480, Brazil
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Recife, 52010-075, Brazil
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Ribeirão Preto, 14026-040, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Rio de Janeiro, 22775-001, Brazil
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Salvador, 41950-640, Brazil
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São Caetano do Sul, 09541-270, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 01323-000, Brazil
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São Paulo, 01323-020, Brazil
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São Paulo, 01509-900, Brazil
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Sorocaba, 18030-005, Brazil
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Sorocaba, 18052-210, Brazil
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Taubaté, 12030-200, Brazil
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Teresina, 64049-200, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100021, China
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Beijing, 100026, China
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Beijing, 100044, China
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Beijing, 100730, China
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Changchun, 130021, China
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Changsha, 410011, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Dalian, 116023, China
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Fuzhou, 350014, China
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Guangzhou, 510120, China
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Hangzhou, 310006, China
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Hangzhou, 310022, China
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Jinan, 250012, China
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Jinan, 250117, China
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Nanchang, 330006, China
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Nanjing, 210004, China
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Shanghai, 200011, China
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Shanghai, 200025, China
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Shanghai, 200072, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Shenzhen, 518116, China
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Shijiazhuang, 050011, China
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Tianjin, 300060, China
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Tianjin, 300110, China
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Wenzhou, 325000, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Zhanjiang, 524001, China
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Zhengzhou, 450002, China
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Nový Jičín, 74101, Czechia
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Ostrava, 708 502, Czechia
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Prague, 12808, Czechia
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Prague, 180 81, Czechia
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V Uvalu 84, 150 06, Czechia
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Herlev, 2730, Denmark
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Odense, 5000, Denmark
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Kuopio, 70210, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Avignon, 84918, France
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Besançon, 25000, France
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Bordeaux, 33076, France
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Chambray-lès-Tours, 37170, France
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Cholet, 49300, France
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Créteil, 94010, France
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Grenoble, 38000, France
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Lille, 59000, France
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Limoges, 87042, France
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Lyon, 69008, France
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Nantes, 44000, France
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Nîmes, 30029, France
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Paris, 75014, France
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Paris, 75020, France
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Paris, 75900, France
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Plerin SUR MER, 22190, France
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Rennes, 35000, France
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Toulouse, 31059, France
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Batumi, 6000, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 0186, Georgia
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Amberg, 92224, Germany
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Chemnitz, 09116, Germany
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Dresden, 01307, Germany
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Essen, 45130, Germany
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Frankfurt am Main, 60596, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Kassel, 34125, Germany
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Mainz, 55131, Germany
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Münster, 48149, Germany
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Paderborn, 33161, Germany
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Regensburg, 93053, Germany
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Schwäbisch Hall, 74523, Germany
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NOT_YET_RECRUITING

Ulm, 89075, Germany
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NOT_YET_RECRUITING

Witten, 58452, Germany
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Athens, 115 28, Greece
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Athens, 11528, Greece
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Athens, 14564, Greece
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Thessaloniki, 55236, Greece
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Ashdod, 7747629, Israel
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Hadera, 38100, Israel
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Haifa, 3109601, Israel
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Holon, 5822012, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 9112001, Israel
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Nahariya, 2210001, Israel
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Ramat Gan, 5262000, Israel
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Safed, 13100, Israel
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Tel Aviv, 6423906, Israel
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Alessandria, 15121, Italy
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Aviano, 33081, Italy
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Catania, 95126, Italy
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Florence, 50134, Italy
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Haifa, 34362, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Milan, 20162, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Parma, 43126, Italy
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Pisa, 56100, Italy
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Ponderano, 13875, Italy
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Roma, 00168, Italy
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Torino, 10128, Italy
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Vicenza, 36100, Italy
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Chūōku, 104-0045, Japan
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Hidaka-shi, 350-1298, Japan
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Isehara-shi, 259-1193, 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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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, 951-8510, Japan
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Okayama, 700-8558, Japan
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Osaka, 637086, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8638, Japan
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Sendai, 980-8574, Japan
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Suita, 565-0871, 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, LT50009, Lithuania
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Vilnius, 08661, Lithuania
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Vilnius, 8660, Lithuania
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Amsterdam, 1081 HV, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Lodz, 93-338, Poland
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Siedlce, 08-110, Poland
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Singapore, 119228, Singapore
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Singapore, 168583, Singapore
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Singapore, 217562, Singapore
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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Goyang-si, 410-769, South Korea
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Gwangjin-gu, 110-744, South Korea
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Seoul, 03722, South Korea
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Seoul, 06273, South Korea
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Seoul, 135-710, South Korea
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Songpa-gu, 05505, South Korea
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Suwon, 16499, South Korea
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NOT_YET_RECRUITING

Badalona, 8916, Spain
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Barcelona, 8025, Spain
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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El Palmar (Murcia), 30120, Spain
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L'Hospitalet de Llobregat, 8908, Spain
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Madrid, 28033, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Seville, 41014, Spain
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Valencia, 46010, Spain
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New Taipei City, 220, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Bebington, CH63 4JY, United Kingdom
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Canterbury, CT1 3NG, United Kingdom
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Derby, DE22 3NE, United Kingdom
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London, E1 1BB, United Kingdom
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London, SE1 7EH, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Tucson, Arizona, 85719, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90095, United States
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Orange, California, 92868, United States
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Washington D.C., District of Columbia, 20016, United States
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Jupiter, Florida, 33458, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33176, United States
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Miami Beach, Florida, 33140, United States
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New Port Richey, Florida, 34655, United States
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Orlando, Florida, 32806, United States
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Tampa, Florida, 33612, United States
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West Palm Beach, Florida, 33401, United States
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NOT_YET_RECRUITING

Honolulu, Hawaii, 96826, United States
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Chicago, Illinois, 60607, United States
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Peoria, Illinois, 61637, United States
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Urbana, Illinois, 61801, United States
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Fort Wayne, Indiana, 46845, United States
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Indianapolis, Indiana, 46260, United States
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Scarborough, Maine, 04074, United States
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NOT_YET_RECRUITING

Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21231, United States
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Silver Spring, Maryland, 20910, United States
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NOT_YET_RECRUITING

Ann Arbor, Michigan, 48109, United States
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Ann Arbor, Michigan, 48197, United States
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Detroit, Michigan, 48201, United States
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Minneapolis, Minnesota, 55404, United States
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NOT_YET_RECRUITING

Camden, New Jersey, 08103, United States
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Paramus, New Jersey, 07652, United States
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Albuquerque, New Mexico, 87109, United States
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NOT_YET_RECRUITING

Brooklyn, New York, 11220, United States
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Stony Brook, New York, 11794, United States
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The Bronx, New York, 10461, United States
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White Plains, New York, 10601, United States
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Greenville, North Carolina, 27834, United States
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Pinehurst, North Carolina, 28374, United States
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Cincinnati, Ohio, 45220, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44109, United States
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Columbus, Ohio, 43219, United States
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Dayton, Ohio, 45459, United States
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Hilliard, Ohio, 43026, United States
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Sylvania, Ohio, 43560, United States
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Eugene, Oregon, 97401, United States
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NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
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Bethlehem, Pennsylvania, 18015, United States
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Hershey, Pennsylvania, 17033, United States
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NOT_YET_RECRUITING

Lancaster, Pennsylvania, 17601, United States
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NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
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NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
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NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
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Willow Grove, Pennsylvania, 19090, United States
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NOT_YET_RECRUITING

York, Pennsylvania, 17403, United States
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NOT_YET_RECRUITING

Sioux Falls, South Dakota, 57104, United States
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Sioux Falls, South Dakota, 57105, United States
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Knoxville, Tennessee, 37920, United States
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NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
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Austin, Texas, 78758, United States
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NOT_YET_RECRUITING

Houston, Texas, 77030, United States
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Tyler, Texas, 75702, United States
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Fairfax, Virginia, 22031, United States
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Falls Church, Virginia, 22042, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23298, United States
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Roanoke, Virginia, 24016, United States
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NOT_YET_RECRUITING

Kennewick, Washington, 99336, United States
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NOT_YET_RECRUITING

Seattle, Washington, 98104, United States
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Morgantown, West Virginia, 26505, United States
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Waukesha, Wisconsin, 53188, United States
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Capital Federal, C1417DTB, Argentina
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Ciudad Autonoma Buenos Aires, 1405, Argentina
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Ciudad de Buenos Aires, C1118AAT, Argentina
Research Site
NOT_YET_RECRUITING

Córdoba, 2356, Argentina
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Córdoba, X5004FHP, Argentina
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Cuidad Autónoma de Buenos Aire, C1426ANZ, Argentina
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La Rioja, 5300, Argentina
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Pergamino, B2700CPM, Argentina
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Viedma, R8500ACE, Argentina
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Malvern, 3144, Australia
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Melbourne, 3000, Australia
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Randwick, 2031, Australia
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St Leonards, 2065, Australia
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Subiaco, 6008, Australia
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Westmead, 2145, Australia
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Graz, 8036, Austria

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