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Clinical Trial NCT07044336 for Endometrial Cancer, Malignant Solid Tumour is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) Phase 3 700 Randomized Open-Label

Recruiting
Clinical Trial NCT07044336 is designed to study Treatment for Endometrial Cancer, Malignant Solid Tumour. It is a Phase 3 interventional study that is recruiting, having started on 1 August 2025, with plans to enroll 700 participants. Led by AstraZeneca, it is expected to complete by 17 July 2029. The latest data from ClinicalTrials.gov was last updated on 5 March 2026.
Brief Summary
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
Detailed Description
The target population of interest in this study is participants with B7-H4-selected advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have received no more than 2 prior lines of therapy in advanced/metastatic setting. Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice...Show More
Official Title

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)

Conditions
Endometrial CancerMalignant Solid Tumour
Other Study IDs
  • D6900C00003
  • GOG-3110 (Other Identifier) (Gynecologic Oncology Group Foundation)
  • ENGOT-en28 (Other Identifier) (European Network for Gynaecological Oncological Trial groups)
NCT ID Number
NCT07044336
Start Date (Actual)
2025-08-01
Last Update Posted
2026-03-05
Completion Date (Estimated)
2029-07-17
Enrollment (Estimated)
700
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
Bluestar-Endometrial01
AZD8205
Puxitatug Samrotecan
Puxi-Sam
Platinum-based chemotherapy
B7-H4
advanced/metastatic
Endometrial Cancer
Anti-PD-1
Anti-PD-L1
antibody-drug conjugate
Topoisomerase 1 Inhibitors
uterine neoplasm
female urogenital neoplasm
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPuxitatug Samrotecan
Puxi-Sam IV (intravenous) Q3W .
Puxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
Active ComparatorChemotherapy
Physician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
Doxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
Paclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression Free Survival (PFS) for Arm A vs Arm B
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Approximately 3 years
Overall survival (OS) for Arm A vs Arm B
OS is defined as the time from randomization until the date of death due to any cause.
Approximately 3 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
ORR is defined as the proportion of participants who have a response of CR or PR, as determined by BICR assessments, per RECIST 1.1.
Approximately 3 years
Assessment of Duration of response (DoR) for Arm A vs Arm B
DoR will be defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Approximately 3 years
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death.
Approximately 3 years
Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B
TFST is defined as the time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of the randomized treatment, or death due to any cause.
Approximately 3 years
Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B
TSST is defined as the time from randomization until the start date of the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death due to any cause.
Approximately 3 years
Time until discontinuation of treatment for any reason, or death (TDT) for Arm A vs Arm B
TDT is defined as the time from randomization until discontinuation of treatment for any reason, including disease progression, toxicity, and death.
Approximately 3 years
Worsening in endometrial symptoms for Arm A vs Arm B
Time to worsening is defined as time from date of randomization to the date of worsening while on treatment for endometrial symptoms, physical functioning, and health-related quality of life based on select items from the EORTC IL389.
Approximately 3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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
AstraZeneca logoAstraZeneca772 active studies to explore
Study Central Contact
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
294 Study Locations in 27 Countries
Research Site, Malvern, 3144, Australia
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Research Site, Melbourne, 3000, Australia
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Research Site, Randwick, 2031, Australia
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Research Site, St Leonards, 2065, Australia
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Research Site, Subiaco, 6008, Australia
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Research Site, Westmead, 2145, Australia
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Arizona

Research Site, Tucson, Arizona, 85719, United States
Not yet recruiting

California

Research Site, La Jolla, California, 92037, United States
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Research Site, Los Angeles, California, 90095, United States
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Research Site, Orange, California, 92868, United States
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Florida

Research Site, Jupiter, Florida, 33458, United States
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Research Site, Miami, Florida, 33136, United States
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Research Site, Miami, Florida, 33176, United States
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Research Site, Miami Beach, Florida, 33140, United States
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Research Site, Orlando, Florida, 32806, United States
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Research Site, West Palm Beach, Florida, 33401, United States
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Hawaii

Research Site, Honolulu, Hawaii, 96826, United States
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Illinois

Research Site, Chicago, Illinois, 60607, United States
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Research Site, Peoria, Illinois, 61637, United States
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Research Site, Urbana, Illinois, 61801, United States
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Indiana

Research Site, Fort Wayne, Indiana, 46845, United States
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Research Site, Indianapolis, Indiana, 46260, United States
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Maine

Research Site, Scarborough, Maine, 04074, United States
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Maryland

Research Site, Baltimore, Maryland, 21201, United States
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Research Site, Baltimore, Maryland, 21231, United States
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Research Site, Silver Spring, Maryland, 20910, United States
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Michigan

Research Site, Ann Arbor, Michigan, 48109, United States
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Research Site, Ann Arbor, Michigan, 48197, United States
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Research Site, Detroit, Michigan, 48201, United States
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Minnesota

Research Site, Minneapolis, Minnesota, 55404, United States
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New Jersey

Research Site, Camden, New Jersey, 08103, United States
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Research Site, Paramus, New Jersey, 07652, United States
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New Mexico

Research Site, Albuquerque, New Mexico, 87109, United States
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New York

Research Site, Brooklyn, New York, 11220, United States
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Research Site, Stony Brook, New York, 11794, United States
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Research Site, The Bronx, New York, 10461, United States
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Research Site, White Plains, New York, 10601, United States
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North Carolina

Research Site, Greenville, North Carolina, 27834, United States
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Research Site, Pinehurst, North Carolina, 28374, United States
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Ohio

Research Site, Cincinnati, Ohio, 45220, United States
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Research Site, Cleveland, Ohio, 44106, United States
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Research Site, Cleveland, Ohio, 44109, United States
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Research Site, Columbus, Ohio, 43219, United States
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Research Site, Dayton, Ohio, 45459, United States
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Research Site, Hilliard, Ohio, 43026, United States
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Research Site, Sylvania, Ohio, 43560, United States
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Oregon

Research Site, Portland, Oregon, 97239, United States
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Pennsylvania

Research Site, Bethlehem, Pennsylvania, 18015, United States
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Research Site, Hershey, Pennsylvania, 17033, United States
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Research Site, Pittsburgh, Pennsylvania, 15213, United States
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Research Site, Pittsburgh, Pennsylvania, 15224, United States
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Research Site, Willow Grove, Pennsylvania, 19090, United States
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South Dakota

Research Site, Sioux Falls, South Dakota, 57104, United States
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Research Site, Sioux Falls, South Dakota, 57105, United States
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Tennessee

Research Site, Knoxville, Tennessee, 37920, United States
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Research Site, Nashville, Tennessee, 37232, United States
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Texas

Research Site, Austin, Texas, 78758, United States
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Research Site, Houston, Texas, 77030, United States
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Research Site, Tyler, Texas, 75702, United States
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Virginia

Research Site, Fairfax, Virginia, 22031, United States
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Research Site, Falls Church, Virginia, 22042, United States
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Research Site, Norfolk, Virginia, 23502, United States
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Research Site, Richmond, Virginia, 23298, United States
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Research Site, Roanoke, Virginia, 24016, United States
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Washington

Research Site, Kennewick, Washington, 99336, United States
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Research Site, Seattle, Washington, 98104, United States
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West Virginia

Research Site, Morgantown, West Virginia, 26505, United States
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Wisconsin

Research Site, Waukesha, Wisconsin, 53188, United States
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Research Site, Capital Federal, C1417DTB, Argentina
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Research Site, Ciudad Autonoma Buenos Aires, 1405, Argentina
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Research Site, Ciudad de Buenos Aires, C1118AAT, Argentina
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Research Site, Córdoba, 2356, Argentina
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Research Site, Córdoba, X5004FHP, Argentina
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Research Site, Cuidad Autónoma de Buenos Aire, C1426ANZ, Argentina
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Research Site, La Rioja, 5300, Argentina
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Research Site, Pergamino, B2700CPM, Argentina
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Research Site, Viedma, R8500ACE, Argentina
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Research Site, Graz, 8036, Austria
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Research Site, Innsbruck, 6020, Austria
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Research Site, Vienna, 1090, Austria
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Research Site, Brussels, 1070, Belgium
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Research Site, Brussels, 1200, Belgium
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Research Site, Charleroi, 6000, Belgium
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Research Site, Edegem, 2650, Belgium
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Research Site, Ghent, 9000, Belgium
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Research Site, Leuven, 3000, Belgium
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Research Site, Liège, 4000, Belgium
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Research Site, Namur, 5000, Belgium
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Research Site, Belém, 66073-005, Brazil
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Research Site, Blumenau, 89010-340, Brazil
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Research Site, Curitiba, 80510-130, Brazil
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Research Site, Curitiba, 80810-050, Brazil
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Research Site, Florianópolis, 88020-210, Brazil
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Research Site, Natal, 59062-000, Brazil
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Research Site, Porto Alegre, 90020-090, Brazil
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Research Site, Porto Alegre, 90470-340, Brazil
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Research Site, Porto Alegre, 90610-001, Brazil
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Research Site, Recife, 50070-480, Brazil
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Research Site, Rio de Janeiro, 22281-100, Brazil
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Research Site, Rio de Janeiro, 22775-001, Brazil
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Research Site, Salvador, 41950-640, Brazil
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Research Site, São Caetano do Sul, 09541-270, Brazil
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Research Site, São Paulo, 01317-000, Brazil
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Research Site, São Paulo, 01323-020, Brazil
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Research Site, São Paulo, 01509-900, Brazil
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Research Site, Sorocaba, 18030-005, Brazil
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Research Site, Sorocaba, 18052-210, Brazil
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Research Site, Taubaté, 12030-200, Brazil
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Research Site, Teresina, 64049-200, Brazil
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Alberta

Research Site, Edmonton, Alberta, T6G 1Z2, Canada
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Ontario

Research Site, Kingston, Ontario, K7L 2V7, Canada
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Quebec

Research Site, Montreal, Quebec, H2X 0C1, Canada
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Research Site, Montreal, Quebec, H3T 1E2, Canada
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Research Site, Beijing, 100021, China
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Research Site, Beijing, 100026, China
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Research Site, Beijing, 100044, China
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Research Site, Beijing, 100730, China
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Research Site, Changchun, 130021, China
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Research Site, Changsha, 410011, China
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Research Site, Changsha, 410013, China
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Research Site, Chengdu, 610041, China
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Research Site, Chongqing, 400030, China
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Research Site, Dalian, 116023, China
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Research Site, Fuzhou, 350014, China
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Research Site, Guangzhou, 510120, China
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Research Site, Hangzhou, 310006, China
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Research Site, Hangzhou, 310022, China
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Research Site, Jinan, 250012, China
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Research Site, Jinan, 250117, China
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Research Site, Nanchang, 330006, China
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Research Site, Nanjing, 210004, China
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Research Site, Shanghai, 200011, China
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Research Site, Shanghai, 200025, China
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Research Site, Shanghai, 200072, China
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Research Site, Shenyang, 110004, China
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Research Site, Shenyang, 110042, China
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Research Site, Shenzhen, 518116, China
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Research Site, Shijiazhuang, 050011, China
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Research Site, Tianjin, 300060, China
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Research Site, Tianjin, 300110, China
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Research Site, Wenzhou, 325000, China
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Research Site, Wuhan, 430022, China
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Research Site, Wuhan, 430030, China
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Research Site, Xi'an, 710061, China
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Research Site, Zhengzhou, 450002, China
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Research Site, Brno, 625 00, Czechia
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Research Site, Brno, 656 53, Czechia
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Research Site, Hradec Králové, 500 05, Czechia
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Research Site, Nový Jičín, 74101, Czechia
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Research Site, Ostrava, 708 502, Czechia
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Research Site, Prague, 12808, Czechia
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Research Site, Prague, 180 81, Czechia
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Research Site, V Uvalu 84, 150 06, Czechia
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Research Site, Herlev, 2730, Denmark
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Research Site, Kuopio, 70210, Finland
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Research Site, Tampere, 33520, Finland
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Research Site, Turku, 20520, Finland
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Research Site, Avignon, 84918, France
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Research Site, Besançon, 25000, France
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Research Site, Bordeaux, 33076, France
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Research Site, Chambray-lès-Tours, 37170, France
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Research Site, Cholet, 49300, France
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Research Site, Créteil, 94010, France
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Research Site, Grenoble, 38000, France
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Research Site, Lille, 59000, France
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Research Site, Limoges, 87042, France
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Research Site, Lyon, 69008, France
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Research Site, Nantes, 44000, France
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Research Site, Nîmes, 30029, France
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Research Site, Paris, 75014, France
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Research Site, Paris, 75020, France
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Research Site, Paris, 75900, France
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Research Site, Plerin SUR MER, 22190, France
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Research Site, Rennes, 35000, France
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Research Site, Toulouse, 31059, France
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Research Site, Batumi, 6000, Georgia
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Research Site, Tbilisi, 0159, Georgia
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Research Site, Tbilisi, 0186, Georgia
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Research Site, Amberg, 92224, Germany
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Research Site, Chemnitz, 09116, Germany
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Research Site, Dresden, 01307, Germany
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Research Site, Essen, 45130, Germany
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Research Site, Frankfurt am Main, 60596, Germany
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Research Site, Freiburg im Breisgau, 79106, Germany
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Research Site, Hamburg, 20246, Germany
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Research Site, Heidelberg, 69120, Germany
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Research Site, Heilbronn, 74078, Germany
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Research Site, Mainz, 55131, Germany
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Research Site, Münster, 48149, Germany
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Research Site, Paderborn, 33161, Germany
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Research Site, Regensburg, 93053, Germany
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Research Site, Schwäbisch Hall, 74523, Germany
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Research Site, Witten, 58452, Germany
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Research Site, Athens, 115 28, Greece
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Research Site, Athens, 11528, Greece
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Research Site, Athens, 14564, Greece
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Research Site, Thessaloniki, 55236, Greece
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Research Site, Budapest, 1082, Hungary
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Research Site, Budapest, 1122, Hungary
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Research Site, Debrecen, 4032, Hungary
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Research Site, Győr, 9024, Hungary
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Research Site, Ashdod, 7747629, Israel
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Research Site, Hadera, 38100, Israel
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Research Site, Haifa, 3109601, Israel
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Research Site, Holon, 5822012, Israel
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Research Site, Jerusalem, 9103102, Israel
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Research Site, Jerusalem, 9112001, Israel
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Research Site, Nahariya, 2210001, Israel
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Research Site, Ramat Gan, 5262000, Israel
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Research Site, Safed, 13100, Israel
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Research Site, Tel Aviv, 6423906, Israel
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Research Site, Alessandria, 15121, Italy
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Research Site, Aviano, 33081, Italy
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Research Site, Bologna, 40138, Italy
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Research Site, Catania, 95126, Italy
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Research Site, Florence, 50134, Italy
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Research Site, Haifa, 34362, Italy
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Research Site, Milan, 20132, Italy
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Research Site, Milan, 20141, Italy
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Research Site, Milan, 20159, Italy
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Research Site, Milan, 20162, Italy
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Research Site, Milan, 35128, Italy
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Research Site, Monza, 20900, Italy
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Research Site, Naples, 80131, Italy
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Research Site, Parma, 43126, Italy
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Research Site, Pisa, 56100, Italy
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Research Site, Ponderano, 13875, Italy
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Research Site, Roma, 00168, Italy
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Research Site, Torino, 10128, Italy
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Research Site, Vicenza, 36100, Italy
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Research Site, Chūōku, 104-0045, Japan
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Research Site, Hidaka-shi, 350-1298, Japan
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Research Site, Isehara-shi, 259-1193, Japan
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Research Site, Kashiwa-shi, 277-8567, Japan
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Research Site, Kōtoku, 135-8550, Japan
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Research Site, Kurume-shi, 830-0011, Japan
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Research Site, Matsuyama, 791-0280, Japan
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Research Site, Minatoku, 105-8471, Japan
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Research Site, Nagoya, 464-8681, Japan
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Research Site, Nakagami-gun, 903-0215, Japan
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Research Site, Niigata, 951-8510, Japan
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Research Site, Okayama, 700-8558, Japan
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Research Site, Osaka, 637086, Japan
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Research Site, Sapporo, 003-0804, Japan
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Research Site, Sapporo, 060-8638, Japan
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Research Site, Sendai, 980-8574, Japan
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Research Site, Suita, 565-0871, Japan
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Research Site, Sunto-gun, 411-8777, Japan
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Research Site, Toon-Shi, 791-0295, Japan
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Research Site, Tsu, 514-8507, Japan
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Research Site, Yokohama, 236-0004, Japan
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Research Site, Kaunas, LT50009, Lithuania
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Research Site, Vilnius, 08661, Lithuania
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Research Site, Vilnius, 8660, Lithuania
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Research Site, Amsterdam, 1081 HV, Netherlands
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Research Site, Maastricht, 6202 AZ, Netherlands
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Research Site, Lodz, 93-338, Poland
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Research Site, Siedlce, 08-110, Poland
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Research Site, Ljubljana, 1000, Slovenia
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Research Site, Maribor, 2000, Slovenia
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Research Site, Goyang-si, 410-769, South Korea
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Research Site, Gwangjin-gu, 110-744, South Korea
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Research Site, Seoul, 03722, South Korea
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Research Site, Seoul, 06273, South Korea
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Research Site, Seoul, 135-710, South Korea
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Research Site, Songpa-gu, 05505, South Korea
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Research Site, Suwon, 16499, South Korea
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Research Site, Badalona, 8916, Spain
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Research Site, Barcelona, 8025, Spain
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Research Site, Barcelona, 8035, Spain
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Research Site, Córdoba, 14004, Spain
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Research Site, El Palmar (Murcia), 30120, Spain
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Research Site, Hospitalet DEL Llobregat, 8908, Spain
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Research Site, Madrid, 28033, Spain
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Research Site, Madrid, 28041, Spain
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Research Site, Málaga, 29010, Spain
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Research Site, Oviedo, 33011, Spain
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Research Site, Santiago de Compostela, 15706, Spain
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Research Site, Seville, 41013, Spain
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Research Site, Seville, 41014, Spain
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Research Site, Valencia, 46010, Spain
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Research Site, New Taipei City, 220, Taiwan
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Research Site, Taichung, 40705, Taiwan
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Research Site, Tainan, 70403, Taiwan
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Research Site, Taipei, 100, Taiwan
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Research Site, Taipei, 10449, Taiwan
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Research Site, Bebington, CH63 4JY, United Kingdom
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Research Site, Canterbury, CT1 3NG, United Kingdom
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Research Site, Derby, DE22 3NE, United Kingdom
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Research Site, London, E1 1BB, United Kingdom
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Research Site, London, W2 1NY, United Kingdom
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Research Site, Manchester, M20 4BX, United Kingdom
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Research Site, Northwood, HA6 2RN, United Kingdom
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Research Site, Truro, TR1 3LJ, United Kingdom
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