AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
Start Date
12/29/2025
Completion Date
12/27/2029
Summary
The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.
Detailed Description
Approximately 1100 adult participants will be enrolled after central FRα testing into two independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until disease progression or another reason for treatment discontinuation. All participants will be followed for overall survival. An independent data monitoring committee (IDMC) of external experts will periodically review unblinded safety and interim efficacy to confirm participant safety and study integrity.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AZD5335
Mirvetuximab Soravtansine (MIRV)
Paclitaxel
Pegylated liposomal Doxorubicin (PLD)
Topotecan
Conditions
Locations
Research Site
Birmingham, Alabama 35223
United States
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Little Rock, Arkansas 72205
United States
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La Jolla, California 92037
United States
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Washington D.C., District of Columbia 20010
United States
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Fort Lauderdale, Florida 33316
United States
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Gainesville, Florida 32608
United States
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Jupiter, Florida 33458
United States
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Miami, Florida 33176
United States
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Weston, Florida 33331
United States
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Chicago, Illinois 60612
United States
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Evanston, Illinois 60201
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 46202
United States
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Louisville, Kentucky 40241
United States
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Towson, Maryland 21204
United States
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Burlington, Massachusetts 01805
United States
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Worcester, Massachusetts 01655
United States
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Minneapolis, Minnesota 55404
United States
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Springfield, Missouri 65807
United States
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Billings, Montana 59106
United States
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Omaha, Nebraska 68114
United States
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Las Vegas, Nevada 89106
United States
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Lebanon, New Hampshire 03756
United States
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Camden, New Jersey 08103
United States
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The Bronx, New York 10461
United States
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Chapel Hill, North Carolina 27599
United States
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Blue Ash, Ohio 45242
United States
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Dayton, Ohio 45459
United States
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Sylvania, Ohio 43560
United States
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Portland, Oregon 97213
United States
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York, Pennsylvania 17403
United States
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Germantown, Tennessee 38138
United States
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San Antonio, Texas 78229
United States
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Tyler, Texas 75702
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Salt Lake City, Utah 84106
United States
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Fairfax, Virginia 22031
United States
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Roanoke, Virginia 24016
United States
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Seattle, Washington 98104
United States
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Adelaide, 5037
Australia
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Auchenflower, 4066
Australia
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Campbelltown, 2560
Australia
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Camperdown, 2050
Australia
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Clayton, 3168
Australia
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Cudgen, 2487
Australia
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Garran, 2605
Australia
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Gosford, 2250
Australia
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Heidelberg, 3084
Australia
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Kogarah, 2217
Australia
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Melbourne, 3000
Australia
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Richmond, 3121
Australia
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St Leonards, 2065
Australia
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Waratah, 2298
Australia
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Charleroi, 6060
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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Libramont-Chevigny, 6800
Belgium
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Namur, 5000
Belgium
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Barretos, 14784-400
Brazil
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Bela Vista, 1317
Brazil
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Curitiba, 81520-060
Brazil
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Goiânia, 74110-060
Brazil
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Natal, 59075-740
Brazil
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Porto Alegre, 90020-090
Brazil
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Porto Alegre, 90035-903
Brazil
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Porto Alegre, 90610-000
Brazil
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Porto Alegre, 91350200
Brazil
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Porto Velho, 76834-899
Brazil
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Rio de Janeiro, 20230-130
Brazil
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São José do Rio Preto, 15090-000
Brazil
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São Paulo, 01401-002
Brazil
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São Paulo, 01409-902
Brazil
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Edmonton, Alberta T6G 1Z2
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 H1T 2M4
Canada
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Montreal, Quebec H3T 1E2
Canada
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Montreal, Quebec H4A 3J1
Canada
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Québec, G1G 5X1
Canada
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Port Montt, 5480000
Chile
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Providencia, 7510032
Chile
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Santiago, 7500587
Chile
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Santiago, 7500653
Chile
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Santiago, 7520426
Chile
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Santiago, 8330032
Chile
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Santiago, 8331143
Chile
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Santiago, 8420383
Chile
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Viña del Mar, 2520000
Chile
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Beijing, 100021
China
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Beijing, 100142
China
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Beijing, 102600
China
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Bengbu, 233004
China
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Changchun, 130012
China
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Changsha, 410008
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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Fuzhou, 350011
China
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Guangzhou, 510000
China
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Guangzhou, 510060
China
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Guangzhou, 510080
China
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Hangzhou, 310003
China
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Hangzhou, 310006
China
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Hangzhou, 310022
China
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Harbin, 150049
China
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Jinan, 250012
China
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Jinan, 250117
China
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Lanzhou, 730000
China
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Linyi, 276000
China
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Nanchang, 330029
China
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Nanjing, 2100008
China
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Nanjing, 210009
China
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Nanning, 530021
China
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Shanghai, 200025
China
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Shanghai, 200032
China
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Shenyang, 110004
China
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Shenyang, 110042
China
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Shijiazhuang, 050020
China
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Taiyuan, 030000
China
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Tianjin, 300060
China
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Wuhan, 430022
China
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Wuhan, 430030
China
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Wuhan, 430079
China
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Xi'an, 710061
China
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Zhanjiang, 524001
China
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Zhengzhou, 450008
China
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Zhengzhou, 450052
China
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Brno, 625 00
Czechia
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Hradec Králové, 500 05
Czechia
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Nový Jičín, 741 01
Czechia
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Olomouc, 77900
Czechia
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Prague, 12808
Czechia
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Prague, 150 06
Czechia
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Prague, 18000
Czechia
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Aalborg, 9000
Denmark
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Aarhus, 8200
Denmark
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Odense, 5000
Denmark
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Vejle, 7100
Denmark
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Amiens, 80054
France
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Avignon, 84000
France
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Nîmes, 30029
France
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Paris, 75005
France
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Pau, 64046
France
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Pierre-Bénite, 69310
France
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Plerin SUR MER, 22190
France
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Reims, 51056
France
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Saint-Herblain, 44805
France
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Saint-Priest-en-Jarez, 42271
France
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Toulouse, 31300
France
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Tours, 37044
France
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Berlin, 13353
Germany
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Bonn, 53127
Germany
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Detmold, 32756
Germany
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Dresden, 01307
Germany
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Düsseldorf, 40225
Germany
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Essen, 45130
Germany
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Essen, 45147
Germany
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Frankfurt am Main, 60487
Germany
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Hamburg, 20246
Germany
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Hamburg, 22457
Germany
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Hanover, 30625
Germany
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Leipzig, 4103
Germany
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Mannheim, 68167
Germany
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Schwäbisch Hall, 74523
Germany
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Tübingen, 72076
Germany
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Ulm, 89075
Germany
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Wiesbaden, 65199
Germany
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Athens, 11528
Greece
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Athens, 12462
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Athens, 14564
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Athens, 15123
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Kalamata, 24100
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Pátrai, 26332
Greece
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Rio, 26504
Greece
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Thessaloniki, 55236
Greece
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Bhubaneswar, 751007
India
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Chennai, 600113
India
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Delhi, 110029
India
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Dhanvantari Nagar, 605006
India
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Kolkata, 700017
India
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Nagpur, 440001
India
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Nashik, 422 009
India
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Surat, 395002
India
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Tiruchirappalli, 620008
India
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Cork, T12 DV56
Ireland
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Dublin, 7
Ireland
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Dublin, D08 NHY1
Ireland
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Dublin, DO4YN63
Ireland
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Waterford, X91 ER8E
Ireland
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Afula, 1834111
Israel
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Beersheba, 84101
Israel
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Hadera, 38100
Israel
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Haifa, 3109601
Israel
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Haifa, 34362
Israel
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Holon, 5822012
Israel
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Jerusalem, 00000
Israel
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Jerusalem, 91031
Israel
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Kfar Saba, 4428164
Israel
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Nahariya, 22100
Israel
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Ramat Gan, 52621
Israel
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Sofia, 1680
Israel
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Tel Aviv, 64239
Israel
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Brescia, 25123
Italy
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Catania, 95126
Italy
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Florence, 50134
Italy
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Lecco, 23900
Italy
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Milan, 20133
Italy
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Milan, 20141
Italy
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Milan, 20159
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Milan, 20162
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Naples, 80131
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Parma, 43126
Italy
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Pisa, 56126
Italy
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Roma, 00161
Italy
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Roma, 00168
Italy
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Torino, 10100
Italy
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Akashi-shi, 673-8558
Japan
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Chūōku, 104-0045
Japan
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Hidaka-shi, 350-1298
Japan
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Kashiwa, 227-8577
Japan
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Kobe, 650-0047
Japan
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Kōtoku, 135-8550
Japan
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Kurume-shi, 830-0011
Japan
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Nagoya, 464-8681
Japan
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Niigata, 951-8566
Japan
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Okayama, 700-8558
Japan
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Osaka, 541-8567
Japan
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Sagamihara-shi, 252-0375
Japan
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Sapporo, 003-0804
Japan
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Sendai, 980-8574
Japan
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Shinjuku-ku, 160-0023
Japan
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Shinjuku-ku, 160-8582
Japan
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Shiwa-gun, 028-3694
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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Busan, 49241
South Korea
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Daegu, 42601
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, 03722
South Korea
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Seoul, 06273
South Korea
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Seoul, 06351
South Korea
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Seoul, 08308
South Korea
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Seoul, 5505
South Korea
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Suwon, 16499
South Korea
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Yangsan, 50612
South Korea
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A Coruña, 15006
Spain
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Badalona, 08916
Spain
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Barcelona, 08036
Spain
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Córdoba, 14004
Spain
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Donostia / San Sebastian, 20014
Spain
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Girona, 17007
Spain
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L'Hospitalet de Llobregat, 08908
Spain
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Madrid, 28034
Spain
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Madrid, 28041
Spain
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Valencia, 46010
Spain
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Linköping, 581 85
Sweden
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Lund, 22242
Sweden
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Solna, 171 64
Sweden
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Umeå, 90737
Sweden
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Uppsala, 751 85
Sweden
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Basel, 4031
Switzerland
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Münsterlingen, 8596
Switzerland
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Sankt Gallen, 9007
Switzerland
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Thun, 3600
Switzerland
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Zollikerberg, CH-8125
Switzerland
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Zurich, 8091
Switzerland
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Changhua,
Taiwan
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New Taipei City, 220
Taiwan
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Taichung, 40447
Taiwan
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Taichung, 40705
Taiwan
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Tainan, 704
Taiwan
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Tainan, 73657
Taiwan
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Taipei, 100
Taiwan
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Taipei, 11259
Taiwan
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Taoyuan, 333
Taiwan
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Bangkok, 10210
Thailand
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Bangkok, 10400
Thailand
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Bangkok, 10700
Thailand
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Chiang Mai, 50200
Thailand
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Dusit, 10300
Thailand
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Khon Kaen, 40002
Thailand
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Songkhla, 90110
Thailand
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Barrow in Furness, LA14 4LF
United Kingdom
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Birmingham, B152GW
United Kingdom
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Cambridge, CB2 0QQ
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Canterbury, CT1 3NG
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Cardiff, CF15 7QZ
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Edinburgh, EH4 2XU
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Greater London, SW3 6JJ
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London, EC1A 7BE
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London, SE1 9RT
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Nottingham, NG5 1PB
United Kingdom
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Sutton, SM2 5PT
United Kingdom
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Swansea, SA12 7BR
United Kingdom