A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Start Date
6/11/2026
Completion Date
9/14/2028
Summary
This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.
Detailed Description
This is a Phase IIb, randomized, placebo-controlled, double-blind, parallel-group 24-week study to assess the efficacy, safety and tolerability of three doses of AZD8965 versus placebo administered to participants with IPF. The enrolled participants will include those on stable dose(s) of one or two approved antifibrotic therapies and those who are not taking any antifibrotic therapy. Approximately 360 participants will be randomized across approximately 200 sites globally.
Eligibility Criteria
Age Range: 40 years to No maximum
Interventions
Placebo for AZD8965
AZD8965 low dose
AZD8965 medium dose
AZD8965 high dose
Conditions
Locations
Research Site
Birmingham, Alabama 35205
United States
Research Site
Phoenix, Arizona 85006
United States
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Phoenix, Arizona 85032
United States
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Loma Linda, California 92350
United States
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Los Angeles, California 90033
United States
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Newport Beach, California 92663
United States
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Sacramento, California 95817
United States
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Stanford, California 94305
United States
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Aurora, Colorado 80045
United States
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Denver, Colorado 80206
United States
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Ocala, Florida 34470
United States
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Weston, Florida 33331
United States
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Atlanta, Georgia 30322
United States
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Boise, Idaho 83712
United States
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Champaign, Illinois 61820
United States
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Chicago, Illinois 60611
United States
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Kansas City, Kansas 66160
United States
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Lexington, Kentucky 40536
United States
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Baltimore, Maryland 21201
United States
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Boston, Massachusetts 02114
United States
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Ann Arbor, Michigan 48109
United States
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Detroit, Michigan 48202
United States
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New York, New York 10017
United States
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New York, New York 10029
United States
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Greensboro, North Carolina 27403
United States
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Cincinnati, Ohio 45267
United States
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Oklahoma City, Oklahoma 73117
United States
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Bethlehem, Pennsylvania 18015
United States
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Philadelphia, Pennsylvania 19104
United States
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Philadelphia, Pennsylvania 19140
United States
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Charleston, South Carolina 29425
United States
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Dallas, Texas 75254
United States
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El Paso, Texas 79902
United States
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Houston, Texas 77030
United States
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Burlington, Vermont 05401
United States
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Richmond, Virginia 23298
United States
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Alberdi, X5033DCE
Argentina
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Buenos Aires, 1425
Argentina
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Ciudad de Buenos Aires, C1414AIF
Argentina
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Florida, B1602DQD
Argentina
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Rosario, 2000
Argentina
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San Fernando, B1646EBJ
Argentina
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Port Macquarie, 2444
Australia
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Wollongong, 2500
Australia
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Haskovo, 6300
Bulgaria
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Plovdiv, 4001
Bulgaria
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Rousse, 7000
Bulgaria
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Sofia, 1618
Bulgaria
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Sofia, 1680
Bulgaria
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Sofia, 1756
Bulgaria
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Sherwood Park, Alberta T8H 2M7
Canada
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Vancouver, British Columbia V5Z 1M9
Canada
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Ajax, Ontario L1S 2J5
Canada
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Burlington, Ontario L7N 3V2
Canada
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Kingston, Ontario K7M 4E7
Canada
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North York, Ontario M2K 1E1
Canada
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Saint-Charles-Borromée, Quebec J6E 2B4
Canada
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Sherbrooke, Quebec J1H 5N4
Canada
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Providencia, 7500504
Chile
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Santiago, 7750495
Chile
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Talca, 3481349
Chile
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Viña del Mar, 2531172
Chile
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Viña del Mar, 2540488
Chile
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Beijing, 100000
China
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Beijing, 100029
China
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Beijing, 100730
China
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Changchun, 130041
China
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Changsha, 430033
China
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Chengdu, 610041
China
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Chengdu, 610078
China
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Guangzhou, 510735
China
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Lanzhou, 730030
China
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Nanchang, 330000
China
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Nanjing, 2100008
China
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Shanghai, 200433
China
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Shenyang, 110015
China
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Wuhan, 430048
China
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Xuzhou, 221000
China
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Zhengzhou, 450000
China
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Aarhus, 8200
Denmark
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Copenhagen, 2100
Denmark
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Hellerup, 2900
Denmark
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Odense C, 5000
Denmark
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Angers, 49933
France
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Brest, 29609
France
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Bron, 69677
France
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Montpellier, 34295
France
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Nice, 6000
France
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Paris, 75877
France
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Rennes, 35033
France
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Tours, 37000
France
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Bonn, 53127
Germany
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Essen, 45239
Germany
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Freiburg im Breisgau, 79106
Germany
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Fulda, 36043
Germany
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Giessen, 35392
Germany
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Hamburg, 20251
Germany
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Hanover, 30459
Germany
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Heidelberg, 69126
Germany
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Hemer, 58675
Germany
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Konstanz, 78464
Germany
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Leipzig, 04103
Germany
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Lübeck, 23538
Germany
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Marburg, 35037
Germany
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Munich, 81377
Germany
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Stuttgart, 70376
Germany
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Witten, 58452
Germany
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Wuppertal-Barmen, 42283
Germany
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Athens, 11527
Greece
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Athens, 12462
Greece
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Heraklion, 71110
Greece
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Ioannina, 45500
Greece
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Pátrai, 26500
Greece
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Thessaloniki, 57010
Greece
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Budapest, 1083
Hungary
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Budapest, 1121
Hungary
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Debrecen, 4032
Hungary
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Törökbálint, 2045
Hungary
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Ashkelon, 78278
Israel
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Jerusalem, 9103102
Israel
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Kfar Saba, 4428164
Israel
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Petah Tikva, 4941492
Israel
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Rehovot, 76100
Israel
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Foggia, 71100
Italy
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Forlì, 47121
Italy
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Modena, 41124
Italy
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Monza, 20900
Italy
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Pavia, 27100
Italy
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Rozzano, 20089
Italy
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Siena, 53100
Italy
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Torino, 10126
Italy
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Fukuoka, 810-8563
Japan
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Hachioji-shi, 193-0998
Japan
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Hamamatsu, 431-3192
Japan
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Hiroshima, 734-8530
Japan
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Kakogawa-shi, 675-8611
Japan
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Kumagaya-shi, 360-0197
Japan
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Kumamoto, 861-4193
Japan
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Matsusaka-shi, 515-8544
Japan
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Sakaishi, 591-8555
Japan
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Sendai, 980-8574
Japan
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Seto-shi, 489-8642
Japan
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Shimotsuke-shi, 329-0498
Japan
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Shinjuku-ku, 162-8655
Japan
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Yokohama, 236-0037
Japan
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Yokohama, 236-0051
Japan
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Benito Juárez, 03330
Mexico
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Chihuahua City, 31203
Mexico
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Coyocan, 04330
Mexico
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León, 37160
Mexico
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Mérida, 97130
Mexico
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Monterrey, 64460
Mexico
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Monterrey, 64465
Mexico
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Oaxaca City, 68000
Mexico
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Pachuca, 42070
Mexico
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Bialystok, 15-044
Poland
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Krakow, 31-202
Poland
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Lodz, 90-153
Poland
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Poznan, 60-569
Poland
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Rzeszów, 35-205
Poland
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Warsaw, 02-507
Poland
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Cape Town, 7700
South Africa
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Durban, 4001
South Africa
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Parktown West, 2193
South Africa
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Somerset West, 7130
South Africa
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Seongnam-si, 13620
South Korea
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Seoul, 02841
South Korea
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Seoul, 04401
South Korea
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Seoul, 06351
South Korea
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Seoul, 5505
South Korea
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Barcelona, 08036
Spain
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Barcelona, 8025
Spain
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L'Hospitalet de Llobregat, 08907
Spain
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Madrid, 28006
Spain
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Málaga, 29010
Spain
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Valencia, 46010
Spain
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Kaohsiung City, 80756
Taiwan
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Kaohsiung City, 824
Taiwan
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Taichung, 40705
Taiwan
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Taipei, 10002
Taiwan
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Taipei, 11220
Taiwan
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Taipei, 11696
Taiwan
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Taoyuan, 333
Taiwan
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Yunlin, 640
Taiwan
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Bristol, BS105NB
United Kingdom
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Cottingham, HU16 5JQ
United Kingdom
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Edinburgh, EH16 4SA
United Kingdom
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Exeter, EX2 5DW
United Kingdom
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Liverpool, L9 7AL
United Kingdom
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London, SW3 6NP
United Kingdom