Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
1 other identifier
observational
2,157
1 country
447
Brief Summary
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Typical duration for all trials
447 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJuly 24, 2023
May 1, 2015
2.2 years
March 18, 2011
July 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire
Check at predose, 4, 8, 16 and 32 weeks
Secondary Outcomes (3)
Number of subjects with improvement in symptoms of GERD
Check at predose, 4, 8, 16 and 32 weeks
Endoscopic healing rate
8 weeks
Adverse events
Every 4-8 weeks
Study Arms (1)
Rabeprazole Sodium
Interventions
Doses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.
Eligibility Criteria
Hospitals and Clinics in Japan
You may qualify if:
- Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)
You may not qualify if:
- Patients with a history of hypersensitivity to any ingredients of PARIET.
- Patients on atazanavir sulfate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (447)
Unknown Facility
Aisai, Aichi-ken, Japan
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Anjo, Aichi-ken, Japan
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Gamagōri, Aichi-ken, Japan
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Ichinomiya, Aichi-ken, Japan
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Inuyama, Aichi-ken, Japan
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Kariya, Aichi-ken, Japan
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Kasugai, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Okazaki, Aichi-ken, Japan
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Owariasahi, Aichi-ken, Japan
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Tokoname, Aichi-ken, Japan
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Toyota, Aichi-ken, Japan
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Tōkai, Aichi-ken, Japan
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Tsushima, Aichi-ken, Japan
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Daisen, Akita, Japan
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Yokote, Akita, Japan
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Yurihonjō, Akita, Japan
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Goshogawara, Aomori, Japan
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Hachinohe, Aomori, Japan
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Hirosaki, Aomori, Japan
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Kitatsugaru, Aomori, Japan
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Mutsu, Aomori, Japan
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Sannohe, Aomori, Japan
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Towada, Aomori, Japan
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Asahi, Chiba, Japan
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Choshi, Chiba, Japan
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Funabashi, Chiba, Japan
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Ichihara, Chiba, Japan
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Ichikawa, Chiba, Japan
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Kashiwa, Chiba, Japan
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Katori-shi, Chiba, Japan
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Matsudo, Chiba, Japan
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Mobara, Chiba, Japan
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Narashino, Chiba, Japan
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Noda, Chiba, Japan
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Imabari, Ehime, Japan
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Kitauwa, Ehime, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Ōzu, Ehime, Japan
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Saijō, Ehime, Japan
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Uwajima, Ehime, Japan
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Mikatakaminaka, Fukui, Japan
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Ono, Fukui, Japan
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Sabae, Fukui, Japan
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Sakai, Fukui, Japan
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Asakura, Fukuoka, Japan
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Buzen, Fukuoka, Japan
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Chikushi, Fukuoka, Japan
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Chikushino-shi, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Miyama, Fukuoka, Japan
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Munakata, Fukuoka, Japan
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Nōgata, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Ōkawa, Fukuoka, Japan
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Tagawa, Fukuoka, Japan
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Tsuiki, Fukuoka, Japan
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Wakasugi, Fukuoka, Japan
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Yame, Fukuoka, Japan
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Iwaki, Fukushima, Japan
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Kōriyama, Fukushima, Japan
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Shirakawa, Fukushima, Japan
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Sōma, Fukushima, Japan
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Yama, Fukushima, Japan
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Hashima, Gifu, Japan
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Kakamigahara, Gifu, Japan
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Minokamo, Gifu, Japan
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Mizunami, Gifu, Japan
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Ōgaki, Gifu, Japan
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Sekimachi, Gifu, Japan
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Tajimi, Gifu, Japan
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Takayama, Gifu, Japan
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Agatsuma, Gunma, Japan
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Kiryū, Gunma, Japan
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Maebashi, Gunma, Japan
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Midori, Gunma, Japan
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Ōta, Gunma, Japan
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Takasaki, Gunma, Japan
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Aki, Hiroshima, Japan
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Fukuyama, Hiroshima, Japan
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Higashihiroshima, Hiroshima, Japan
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Kure, Hiroshima, Japan
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Mihara, Hiroshima, Japan
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Miyoshi, Hiroshima, Japan
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Onomichi, Hiroshima, Japan
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Takehara, Hiroshima, Japan
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Abashiri, Hokkaido, Japan
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Abuta, Hokkaido, Japan
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Asahikawa, Hokkaido, Japan
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Date, Hokkaido, Japan
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Ebetsu, Hokkaido, Japan
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Eniwa, Hokkaido, Japan
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Fukagawa, Hokkaido, Japan
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Furano, Hokkaido, Japan
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Hakodate, Hokkaido, Japan
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Hokuto, Hokkaido, Japan
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Ishikari, Hokkaido, Japan
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Kamiiso, Hokkaido, Japan
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Kasai, Hokkaido, Japan
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Kato, Hokkaido, Japan
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Kayabe, Hokkaido, Japan
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Kitami, Hokkaido, Japan
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Kushiro, Hokkaido, Japan
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Muroran, Hokkaido, Japan
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Nakagawa, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Otaru, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Shibetsu, Hokkaido, Japan
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Suttsu, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Yoichi, Hokkaido, Japan
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Aioi, Hyōgo, Japan
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Akashi, Hyōgo, Japan
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Ako, Hyōgo, Japan
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Amagasaki, Hyōgo, Japan
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Ashiya, Hyōgo, Japan
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Awaji, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Itami, Hyōgo, Japan
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Kakogawa, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Miki, Hyōgo, Japan
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Nishinomiya, Hyōgo, Japan
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Ono, Hyōgo, Japan
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Sanda, Hyōgo, Japan
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Sasayama, Hyōgo, Japan
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Sumoto, Hyōgo, Japan
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Takarazuka, Hyōgo, Japan
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Tamba, Hyōgo, Japan
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Bandō, Ibaraki, Japan
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Hitachi, Ibaraki, Japan
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Hitachiota, Ibaraki, Japan
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Hokota, Ibaraki, Japan
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Ishioka, Ibaraki, Japan
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Itako, Ibaraki, Japan
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Jōsō, Ibaraki, Japan
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Kitaibaraki, Ibaraki, Japan
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Koga, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Moriya, Ibaraki, Japan
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Naka, Ibaraki, Japan
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Ryūgasaki, Ibaraki, Japan
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Shimo-tsuma, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Ushiku, Ibaraki, Japan
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Hakui, Ishikawa-ken, Japan
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Hakusan, Ishikawa-ken, Japan
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Kahoku, Ishikawa-ken, Japan
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Kanazawa, Ishikawa-ken, Japan
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Nomi, Ishikawa-ken, Japan
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Hanamaki, Iwate, Japan
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Ichinoseki, Iwate, Japan
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Morioka, Iwate, Japan
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Ōshū, Iwate, Japan
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Tōno, Iwate, Japan
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Kan’onjichō, Kagawa-ken, Japan
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Marugame, Kagawa-ken, Japan
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Mitoyo, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Aira, Kagoshima-ken, Japan
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Ichikikushikino, Kagoshima-ken, Japan
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Isa, Kagoshima-ken, Japan
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Izumi, Kagoshima-ken, Japan
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Kanoya, Kagoshima-ken, Japan
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Kirishima, Kagoshima-ken, Japan
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Kumage, Kagoshima-ken, Japan
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Sendai, Kagoshima-ken, Japan
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Ashigarashimo, Kanagawa, Japan
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Atsugi, Kanagawa, Japan
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Chigasaki, Kanagawa, Japan
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Fujisawa, Kanagawa, Japan
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Hadano, Kanagawa, Japan
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Hiratsuka, Kanagawa, Japan
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Isehara, Kanagawa, Japan
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Kamakura, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Minamiashigara, Kanagawa, Japan
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Naka, Kanagawa, Japan
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Odawara, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Zama, Kanagawa, Japan
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Aso, Kumamoto, Japan
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Hitoyoshi, Kumamoto, Japan
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Isshōchi, Kumamoto, Japan
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Kamimashiki, Kumamoto, Japan
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Kōshi, Kumamoto, Japan
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Yatsushiro, Kumamoto, Japan
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Fukuchiyama, Kyoto, Japan
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Kameoka, Kyoto, Japan
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Kyōtango, Kyoto, Japan
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Maizuru, Kyoto, Japan
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Mukō, Kyoto, Japan
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Nantan, Kyoto, Japan
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Yosa, Kyoto, Japan
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Iga, Mie-ken, Japan
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Ise, Mie-ken, Japan
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Kameyama, Mie-ken, Japan
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Kitamuro, Mie-ken, Japan
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Kuwana, Mie-ken, Japan
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Matsusaka, Mie-ken, Japan
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Suzuka, Mie-ken, Japan
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Tsu, Mie-ken, Japan
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Yokkaichi, Mie-ken, Japan
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Ōsaki, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shiroishi, Miyagi, Japan
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Toda, Miyagi, Japan
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Tome, Miyagi, Japan
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Ebino, Miyazaki, Japan
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Hyūga, Miyazaki, Japan
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Koyu, Miyazaki, Japan
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Kushima, Miyazaki, Japan
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Miyakonojō, Miyazaki, Japan
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Nobeoka, Miyazaki, Japan
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Ina, Nagano, Japan
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Kamiina, Nagano, Japan
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Kiso, Nagano, Japan
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Komagane, Nagano, Japan
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Matsumoto, Nagano, Japan
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Nakano, Nagano, Japan
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Saku, Nagano, Japan
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Ueda, Nagano, Japan
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Isahaya, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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Unzen, Nagasaki, Japan
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Gojō, Nara, Japan
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Ikoma, Nara, Japan
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Kashihara, Nara, Japan
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Kitakatsuragi, Nara, Japan
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Ōuda-yamaguchi, Nara, Japan
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Sakurai, Nara, Japan
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Tenri, Nara, Japan
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Yamatokōriyama, Nara, Japan
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Yamatotakada, Nara, Japan
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Jōetsu, Niigata, Japan
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Kashiwazaki, Niigata, Japan
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Minamiuonuma, Niigata, Japan
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Mitsuke, Niigata, Japan
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Nagaoka, Niigata, Japan
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Sado, Niigata, Japan
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Shibata, Niigata, Japan
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Tōkamachi, Niigata, Japan
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Kunisaki, Oita Prefecture, Japan
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Nakatsu, Oita Prefecture, Japan
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Taketa, Oita Prefecture, Japan
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Usa, Oita Prefecture, Japan
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Yufu, Oita Prefecture, Japan
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Akaiwa, Okayama-ken, Japan
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Asakuchi, Okayama-ken, Japan
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Bizen, Okayama-ken, Japan
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Kurashiki, Okayama-ken, Japan
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Niimi, Okayama-ken, Japan
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Tsukubo, Okayama-ken, Japan
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Tsuyama, Okayama-ken, Japan
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Itoman, Okinawa, Japan
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Nago, Okinawa, Japan
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Nakagami, Okinawa, Japan
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Tomigusuku, Okinawa, Japan
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Urasoe, Okinawa, Japan
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Daitō, Osaka, Japan
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Fujiidera, Osaka, Japan
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Higashiosaka, Osaka, Japan
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Hirakata, Osaka, Japan
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Ibaraki, Osaka, Japan
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Izumi, Osaka, Japan
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Izumiōtsu, Osaka, Japan
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Izumisano, Osaka, Japan
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Kadoma, Osaka, Japan
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Katano, Osaka, Japan
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Kishiwada, Osaka, Japan
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Matsubara, Osaka, Japan
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Minamikawachi, Osaka, Japan
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Mino, Osaka, Japan
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Moriguchi, Osaka, Japan
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Neyagawa, Osaka, Japan
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Sakai, Osaka, Japan
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Sayama, Osaka, Japan
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Sennan, Osaka, Japan
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Settsu, Osaka, Japan
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Suita, Osaka, Japan
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Takaishi, Osaka, Japan
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Takatsuki, Osaka, Japan
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Tondabayashi, Osaka, Japan
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Toyonaka, Osaka, Japan
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Yao, Osaka, Japan
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Imari, Saga-ken, Japan
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Kanzaki, Saga-ken, Japan
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Ogi, Saga-ken, Japan
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Takeo, Saga-ken, Japan
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Taku, Saga-ken, Japan
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Tosu, Saga-ken, Japan
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Ageo, Saitama, Japan
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Chichibu, Saitama, Japan
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Fujimi, Saitama, Japan
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Fukaya, Saitama, Japan
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Hannō, Saitama, Japan
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Hidaka, Saitama, Japan
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Kasukabe, Saitama, Japan
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Kawagoe, Saitama, Japan
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Kawaguchi, Saitama, Japan
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Kazo, Saitama, Japan
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Kitaadachi, Saitama, Japan
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Koshigaya, Saitama, Japan
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Kukichūō, Saitama, Japan
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Sayama, Saitama, Japan
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Toda, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Warabi, Saitama, Japan
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Kōka, Shiga, Japan
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Kusatsu, Shiga, Japan
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Moriyama, Shiga, Japan
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Nagahama, Shiga, Japan
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Ōtsu, Shiga, Japan
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Rittō, Shiga, Japan
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Izumo, Shimane, Japan
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Matsue, Shimane, Japan
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Yasugi, Shimane, Japan
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Fuji, Shizuoka, Japan
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Fujieda, Shizuoka, Japan
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Fujinomiya, Shizuoka, Japan
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Fukuroi, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Itō, Shizuoka, Japan
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Iwata, Shizuoka, Japan
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Kikugawa, Shizuoka, Japan
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Mishima, Shizuoka, Japan
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Numazu, Shizuoka, Japan
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Shimada, Shizuoka, Japan
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Shimoda, Shizuoka, Japan
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Susono, Shizuoka, Japan
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Yaizu, Shizuoka, Japan
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Mooka, Tochigi, Japan
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Nikkō, Tochigi, Japan
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Sano, Tochigi, Japan
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Shimotsuga, Tochigi, Japan
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Utsunomiya, Tochigi, Japan
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Anan, Tokushima, Japan
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Awa, Tokushima, Japan
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Myozai, Tokushima, Japan
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Narutochō-mitsuishi, Tokushima, Japan
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Okuno, Tokushima, Japan
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Adachi City, Tokyo, Japan
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Akiruno, Tokyo, Japan
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Akishima, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chiyoda City, Tokyo, Japan
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Chūō, Tokyo, Japan
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Edogawa City, Tokyo, Japan
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Fuchū, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Higashimurayama, Tokyo, Japan
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Higashiyamato, Tokyo, Japan
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Hino, Tokyo, Japan
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Inagi, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Kita-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Koganei, Tokyo, Japan
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Koto, Tokyo, Japan
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Machida, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Minato, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Nakano City, Tokyo, Japan
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Nerima City, Tokyo, Japan
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Nishitōkyō, Tokyo, Japan
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Ōme, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shibuya City, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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Suginami, Tokyo, Japan
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Sumida City, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Toshima City, Tokyo, Japan
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Kurayoshi, Tottori, Japan
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Sakaiminato, Tottori, Japan
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Imizu, Toyama, Japan
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Kurobe-shi, Toyama, Japan
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Nakaniikawa, Toyama, Japan
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Namerikawa, Toyama, Japan
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Nanto, Toyama, Japan
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Takaoka, Toyama, Japan
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Tonami, Toyama, Japan
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Gobō, Wakayama, Japan
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Higashimuro, Wakayama, Japan
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Iwade, Wakayama, Japan
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Kainan, Wakayama, Japan
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Nishimuro, Wakayama, Japan
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Tanabe, Wakayama, Japan
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Higashiokitama, Yamagata, Japan
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Kaminoyama, Yamagata, Japan
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Sakata, Yamagata, Japan
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Hagi, Yamaguchi, Japan
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Hikari, Yamaguchi, Japan
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Iwakuni, Yamaguchi, Japan
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Sanyōonoda, Yamaguchi, Japan
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Shimonoseki, Yamaguchi, Japan
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Ube, Yamaguchi, Japan
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Yanai, Yamaguchi, Japan
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Chūō, Yamanashi, Japan
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Fuefuki, Yamanashi, Japan
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Kofu, Yamanashi, Japan
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Kōshū, Yamanashi, Japan
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Minami-Alps, Yamanashi, Japan
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Minamikoma, Yamanashi, Japan
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Tsuru, Yamanashi, Japan
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Aichi, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Mie, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Yamanashi, Japan
Related Publications (1)
Kinoshita Y, Hongo M, Kusano M, Furuhata Y, Miyagishi H, Ikeuchi S; RPZ Study Group. Therapeutic Response to Twice-daily Rabeprazole on Health-related Quality of Life and Symptoms in Patients with Refractory Reflux Esophagitis: A Multicenter Observational Study. Intern Med. 2017;56(10):1131-1139. doi: 10.2169/internalmedicine.56.7896. Epub 2017 May 15.
PMID: 28502925RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yoshinori Furuhata
Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 23, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2013
Study Completion
August 1, 2013
Last Updated
July 24, 2023
Record last verified: 2015-05