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Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

NCT ID: NCT04593927

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-28

Study Completion Date

2023-08-30

Brief Summary

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This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

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Detailed Description

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This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.

Conditions

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Secondary Progressive Multiple Sclerosis (SPMS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mayzent

Patients administered Mayzent by prescription

Mayzent

Intervention Type DRUG

There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.

Interventions

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Mayzent

There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis

Exclusion Criteria

\-
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anjo, Aichi-ken, Japan

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Hekinan, Aichi-ken, Japan

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Ichinomiya, Aichi-ken, Japan

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Kariya, Aichi-ken, Japan

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Kasugai, Aichi-ken, Japan

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Nagakute, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Seto, Aichi-ken, Japan

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Hachinohe, Aomori, Japan

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Hirosaki, Aomori, Japan

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Ichihara, Chiba, Japan

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Ichikawa, Chiba, Japan

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Yachiyo, Chiba, Japan

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Tōon, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Gifu, Gifu, Japan

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Gifu, Gifu, Japan

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Isesaki, Gunma, Japan

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Maebashi, Gunma, Japan

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Maebashi, Gunma, Japan

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Ōta, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Kure, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Iwamizawa, 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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Rumoi, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Ako, Hyōgo, Japan

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Awaji, Hyōgo, Japan

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Itami, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Hitachi, Ibaraki, Japan

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Hitachi-Naka, Ibaraki, Japan

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Toride, Ibaraki, Japan

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Tsuchiura, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Hanamaki, Iwate, Japan

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Ichinoseki, Iwate, Japan

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Kita-gun, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Kamikoshikichō-oshima, Kagoshima-ken, Japan

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Ashigarakami, Kanagawa, Japan

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Atsugi, Kanagawa, Japan

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Hiratsuka, Kanagawa, Japan

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Isehara, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Nankoku, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Suzuka, Mie-ken, Japan

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Tsu, Mie-ken, Japan

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Kesennuma, Miyagi, Japan

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Sendai, Miyagi, Japan

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Miyakonojō, Miyazaki, Japan

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Chiisagata, Nagano, Japan

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Iida, Nagano, Japan

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Ina, Nagano, Japan

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Kitaazumi, Nagano, Japan

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Matsumoto, Nagano, Japan

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Matsumoto, Nagano, Japan

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Nagano, Nagano, Japan

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Saku, Nagano, Japan

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Suwa, Nagano, Japan

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Sasebo, Nagasaki, Japan

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Kashihara, Nara, Japan

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Nagaoka, Niigata, Japan

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Nagaoka, Niigata, Japan

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Niigata, Niigata, Japan

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Tsubame, Niigata, Japan

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Tsubame, Niigata, Japan

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Beppu, Oita Prefecture, Japan

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Ōita, Oita Prefecture, Japan

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Usa, Oita Prefecture, Japan

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Yufu, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Ginowan, Okinawa, Japan

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Fujiidera, Osaka, Japan

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Higashiosaka, Osaka, Japan

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Osaka, Osaka, Japan

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Ōsaka-sayama, Osaka, Japan

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Sakai, Osaka, Japan

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Suita, Osaka, Japan

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Takatsuki, Osaka, Japan

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Saga, Saga-ken, Japan

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Ageo, Saitama, Japan

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Iruma-gun, Saitama, Japan

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Kawagoe, Saitama, Japan

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Koshigaya, Saitama, Japan

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Koshigaya, Saitama, Japan

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Wako, Saitama, Japan

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Ohtsu-city, Shiga, Japan

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Ōmihachiman, Shiga, Japan

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Izumo, Shimane, Japan

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Fuji, Shizuoka, Japan

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Hamamatsu, Shizuoka, Japan

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Izunokuni, Shizuoka, Japan

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Oyama, Tochigi, Japan

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Shimotsuke, Tochigi, Japan

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Adachi City, Tokyo, Japan

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Adachi-ku, Tokyo, Japan

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Bunkyo Ku, Tokyo, Japan

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Bunkyo Ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Edogawa City, Tokyo, Japan

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Fuchū, Tokyo, Japan

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Fuchū, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Itabashi Ku, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Meguro City, Tokyo, Japan

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Nakano City, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Kurayoshi, Tottori, Japan

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Toyama, Toyama, Japan

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Sakata, Yamagata, Japan

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Shimonoseki, Yamaguchi, Japan

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Shūnan, Yamaguchi, Japan

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Ube, Yamaguchi, 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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Gifu, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Kagoshima, , 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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Kyoto, , Japan

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Nagasaki, , Japan

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Nagasaki, , Japan

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Niigata, , 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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Tokushima, , Japan

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Tokushima, , Japan

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Countries

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Japan

Other Identifiers

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CBAF312A1401

Identifier Type: -

Identifier Source: org_study_id

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