Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
Pramipexole Special Survey on Long-Term Use
Studieoversigt
Status
Status
Betingelser
Betingelser
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
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Agano, Japan
- Boehringer Ingelheim Investigational Site
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Aizuwakamatsu, Japan
- Boehringer Ingelheim Investigational Site
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Akashi, Japan
- Boehringer Ingelheim Investigational Site
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Akita, Japan
- Boehringer Ingelheim Investigational Site
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Asahikawa, Japan
- Boehringer Ingelheim Investigational Site
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Asakura, Japan
- Boehringer Ingelheim Investigational Site
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Ayagawa, Japan
- Boehringer Ingelheim Investigational Site
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Azumino, Japan
- Boehringer Ingelheim Investigational Site
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Bando, Japan
- Boehringer Ingelheim Investigational Site
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Beppu, Japan
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Bihoro, Japan
- Boehringer Ingelheim Investigational Site
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Chiba, Japan
- Boehringer Ingelheim Investigational Site
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Chikusei, Japan
- Boehringer Ingelheim Investigational Site
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Chuo, Japan
- Boehringer Ingelheim Investigational Site
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Date, Japan
- Boehringer Ingelheim Investigational Site
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Ebetsu, Japan
- Boehringer Ingelheim Investigational Site
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Ebina, Japan
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Eiheiji, Japan
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Fuchu, Japan
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Fuji, Japan
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Fujieda, Japan
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Fujinomiya, Japan
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Fujioka, Japan
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Fujisawa, Japan
- Boehringer Ingelheim Investigational Site
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Fujiyoshida, Japan
- Boehringer Ingelheim Investigational Site
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Fukaya, Japan
- Boehringer Ingelheim Investigational Site
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Fukui, Japan
- Boehringer Ingelheim Investigational Site
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site
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Fukushima, Japan
- Boehringer Ingelheim Investigational Site
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Fukuyama, Japan
- Boehringer Ingelheim Investigational Site
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Geisei, Japan
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Gifu, Japan
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Ginowan, Japan
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Hachinohe, Japan
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Hadano, Japan
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Haebaru, Japan
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Hagahama, Japan
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Hakodate, Japan
- Boehringer Ingelheim Investigational Site
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Hamada, Japan
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site
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Hayashima, Japan
- Boehringer Ingelheim Investigational Site
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Higashimurayama, Japan
- Boehringer Ingelheim Investigational Site
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Higashiosaka, Japan
- Boehringer Ingelheim Investigational Site
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Higashiyamato, Japan
- Boehringer Ingelheim Investigational Site
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Himeji, Japan
- Boehringer Ingelheim Investigational Site
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Hiratsuka, Japan
- Boehringer Ingelheim Investigational Site
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Hirokawa, Japan
- Boehringer Ingelheim Investigational Site
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Hirosaki, Japan
- Boehringer Ingelheim Investigational Site
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Hiroshima, Japan
- Boehringer Ingelheim Investigational Site
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Hita, Japan
- Boehringer Ingelheim Investigational Site
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Hofu, Japan
- Boehringer Ingelheim Investigational Site
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Ibaragi, Japan
- Boehringer Ingelheim Investigational Site
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Ichikikushikino, Japan
- Boehringer Ingelheim Investigational Site
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Ichinomiya, Japan
- Boehringer Ingelheim Investigational Site
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Ichinoseki, Japan
- Boehringer Ingelheim Investigational Site
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Iizuka, Japan
- Boehringer Ingelheim Investigational Site
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Ikeda, Japan
- Boehringer Ingelheim Investigational Site
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Ikoma, Japan
- Boehringer Ingelheim Investigational Site
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Ina, Japan
- Boehringer Ingelheim Investigational Site
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Inazawa, Japan
- Boehringer Ingelheim Investigational Site
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Inba, Japan
- Boehringer Ingelheim Investigational Site
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Inuyama, Japan
- Boehringer Ingelheim Investigational Site
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Isezaki, Japan
- Boehringer Ingelheim Investigational Site
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Itoigawa, Japan
- Boehringer Ingelheim Investigational Site
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Iwaki, Japan
- Boehringer Ingelheim Investigational Site
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Iwata, Japan
- Boehringer Ingelheim Investigational Site
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Joetsu, Japan
- Boehringer Ingelheim Investigational Site
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Kagoshima, Japan
- Boehringer Ingelheim Investigational Site
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Kahoku, Japan
- Boehringer Ingelheim Investigational Site
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Kajiki, Japan
- Boehringer Ingelheim Investigational Site
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Kakegawa, Japan
- Boehringer Ingelheim Investigational Site
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Kakogawa, Japan
- Boehringer Ingelheim Investigational Site
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Kamisu, Japan
- Boehringer Ingelheim Investigational Site
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Kamogawa, Japan
- Boehringer Ingelheim Investigational Site
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Kanazawa, Japan
- Boehringer Ingelheim Investigational Site
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Kannonji, Japan
- Boehringer Ingelheim Investigational Site
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Karatsu, Japan
- Boehringer Ingelheim Investigational Site
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Kashima, Japan
- Boehringer Ingelheim Investigational Site
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Kashiwa, Japan
- Boehringer Ingelheim Investigational Site
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Kashiwazaki, Japan
- Boehringer Ingelheim Investigational Site
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Kasukabe, Japan
- Boehringer Ingelheim Investigational Site
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Kato, Japan
- Boehringer Ingelheim Investigational Site
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Kawagoe, Japan
- Boehringer Ingelheim Investigational Site
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Kawasaki, Japan
- Boehringer Ingelheim Investigational Site
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Kawatana, Japan
- Boehringer Ingelheim Investigational Site
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Kikugawa, Japan
- Boehringer Ingelheim Investigational Site
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Kirishima, Japan
- Boehringer Ingelheim Investigational Site
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Kitakyushu, Japan
- Boehringer Ingelheim Investigational Site
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Kiyose, Japan
- Boehringer Ingelheim Investigational Site
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Kiyotake, Japan
- Boehringer Ingelheim Investigational Site
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Kizugawa, Japan
- Boehringer Ingelheim Investigational Site
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Kobayashi, Japan
- Boehringer Ingelheim Investigational Site
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Kobe, Japan
- Boehringer Ingelheim Investigational Site
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Kochi, Japan
- Boehringer Ingelheim Investigational Site
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Kodaira, Japan
- Boehringer Ingelheim Investigational Site
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Kofu, Japan
- Boehringer Ingelheim Investigational Site
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Koga, Japan
- Boehringer Ingelheim Investigational Site
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Kokubunji, Japan
- Boehringer Ingelheim Investigational Site
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Komae, Japan
- Boehringer Ingelheim Investigational Site
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Komatsu, Japan
- Boehringer Ingelheim Investigational Site
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Komoro, Japan
- Boehringer Ingelheim Investigational Site
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Koriyama, Japan
- Boehringer Ingelheim Investigational Site
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Koshi, Japan
- Boehringer Ingelheim Investigational Site
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Koshigawa, Japan
- Boehringer Ingelheim Investigational Site
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Kumamoto, Japan
- Boehringer Ingelheim Investigational Site
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Kurashiki, Japan
- Boehringer Ingelheim Investigational Site
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Kurayoshi, Japan
- Boehringer Ingelheim Investigational Site
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Kure, Japan
- Boehringer Ingelheim Investigational Site
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Kurume, Japan
- Boehringer Ingelheim Investigational Site
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Kushiro, Japan
- Boehringer Ingelheim Investigational Site
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Kutchan, Japan
- Boehringer Ingelheim Investigational Site
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Kuwana, Japan
- Boehringer Ingelheim Investigational Site
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Kyonan, Japan
- Boehringer Ingelheim Investigational Site
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Kyoto, Japan
- Boehringer Ingelheim Investigational Site
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Maebaru, Japan
- Boehringer Ingelheim Investigational Site
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Maebashi, Japan
- Boehringer Ingelheim Investigational Site
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Maibara, Japan
- Boehringer Ingelheim Investigational Site
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Maizuru, Japan
- Boehringer Ingelheim Investigational Site
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Marugame, Japan
- Boehringer Ingelheim Investigational Site
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Matsuda, Japan
- Boehringer Ingelheim Investigational Site
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Matsudo, Japan
- Boehringer Ingelheim Investigational Site
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Matsue, Japan
- Boehringer Ingelheim Investigational Site
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Matsumoto, Japan
- Boehringer Ingelheim Investigational Site
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Matsuyama, Japan
- Boehringer Ingelheim Investigational Site
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Mibu, Japan
- Boehringer Ingelheim Investigational Site
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Mihara, Japan
- Boehringer Ingelheim Investigational Site
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Miki, Japan
- Boehringer Ingelheim Investigational Site
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Minakami, Japan
- Boehringer Ingelheim Investigational Site
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Minamata, Japan
- Boehringer Ingelheim Investigational Site
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Minobu, Japan
- Boehringer Ingelheim Investigational Site
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Misashino, Japan
- Boehringer Ingelheim Investigational Site
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Mito, Japan
- Boehringer Ingelheim Investigational Site
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Miyaki, Japan
- Boehringer Ingelheim Investigational Site
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Miyakonojo, Japan
- Boehringer Ingelheim Investigational Site
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Miyazaki, Japan
- Boehringer Ingelheim Investigational Site
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Mooka, Japan
- Boehringer Ingelheim Investigational Site
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Moriguchi, Japan
- Boehringer Ingelheim Investigational Site
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Morioka, Japan
- Boehringer Ingelheim Investigational Site
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Moriya, Japan
- Boehringer Ingelheim Investigational Site
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Moriyama, Japan
- Boehringer Ingelheim Investigational Site
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Muroran, Japan
- Boehringer Ingelheim Investigational Site
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Nagakute, Japan
- Boehringer Ingelheim Investigational Site
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Nagaoka, Japan
- Boehringer Ingelheim Investigational Site
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Nagaokakyo, Japan
- Boehringer Ingelheim Investigational Site
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Nagasaki, Japan
- Boehringer Ingelheim Investigational Site
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Nagoya, Japan
- Boehringer Ingelheim Investigational Site
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Nangoku, Japan
- Boehringer Ingelheim Investigational Site
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Nara, Japan
- Boehringer Ingelheim Investigational Site
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Narita, Japan
- Boehringer Ingelheim Investigational Site
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Naruto, Japan
- Boehringer Ingelheim Investigational Site
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Nichinan, Japan
- Boehringer Ingelheim Investigational Site
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Niigata, Japan
- Boehringer Ingelheim Investigational Site
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Niihama, Japan
- Boehringer Ingelheim Investigational Site
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Nikko, Japan
- Boehringer Ingelheim Investigational Site
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Nishigo, Japan
- Boehringer Ingelheim Investigational Site
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Nishihara, Japan
- Boehringer Ingelheim Investigational Site
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Nishinomiya, Japan
- Boehringer Ingelheim Investigational Site
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Nishio, Japan
- Boehringer Ingelheim Investigational Site
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Nishitokyo, Japan
- Boehringer Ingelheim Investigational Site
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Nobeoka, Japan
- Boehringer Ingelheim Investigational Site
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Noboribetsu, Japan
- Boehringer Ingelheim Investigational Site
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Numazu, Japan
- Boehringer Ingelheim Investigational Site
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Obama, Japan
- Boehringer Ingelheim Investigational Site
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Obihiro, Japan
- Boehringer Ingelheim Investigational Site
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Odate, Japan
- Boehringer Ingelheim Investigational Site
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Odawara, Japan
- Boehringer Ingelheim Investigational Site
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Ofunato, Japan
- Boehringer Ingelheim Investigational Site
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Ogaki, Japan
- Boehringer Ingelheim Investigational Site
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Ohzu, Japan
- Boehringer Ingelheim Investigational Site
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Oiso, Japan
- Boehringer Ingelheim Investigational Site
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Oita, Japan
- Boehringer Ingelheim Investigational Site
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Ojiya, Japan
- Boehringer Ingelheim Investigational Site
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Okawa, Japan
- Boehringer Ingelheim Investigational Site
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Okayama, Japan
- Boehringer Ingelheim Investigational Site
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Omaezaki, Japan
- Boehringer Ingelheim Investigational Site
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Omura, Japan
- Boehringer Ingelheim Investigational Site
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Omuta, Japan
- Boehringer Ingelheim Investigational Site
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Onga, Japan
- Boehringer Ingelheim Investigational Site
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Onojo, Japan
- Boehringer Ingelheim Investigational Site
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Onomichi, Japan
- Boehringer Ingelheim Investigational Site
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Osaka, Japan
- Boehringer Ingelheim Investigational Site
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Otsu, Japan
- Boehringer Ingelheim Investigational Site
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Ozu, Japan
- Boehringer Ingelheim Investigational Site
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Sado, Japan
- Boehringer Ingelheim Investigational Site
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Saga, Japan
- Boehringer Ingelheim Investigational Site
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Sagamihara, Japan
- Boehringer Ingelheim Investigational Site
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Saitama, Japan
- Boehringer Ingelheim Investigational Site
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Sakai, Japan
- Boehringer Ingelheim Investigational Site
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Sakaide, Japan
- Boehringer Ingelheim Investigational Site
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Sakata, Japan
- Boehringer Ingelheim Investigational Site
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Saku, Japan
- Boehringer Ingelheim Investigational Site
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Sanjo, Japan
- Boehringer Ingelheim Investigational Site
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Sano, Japan
- Boehringer Ingelheim Investigational Site
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Sanyoonoda, Japan
- Boehringer Ingelheim Investigational Site
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site
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Sasebo, Japan
- Boehringer Ingelheim Investigational Site
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Seijo, Japan
- Boehringer Ingelheim Investigational Site
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Sendai, Japan
- Boehringer Ingelheim Investigational Site
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Shimabara, Japan
- Boehringer Ingelheim Investigational Site
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Shimonoseki, Japan
- Boehringer Ingelheim Investigational Site
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Shimotsuke, Japan
- Boehringer Ingelheim Investigational Site
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Shingu, Japan
- Boehringer Ingelheim Investigational Site
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Shinshiro, Japan
- Boehringer Ingelheim Investigational Site
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Shizuoka, Japan
- Boehringer Ingelheim Investigational Site
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Shunan, Japan
- Boehringer Ingelheim Investigational Site
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Soo, Japan
- Boehringer Ingelheim Investigational Site
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Suita, Japan
- Boehringer Ingelheim Investigational Site
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Tajimi, Japan
- Boehringer Ingelheim Investigational Site
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Takamatsu, Japan
- Boehringer Ingelheim Investigational Site
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Takanabe, Japan
- Boehringer Ingelheim Investigational Site
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Takaoka, Japan
- Boehringer Ingelheim Investigational Site
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Takasago, Japan
- Boehringer Ingelheim Investigational Site
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Takasaki, Japan
- Boehringer Ingelheim Investigational Site
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Takatsuki, Japan
- Boehringer Ingelheim Investigational Site
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Takehara, Japan
- Boehringer Ingelheim Investigational Site
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Toda, Japan
- Boehringer Ingelheim Investigational Site
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Togitsu, Japan
- Boehringer Ingelheim Investigational Site
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Tokoname, Japan
- Boehringer Ingelheim Investigational Site
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Tokushima, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Adachi-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Chiyoda-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Edogawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Itabashi-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Katsushika-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Kita-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Minayo-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Nakano-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjuku-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Suginami-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tomakomai, Japan
- Boehringer Ingelheim Investigational Site
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Tomiai, Japan
- Boehringer Ingelheim Investigational Site
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Tondabayashi, Japan
- Boehringer Ingelheim Investigational Site
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Toon, Japan
- Boehringer Ingelheim Investigational Site
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Toride, Japan
- Boehringer Ingelheim Investigational Site
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Toyama, Japan
- Boehringer Ingelheim Investigational Site
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Toyoake, Japan
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japan
- Boehringer Ingelheim Investigational Site
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Toyonaka, Japan
- Boehringer Ingelheim Investigational Site
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Toyooka, Japan
- Boehringer Ingelheim Investigational Site
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Tsu, Japan
- Boehringer Ingelheim Investigational Site
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Tsubata, Japan
- Boehringer Ingelheim Investigational Site
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Tsuchiura, Japan
- Boehringer Ingelheim Investigational Site
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Tsukuba, Japan
- Boehringer Ingelheim Investigational Site
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Tsuruoka, Japan
- Boehringer Ingelheim Investigational Site
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Uchinada, Japan
- Boehringer Ingelheim Investigational Site
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Ueda, Japan
- Boehringer Ingelheim Investigational Site
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Uji, Japan
- Boehringer Ingelheim Investigational Site
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Ujo, Japan
- Boehringer Ingelheim Investigational Site
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Urayasu, Japan
- Boehringer Ingelheim Investigational Site
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Uruma, Japan
- Boehringer Ingelheim Investigational Site
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Utsunomiya, Japan
- Boehringer Ingelheim Investigational Site
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Wakayama, Japan
- Boehringer Ingelheim Investigational Site
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Yamagata, Japan
- Boehringer Ingelheim Investigational Site
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Yamaguchi, Japan
- Boehringer Ingelheim Investigational Site
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Yamamoto, Japan
- Boehringer Ingelheim Investigational Site
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Yanai, Japan
- Boehringer Ingelheim Investigational Site
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Yao, Japan
- Boehringer Ingelheim Investigational Site
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Yashiro, Japan
- Boehringer Ingelheim Investigational Site
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Yazu, Japan
- Boehringer Ingelheim Investigational Site
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Yokkaichi, Japan
- Boehringer Ingelheim Investigational Site
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Yokohama, Japan
- Boehringer Ingelheim Investigational Site
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Yokote, Japan
- Boehringer Ingelheim Investigational Site
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Yoro, Japan
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, Japan
- Boehringer Ingelheim Investigational Site
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Yufu, Japan
- Boehringer Ingelheim Investigational Site
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Zama, Japan
- Boehringer Ingelheim Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Patients with Parkinson's disease
Exclusion Criteria:
Patients should have been treated according to the Japanese insert slip
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Tidsramme: during 18 months
|
The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients.
Therefore these items were considered as a safety evaluation.
|
during 18 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Global Impression of Improvement
Tidsramme: 18 months
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Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
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18 months
|
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Tidsramme: Baseline and at 18 months (or at the time of discontinuation)
|
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section.
Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst).
A decrease in the score means improvement.
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Baseline and at 18 months (or at the time of discontinuation)
|
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Change From Baseline in Modified Hoehn & Yahr Rating Scale
Tidsramme: Baseline and at 18 months (or at the time of discontinuation)
|
A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale.
This scale consist of 10 levels including additional evaluation levels defined in Japan.
Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
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Baseline and at 18 months (or at the time of discontinuation)
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 248.547
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .