MedPath

Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Completed
Conditions
Parkinson Disease
Interventions
Registration Number
NCT01525641
Lead Sponsor
Boehringer Ingelheim
Brief Summary

Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
615
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patient with Parkinson's DiseaseMirapex LA-
Primary Outcome Measures
NameTimeMethod
Percentage of Adverse Drug ReactionsFrom baseline up to week 52

Percentage of subjects with adverse drug reactions

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in the Modified Hoehn & Yahr to Last ObservationBaseline and week 52

Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.

Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPAWeek 52

Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off".

Clinical Global Impression of EffectWeek 52

Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.

Change From Baseline in Total Score of the UPDRS Part III to Last ObservationBaseline and week 52

Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score.

UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status.

The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.

The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.

Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPAWeek 52

Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.

Trial Locations

Locations (118)

Boehringer Ingelheim Investigational Site 4

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Muroran,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 52

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Nanao,Ishikawa, Japan

Boehringer Ingelheim Investigational Site 40

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Chuo,Tokyo, Japan

Boehringer Ingelheim Investigational Site 109

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Fukuoka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 28

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Abiko,Chiba, Japan

Boehringer Ingelheim Investigational Site 96

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Hiroshima,Hiroshima, Japan

Boehringer Ingelheim Investigational Site 114

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Kumamoto,Kumamoto, Japan

Boehringer Ingelheim Investigational Site 30

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Nagareyama,Chiba, Japan

Boehringer Ingelheim Investigational Site 67

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Nagoya,Aichi, Japan

Boehringer Ingelheim Investigational Site 80

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Osaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 84

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Toyonaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 22

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Fujioka,Gunma, Japan

Boehringer Ingelheim Investigational Site 48

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Fujisawa,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 16

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Fukushima,Fukushima, Japan

Boehringer Ingelheim Investigational Site 44

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Hadano,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 62

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Hamamatsu,Shizuoka, Japan

Boehringer Ingelheim Investigational Site 77

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Kyoto,Kyoto, Japan

Boehringer Ingelheim Investigational Site 74

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Moriyama,Shiga, Japan

Boehringer Ingelheim Investigational Site 115

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Oita,Oita, Japan

Boehringer Ingelheim Investigational Site 18

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Ryugasaki,Ibaragi, Japan

Boehringer Ingelheim Investigational Site 26

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Saitama,Saitama, Japan

Boehringer Ingelheim Investigational Site 102

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Sakaide,Kagawa, Japan

Boehringer Ingelheim Investigational Site 8

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Sapporo,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 69

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Seto,Aichi, Japan

Boehringer Ingelheim Investigational Site 53

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Fukui,Fukui, Japan

Boehringer Ingelheim Investigational Site 60

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Gifu,Gifu, Japan

Boehringer Ingelheim Investigational Site 17

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Iwaki,Fukushima, Japan

Boehringer Ingelheim Investigational Site 107

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Kurume,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 23

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Maebashi,Gunma, Japan

Boehringer Ingelheim Investigational Site 85

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Nishinomiya,Hyogo, Japan

Boehringer Ingelheim Investigational Site 61

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Ogaki,Gifu, Japan

Boehringer Ingelheim Investigational Site 93

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Okayama,Okayama, Japan

Boehringer Ingelheim Investigational Site 95

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Okayama,Okayama, Japan

Boehringer Ingelheim Investigational Site 11

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Sendai,Miyagi, Japan

Boehringer Ingelheim Investigational Site 33

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Setagaya,Tokyo, Japan

Boehringer Ingelheim Investigational Site 99

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Shimonoseki,Yamaguchi, Japan

Boehringer Ingelheim Investigational Site 118

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Okinawa,Okinawa, Japan

Boehringer Ingelheim Investigational Site 9

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Aomori,Aomori, Japan

Boehringer Ingelheim Investigational Site 36

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Bunkyo,Tokyo, Japan

Boehringer Ingelheim Investigational Site 27

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Koshigaya,Saitama, Japan

Boehringer Ingelheim Investigational Site 65

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Nagoya,Aichi, Japan

Boehringer Ingelheim Investigational Site 50

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Niigata,Niigata, Japan

Boehringer Ingelheim Investigational Site 72

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Obu,Aichi, Japan

Boehringer Ingelheim Investigational Site 81

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Osaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 25

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Saitama,Saitama, Japan

Boehringer Ingelheim Investigational Site 51

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Takaoka,Toyama, Japan

Boehringer Ingelheim Investigational Site 14

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Yokote,Akita, Japan

Boehringer Ingelheim Investigational Site 57

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Iida,Nagano, Japan

Boehringer Ingelheim Investigational Site 3

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Iwamizawa,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 55

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Kofu,Yamanashi, Japan

Boehringer Ingelheim Investigational Site 42

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Minato,Tokyo, Japan

Boehringer Ingelheim Investigational Site 116

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Miyakonojo,Miyazaki, Japan

Boehringer Ingelheim Investigational Site 10

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Morioka,Iwate, Japan

Boehringer Ingelheim Investigational Site 56

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Nagano,Nagano, Japan

Boehringer Ingelheim Investigational Site 113

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Nagasaki,Nagasaki, Japan

Boehringer Ingelheim Investigational Site 104

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Nangoku,Kouchi, Japan

Boehringer Ingelheim Investigational Site 92

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Ohta,Shimane, Japan

Boehringer Ingelheim Investigational Site 98

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Sanyo-Onoda, Japan

Boehringer Ingelheim Investigational Site 1

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Sapporo,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 7

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Sapporo,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 12

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Sendai,Miyagi, Japan

Boehringer Ingelheim Investigational Site 20

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Shimotsuke,Tochigi, Japan

Boehringer Ingelheim Investigational Site 21

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Shimotsuke,Tochigi, Japan

Boehringer Ingelheim Investigational Site 39

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Shinjuku,Tokyo, Japan

Boehringer Ingelheim Investigational Site 41

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Shinjuku,Tokyo, Japan

Boehringer Ingelheim Investigational Site 101

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Tokushima,Tokushima, Japan

Boehringer Ingelheim Investigational Site 112

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Tosu,Saga, Japan

Boehringer Ingelheim Investigational Site 71

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Toyokawa,Aichi, Japan

Boehringer Ingelheim Investigational Site 64

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Shimoda,Shizuoka, Japan

Boehringer Ingelheim Investigational Site 37

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Shinjuku,Tokyo, Japan

Boehringer Ingelheim Investigational Site 100

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Yoshinogawa,Tokushima, Japan

Boehringer Ingelheim Investigational Site 94

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Tsukubo,Okayama, Japan

Boehringer Ingelheim Investigational Site 89

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Wakayama,Wakayama, Japan

Boehringer Ingelheim Investigational Site 78

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Ibaraki,Osaka, Japan

Boehringer Ingelheim Investigational Site 29

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Ichihara,Chiba, Japan

Boehringer Ingelheim Investigational Site 68

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Ichinomiya,Aichi, Japan

Boehringer Ingelheim Investigational Site 108

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Iiduka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 88

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Ikoma,Nara, Japan

Boehringer Ingelheim Investigational Site 103

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Imabari,Ehime, Japan

Boehringer Ingelheim Investigational Site 117

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Kirishima,Kagoshima, Japan

Boehringer Ingelheim Investigational Site 111

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Kitakyushu,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 70

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Konan,Aichi, Japan

Boehringer Ingelheim Investigational Site 110

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Onojo,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 38

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Ota,Tokyo, Japan

Boehringer Ingelheim Investigational Site 75

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Otsu,Shiga, Japan

Boehringer Ingelheim Investigational Site 76

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Otsu,Shiga, Japan

Boehringer Ingelheim Investigational Site 43

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Sagamihara,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 47

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Sagamihara,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 83

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Sakai,Osaka, Japan

Boehringer Ingelheim Investigational Site 58

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Saku,Nagano, Japan

Boehringer Ingelheim Investigational Site 59

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Sekigahara,Gifu, Japan

Boehringer Ingelheim Investigational Site 91

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Yazu,Tottori, Japan

Boehringer Ingelheim Investigational Site 46

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Fujisawa,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 105

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Fukuoka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 13

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Akita,Akita, Japan

Boehringer Ingelheim Investigational Site 2

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Asahikawa,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 35

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Chuo,Tokyo, Japan

Boehringer Ingelheim Investigational Site 54

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Chuo,Yamanashi, Japan

Boehringer Ingelheim Investigational Site 34

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Edogawa,Tokyo, Japan

Boehringer Ingelheim Investigational Site 32

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Fuchu,Tokyo, Japan

Boehringer Ingelheim Investigational Site 86

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Akashi,Hyogo, Japan

Boehringer Ingelheim Investigational Site 6

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Date,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 24

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Fukaya,Saitama, Japan

Boehringer Ingelheim Investigational Site 106

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Fukuoka,Fukuoka, Japan

Boehringer Ingelheim Investigational Site 97

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Hiroshima,Hiroshima, Japan

Boehringer Ingelheim Investigational Site 5

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Kitami,Hokkaido, Japan

Boehringer Ingelheim Investigational Site 66

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Miyoshi,Aichi, Japan

Boehringer Ingelheim Investigational Site 82

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Osaka,Osaka, Japan

Boehringer Ingelheim Investigational Site 79

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Sakai,Osaka, Japan

Boehringer Ingelheim Investigational Site 63

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Shimoda,Shizuoka, Japan

Boehringer Ingelheim Investigational Site 90

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Shingu,Wakayama, Japan

Boehringer Ingelheim Investigational Site 31

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Sakura,Chiba, Japan

Boehringer Ingelheim Investigational Site 87

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Toyooka,Hyogo, Japan

Boehringer Ingelheim Investigational Site 73

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Tsu,Mie, Japan

Boehringer Ingelheim Investigational Site 19

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Tsukuba,Ibaragi, Japan

Boehringer Ingelheim Investigational Site 15

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Tsuruoka,Yamagata, Japan

Boehringer Ingelheim Investigational Site 45

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Yokohama,Kanagawa, Japan

Boehringer Ingelheim Investigational Site 49

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Yokohama,Kanagawa, Japan

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