Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

NCT ID: NCT01100073

Last Updated: 2014-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1703 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Brief Summary

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The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Parkinson's disease

Early and advanced Parkinson's disease patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Idiopathic Parkinson's disease with or without fluctuations
2. Indication for treatment with pramipexole (Mirapexin®)
3. Presence of at least mild tremor symptoms (as judged by the treating physician)

Exclusion Criteria

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with pramipexole (Mirapexin®)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 5

Keila, , Estonia

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Boehringer Ingelheim Investigational Site 4

Kohtla-Järve, , Estonia

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Rakvere, , Estonia

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Boehringer Ingelheim Investigational Site 1

Tallinn, , Estonia

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Boehringer Ingelheim Investigational Site 2

Tallinn, , Estonia

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Tallinn, , Estonia

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Boehringer Ingelheim Investigational Site 7

Tartu, , Estonia

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Valga, , Estonia

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Kuldīga, , Latvia

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Liepāja, , Latvia

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Liepāja, , Latvia

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Liepāja, , Latvia

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Liepāja, , Latvia

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Limbaži, , Latvia

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Limbaži, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Aiud, , Romania

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Arges, , Romania

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Arges, , Romania

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Arges, , Romania

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Arges, , Romania

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Arges, , Romania

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Arges, , Romania

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Arges, , Romania

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Bacau, , Romania

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Bacau, , Romania

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Bistriţa, , Romania

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Botoșani, , Romania

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Botoșani, , Romania

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Brasov, , Romania

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Brasov, , Romania

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Brăila, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Buzău, , Romania

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Buzău, , Romania

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Caracal, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Constanța, , Romania

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Constanța, , Romania

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Craiova, , Romania

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Craiova, , Romania

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Craiova, , Romania

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Craiova, , Romania

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Deva, , Romania

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Deva, , Romania

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Focşani, , Romania

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Focşani, , Romania

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Galati, , Romania

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Galati, , Romania

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Hunedoara, , Romania

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Hunedoara, , Romania

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Iași, , Romania

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Iași, , Romania

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Iași, , Romania

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Iași, , Romania

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Lugoj, , Romania

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Maramures, , Romania

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Orăştie, , Romania

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Paşcani, , Romania

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Paşcani, , Romania

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Petroşani, , Romania

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Piatra Neamţ, , Romania

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Prahova, , Romania

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Prahova, , Romania

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Prahova, , Romania

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Radauti, , Romania

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Reşiţa, , Romania

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Satu Mare, , Romania

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Sibiu, , Romania

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Sibiu, , Romania

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Slatina, , Romania

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Suceava, , Romania

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Suceava, , Romania

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Teleorman, , Romania

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Tg. Mures, , Romania

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Timișoara, , Romania

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Timișoara, , Romania

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Timișoara, , Romania

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Timișoara, , Romania

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Tulcea, , Romania

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Tulcea, , Romania

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Krasnodar, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Kruševac, , Serbia

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Niš, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Sombor, , Serbia

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Užice, , Serbia

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Valjevo, , Serbia

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Vranje, , Serbia

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?adca, , Slovakia

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Banská Bystrica, , Slovakia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Brezno, , Slovakia

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Humenné, , Slovakia

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Ilava, , Slovakia

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Komárno, , Slovakia

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Kosice- Saca, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Krompachy, , Slovakia

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Levice, , Slovakia

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Liptovský Mikulás, , Slovakia

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Lučenec, , Slovakia

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Martin, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Nováky, , Slovakia

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Nové Mesto N/ Váhom, , Slovakia

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Pezinok, , Slovakia

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Pies?any, , Slovakia

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Povazská Bystrica, , Slovakia

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Prešov, , Slovakia

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Prešov, , Slovakia

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Prešov, , Slovakia

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Revúca, , Slovakia

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Rimavská Sobota, , Slovakia

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Rožňava, , Slovakia

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Rožňava, , Slovakia

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Sereď, , Slovakia

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Skalica, , Slovakia

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Stropkov, , Slovakia

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Šaľa, , Slovakia

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Šurany, , Slovakia

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Trebišov, , Slovakia

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Tren?in, , Slovakia

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Trnava, , Slovakia

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Trnava, , Slovakia

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Trstená, , Slovakia

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Veľké Kapušany, , Slovakia

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Ziar N/Hronom, , Slovakia

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Zlaté Moravce, , Slovakia

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Zvolen, , Slovakia

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Zvolen, , Slovakia

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Žilina, , Slovakia

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Žilina, , Slovakia

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Bled, , Slovenia

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Celje, , Slovenia

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Ljubljana, , Slovenia

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Ljubljana, , Slovenia

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Maribor, , Slovenia

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Maribor, , Slovenia

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Maribor, , Slovenia

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Maribor, , Slovenia

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Šempeter pri Gorici, , Slovenia

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Šempeter pri Gorici, , Slovenia

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Boehringer Ingelheim Investigational Site 214

Ternopil, , Ukraine

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Boehringer Ingelheim Investigational Site 213

Vinnitsa, , Ukraine

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Countries

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Estonia Latvia Romania Russia Serbia Slovakia Slovenia Ukraine

Other Identifiers

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248.657

Identifier Type: -

Identifier Source: org_study_id

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