Study Results
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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COMPLETED
6620 participants
OBSERVATIONAL
2007-06-29
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tysabri
According to the local prescribing information
Tysabri
According to the local prescribing information
Interventions
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Tysabri
According to the local prescribing information
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The decision to treat with Tysabri must precede enrollment
* Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
* Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri
Exclusion Criteria
* History of positive anti-Tysabri antibodies
* Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
* Patient immunocompromised at the time of enrollment
* Known active malignancy
* Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)
18 Years
65 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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Santa Fe, , Argentina
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Camperdown, New South Wales, Australia
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Liverpool, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Gold Coast, Queensland, Australia
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Adelaide, South Australia, Australia
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North Adelaide, South Australia, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
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Aalst, , Belgium
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Anderlecht, , Belgium
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Antwerp, , Belgium
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Bocholt, , Belgium
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Brasschaat, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Fraiture, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Jette, , Belgium
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Kortrijk, , Belgium
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La Louvière, , Belgium
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Leuven, , Belgium
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Libramont, , Belgium
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Liège, , Belgium
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Malmedy, , Belgium
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Melsbroek, , Belgium
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Ostend, , Belgium
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Ottignies, , Belgium
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Overpelt, , Belgium
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Sijsele, , Belgium
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Tournai, , Belgium
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Wilrijk, , Belgium
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Woluwe-Saint-Lambert, , Belgium
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Belo Horizonte, , Brazil
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Botucatu, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Burnaby, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Bracebridge, Ontario, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Milton, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Brno, , Czechia
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Brno, , Czechia
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České Budějovice, , Czechia
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Hradec Kralové, , Czechia
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Jihlava, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Teplice, , Czechia
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Zlín, , Czechia
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Helsinki, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Pori, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Agen, , France
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Aix-en-Provence, , France
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Alençon, , France
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Angoulême, , France
Research site ,1 Allée du Château- Dr Wagner
Ars-Laquenexy, , France
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Auxerre, , France
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Avranches, , France
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Bayonne, , France
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Beauvais, , France
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Belfort, , France
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Beuvry, , France
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Béthune, , France
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Boulogne-sur-Mer, , France
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Calais, , France
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Castelnau-le-Lez, , France
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Castres, , France
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Chambéry, , France
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Chambéry, , France
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Colmar, , France
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Compiègne, , France
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Dieppe, , France
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Dreux, , France
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Dunkirk, , France
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Épinal, , France
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Évreux, , France
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Haguenau, , France
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La Rochelle, , France
Research site 177, rue de Versailles- Dr Servan
Le Chesnay, , France
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Le Chesnay, , France
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Le Coudray, , France
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Le Havre, , France
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Le Mans, , France
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Lille, , France
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Lisieux, , France
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Lomme, , France
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Mantes-la-Jolie, , France
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Maubeuge, , France
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Metz, , France
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Metz-Tessy, , France
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Mont-de-Marsan, , France
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Montauban, , France
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Montluçon, , France
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Montpellier, , France
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Montpellier, , France
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Mulhouse, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Pau, , France
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Quimper, , France
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Reims, , France
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Saint-Aubin-sur-Scie, , France
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Sarreguemines, , France
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Saumur, , France
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St-Malo, , France
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Talant, , France
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Tarbes, , France
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Tourcoing, , France
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Trappes, , France
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Trélazé, , France
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Valenciennes, , France
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Vesoul, , France
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Vichy, , France
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Abensberg, , Germany
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Andernach, , Germany
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Arnsdorf, , Germany
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Asperg, , Germany
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Augsburg, , Germany
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Bad Hersfeld, , Germany
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Bad Honnef, , Germany
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Bad Kissingen, , Germany
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Bad Mergentheim, , Germany
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Bad Reichenhall, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bogen, , Germany
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Bonn, , Germany
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Bruchsal, , Germany
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Buchholz, , Germany
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Celle, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Cologne, , Germany
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Dillingen, , Germany
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Dresden, , Germany
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Duisburg, , Germany
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Düren, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Eisenach, , Germany
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Emden, , Germany
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Emmendingen, , Germany
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Erbach im Odenwald, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Essen, , Germany
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Essen, , Germany
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Falkenstein, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Görlitz, , Germany
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Göttingen, , Germany
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Greifswald, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Herford, , Germany
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Itzehoe, , Germany
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Jena, , Germany
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Kaiserslautern, , Germany
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Kaltenkirchen, , Germany
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Kandel, , Germany
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Kassel, , Germany
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Kastellaun, , Germany
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Kirchberg, , Germany
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Kirchheim unter Teck, , Germany
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Kreuzau, , Germany
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Ladenburg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lengerich, , Germany
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Ludwigshafen, , Germany
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Lüdenscheid, , Germany
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Lüdenscheid, , Germany
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Lüneburg, , Germany
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Magdeburg, , Germany
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Mannheim, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Neuburg am Inn, , Germany
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Neukirchen-Vluyn, , Germany
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Neuruppin, , Germany
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Nuremberg, , Germany
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Nuremberg, , Germany
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Nuremberg, , Germany
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Oldenburg, , Germany
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Oldenburg, , Germany
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Olpe, , Germany
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Osnabrück, , Germany
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Osnabrück, , Germany
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Osnabrück, , Germany
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Paderborn, , Germany
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Potsdam, , Germany
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Regensburg, , Germany
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Remscheid, , Germany
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Rüdersdorf, , Germany
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Rülzheim, , Germany
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Schlüchtern, , Germany
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Schorndorf, , Germany
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Schwaebisch, , Germany
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Siegen, , Germany
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Sinsheim, , Germany
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Stade, , Germany
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Stadtroda, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Tegel, , Germany
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Teupitz, , Germany
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Trier, , Germany
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Troisdorf, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Unterhaching, , Germany
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Wasserburg, , Germany
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Weimar, , Germany
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Weinheim, , Germany
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Wermsdorf, , Germany
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Wernigerode, , Germany
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Wiesbaden, , Germany
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Wolfenbüttel, , Germany
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Wolfratshausen, , Germany
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Würzburg, , Germany
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Zwickau, , Germany
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Heraklion, Crete, Greece
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Ioannina, , Greece
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Pátrai, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Bari, , Italy
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Bergamo, , Italy
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Cagliari, , Italy
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Cefalù, , Italy
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Chieti, , Italy
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Cuneo, , Italy
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Fidenza, , Italy
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Florence, , Italy
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Foggia, , Italy
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Gallarate, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Zapopan, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Aguascalientes, , Mexico
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Estado de México, , Mexico
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León, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Puebla City, , Mexico
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Puebla City, , Mexico
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San Luis Potosí City, , Mexico
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's-Hertogenbosch, , Netherlands
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Almelo, , Netherlands
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Blaricum, , Netherlands
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Geldrop, , Netherlands
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Gouda, , Netherlands
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Heerenveen, , Netherlands
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Heerlen, , Netherlands
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Helmond, , Netherlands
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Hengelo, , Netherlands
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Hoorn, , Netherlands
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Leeuwarden, , Netherlands
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Meppel, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Roermond, , Netherlands
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Rotterdam, , Netherlands
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Sittard-Geleen, , Netherlands
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The Hague, , Netherlands
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Tilburg, , Netherlands
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Venray, , Netherlands
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Woerden, , Netherlands
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Zwolle, , Netherlands
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Bergen, , Norway
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Bodø, , Norway
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Drammen, , Norway
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Fredrikstad, , Norway
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Førde, , Norway
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Haugesund, , Norway
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Lillehammer, , Norway
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Lørenskog, , Norway
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Molde, , Norway
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Namsos, , Norway
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Oslo, , Norway
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Oslo, , Norway
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Skien, , Norway
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Stavanger, , Norway
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Tromsø, , Norway
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Trondheim, , Norway
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Tønsberg, , Norway
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Aveiro, , Portugal
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Beja, , Portugal
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Evora, , Portugal
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Funchal, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Setúbal, , Portugal
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Ávila, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Girona, , Spain
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Langreo, , Spain
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Logroño, , Spain
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Palma de Mallorca, , Spain
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Ponferrada, , Spain
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Tarragona, , Spain
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Tarragona, , Spain
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Vitoria-Gasteiz, , Spain
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Edgbaston, Birmingham, United Kingdom
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Canterbury, Kent, United Kingdom
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Hammersmith, London, United Kingdom
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Salford, Manchester, United Kingdom
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Belfast, , United Kingdom
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Brighton, , United Kingdom
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Bristol, , United Kingdom
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Coventry, , United Kingdom
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Exeter, , United Kingdom
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Liverpool, , United Kingdom
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Middlesbrough, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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Butzkueven H, Kappos L, Spelman T, Trojano M, Wiendl H, Su R, Liao S, Hyde R, Licata S, Ho PR, Campbell N. No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP). Ther Adv Neurol Disord. 2021 Sep 27;14:17562864211042458. doi: 10.1177/17562864211042458. eCollection 2021.
Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Chang I, Kasliwal R, Jaitly S, Campbell N, Ho PR, Licata S; Tysabri Observational Program (TOP) Investigators. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):660-668. doi: 10.1136/jnnp-2019-322326. Epub 2020 Mar 31.
Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S; TYSABRI Observational Program (TOP) Investigators. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1190-7. doi: 10.1136/jnnp-2013-306936. Epub 2014 Feb 14.
Other Identifiers
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IMA-06-02
Identifier Type: -
Identifier Source: org_study_id
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