Local Phase 4 Pan-European SMART Study
March 8, 2010 updated by: AstraZeneca
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients.
A 6 month treatment period
Study Overview
Study Type
Interventional
Enrollment (Actual)
8424
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalst, Belgium
- Research Site
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Aarschot, Belgium
- Research Site
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Aatrijken, Belgium
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Asse, Belgium
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Balen, Belgium
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Bastogne, Belgium
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Bellaire, Belgium
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Betrix, Belgium
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Binche, Belgium
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Blankenberge, Belgium
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Boortmeerbeek, Belgium
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Bornem, Belgium
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Boussu, Belgium
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Brugge, Belgium
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Bruxelles, Belgium
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Buizingen, Belgium
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Burdinne, Belgium
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Champion, Belgium
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Charleroi, Belgium
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Chatelet, Belgium
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Chenee, Belgium
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Dendermonde, Belgium
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Diksmuide, Belgium
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Drongen, Belgium
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Duffel, Belgium
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Edegem, Belgium
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Eeklo, Belgium
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Ekeren, Belgium
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Erembodegem, Belgium
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Evergem, Belgium
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Fleurus, Belgium
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Gembloux, Belgium
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Genk, Belgium
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Gent, Belgium
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Gilly, Belgium
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Graty, Belgium
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Grivegnee, Belgium
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Halle, Belgium
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Ham, Belgium
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Ham-sur-Heure, Belgium
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Hasselt, Belgium
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Havinnes, Belgium
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Heist-op-Den-Berg, Belgium
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Herentals, Belgium
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Herstal, Belgium
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Hoboken, Belgium
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Hoeselt, Belgium
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Hooglede, Belgium
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Hornu, Belgium
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Houthalen-Helchteren, Belgium
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Huldenberg, Belgium
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Izegem, Belgium
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Jambes, Belgium
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Jodoigne, Belgium
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Kinrooi, Belgium
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Kontich, Belgium
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Kraainem, Belgium
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La Louviere, Belgium
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Langdorp, Belgium
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Lauwe, Belgium
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Leopoldsburg, Belgium
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Leuven, Belgium
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Liege, Belgium
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Lier, Belgium
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Lommel, Belgium
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Lovendegem, Belgium
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Malmedy, Belgium
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Marchovelette, Belgium
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Meelbeke, Belgium
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Moerkerke, Belgium
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Mol, Belgium
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Monceau-sur-Sambre, Belgium
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Mons, Belgium
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Montegnee, Belgium
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Moorsel, Belgium
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Mouscron, Belgium
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Namur, Belgium
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Natoye, Belgium
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Nijlen, Belgium
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Nivelles, Belgium
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Oedelem, Belgium
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Oostende, Belgium
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Oostkamp, Belgium
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Oppuurs, Belgium
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Oudenaarde, Belgium
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Paal, Belgium
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Peutie, Belgium
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Poederlee, Belgium
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Pulle, Belgium
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Rijkevorsel, Belgium
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Rixensart, Belgium
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Rotselaar, Belgium
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Roux, Belgium
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Sijsele, Belgium
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Sint-Genesius-Rode, Belgium
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Sint-Niklaas, Belgium
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St Katharina Lombeek, Belgium
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St-Vith, Belgium
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Steenokkerzeel, Belgium
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Stekene, Belgium
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Tavier, Belgium
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Thieusies, Belgium
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Tielt, Belgium
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Tienen, Belgium
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Tirlt, Belgium
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Tongeren, Belgium
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Tournai, Belgium
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Tremelo, Belgium
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Turhout, Belgium
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Vedrin, Belgium
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Villers-Poterie, Belgium
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Vilvoorde, Belgium
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Vosselaar, Belgium
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Wambeek, Belgium
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Waregem, Belgium
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Waterloo, Belgium
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Wetteren, Belgium
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Wijnegem, Belgium
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Willebroek, Belgium
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Wilsele, Belgium
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Zele, Belgium
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Zemst, Belgium
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Zoersel, Belgium
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Zottegem, Belgium
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Zwijnaarde, Belgium
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Espho, Finland
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Espoo, Finland
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Hameenlinna, Finland
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Harjavalta, Finland
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Helsinki, Finland
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Hyvinkaa, Finland
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Joensuu, Finland
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Jokioinen, Finland
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Kannus, Finland
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Kemi, Finland
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Kereva, Finland
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Kokkola, Finland
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Korpilahti, Finland
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Kotka, Finland
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Kouvola, Finland
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Kuopio, Finland
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Kuusankoski, Finland
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Lahti, Finland
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Lappeenranta, Finland
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Lapua, Finland
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Lathi, Finland
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Lempaala, Finland
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Lohja, Finland
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Mikkeli, Finland
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Muurame, Finland
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Nurmij�rvi, Finland
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Oulu, Finland
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Pello, Finland
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Pieksamaki, Finland
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Pietarsaari, Finland
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Pori, Finland
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Porvo, Finland
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Pudasj�rvi, Finland
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Pyhajoki, Finland
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Riihimaki, Finland
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Seinajoki, Finland
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Suonenjoki, Finland
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Tamepare, Finland
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Tampera, Finland
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Turku, Finland
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Ulvila, Finland
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Vaajakoksi, Finland
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Vantaa, Finland
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Agen, France
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Aix En Provence, France
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Ajaccio, France
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Ales, France
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Amboise, France
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Amelie Les Bains Palalda, France
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Amiens, France
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Angers, France
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Angouleme, France
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Annecy, France
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Annonay, France
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Antibes Cedex, France
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Arpajon, France
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Asnieres Sur seine, France
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Aubagne Cedex, France
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Aulnay Sous Bois, France
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Avignon, France
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Bastia, France
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Bayonne, France
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Belfort, France
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Bernay, France
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Besancon, France
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Bethune, France
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Beziers, France
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Biganos, France
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Bois Guillaume, France
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Bordeaux, France
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Bouoin Jallieu, France
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Bourges, France
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Brest, France
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Briey Cedex, France
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Brive La Gaillarde, France
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Cachan, France
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Caen Cedex 4, France
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Cagnes Sur Mer, France
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Caluire Et Cuire, France
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Cambrai, France
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Carpentras, France
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Castelnau Le Lez, France
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Castres, France
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Cavaillon, France
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Challans, France
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Chalons En Champagne, France
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Charleville Mezieres, France
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Chateauroux, France
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Chauny, France
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Chaville, France
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Chevillu Larue Cedex, France
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Cholet, France
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Cluses, France
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Colma, France
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Colmar, France
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Colomiers, France
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Corbeil Essonnes, France
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Creteil Cedex, France
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Denain Cedex, France
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Eaubonne, France
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Echirolles, France
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Ecully, France
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Epernay, France
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Epinal, France
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Etampes, France
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Ferolles Attilly, France
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Forbach, France
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Gentilly, France
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Gleize, France
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Grasse, France
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Grenoble, France
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Hagondange, France
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Hazebrouck, France
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Herblay, France
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Hyeres, France
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Joue Les Tours, France
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Juan Les Pins, France
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La Garda, France
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La Roche Sur Yon, France
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La Rochelle, France
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La Teste De Buch, France
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Lagny Sur Marne, France
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Langon, France
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Laval, France
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Le Bouscat, France
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Le Perreux Sur Marne, France
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Lens, France
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Les Sbles D Olonne, France
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Libourne, France
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Lille, France
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Limoges, France
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Limoges Cedex 1, France
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Lorient, France
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Lunel, France
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Luneville, France
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Lyon, France
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Maisons Laffitte, France
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Mandelieu La Napoule, France
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Marmande, France
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Marseille, France
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Marselle, France
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Martigues, France
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Maubeuge, France
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Meaux, France
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Melun, France
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Mende, France
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Menton, France
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Metz, France
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Montauban, France
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Montbeliard, France
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Montereau Fault Yonne, France
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Montferrier Sur Lez, France
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Montigny Les Metz, France
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Montpellier, France
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Montreuil, France
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Nantes, France
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Narbonne, France
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Nevers Cedex, France
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Nice, France
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Nimes, France
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Niort, France
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Obernai, France
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Ollioules, France
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Oloron Ste Marie, France
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Orange, France
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Orleans, France
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Oyonnax, France
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Paris, France
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Pau Cedex, France
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Perigueux, France
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Perpignan, France
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Pertuis, France
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Pezenas, France
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Poitiers, France
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Pontault Combault, France
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Pontoise, France
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Privas, France
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Quimper, France
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Reims, France
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Rennes, France
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Reze, France
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Roanne, France
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Rochefort, France
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Romans Sur Isere, France
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Romorantin Lanthenay, France
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Rosny Sous Bois, France
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Rouen, France
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Rueil Malmaison, France
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Saint Etienne, France
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Saintes, France
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Salon De Provence, France
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Sarlat La Ceneda, France
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Schiltigheim, France
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Sedan, France
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Selestat, France
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Six Fours Les Plages, France
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St Amand Les Eaux, France
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St Andre Les Verges, France
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St Brieuc cedex 1, France
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St Denis, France
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St Dizier, France
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St Esteve Cedex, France
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St Etienne, France
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St Girons, France
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St Herblain, France
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St Jean, France
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St Jean De Luz, France
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St Jean De Maurienne, France
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St Laurent Du Var Cedex, France
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St Malo, France
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St Orenes De Gameville, France
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St Quentin, France
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St Raphael, France
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Ste Feyre, France
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Strasbourg, France
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Tergnier, France
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Thionville, France
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Thonon Les Bains, France
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Toulon, France
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Toulouse, France
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Tours, France
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Valence, France
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Vannes, France
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Verneuil Sur Seine, France
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Vienne, France
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Villebon Sur Yvette, France
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Villejuif, France
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Viooefranche Sur Saone, France
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Voiron, France
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Aachen, Germany
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Annaberg-Buchholz, Germany
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Ansbach, Germany
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Apolda, Germany
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Aschaffenburg, Germany
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Auerbach, Germany
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Augusburg, Germany
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Bad Bramstedt, Germany
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Bad Lippspringe, Germany
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Bad Naustadt, Germany
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Bad Sassendorf, Germany
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Bergkamen, Germany
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Bergrheinfeld, Germany
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Berlin, Germany
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Bernau, Germany
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Bernsheim, Germany
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Beucha, Germany
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Bochum, Germany
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Bockenem, Germany
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Bogen, Germany
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Bonn, Germany
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Borna, Germany
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Braunschweig, Germany
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Buchholz, Germany
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Burgwedel, Germany
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Chemnitz, Germany
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Coswig, Germany
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Cottbus, Germany
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Deggendorf, Germany
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Dillingen, Germany
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Dortmund, Germany
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Dresden, Germany
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Dusseldorf, Germany
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Emeden, Germany
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Eppelborn, Germany
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Erfurt, Germany
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Essen, Germany
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Esslingen, Germany
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Flensburg, Germany
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Frankfurt, Germany
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Freiberg, Germany
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Freital, Germany
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Furstenfeldbruck, Germany
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Furstenwalde, Germany
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Furth, Germany
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Geesthacht, Germany
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Geisen, Germany
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Gelnhausen, Germany
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Gelsenkirchen, Germany
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Greven, Germany
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Gutersloh, Germany
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Hagen, Germany
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Halle, Germany
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Hamburg, Germany
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Hannover, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Hsloch, Germany
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Ingolstadt, Germany
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Kaarst, Germany
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Karlsruhe, Germany
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Karlsruhe-Durlach, Germany
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Kassel, Germany
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Katzhutte, Germany
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Kempten, Germany
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Ketzin, Germany
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Kiel, Germany
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Kippenheim, Germany
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Kirchhain, Germany
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Koln, Germany
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Krefeld, Germany
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Laage, Germany
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Landsberg, Germany
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Lebach, Germany
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Leipzig, Germany
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Lippstadt, Germany
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Lubeck, Germany
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Ludenscheid, Germany
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Lutjenburg, Germany
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Magdenburg, Germany
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Mainz, Germany
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Marburg, Germany
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Marl, Germany
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Meisen, Germany
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Mittelbach, Germany
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Moers, Germany
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Muhlhausen, Germany
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Mulheim, Germany
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Mulsen, Germany
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Munchen, Germany
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Neukirchen-Vluyn, Germany
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Neunkirchen, Germany
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Neunstadt, Germany
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Neuss, Germany
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Niesky, Germany
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Oranienburg, Germany
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Oschersleben, Germany
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Osnabr�ck, Germany
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Pirmasens, Germany
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Potsda, Germany
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Potsdam, Germany
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Rathenow, Germany
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Ratingen, Germany
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Recklinghausen, Germany
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Remscheid, Germany
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Rodgau, Germany
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Saarbrucken, Germany
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Saarlouis, Germany
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Sangerhausen, Germany
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Schimiedeberg, Germany
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Schwetzingen, Germany
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Silbitz, Germany
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Sindelfingen, Germany
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Solingen, Germany
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Stade, Germany
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Steinhagen, Germany
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Stockach, Germany
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Straelen, Germany
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Stutensee, Germany
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Stuttgart, Germany
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Tiefenbach, Germany
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Ueckermunde, Germany
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Wallerfangen, Germany
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Wedel, Germany
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Weimar, Germany
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Wesseling, Germany
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Weyhe, Germany
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Wilhelmshaven, Germany
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Wunstorf, Germany
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Wuppertal, Germany
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Alexandroupolos, Greece
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Athens, Greece
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Crete, Greece
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Kavala, Greece
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Larissa, Greece
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Thessaloniki, Greece
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Reykjavik, Iceland
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Bautry, Ireland
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Beaumont Park, Ireland
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Bishopstown, Ireland
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Blaemy, Ireland
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Blanchardstown, Ireland
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Canigtwohill, Ireland
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Carlow Town, Ireland
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Carrigaline, Ireland
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Clonakilty, Ireland
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Douglas East, Ireland
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Drogheda, Ireland
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Dublin, Ireland
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Gorey, Ireland
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Headford, Ireland
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Kilfinanen, Ireland
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Kilmallock, Ireland
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Kinvara, Ireland
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Macroom, Ireland
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Mallow, Ireland
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Maynooth, Ireland
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Arezzo, Italy
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Ascoli Piceno, Italy
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Avellino, Italy
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Bari, Italy
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Benevento, Italy
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Bologna, Italy
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Brescia, Italy
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Cagliari, Italy
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Cantanzaro, Italy
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Caserta, Italy
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Catania, Italy
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Catanzaro, Italy
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Cattinara, Italy
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Cava dei Tirreni, Italy
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Chieti, Italy
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Cittadella, Italy
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Como, Italy
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Coppito, Italy
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Crema, Italy
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Cuneo, Italy
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Fano, Italy
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Ferrara, Italy
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Firenze, Italy
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Foggia, Italy
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Genova, Italy
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Jesi, Italy
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Latina, Italy
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Lecco, Italy
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Livorno, Italy
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Lugo, Italy
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Lungro, Italy
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Macerata, Italy
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Matera, Italy
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Mercatino San Severiono, Italy
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Messina, Italy
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Milano, Italy
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Modena, Italy
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Monza, Italy
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Napoli, Italy
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Novara, Italy
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Orbassano, Italy
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Padova, Italy
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Palermo, Italy
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Parma, Italy
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Pavia, Italy
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Perugia, Italy
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Pesaro, Italy
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Pescara, Italy
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Pietra Ligure, Italy
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Pisa, Italy
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Pordenone, Italy
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Prato, Italy
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Reggio Calabria, Italy
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Reggio Emilia, Italy
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Rocca Priora, Italy
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Roma, Italy
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Rovigo, Italy
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Rozzano, Italy
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San Pietro Vernotico, Italy
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Sarzana, Italy
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Sassari, Italy
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Sesto San Giovanni, Italy
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Siena, Italy
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Siracusa, Italy
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Terni, Italy
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Torino, Italy
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Torrette, Italy
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Den Bosch, Netherlands
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Den Haag, Netherlands
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Deurne, Netherlands
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Dordrecht, Netherlands
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Echt, Netherlands
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Ermelo, Netherlands
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Fen Haag, Netherlands
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Hoogvliet, Netherlands
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Hoogwoud, Netherlands
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Lieshout, Netherlands
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Losser, Netherlands
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Nijmegen, Netherlands
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Oude-Pekela, Netherlands
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Poortvliet, Netherlands
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Rijswijk, Netherlands
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Roelofarends, Netherlands
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Soerendonk, Netherlands
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Spijkenisse, Netherlands
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Voerendaal, Netherlands
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Weerselo, Netherlands
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Wildevank, Netherlands
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Woerden, Netherlands
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Zaandam, Netherlands
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Zutphen, Netherlands
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Bergen, Norway
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B�verbru, Norway
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Elverum, Norway
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Fevik, Norway
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Fredrikstad, Norway
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Larvik, Norway
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Lovenstad, Norway
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Oslo, Norway
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Radal, Norway
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Roa, Norway
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Ski, Norway
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Ulstet, Norway
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Kasan, Russian Federation
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Moscow, Russian Federation
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St-Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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Alcala de Henares, Spain
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Alcorcon, Spain
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Alicante Orihuela, Spain
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Alicante. Elda, Spain
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Andujar, Spain
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Aviles, Spain
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Badajoz, Spain
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Bailbao, Spain
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Barakaldi/Vizcaya, Spain
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Barakaldo Bizkaia, Spain
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Barcelona, Spain
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Burgos, Spain
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Caceres, Spain
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Cadiz, Spain
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Castellon, Spain
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Coruna, Spain
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Elche Alicante, Spain
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Ferrol, Spain
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Fuenlabrada, Spain
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Gandia, Spain
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Getafe, Spain
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Gijon, Spain
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Girona, Spain
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Granada, Spain
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Huelva, Spain
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Huercal Overa, Spain
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Jaen, Spain
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Laredo, Spain
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Leganes, Spain
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Lugo, Spain
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Madrid, Spain
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Malaga, Spain
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Manacor, Spain
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Marbella, Spain
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Merida, Spain
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Mostoles Madrid, Spain
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Murcia, Spain
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Orense, Spain
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Oviedo, Spain
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Palencia, Spain
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Palma Mallorca, Spain
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Pamplona, Spain
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Ponferrada, Spain
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Pontevedra, Spain
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Requena, Spain
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Ronda, Spain
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Sagunto, Spain
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Salamanca, Spain
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San Zebastian, Spain
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Santa Cruz d e Tenerife, Spain
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Santander, Spain
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Segovia, Spain
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Sevilla, Spain
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Valencia, Spain
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Valladolid, Spain
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Viadecans, Spain
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Vigo, Spain
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Vitoria, Spain
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Bromma, Sweden
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Eskilstuna, Sweden
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Gavle, Sweden
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Goteborg, Sweden
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Grangesberg, Sweden
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Hesingborg, Sweden
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Jarfalla, Sweden
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Karskrona, Sweden
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Kil, Sweden
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Laholm, Sweden
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Limhamn, Sweden
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Linkoping, Sweden
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Ludvika, Sweden
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Lulea, Sweden
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Malmo, Sweden
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Nacka, Sweden
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Orebro, Sweden
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Pitea, Sweden
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Stockholm, Sweden
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Torsas, Sweden
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Tyreso, Sweden
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Uppsala, Sweden
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Vannas, Sweden
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Varnamo, Sweden
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Aldershot, United Kingdom
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Aylesbury, United Kingdom
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Ayrchire, United Kingdom
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Barry, United Kingdom
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Basildon, United Kingdom
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Bath, United Kingdom
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Belfast, United Kingdom
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Bellshill, United Kingdom
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Bexhill on Sea, United Kingdom
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Blackburn, United Kingdom
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Blantyre, United Kingdom
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Bolton, United Kingdom
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Borehamwood, United Kingdom
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Box, United Kingdom
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Bracknell, United Kingdom
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Bradford On Avon, United Kingdom
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Burbage, United Kingdom
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Bury St Edmonds, United Kingdom
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Canterbury, United Kingdom
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Cardiff, United Kingdom
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Chesterfield, United Kingdom
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Chippenham, United Kingdom
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Coatbridge, United Kingdom
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Cookstown, United Kingdom
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Corsham, United Kingdom
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Coventry, United Kingdom
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Crawley, United Kingdom
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Crowthorne, United Kingdom
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Cumbernauld, United Kingdom
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Darlington, United Kingdom
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Doncaste, United Kingdom
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Dumbarton, United Kingdom
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Dumfries, United Kingdom
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East Kilbride, United Kingdom
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Ecclwsfield, United Kingdom
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Ely, United Kingdom
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Fowey, United Kingdom
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Frome, United Kingdom
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Glasgow, United Kingdom
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Greenock, United Kingdom
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Hamilton, United Kingdom
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Headcorn, United Kingdom
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High Valleyfield, United Kingdom
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Huntington, United Kingdom
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Kirkintilloch, United Kingdom
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Larne, United Kingdom
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Leicester, United Kingdom
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Limavady, United Kingdom
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Lockerbie, United Kingdom
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London, United Kingdom
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Maidenhead, United Kingdom
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Manhester, United Kingdom
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Motherwell, United Kingdom
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New Stevenson, United Kingdom
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Newcastle, United Kingdom
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Newtonstewart, United Kingdom
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Newtownabbey, United Kingdom
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Northampton, United Kingdom
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Norwich, United Kingdom
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Nottingham, United Kingdom
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Nr Penzance, United Kingdom
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Paignton, United Kingdom
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Paisley, United Kingdom
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Penzance, United Kingdom
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Peterborough, United Kingdom
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Plymouth, United Kingdom
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Port Glasgow, United Kingdom
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Praze-on-Beeble, United Kingdom
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Reading, United Kingdom
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Reddich, United Kingdom
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Renfrew, United Kingdom
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Saltash, United Kingdom
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Sandy, United Kingdom
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Sheffield, United Kingdom
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Shepshed, United Kingdom
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Slough, United Kingdom
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Spalding, United Kingdom
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Spennymoor, United Kingdom
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Strathaven, United Kingdom
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Strathblane, United Kingdom
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Sunbury on Thames, United Kingdom
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Swindon, United Kingdom
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Thornhill, United Kingdom
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Thornton Heath, United Kingdom
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Tichfield, United Kingdom
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Torpoint, United Kingdom
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Trowbridge, United Kingdom
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Walsall, United Kingdom
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Welingborough, United Kingdom
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Wells next the sea, United Kingdom
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Weston-Super-Mare, United Kingdom
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Whitstable, United Kingdom
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Wishaw, United Kingdom
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Yaxley, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients at out-patient clinics
- >18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief
Exclusion Criteria:
- Asthma exacerbation within the last 14 days prior to study start
- subject aged >40 years with a smoking history of >10pack-years
- subjects with chronic obstructive lung disease or other significant respiratory disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Severe Asthma Exacerbations Per Participant.
Time Frame: 6 months
|
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant.
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fraction of Participants With Severe Asthma Exacerbation
Time Frame: 6 months.
|
The total number of severe asthma exacerbations was calculated for each participant.
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
|
6 months.
|
|
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
Time Frame: 6 months.
|
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Number of events per participant
|
6 months.
|
|
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
Time Frame: 6 months.
|
Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant.
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
|
6 months.
|
|
Mean Daily Number of Inhalations of As-needed Medication.
Time Frame: 4 weeks
|
The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
|
4 weeks
|
|
Percent of Participants With a Well Controlled Asthma Week.
Time Frame: 6 months.
|
The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment.
A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.
|
6 months.
|
|
Mean Overall Asthma Control Questionnaire (ACQ) Score
Time Frame: 6 months.
|
The ACQ5 was used.
The lower value the better with a full range from 0=no impairment, 6= maximum impairment.
Awakenings, morning symptoms, limitations, shortness of breath and wheeze.
|
6 months.
|
|
The Mean Total Daily Dose of Steroids From Symbicort.
Time Frame: 4 weeks
|
The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
|
4 weeks
|
|
Mean Cost Per Participant Per Country
Time Frame: 6 months
|
Mean cost is calculated for each country using participants from the whole study and country specific costs.
Mean value for the whole study can not be calculated.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Aubier, Prof, France
- Study Chair: Juliette Ostinelli, MD, AstraZeneca, MC France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17. Erratum In: Ther Adv Respir Dis. 2012 Aug;6(4):247.
- Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.
- Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
April 19, 2007
First Submitted That Met QC Criteria
April 19, 2007
First Posted (Estimate)
April 20, 2007
Study Record Updates
Last Update Posted (Estimate)
March 22, 2010
Last Update Submitted That Met QC Criteria
March 8, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
Other Study ID Numbers
- D5890L00022
- EUROSMART
- EudraCTNo. 2006-006512-30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.