European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
January 21, 2020 updated by: AstraZeneca
Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.
This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments.
For this purpose patients will be asked to answer a questionnaire over the phone
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
7400
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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Baden, Austria
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Feldbach, Austria
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Feldkirch, Austria
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Gussing, Austria
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Innsbruck, Austria
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Landeck, Austria
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Linz, Austria
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Linz-Urfahr, Austria
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Neusiedl am See, Austria
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Salzburg, Austria
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SchluSSlberg, Austria
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Steyr, Austria
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Thalheim/Wels, Austria
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Wels, Austria
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Wien, Austria
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Winden, Austria
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Wr.Neustadt, Austria
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Zwettl, Austria
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Aalst, Belgium
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Antwerpen, Belgium
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Ath, Belgium
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Bertogne, Belgium
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Boussu, Belgium
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Carnieres, Belgium
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Chatelet, Belgium
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Courcelles, Belgium
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Duffel, Belgium
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Florennes, Belgium
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Gent, Belgium
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Geraardsbergen, Belgium
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Gosselies, Belgium
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Haine-Saint-Paul, Belgium
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Houthulst, Belgium
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Houtvenne, Belgium
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Izegem, Belgium
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Kortessem, Belgium
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Kraainem, Belgium
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Lauwe, Belgium
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Liege, Belgium
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Lokeren, Belgium
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Lommel, Belgium
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Micheroux, Belgium
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Mons, Belgium
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Montzen, Belgium
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Olsene, Belgium
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Oostende, Belgium
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Saive, Belgium
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Schaerbeek, Belgium
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Sint-Pieters-Woluwe, Belgium
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Vielsalm, Belgium
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Willebroek, Belgium
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Zomergem, Belgium
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Aalborg, Denmark
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Arhus, Denmark
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Brorup, Denmark
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Copenhagen S, Denmark
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Frederikssund, Denmark
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Fredriksberg, Denmark
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Grenaa, Denmark
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Helsingor, Denmark
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Holbaek, Denmark
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Holstebro, Denmark
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Hvidovre, Denmark
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Ikast, Denmark
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Jaegerspris, Denmark
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Middelfart, Denmark
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Oksbol, Denmark
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Praesto, Denmark
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Roskilde, Denmark
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Sindal, Denmark
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Skive, Denmark
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Svinninge, Denmark
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Thisted, Denmark
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Hameenlinna, Finland
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Helsingin Kaupunki, Finland
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Kajaani, Finland
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Klaukkala, Finland
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Kuopio, Finland
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Lahti, Finland
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Lappeenranta, Finland
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Lohja, Finland
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Mikkeli, Finland
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Narpio, Finland
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Oulu, Finland
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Pietarsaari, Finland
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Pori, Finland
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Pyhajoki, Finland
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Sairaalamaki, Finland
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Seinajoki, Finland
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Tammisaari, Finland
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Tampere, Finland
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Turku, Finland
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Vaaksy, Finland
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Agde, France
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Aix en Provence, France
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Albi, France
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Amelie les Bains, France
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Angers, France
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Annecy, France
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Argentan, France
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Arles, France
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Armentiere, France
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Auchy les Mines, France
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Augny, France
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Aureilhan, France
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Avignon, France
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Babarthe Sur Leze, France
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Bandol, France
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Bar le Duc, France
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Bayonne, France
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Beauvais, France
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Belfort, France
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Bethune, France
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Beziers, France
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Bois Guillaume, France
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Bordeaux, France
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Bourg en Bresse, France
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Brest, France
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Caen, France
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Castelnau le Lez, France
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Castelnaudary, France
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Cerizay, France
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Chalon En Champagne, France
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Champs sur Marne, France
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Charleville Mezieres, France
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Chateauroux, France
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Clermont Ferrand, France
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Colmar, France
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Colomiers, France
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Corbeil Essones, France
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Creil, France
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Creteil, France
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Croix, France
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Cugnaux, France
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Cuise la Motte, France
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Denain, France
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Desseges, France
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Draguignan, France
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Echirolles, France
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Epernay, France
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Epinal, France
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Ferolles Attilly, France
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Foix, France
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Fontainebleau, France
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Forbach, France
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Giens, France
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Gonesse, France
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Grasse, France
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Graulhet, France
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Guingamp, France
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Harnes, France
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Hyeres, France
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Istres, France
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Juan les Pins, France
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La Baule, France
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La Destrousse, France
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La Grande Motte, France
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La Rochelle, France
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Laon, France
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Laval, France
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Le Brusc, France
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Le Chesnay, France
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Le Kremlin Bicetre, France
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Le Perreux sur Marne, France
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Lievin, France
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Lille, France
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Limoges, France
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Lomme, France
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Lourdes, France
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Luce, France
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Lyon, France
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Mamande, France
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Mandelieu la Napoule, France
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Marseille, France
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Maury, France
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Maxeville, France
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Mensignac, France
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Molsheim, France
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Mont de Marsan, France
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Montauban, France
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Montbeliard, France
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Montfermeil, France
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Montigny les Metz, France
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Morlaix, France
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Nantes, France
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Nevers, France
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Nice, France
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Nimes, France
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Niort, France
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Nogent sur Marne, France
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Obernai, France
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Olioules, France
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Orsay, France
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Paris, France
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Perpignan, France
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Pertuis, France
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Pierre Benite, France
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Plouzane, France
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Poitiers, France
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Pont Eveque, France
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Pontallier Sur Saone, France
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Ponteil Et Bresis, France
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Quimper, France
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Quincy Voisins, France
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Remiremont, France
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Renaze, France
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Rennes, France
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Roanne, France
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Rochefort Cedex, France
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Ronchin, France
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Rougegoutte, France
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Royan, France
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Rueil-Malmaison, France
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Saint Aubin Des Chateux, France
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Saint Feyre, France
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Saint-Aubin-les-Elbeuf, France
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Saint-Hilaire Agen, France
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Saintes, France
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Salome, France
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Saulnes, France
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Segre, France
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Selestat, France
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Soissons, France
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St Amand les Eaux, France
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St Cyr sur Loire, France
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St Die des Vosges, France
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St Etienne, France
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St Genis Laval, France
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St Jean d'Angely, France
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St Jean de Luz, France
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St Julien en Genevois, France
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St Mamert du Gard, France
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St Mandrier sur Mer, France
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St Michel, France
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St Priest, France
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St Priest en Jarez, France
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St Quentin, France
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St Romain La Motte, France
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St Rome de Cernon, France
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St Symphorien sur Coise, France
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Ste Severe Sur Indre, France
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Strasbourg, France
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Taden, France
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Tarbes, France
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Thionville, France
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Toul, France
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Toulon, France
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Toulouse, France
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Vabres Labaye, France
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Vannes, France
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Venerque, France
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Venissieux, France
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Verdun, France
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Villefranche, France
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Arnsberg, Germany
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Augsburg, Germany
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Bad Krozingen, Germany
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Bad Sooden-Allendorf, Germany
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Bad Vilbel, Germany
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Belm, Germany
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Bergisch Gladbach, Germany
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Berlin, Germany
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Bernau, Germany
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Bochum, Germany
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Bonn, Germany
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Borchen, Germany
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Borstel, Germany
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Brakel, Germany
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Burkhardtsdorf, Germany
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Castrop-Rauxel, Germany
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Delitzsch, Germany
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Dieburg, Germany
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Dreieich, Germany
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Dresden, Germany
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Eckental, Germany
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Elbingerode, Germany
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Eschwege, Germany
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Essen, Germany
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Frankenberg, Germany
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Frankfurt, Germany
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Franzburg, Germany
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Freiburg, Germany
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Freital, Germany
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Friedrichsthal, Germany
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Furstenfeldbruck, Germany
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Furth, Germany
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Gelnhausen, Germany
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Gelsenkirchen, Germany
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Gerolzhofen, Germany
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Haan, Germany
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Halle, Germany
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Haltern, Germany
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Hamburg, Germany
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Hannover, Germany
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Hemmingen, Germany
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Ingolstadt, Germany
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Kamen, Germany
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Kempten, Germany
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Kiel, Germany
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Koln, Germany
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Kothen, Germany
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Kronach, Germany
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Laichingen, Germany
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Leinach, Germany
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Leipzig, Germany
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Leopoldshohe, Germany
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Liebenau, Germany
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Ludenscheid, Germany
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Magdeburg, Germany
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Mammendorf, Germany
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Manching, Germany
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Marburg, Germany
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Marktheidenfeld, Germany
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Moers, Germany
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Muhlhausen, Germany
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Niesky, Germany
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Nurnberg, Germany
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Oranienburg, Germany
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Osnabruck, Germany
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Pfronten, Germany
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Pleystein, Germany
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Pocking, Germany
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Potsdam, Germany
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Puchheim, Germany
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Roth, Germany
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Ruhmannsfelden, Germany
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Saarbrucken, Germany
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Saerbeck, Germany
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Schwabach, Germany
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Schwedt, Germany
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Sebnitz, Germany
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Solingen, Germany
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Starzach, Germany
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Straubing, Germany
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Stuttgart, Germany
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Teterow, Germany
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Welver, Germany
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Westerland, Germany
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Wettin, Germany
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Wiesbaden, Germany
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Witten, Germany
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Zerbst, Germany
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Athens, Greece
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Chalkida, Greece
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Chania, Greece
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Drapetsona, Greece
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Florina, Greece
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Heraklio, Greece
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Ilioupoli, Greece
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Ithaki, Greece
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Kalamaria, Greece
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Kifissia, Greece
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Koropi, Greece
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Lamia, Greece
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Messini, Greece
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N.Santa, Greece
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Patra, Greece
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Platamonas, Greece
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Preveza, Greece
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Serres, Greece
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Thessaloniki, Greece
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Veroia, Greece
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Cavan, Ireland
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Dublin, Ireland
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Enniscorthy, Ireland
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Gorey, Ireland
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Letterkenny, Ireland
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Mullingar, Ireland
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Turloughmore, Ireland
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Waterford, Ireland
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Alife, Italy
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Avezzano, Italy
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Badolato, Italy
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Balsorano, Italy
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Carsoli, Italy
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Casa Giove, Italy
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Caserta, Italy
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Ceparana, Italy
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Copertino, Italy
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Cutrofiano, Italy
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Eboli, Italy
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Grosseto, Italy
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La Spezia, Italy
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Macerata Campania, Italy
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Montiano, Italy
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Napoli, Italy
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Orbetello, Italy
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Ortonovo, Italy
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Paganico, Italy
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Palermo, Italy
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Pellezzano, Italy
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Pontecagnano, Italy
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Rispescia, Italy
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S.Maria Di Cantanzzaro, Italy
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Salerno, Italy
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San Felice a Cancello, Italy
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San Nicola La Strada, Italy
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San Pietro in Lama, Italy
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Srubo, Italy
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Trasacco, Italy
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Veglie, Italy
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Almere, Netherlands
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Alphen Aan Den Rijn, Netherlands
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Amsterdam, Netherlands
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Andijk, Netherlands
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Arnhem, Netherlands
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Delfzijl, Netherlands
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Den Helder, Netherlands
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Drachten, Netherlands
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Enschede, Netherlands
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Gouda, Netherlands
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Groningen, Netherlands
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Heemstede, Netherlands
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Heerlen, Netherlands
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Hilversum, Netherlands
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Hoogwoud, Netherlands
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Landgraaf, Netherlands
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Leiden, Netherlands
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Meppel, Netherlands
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Onstwedde, Netherlands
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Oude Pekela, Netherlands
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Roermond, Netherlands
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Rotterdam, Netherlands
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S-Gravenhage, Netherlands
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S-Hertogenbosch, Netherlands
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Sint Philipsland, Netherlands
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Sneek, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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Zutphen, Netherlands
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Alesund, Norway
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Brevik, Norway
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Hakadal, Norway
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Molde, Norway
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Oslo, Norway
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Trondheim, Norway
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Coimbra, Portugal
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Lisboa, Portugal
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Melgaco, Portugal
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Odivelas, Portugal
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Santarém, Portugal
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Torres Vedras, Portugal
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A Coruna, Spain
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Alamagro, Spain
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Alcal De Henares, Spain
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Alcoy, Spain
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Alicante, Spain
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Andujar, Spain
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Arcos De La Fortera, Spain
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As Pontes De Garcia Rodriguez, Spain
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Avila, Spain
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Aviles, Spain
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Badalona, Spain
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Baracaldo, Spain
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Barcelona, Spain
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Bellaterra, Spain
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Bilbao, Spain
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Boqueixon (Pontella), Spain
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Brean Alta, Spain
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Burela, Spain
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Burgos, Spain
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Burguillos, Spain
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Carvaca De La Cruz, Spain
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Castellon de la Plana, Spain
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Cervera, Spain
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Cesuras, Spain
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Cuenca, Spain
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El Vendrell, Spain
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Ferrol, Spain
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Fuenlabrada, Spain
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Girona, Spain
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Granollers, Spain
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Guadalajara, Spain
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Huelva, Spain
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Jaen, Spain
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Joiosa, Spain
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La Almunia de Dona Godina, Spain
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Laredo, Spain
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Las Palmas De Gran Canaria, Spain
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Leganes, Spain
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Llobregat, Spain
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Logrono, Spain
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Lora Del Rio, Spain
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Lugo, Spain
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Madrid, Spain
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Manacor, Spain
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Melilla, Spain
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Mieres, Spain
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Montilla, Spain
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Murcia, Spain
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Outes, Spain
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Oviedo, Spain
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Palma De Mallorca, Spain
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Pamplona, Spain
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Ponferrada, Spain
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Porreres, Spain
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Portugalete, Spain
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Pozoblanco, Spain
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Quart de Poblet, Spain
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Quintanar Del Rey, Spain
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Ronda, Spain
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Sabadell, Spain
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Sagunto, Spain
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Salamanca, Spain
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Salt, Spain
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San Sebastian, Spain
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Sant Antoni de Portmany, Spain
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Sant Boi De Llobregat, Spain
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Sant Pere De Ribes, Spain
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Sant Vicent Del Raspeig, Spain
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Santa Coloma De Queralt, Spain
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Santiago De Compostella, Spain
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Santurtzi, Spain
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Teruel, Spain
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Toledo, Spain
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Torrebonica, Spain
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Torrelavega, Spain
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Valdepenas, Spain
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Valencia, Spain
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Valladolid, Spain
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Vigo, Spain
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Viladecans, Spain
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Xativa, Spain
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santa Coloma de Gramenet, Spain
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Angered, Sweden
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Atvidaberg, Sweden
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Bjarred, Sweden
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Borlange, Sweden
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Danderyd, Sweden
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Falun, Sweden
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Forserum, Sweden
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Fredriksberg, Sweden
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Gavle, Sweden
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Goteborg, Sweden
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Hollviken, Sweden
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Hunnebostrand, Sweden
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Kalarne, Sweden
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Kinna, Sweden
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Kungsbacka, Sweden
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Malmo, Sweden
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Norrkoping, Sweden
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Ostersund, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Uppsala, Sweden
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Varnamo, Sweden
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Bern, Switzerland
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Davos Wolfgang, Switzerland
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Herisau, Switzerland
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Lausanne, Switzerland
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Martigny, Switzerland
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Samedan, Switzerland
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Spiez, Switzerland
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Zurich, Switzerland
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Adana, Turkey
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Akyokus-Konya, Turkey
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Anamur/mersin, Turkey
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Ankara, Turkey
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Aydin, Turkey
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Denizli, Turkey
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Erzincan, Turkey
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Eskisehir, Turkey
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Hatay, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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K.Maras, Turkey
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Konya, Turkey
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Malatya, Turkey
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Mezitli-Mersin, Turkey
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Osmaniye, Turkey
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Sakarya, Turkey
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Sanliurfa, Turkey
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Yenisehir, Turkey
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Yozgat, Turkey
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Zonguldak, Turkey
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umraniye-Istanbul, Turkey
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Ashwell, United Kingdom
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Atherstone, United Kingdom
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Barry, United Kingdom
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Birmingham, United Kingdom
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Blackburn, United Kingdom
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Blackpool, United Kingdom
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Bradford-On-Avon, United Kingdom
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Cardiff, United Kingdom
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Chertsey, United Kingdom
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Chesterfield, United Kingdom
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Chippenham, 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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Doncaster, United Kingdom
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Fife, United Kingdom
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High Valleyfield, United Kingdom
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Maidenhead, United Kingdom
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Nottingham, United Kingdom
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Peterborough, United Kingdom
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Plymouth, United Kingdom
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Ruislip, United Kingdom
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Sandy, United Kingdom
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Southampton, United Kingdom
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Sunbury on Thames, United Kingdom
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Thornton Heath, United Kingdom
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Trowbridge, United Kingdom
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Warminster, United Kingdom
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Wells next the Sea, United Kingdom
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Westbury, 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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participating physicians (GPs and Respiratory physicians) will be asked to recruit 4 patients (on average).
The first patients presenting for a consultation for any reason, who meet eligibility criteria, and give informed consent, should be enrolled.
Description
Inclusion Criteria:
- Outpatients with a diagnosis of COPD
- FEV1<50% and FEV1/FVC<0.7 according to lung function data in medical records.
- Smoker or ex-smoker > 10 pack-years
- Informed consent obtained
Exclusion Criteria:
- Ongoing exacerbation of COPD or within the previous 3 months
- Any other significant respiratory disease (including asthma and allergic rhinitis)
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year
Time Frame: Once
|
Once
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality.
Time Frame: Once
|
Once
|
|
Describe how patient use their COPD treatment
Time Frame: Once
|
Once
|
|
Factors that may influence the patient's perception of symptom variability
Time Frame: Once
|
Once
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
July 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
July 23, 2008
First Submitted That Met QC Criteria
July 23, 2008
First Posted (Estimate)
July 25, 2008
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-REU-DUM-2007/1
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.
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