Local Phase 4 Pan-European SMART Study

NCT ID: NCT00463866

Last Updated: 2010-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Budesonide/formoterol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Michel Aubier, Prof

Role: PRINCIPAL_INVESTIGATOR

FRANCE

Juliette Ostinelli, MD

Role: STUDY_CHAIR

AstraZeneca, MC France

Locations

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Aalst, , Belgium

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Aarschot, , Belgium

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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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Bruges, , Belgium

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Brussels, , 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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Châtelet, , Belgium

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Chênée, , 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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Ghent, , Belgium

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Gilly, , Belgium

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Graty, , Belgium

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Grivegnée, , 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 Louvière, , 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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Lier, , Belgium

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Liège, , 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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Montegnée, , 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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Oostkamp, , Belgium

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Oppuurs, , Belgium

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Ostend, , 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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Saint Katharina Lombeek, , Belgium

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Sankt Vith, , 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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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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Harjavalta, , Finland

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Hämeenlinna, , Finland

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Helsinki, , Finland

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Hyvinkää, , Finland

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Jakobstad, , 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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Pyhäjoki, , 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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Alès, , 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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Angoulême, , France

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Annecy, , France

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Annonay, , France

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Antibes, , France

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Arpajon, , France

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Asnières-sur-Seine, , France

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Aubagne, , 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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Besançon, , France

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Béthune, , France

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Béziers, , 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, , France

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Brive-la-Gaillarde, , France

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Cachan, , France

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Caen, , 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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Charleville-Mézières, , France

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Chauny, , France

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Chaville, , France

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Châlons-en-Champagne, , France

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Châteauroux, , 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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Colmar, , France

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Colma, , France

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Colomiers, , France

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Corbeil-Essonnes, , France

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Créteil, , France

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Denain, , France

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Eaubonne, , France

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Échirolles, , France

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Écully, , France

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Épernay, , France

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Étampes, , France

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Férolles-Attilly, , France

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Forbach, , France

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Gentilly, , France

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Gleizé, , 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-sur-Seine, , France

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Hyères, , France

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Joué-lès-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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Lorient, , France

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Lunel, , France

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Lunéville, , 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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Montbéliard, , France

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Montereau-Fault-Yonne, , France

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Montferrier-sur-Lez, , France

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Montigny-lès-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, , France

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Nice, , France

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Niort, , France

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Nîmes, , France

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Obernai, , France

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Ollioules, , France

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Oloron-Sainte-Marie, , France

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Orange, , France

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Orléans, , France

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Oyonnax, , France

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Paris, , France

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Pau, , France

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Perpignan, , France

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Pertuis, , France

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Périgueux, , France

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Pézenas, , 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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Rezé, , France

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Roanne, , France

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Rochefort, , France

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Romans-sur-Isère, , 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 Andre Les Verges, , France

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Saint Orenes de Gameville, , France

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Saint-Amand-les-Eaux, , France

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Saint-Brieuc, , France

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Saint-Denis, , France

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Saint-Dizier, , France

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Saint-Estève, , France

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Saint-Etienne, , France

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Saint-Girons, , France

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Saint-Herblain, , France

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Saint-Jean-de-Luz, , France

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Saint-Jean-de-Maurienne, , France

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Saint-Laurent-du-Var, , France

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Saint-Quentin, , France

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Saint-Raphaël, , 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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Sélestat, , France

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Six-Fours-les-Plages, , France

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St-Malo, , France

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St.-Jean, , 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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Cologne, , 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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Düsseldorf, , 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 am Neckar, , 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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Fürstenfeldbruck, , Germany

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Fürstenwalde, , Germany

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Fürth, , 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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Gütersloh, , Germany

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Hagen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , 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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Katzhütte, , 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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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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Lübeck, , Germany

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Lüdenscheid, , Germany

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Lütjenburg, , 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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Mühlhausen, , Germany

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Mülheim, , Germany

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Mülsen, , Germany

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München, , Germany

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Neukirchen-Vluyn, , Germany

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References

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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.

Reference Type DERIVED
PMID: 21586508 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21435854 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20595145 (View on PubMed)

Other Identifiers

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EUROSMART

Identifier Type: -

Identifier Source: secondary_id

EudraCTNo. 2006-006512-30

Identifier Type: -

Identifier Source: secondary_id

D5890L00022

Identifier Type: -

Identifier Source: org_study_id

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