European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT ID: NCT02495974

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1763 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-08

Study Completion Date

2019-02-08

Brief Summary

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The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

Detailed Description

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Conditions

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Metastatic Castration Resistant Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with mCRPC prescribed enzalutamide

Oral

enzalutamide

Intervention Type DRUG

oral

Interventions

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enzalutamide

oral

Intervention Type DRUG

Other Intervention Names

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Xtandi

Eligibility Criteria

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Inclusion Criteria

* Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice
* Germany only: Enzalutamide will be prescribed according to the current SmPC (Summary of Product Characteristics)

Exclusion Criteria

* Patients with the following will be excluded from study participation in France only:

* Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy.
* Patients who have previously been treated with cabazitaxel (Jevtana®)
* Patients who have previously been treated with Xtandi®
* Patients taking part in an interventional clinical trial
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medivation, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Research Physician

Role: STUDY_DIRECTOR

Astellas Pharma Europe Ltd.

Locations

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Site AT43001

Bregenz, , Austria

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Site AT43005

Innsbruck, , Austria

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Site AT43006

Linz, , Austria

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Site AT43004

Vienna, , Austria

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Site BL32003

Bonheiden, Antwerpen, Belgium

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Site BL32004

Brasschaat, Antwerpen, Belgium

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Site BL32007

Haine-Saint-Paul, Hainaut, Belgium

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Site BL32008

Aalst, Oost-Vlaanderen, Belgium

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Site BL32009

Ghent, Oost-Vlaanderen, Belgium

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Site BL32010

Sint-Niklaas, Oost-Vlaanderen, Belgium

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Site BL32013

Leuven, Vlaams Brabant, Belgium

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Site BL32005

Kortrijk, West-Vlaanderen, Belgium

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Site BL32001

Brussels, , Belgium

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Site BL32011

Brussels, , Belgium

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Site BL32012

Hasselt, , Belgium

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Site BG35903

Plovdiv, , Bulgaria

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Site BG35901

Sofia, , Bulgaria

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Site CZ42004

Brno, , Czechia

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Site CZ42007

Jihlava, , Czechia

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Site CZ42003

Nový Jičín, , Czechia

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Site CZ42001

Prague, , Czechia

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Site CZ42006

Prague, , Czechia

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Site DK45003

Aalborg, , Denmark

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Site DK45004

Aarhus, , Denmark

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Site DK45002

Copenhagen, , Denmark

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Site DK45001

Herlev, , Denmark

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Site FR33015

Colmar, Alsace, France

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Site FR33003

Strasbourg, Alsace, France

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Site FR33017

Bordeaux, Aquitaine, France

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Site FR33051

Bordeaux, Aquitaine, France

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Site FR33018

Bordeaux, Aquitaine, France

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Site FR33009

Valence, Auvergne-Rhône-Alpes, France

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Site FR33022

Clermont-Ferrand, Auvergne, France

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Site FR33006

Aix-en-Provence, Bouches-du-Rhône, France

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Site FR33027

Marseille, Bouches-du-Rhône, France

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Site FR33041

Marseille, Bouches-du-Rhône, France

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Site FR33069

Saint-Martin-Boulogne, Boulogne-sur-Mer, France

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Site FR33043

Sens, Bourgogne-Franche-Comté, France

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Site FR33026

Brest, Brittany Region, France

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Site FR33004

Saint-Grégoire, Brittany Region, France

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Site FR33025

Vannes, Brittany Region, France

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Site FR33010

Reims, Champagne-Ardenne, France

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Site FR33067

Dijon, Côte-d'Or, France

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Site FR33062

Longjumeau, Essonne, France

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Site FR33033

Évreux, Eure, France

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Site FR33002

Quimper, Finistère, France

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Site FR33040

Toulouse, Haute-Garonne, France

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Site FR33049

Gap, Hautes-Alpes, France

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Site FR33039

Lille, Hauts-de-France, France

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Site FR33042

Suresnes, Hauts-de-Seine, France

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Site FR33020

Tours, Indre-et-Loire, France

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Site FR33060

Grenoble, Isère, France

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Site FR33050

Bézier, Languedoc-Roussillon, France

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Site FR33066

Orléans, Loiret, France

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Site FR33061

Vandœuvre-lès-Nancy, Lorraine, France

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Site FR33065

Agen, Lot-et-Garonne, France

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Site FR33019

Angers, Maine-et-Loire, France

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Site FR33007

Nancy, Meurthe-et-Moselle, France

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Site FR33059

Albi, Midi-Pyrénées, France

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Site FR33021

Coudekerque-Branche, Nord, France

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Site FR33063

Beauvais, Oise, France

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Site FR33016

Saint-Priest-en-Jarez, Pays de la Loire Region, France

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Site FR33070

Amiens, Picardie, France

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Site FR33044

Saint-Quentin, Picardie, France

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Site FR33028

Clermont-Ferrand, Puy-de-Dôme, France

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Site FR33035

Bayonne, Pyrénées-Atlantiques, France

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Site FR33012

Lyon, Rhône, France

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Site FR33030

Lyon, Rhône, France

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Site FR33058

Chalon-Sus-Saone, Saône-et-Loire, France

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Site FR33008

Amiens, Somme, France

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Site FR33032

Amiens, Somme, France

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Site FR33014

Créteil, Val-de-Marne, France

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Site FR33037

Saint-Mandé, Val-de-Marne, France

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Site FR33011

Toulon, Var, France

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Site FR33001

Avignon, Vaucluse, France

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Site FR33046

Arras, , France

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Site FR33054

Hyères, , France

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Site FR33038

La Chaussée-Saint-Victor, , France

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Site FR33057

Paris, , France

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Site FR33034

Paris, , France

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Site FR33029

Paris, , France

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Site FR33064

Paris, , France

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Site DE49001

Nürtingen, Baden-Wurttemberg, Germany

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Site DE49016

Wiesbaden, Hesse, Germany

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Site DE49003

Lüneburg, Lower Saxony, Germany

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Site DE49011

Soltau, Lower Saxony, Germany

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Site DE49013

Bonn, North Rhine-Westphalia, Germany

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Site DE49012

Chemnitz, Saxony, Germany

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Site DE49009

Bernburg, Saxony-Anhalt, Germany

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Site DE49015

Kiel, Schleswig-Holstein, Germany

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Site DE49005

Cologne, , Germany

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Site DE49006

Rostock, , Germany

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Site DE49014

Wuppertal, , Germany

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Site DE49010

Würselen, , Germany

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Site GC30001

Kifissia, Attica, Greece

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Site GC30013

Athens, , Greece

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Site GC30007

Athens, , Greece

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Site GC30005

Athens, , Greece

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Site GC30010

Athens, , Greece

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Site GC30003

Athens, , Greece

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Site GC30004

Ioannina, , Greece

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Site GC30006

Ioannina, , Greece

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Site GC30012

Larissa, , Greece

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Site GC30008

Thessaloniki, , Greece

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Site GC30002

Thessaloniki, , Greece

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Site GC30011

Thessaloniki, , Greece

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Site HU36006

Debrecen, Hajdú-Bihar, Hungary

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Site HU36002

Budapest, , Hungary

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Site HU36001

Budapest, , Hungary

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Site HU36005

Szeged, , Hungary

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Site HU36003

Szombathely, , Hungary

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Site IR35304

Dublin, , Ireland

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Site IR35302

Dublin, , Ireland

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Site IR35305

Dublin, , Ireland

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Site IR35306

Dublin, , Ireland

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Site IT39001

Meldola, Forlì, Italy

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Site IT39010

Lecco, Lombardy, Italy

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Site IT39009

Rozzano, Milano, Italy

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Site IT39002

Aviano, Pordenone, Italy

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Site IT39013

Candiolo, Torino, Italy

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Site IT39011

Mirano, Venezia, Italy

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Site IT39005

Bari, , Italy

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Site IT39012

Catania, , Italy

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Site IT39006

Florence, , Italy

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Site IT39004

Milan, , Italy

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Site IT39017

Milan, , Italy

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Site IT39003

Modena, , Italy

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Site IT39007

Napoli, , Italy

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Site IT39018

Novara, , Italy

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Site IT39008

Padua, , Italy

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Site IT39015

Palermo, , Italy

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Site IT39014

Pisa, , Italy

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Site IT39016

Reggio Emilia, , Italy

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Site NL31006

Arnhem, , Netherlands

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Site NL31007

Breda, , Netherlands

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Site NL31005

Doetinchem, , Netherlands

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Site NL31008

Helmond, , Netherlands

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Site NL31001

Hilversum, , Netherlands

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Site NL31004

Hoofddorp, , Netherlands

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Site NL31010

Nieuwegein, , Netherlands

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Site NL31003

The Hague, , Netherlands

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Site NL31011

Zwolle, , Netherlands

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Site PT35101

Porto, , Portugal

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Site SV38501

Ljubljana, , Slovenia

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Site ES34007

Zaragoza, Aragon, Spain

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Site ES34012

Zaragoza, Aragon, Spain

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Site ES34008

Guadalajara, Castille-La Mancha, Spain

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Site ES34009

Toledo, Castille-La Mancha, Spain

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Site ES34013

Barcelona, Catalonia, Spain

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Site ES34011

Lleida, Catalonia, Spain

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Site ES34010

Reus, Catalonia, Spain

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Site ES34004

Badajoz, Extremadura, Spain

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Site ES34006

Cáceres, Extremadura, Spain

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Site ES34005

A Coruña, Galicia, Spain

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Site ES34016

Lugo, Galicia, Spain

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Site ES34003

Ourense, Galicia, Spain

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Site ES34001

Santiago de Compostela, Galicia, Spain

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Site ES34017

Vigo, Galicia, Spain

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Site GB44001

Aberdeen, Aberdeenshire, United Kingdom

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Site GB44012

Torquay, Devon, United Kingdom

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Site GB44025

Poole, Dorset, United Kingdom

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Site GB44026

Blackburn, Lancashire, United Kingdom

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Site GB44011

Preston, Lancashire, United Kingdom

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Site GB44004

Boston, Lincolnshire, United Kingdom

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Site GB44002

Lincoln, Lincolnshire, United Kingdom

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Site GB44008

Berkshire, Slough, United Kingdom

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Site GB44013

Weston-super-Mare, Somerset, United Kingdom

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Site GB44007

Treliske, Truro, United Kingdom

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Site GB44009

Swindon, Wiltshire, United Kingdom

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Site GB44005

Worcester, Worcestershire, United Kingdom

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Site GB44023

Birmingham, , United Kingdom

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Site GB44010

Brighton, , United Kingdom

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Site GB44016

Derby, , United Kingdom

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Site GB44020

Guildford, , United Kingdom

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Site GB44022

Inverness-shire, , United Kingdom

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Site GB44024

Leicester, , United Kingdom

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Site GB44003

London, , United Kingdom

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Site GB44017

Newcastle upon Tyne, , United Kingdom

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Site GB44015

Norfolk, , United Kingdom

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Site GB44006

Reading, , United Kingdom

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Site GB44014

Taunton, , United Kingdom

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Site GB44018

Wolverhampton, , United Kingdom

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Countries

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Austria Belgium Bulgaria Czechia Denmark France Germany Greece Hungary Ireland Italy Netherlands Portugal Slovenia Spain United Kingdom

Other Identifiers

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9785-MA-1002

Identifier Type: -

Identifier Source: org_study_id

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