Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

NCT ID: NCT00857012

Last Updated: 2012-11-12

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

2313 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-02-29

Brief Summary

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Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.

Detailed Description

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The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.

Conditions

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Breast Cancer

Keywords

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Primary early MCa Arimidex

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

treated with Anastrozole as per SPC

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses \>1 year ago or Serum FSH (\> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
* Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
* Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
* In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Exclusion Criteria

* Patients with severe renal function disorders (Creatinine clearance \< 20 ml/min or Patients with moderate or severe disorders of hepatic function
* Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
* Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
* Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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H Brasch

Role: STUDY_DIRECTOR

AstraZeneca, Germany

Locations

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Aachen, Germany, Germany

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Aalen, Germany, Germany

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Ahaus, Germany, Germany

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Albstadt, Germany, Germany

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Altötting, Germany, Germany

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Alzey, Germany, Germany

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Amberg, Germany, Germany

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Apolda, Germany, Germany

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Aschaffenburg, Germany, Germany

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Aschersleben, Germany, Germany

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Augsburg, Germany, Germany

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Aurich, Germany, Germany

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Babenhausen, Germany, Germany

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Bad Dürkheim, Germany, Germany

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Bad Herrenalb, Germany, Germany

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Bad Nauheim, Germany, Germany

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Bad Neuenahr-Ahrweiler, Germany, Germany

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Bad Oeynhausen, Germany, Germany

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Bad Oldesloe, Germany, Germany

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Bad Reichenhall, Germany, Germany

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Bad Saarow, Germany, Germany

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Bad Segeberg, Germany, Germany

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Bad Tölz, Germany, Germany

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Bad Urach, Germany, Germany

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Bad Wildbad, Germany, Germany

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Bad Wildungen, Germany, Germany

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Bad Windsheim, Germany, Germany

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Baden-Baden, Germany, Germany

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Bamberg, Germany, Germany

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Bautzen, Germany, Germany

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Bayreuth, Germany, Germany

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Berlin, Germany, Germany

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Bexbach, Germany, Germany

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Biberach, Germany, Germany

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Biedenkopf, Germany, Germany

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Bielefeld, Germany, Germany

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Bietigheim-Bissingen, Germany, Germany

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Blankenburg, Germany, Germany

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Blumberg in Baden, Germany, Germany

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Bocholt, Germany, Germany

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Bochum, Germany, Germany

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Bonn, Germany, Germany

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Borna, Germany, Germany

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Bottrop, Germany, Germany

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Böblingen, Germany, Germany

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Brackenheim, Germany, Germany

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Bramsche, Germany, Germany

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Brandenburg, Germany, Germany

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Braunschweig, Germany, Germany

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Bretten, Germany, Germany

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Bruchsal, Germany, Germany

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Brühl, Germany, Germany

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Burg, Germany, Germany

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Burghausen, Germany, Germany

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Bühl, Germany, Germany

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Bünde, Germany, Germany

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Celle, Germany, Germany

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Chemnitz, Germany, Germany

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Cloppenburg, Germany, Germany

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Coburg, Germany, Germany

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Coesfeld, Germany, Germany

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Cologne, Germany, Germany

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Dachau, Germany, Germany

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Damme, Germany, Germany

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Datteln, Germany, Germany

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Demmin, Germany, Germany

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Dessau, Germany, Germany

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Dießen, Germany, Germany

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Dillenburg, Germany, Germany

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Dillingen, Germany, Germany

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Dinkelsbühl, Germany, Germany

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Ditzingen, Germany, Germany

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Doberlug-Kirchhain, Germany, Germany

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Dornstadt, Germany, Germany

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Dorsten, Germany, Germany

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Dortmund, Germany, Germany

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Dreieich, Germany, Germany

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Dresden, Germany, Germany

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Duisburg, Germany, Germany

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Düren, Germany, Germany

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Düsseldorf, Germany, Germany

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Ebermannstadt, Germany, Germany

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Ebersbach, Germany, Germany

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Eggenfelden, Germany, Germany

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Eisenach, Germany, Germany

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Ellwangen, Germany, Germany

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Elmshorn, Germany, Germany

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Emmendingen, Germany, Germany

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Erding, Germany, Germany

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Erfurt, Germany, Germany

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Ergolding, Germany, Germany

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Erkelenz, Germany, Germany

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Eschweiler, Germany, Germany

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Esens, Germany, Germany

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Essen, Germany, Germany

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Ettlingen, Germany, Germany

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Euskirchen, Germany, Germany

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Eutin, Germany, Germany

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Feuchtwangen, Germany, Germany

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Flensburg, Germany, Germany

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Frankenberg, Germany, Germany

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Frankenthal, Germany, Germany

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Frankfurt (Oder), Germany, Germany

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Frechen, Germany, Germany

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Freiburg im Breisgau, Germany, Germany

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Freising, Germany, Germany

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Freital, Germany, Germany

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Freyung, Germany, Germany

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Friedrichshafen, Germany, Germany

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Fulda, Germany, Germany

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Fürstenfeldbruck, Germany, Germany

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Fürstenwalde, Germany, Germany

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Fürth, Germany, Germany

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Garbsen, Germany, Germany

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Geesthacht, Germany, Germany

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Geilenkirchen, Germany, Germany

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Gelsenkirchen, Germany, Germany

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Georgsmarienhütte, Germany, Germany

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Gera, Germany, Germany

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Geretsried, Germany, Germany

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Gerlingen, Germany, Germany

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Gersthofen, Germany, Germany

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Giesen, Germany, Germany

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Gifhorn, Germany, Germany

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Gladbeck, Germany, Germany

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Goslar, Germany, Germany

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Göppingen, Germany, Germany

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Göttingen, Germany, Germany

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Gräfelfing, Germany, Germany

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Griesheim, Germany, Germany

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Gummersbach, Germany, Germany

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Günzburg, Germany, Germany

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Güstrow, Germany, Germany

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Haiger, Germany, Germany

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Halberstadt, Germany, Germany

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Halle, Germany, Germany

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Hamburg, Germany, Germany

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Hamelin, Germany, Germany

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Hamm, Germany, Germany

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Hanover, Germany, Germany

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Hartha, Germany, Germany

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Heide, Germany, Germany

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Heidelberg, Germany, Germany

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Heidenheim, Germany, Germany

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Heilbronn, Germany, Germany

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Heinsberg, Germany, Germany

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Hemmingen, Germany, Germany

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Henstedt-Ulzburg, Germany, Germany

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Heppenheim an der Bergstrasse, Germany, Germany

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Herborn, Germany, Germany

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Herbrechtingen, Germany, Germany

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Herdecke, Germany, Germany

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Herford, Germany, Germany

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Hermsdorf, Germany, Germany

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Herne, Germany, Germany

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Herzberg, Germany, Germany

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Herzberg am Harz, Germany, Germany

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Hessisch Oldendorf, Germany, Germany

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Hilchenbach, Germany, Germany

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Hildesheim, Germany, Germany

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Hillesheim, Germany, Germany

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Hochstadt, Germany, Germany

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Hof, Germany, Germany

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Hofheim, Germany, Germany

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Holzminden, Germany, Germany

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Homburg/Saar, Germany, Germany

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Hückelhoven, Germany, Germany

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Ilsede, Germany, Germany

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Ingolstadt, Germany, Germany

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Isny, Germany, Germany

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Itzehoe, Germany, Germany

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Jena, Germany, Germany

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Kahla, Germany, Germany

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Kalkar, Germany, Germany

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Karlsbad, Germany, Germany

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Karlsruhe, Germany, Germany

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Kassel, Germany, Germany

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Kaufbeuren, Germany, Germany

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Kempten, Germany, Germany

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Kerpen, Germany, Germany

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Kiel, Germany, Germany

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Koblenz, Germany, Germany

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Konstanz, Germany, Germany

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Korntal, Germany, Germany

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Königs Wusterhausen, Germany, Germany

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Krefeld, Germany, Germany

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Kreuzberg, Germany, Germany

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Kreuztal, Germany, Germany

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Krumbach, Germany, Germany

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Kusel, Germany, Germany

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Künzelsau, Germany, Germany

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Laatzen, Germany, Germany

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Lahnstein, Germany, Germany

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Landau, Germany, Germany

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Landshut, Germany, Germany

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Langen, Germany, Germany

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Langenhagen, Germany, Germany

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Lauf, Germany, Germany

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Lehrte, Germany, Germany

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Leichlingen, Germany, Germany

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Leipzig, Germany, Germany

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Leisnig, Germany, Germany

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Leonberg, Germany, Germany

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Leverkusen, Germany, Germany

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Lich, Germany, Germany

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Limburg, Germany, Germany

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Lingen, Germany, Germany

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Lohsa OT Weisskollm, Germany, Germany

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Löbau, Germany, Germany

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Ludwigsfelde, Germany, Germany

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Ludwigshafen, Germany, Germany

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Lübeck, Germany, Germany

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Lüneburg, Germany, Germany

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Lünen, Germany, Germany

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Magdeburg, Germany, Germany

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Mannheim, Germany, Germany

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Marburg, Germany, Germany

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Marienheide, Germany, Germany

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Markranstädt, Germany, Germany

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Marktredwitz, Germany, Germany

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Marl, Germany, Germany

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Mayen, Germany, Germany

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Meiningen, Germany, Germany

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Meissen, Germany, Germany

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Memmingen, Germany, Germany

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Mendig, Germany, Germany

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Mettingen, Germany, Germany

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Metzingen, Germany, Germany

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Minden, Germany, Germany

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Mittweida, Germany, Germany

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Moers, Germany, Germany

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Mönchengladbach, Germany, Germany

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Mulheim A. D. Ruhr, Germany, Germany

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Mutlangen, Germany, Germany

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Mühldorf, Germany, Germany

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Mühlhausen, Germany, Germany

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Mühlheim, Germany, Germany

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München, Germany, Germany

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Münster, Germany, Germany

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Nauen, Germany, Germany

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Naunhof, Germany, Germany

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Neckarsulm, Germany, Germany

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Netphen, Germany, Germany

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Neubrandenburg, Germany, Germany

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Neuhaus am Rennweg, Germany, Germany

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Neumarkt, Germany, Germany

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Neumünster, Germany, Germany

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Neuruppin, Germany, Germany

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Neustadt, Germany, Germany

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Neustadt an der Weinstraße, Germany, Germany

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Nienburg, Germany, Germany

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Nordhausen, Germany, Germany

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Nordhorn, Germany, Germany

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Nuremberg, Germany, Germany

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Nümbrecht, Germany, Germany

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Nürtingen, Germany, Germany

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Oberhausen, Germany, Germany

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Oberstdorf, Germany, Germany

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Ochsenfurt, Germany, Germany

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Offenbach, Germany, Germany

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Offenburg, Germany, Germany

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Oranienburg, Germany, Germany

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Osnabrück, Germany, Germany

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Paderborn, Germany, Germany

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Parchim, Germany, Germany

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Passau, Germany, Germany

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Peine, Germany, Germany

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Penzberg, Germany, Germany

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Pfinztal, Germany, Germany

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Pforzheim, Germany, Germany

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Pfullingen, Germany, Germany

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Pinneberg, Germany, Germany

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Pirmasens, Germany, Germany

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Plauen-Kauschwitz, Germany, Germany

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Pocking, Germany, Germany

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Potsdam, Germany, Germany

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Quickborn, Germany, Germany

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Rahden, Germany, Germany

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Rangsdorf, Germany, Germany

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Ravensburg, Germany, Germany

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Recklinghausen, Germany, Germany

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Regensburg, Germany, Germany

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Reinbek, Germany, Germany

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Remchingen, Germany, Germany

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Remscheid, Germany, Germany

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Rendsburg, Germany, Germany

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Reutlingen, Germany, Germany

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Rheine, Germany, Germany

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Rheinfelden, Germany, Germany

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Riebnitz-Damgarten, Germany, Germany

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Riesa, Germany, Germany

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Rodewisch, Germany, Germany

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Rodgau, Germany, Germany

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Rosenheim, Germany, Germany

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Rotenburg (Wümme), Germany, Germany

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Rottenburg, Germany, Germany

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Rottweil, Germany, Germany

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Rösrath, Germany, Germany

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Saarbrücken, Germany, Germany

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Saarlouis, Germany, Germany

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Saint Wendel, Germany, Germany

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Salzgitter, Germany, Germany

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Salzwedel, Germany, Germany

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Sandhausen, Germany, Germany

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Sayda, Germany, Germany

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Schalksmühle, Germany, Germany

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Scheibenberg, Germany, Germany

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Schkeuditz, Germany, Germany

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Schleswig, Germany, Germany

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Schorndorf, Germany, Germany

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Schönaich, Germany, Germany

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Schönebeck, Germany, Germany

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Schwabach, Germany, Germany

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Schwandorf in Bayern, Germany, Germany

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Schwäbisch Hall, Germany, Germany

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Schweinfurt, Germany, Germany

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Schwerin, Germany, Germany

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Schwerte, Germany, Germany

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Schwetzingen, Germany, Germany

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Sebnitz, Germany, Germany

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Senden, Germany, Germany

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Siegen, Germany, Germany

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Simmern, Germany, Germany

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Singen (Hohentwiel), Germany, Germany

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Solingen, Germany, Germany

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Sögel, Germany, Germany

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Sömmerda, Germany, Germany

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Spremberg, Germany, Germany

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Sprockhövel, Germany, Germany

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Starnberg, Germany, Germany

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Steglitz, Germany, Germany

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Stendal, Germany, Germany

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Stockelsdorf, Germany, Germany

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Stralsund, Germany, Germany

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Stuhr, Germany, Germany

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Stuttgart, Germany, Germany

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Sulzbach-Rosenberg, Germany, Germany

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Teltow, Germany, Germany

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Tettnang, Germany, Germany

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Torgau, Germany, Germany

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Tornesch, Germany, Germany

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Tübingen, Germany, Germany

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Uelzen, Germany, Germany

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Uetze, Germany, Germany

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Ulm, Germany, Germany

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Vechta, Germany, Germany

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Vechta-Langforden, Germany, Germany

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Veitshöchheim, Germany, Germany

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Viersen, Germany, Germany

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Villingen-Schwenningen, Germany, Germany

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Vilsbiburg, Germany, Germany

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Vlotho, Germany, Germany

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Vöhringen, Germany, Germany

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Völklingen, Germany, Germany

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Waldmünchen, Germany, Germany

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Walsrode, Germany, Germany

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Wangen, Germany, Germany

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Warburg, Germany, Germany

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Warendorf, Germany, Germany

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Warin, Germany, Germany

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Wasserburg, Germany, Germany

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Weiden in Der Oberpfalz, Germany, Germany

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Weingarten, Germany, Germany

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Wermelskirchen, Germany, Germany

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Werneck, Germany, Germany

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Wertheim am Main, Germany, Germany

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Wetzlar, Germany, Germany

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Wiesbaden, Germany, Germany

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Wilster, Germany, Germany

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Wismar, Germany, Germany

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Witten, Germany, Germany

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Witterda, Germany, Germany

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Wolfen, Germany, Germany

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Wolfsburg, Germany, Germany

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Worms, Germany, Germany

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Wuppertal, Germany, Germany

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Würselen, Germany, Germany

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Würzburg, Germany, Germany

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Zittau, Germany, Germany

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Zossen, Germany, Germany

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Zwickau, Germany, Germany

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Zwiesel, Germany, Germany

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Zwönitz, Germany, Germany

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Countries

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Germany

References

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Hadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, Konig K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.

Reference Type DERIVED
PMID: 24355487 (View on PubMed)

Other Identifiers

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NIS-ODE-ARI-2008/1

Identifier Type: -

Identifier Source: org_study_id