Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
COMPACT
1 other identifier
observational
2,313
1 country
383
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Typical duration for all trials
383 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 12, 2012
November 1, 2012
March 5, 2009
November 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.
12 months
Secondary Outcomes (5)
Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.
12 months
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.
12 months
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.
12 months
Identification of factors influencing and correlating to treatment-emergent arthralgias
12 months
Assessment of safety and tolerability of anastrozole.
12 months
Study Arms (1)
All patients
treated with Anastrozole as per SPC
Eligibility Criteria
The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (383)
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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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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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Gladbeck, Germany, Germany
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Goslar, 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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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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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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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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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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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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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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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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Wolfen, 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
Related Publications (1)
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.
PMID: 24355487DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
H Brasch
AstraZeneca, Germany
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
April 1, 2009
Study Completion
February 1, 2012
Last Updated
November 12, 2012
Record last verified: 2012-11