RecruitingNCT06830720

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life

Sponsor

Novartis Pharmaceuticals

Enrollment

3,250 participants

Start Date

Feb 20, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms

Summary

This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on patients with hormone receptor-positive (HR+), HER2-negative early breast cancer who are receiving ribociclib (Kisqali) combined with hormone therapy after surgery. The goal is to understand how this treatment works in everyday clinical practice outside of a controlled trial setting. **You may be eligible if...** - You have been diagnosed with HR+/HER2-negative early breast cancer with a high risk of it coming back - Your doctor has already decided to treat you with ribociclib plus hormone therapy (aromatase inhibitor), or hormone therapy alone, as part of standard care - You are receiving treatment in the adjuvant (after surgery) setting **You may NOT be eligible if...** - Your doctor has not already made a treatment decision before you were approached for this study - You do not meet the criteria described in the approved prescribing information for ribociclib or abemaciclib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGribociclib + AI ± LHRH

ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

DRUGabemaciclib + ET ± LHRH

abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

DRUGET mono ± LHRH

endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Locations(274)

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Novartis Investigative Site

Linz, Upper Austria, Austria

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Klagenfurt, Austria

Novartis Investigative Site

Leoben, Austria

Novartis Investigative Site

Schwaz, Austria

Novartis Investigative Site

Steyr, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Baden-Baden, Baden-Wurttemberg, Germany

Novartis Investigative Site

Filderstadt, Baden-Wurttemberg, Germany

Novartis Investigative Site

Freudenstadt, Baden-Wurttemberg, Germany

Novartis Investigative Site

Heidelberg, Baden-Wurttemberg, Germany

Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Konstanz, Baden-Wurttemberg, Germany

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Nürtingen, Baden-Wurttemberg, Germany

Novartis Investigative Site

Ostfildern, Baden-Wurttemberg, Germany

Novartis Investigative Site

Pforzheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Ravensburg, Baden-Wurttemberg, Germany

Novartis Investigative Site

Reutlingen, Baden-Wurttemberg, Germany

Novartis Investigative Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

Novartis Investigative Site

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Novartis Investigative Site

Winnenden, Baden-Wurttemberg, Germany

Novartis Investigative Site

Altötting, Bavaria, Germany

Novartis Investigative Site

Ansbach, Bavaria, Germany

Novartis Investigative Site

Augsburg, Bavaria, Germany

Novartis Investigative Site

Bamberg, Bavaria, Germany

Novartis Investigative Site

Bayreuth, Bavaria, Germany

Novartis Investigative Site

Dillingen an der Donau, Bavaria, Germany

Novartis Investigative Site

Donauwörth, Bavaria, Germany

Novartis Investigative Site

Ebersberg, Bavaria, Germany

Novartis Investigative Site

Erlangen, Bavaria, Germany

Novartis Investigative Site

Fürth, Bavaria, Germany

Novartis Investigative Site

Herrsching am Ammersee, Bavaria, Germany

Novartis Investigative Site

Kempten (Allgäu), Bavaria, Germany

Novartis Investigative Site

Kronach, Bavaria, Germany

Novartis Investigative Site

Landsberg am Lech, Bavaria, Germany

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Munich, Bavaria, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Neumarkt in der Oberpfalz, Bavaria, Germany

Novartis Investigative Site

Prien am Chiemsee, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Rosenheim, Bavaria, Germany

Novartis Investigative Site

Traunstein, Bavaria, Germany

Novartis Investigative Site

Ulm, Bavaria, Germany

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Waldmuenchen, Bavaria, Germany

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Weiden in Der Oberpfalz, Bavaria, Germany

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Weilheim, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Brandenburg an der Havel, Brandenburg, Germany

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Cottbus, Brandenburg, Germany

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Königs Wusterhausen, Brandenburg, Germany

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Hamburg, Free and Hanseatic City of Hamburg, Germany

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Hamburg, Free and Hanseatic City of Hamburg, Germany

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Bremen, Free Hanseatic City of Bremen, Germany

Novartis Investigative Site

Bremen, Free Hanseatic City of Bremen, Germany

Novartis Investigative Site

Bremerhaven, Free Hanseatic City of Bremen, Germany

Novartis Investigative Site

Bad Homburg, Hesse, Germany

Novartis Investigative Site

Bad Nauheim, Hesse, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Langen, Hesse, Germany

Novartis Investigative Site

Marburg, Hesse, Germany

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Marburg, Hesse, Germany

Novartis Investigative Site

Wiesbaden, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Braunschweig, Lower Saxony, Germany

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Georgsmarienhütte, Lower Saxony, Germany

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Göttingen, Lower Saxony, Germany

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Hildesheim, Lower Saxony, Germany

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Ilsede, Lower Saxony, Germany

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Lingen Ems, Lower Saxony, Germany

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Osnabrück, Lower Saxony, Germany

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Rotenburg (Wümme), Lower Saxony, Germany

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Twistringen, Lower Saxony, Germany

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Westerstede, Lower Saxony, Germany

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Winsen, Lower Saxony, Germany

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Wolfenbüttel, Lower Saxony, Germany

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Wunstorf, Lower Saxony, Germany

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Rostock, Mecklenburg-Vorpommern, Germany

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Bergisch Gladbach, North Rhine-Westphalia, Germany

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Bielefeld, North Rhine-Westphalia, Germany

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Bielefeld, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Mönchengladbach, North Rhine-Westphalia, Germany

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Olpe, North Rhine-Westphalia, Germany

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Paderborn, North Rhine-Westphalia, Germany

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Remscheid, North Rhine-Westphalia, Germany

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Remscheid, North Rhine-Westphalia, Germany

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Schwerte, North Rhine-Westphalia, Germany

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Siegen, North Rhine-Westphalia, Germany

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Troisdorf, North Rhine-Westphalia, Germany

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Velbert, North Rhine-Westphalia, Germany

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Mayen, Rhineland-Palatinate, Germany

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Speyer, Rhineland-Palatinate, Germany

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Lebach, Saarland, Germany

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Borna, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Neustadt in Sachsen, Saxony, Germany

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Plauen, Saxony, Germany

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Radebeul, Saxony, Germany

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Rodewisch, Saxony, Germany

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Scheibenberg, Saxony, Germany

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Schkeuditz, Saxony, Germany

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Zittau, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Halle, Saxony-Anhalt, Germany

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Hansestadt Salzwedel, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Stendal, Saxony-Anhalt, Germany

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Flensburg, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Rendsburg, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Jena, Thuringia, Germany

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Mühlhausen, Thuringia, Germany

Novartis Investigative Site

Nordhausen, Thuringia, Germany

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Saalfeld, Thuringia, Germany

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Aachen, Germany

Novartis Investigative Site

Amberg, Germany

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Apolda, Germany

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Arnsberg, Germany

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Augsburg, Germany

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Bad Friedrichshall, Germany

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Bad Kreuznach, Germany

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Bad Langensalza, Germany

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Bad Mergentheim, Germany

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Bad Reichenhall, Germany

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Bad Saarow, Germany

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Bad Soden, Germany

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Balingen, Germany

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Bautzen, Germany

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Bayreuth, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Biberach, Germany

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Bochum, Germany

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Bonn, Germany

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Bonn, Germany

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Bottrop, Germany

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Böblingen, Germany

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Brandenburg, Germany

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Bremen, Germany

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Bremerhaven, Germany

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Bruchsal, Germany

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Celle, Germany

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Chemnitz, Germany

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Chemnitz, Germany

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Coburg, Germany

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Cologne, Germany

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Dachau, Germany

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Dessau, Germany

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Dorfen, Germany

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Dresden, Germany

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Dresden, Germany

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Duisburg, Germany

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Düsseldorf, Germany

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Eggenfelden, Germany

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Ehingen, Germany

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Ehrenfriedersdorf, Germany

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Eisenach, Germany

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Erding, Germany

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Erfurt, Germany

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Erfurt, Germany

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Eschweiler, Germany

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Essen, Germany

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Essen, Germany

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Esslingen am Neckar, Germany

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Eutin, Germany

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Freiburg im Breisgau, Germany

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Friedrichshafen, Germany

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Friedrichshafen, Germany

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Fürstenwalde, Germany

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Gera, Germany

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Gerlingen, Germany

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Goslar, Germany

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Göttingen, Germany

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Greifswald, Germany

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Gummersbach, Germany

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Günzburg, Germany

Novartis Investigative Site

Hagen, Germany

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Haldensleben I, Germany

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Hamburg, Germany

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Hamburg, Germany

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Hamburg, Germany

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Hanover, Germany

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Hanover, Germany

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Hanover, Germany

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Heide, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Hennigsdorf, Germany

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Herdecke, Germany

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Homburg, Germany

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Itzehoe, Germany

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Jena, Germany

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Kaiserslautern, Germany

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Karlsruhe, Germany

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Karlsruhe, Germany

Novartis Investigative Site

Kiel, Germany

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Krefeld, Germany

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Kulmbach, Germany

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Leipzig, Germany

Novartis Investigative Site

Loerrach, Germany

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Lübeck, Germany

Novartis Investigative Site

Mainz, Germany

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Marktredwitz, Germany

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Memmingen, Germany

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Moers, Germany

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Mutlangen, Germany

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Münster, Germany

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Münster, Germany

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Naunhof, Germany

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Neubrandenburg, Germany

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Neumünster, Germany

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Neuss, Germany

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Nuremberg, Germany

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Nuremberg, Germany

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Offenburg, Germany

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Oldenburg, Germany

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Passau, Germany

Novartis Investigative Site

Potsdam, Germany

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Regensburg, Germany

Novartis Investigative Site

Rheine, Germany

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Rüsselsheim am Main, Germany

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Saarlouis, Germany

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Schorndorf, Germany

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Schweinfurt, Germany

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Siegen, Germany

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Sigmaringen, Germany

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Singen, Germany

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Sinsheim, Germany

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Soest, Germany

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Stendal, Germany

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Stralsund, Germany

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Stuttgart, Germany

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Stuttgart, Germany

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Suhl, Germany

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Torgau, Germany

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Traunstein, Germany

Novartis Investigative Site

Trier, Germany

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Tübingen, Germany

Novartis Investigative Site

Ulm, Germany

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Waldkirchen, Germany

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Waldsassen, Germany

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Walsrode, Germany

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Weinheim, Germany

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Werdau, Germany

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Wernigerode, Germany

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Wesel, Germany

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Wetzlar, Germany

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Witten, Germany

Novartis Investigative Site

Worms, Germany

Novartis Investigative Site

Würzburg, Germany

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NCT06830720

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