Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

NCT ID: NCT04847895

Last Updated: 2021-04-19

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

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2021-03-31

Brief Summary

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This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.

Detailed Description

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The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion.

The study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye.

Conditions

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Neovascular (Wet) Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lucentis

Patients administered Lucentis by prescription

Lucentis

Intervention Type DRUG

There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.

Interventions

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Lucentis

There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
* Written informed consent

Exclusion Criteria

* As described in Lucentis® SmPC
* Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Ettlingen, Baden-Wurttemberg, Germany

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Ahaus, , Germany

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Andernach, , Germany

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Augsburg, , Germany

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Augsburg, , Germany

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Bad Arolsen-Meneringhausen, , Germany

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Bad Liebenzell, , Germany

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Bad Säckingen, , Germany

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Baden-Baden, , Germany

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Bautzen, , Germany

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Beckum, , 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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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bonn, , Germany

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Borna, , Germany

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Braunschweig, , Germany

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Breisach, , Germany

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Bremen, , Germany

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Bremerhaven, , Germany

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Bremerhaven, , Germany

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Bremervörde, , Germany

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Brühl, , Germany

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Buchholz, , Germany

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Buxtehude, , Germany

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Celle, , Germany

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Cham, , Germany

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Chemnitz, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Coswig, , Germany

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Dannenberg, , Germany

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Darmstadt, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Düsseldorf, , Germany

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Düsseldorf, , Germany

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Eckental, , Germany

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Ehingen, , Germany

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Einbeck, , Germany

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Erding, , Germany

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Erkrath, , Germany

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Esslingen am Neckar, , Germany

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Frankenthal, , Germany

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Frankfurt, , Germany

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Frankfurt am Main, , Germany

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Freudenstadt, , Germany

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Friedberg, , Germany

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Fulda, , Germany

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Garching, , Germany

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Glauchau, , Germany

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Göttingen, , Germany

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Göttingen, , Germany

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Gütersloh, , Germany

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Halle, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Heppenheim an der Bergstrasse, , Germany

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Herrsching am Ammersee, , Germany

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Herzberg, , Germany

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Homburg, , Germany

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Hoppegarten, , Germany

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Höhr-Grenzhausen, , Germany

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Hösbach, , Germany

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Jülich, , Germany

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Kaiserslautern, , Germany

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Karlsruhe, , Germany

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Kempten, , Germany

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Kiel, , Germany

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Koblenz, , Germany

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Leer, , Germany

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Leipzig, , Germany

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Leipzig, , Germany

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Ludwigshafen, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Mainz, , Germany

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Mainz, , Germany

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Meiben, , Germany

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Minden, , Germany

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Moers, , Germany

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Mutterstadt, , Germany

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München, , Germany

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München, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Münster, , Germany

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Neu-Ulm, , Germany

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Neubrandenburg, , Germany

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Neubrandenburg, , Germany

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Neustadt, , Germany

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Neustadt A. D. Weinstraße, , Germany

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Neutraubling, , Germany

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Neuwied, , Germany

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Nuremberg, , Germany

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Obernkirchen, , Germany

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Offenburg, , Germany

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Oldenburg, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Paderborn, , Germany

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Paderborn, , Germany

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Peine, , Germany

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Pfaffenhofen, , Germany

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Pirna, , Germany

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Plauen, , Germany

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Polch, , Germany

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Prien am Chiemsee, , Germany

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Quakenbrück, , Germany

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Raesfeld, , Germany

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Ratingen, , Germany

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Regensburg, , Germany

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Rhauderfehn, , Germany

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Rheine, , Germany

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Rostock, , Germany

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Rüsselsheim am Main, , Germany

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Saarbrücken, , Germany

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Saarbrücken, , Germany

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Saarburg, , Germany

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Saarlouis, , Germany

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Salzgitter, , Germany

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Schweinfurt, , Germany

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Siegen, , Germany

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Sindelfingen, , Germany

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Speyer, , Germany

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Straubing, , Germany

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Torgau, , Germany

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Trier, , Germany

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Troisdorf, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Waldshut-Tiengen, , Germany

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Wedel, , Germany

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Westerstede, , Germany

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Wismar, , Germany

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Worms, , Germany

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Würzburg, , Germany

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Bergen op Zoom, North Brabant, Netherlands

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Heerhugowaard, North Holland, Netherlands

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's-Hertogenbosch, , Netherlands

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Deventer, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Terneuzen, , Netherlands

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Tilburg, , Netherlands

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Bern, Canton of Bern, Switzerland

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Neuchâtel, Canton of Neuchâtel, Switzerland

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Wil, Canton of St. Gallen, Switzerland

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Aarau, , Switzerland

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Basel, , Switzerland

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Basel, , Switzerland

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Fribourg, , Switzerland

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Geneva, , Switzerland

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Geneva, , Switzerland

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Zurich, , Switzerland

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Countries

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Germany Netherlands Switzerland

Other Identifiers

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CRFB002ADE28

Identifier Type: -

Identifier Source: org_study_id

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