OSCA - Olaparib Standard of CAre Study

NCT ID: NCT02262273

Last Updated: 2017-03-01

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

2123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-04-30

Brief Summary

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This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

Detailed Description

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Conditions

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Platinum-sensitive Recurrent Serous Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Serous ovarian cancer:

Women with platinum-sensitive recurrent serous ovarian cancer

Data Collection

Intervention Type OTHER

Colleciton of data from medical records only

Interventions

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Data Collection

Colleciton of data from medical records only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date.
2. At least 18 years of age on the index date.
3. Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer.
4. Patients can be either alive or deceased at the time of medical record abstraction.

Exclusion Criteria

1\. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RTI Health Solutions

OTHER

Sponsor Role collaborator

A+A Healthcare Marketing Research

INDUSTRY

Sponsor Role collaborator

Freelance CRA (FCRA)

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicoletta Colombo, MD

Role: STUDY_DIRECTOR

Steering Committee/Advisory Board Members

Laurence Gladieff, MD

Role: STUDY_DIRECTOR

Steering Committee/Advisory Board Members

Sven Mahner, MD

Role: STUDY_DIRECTOR

Steering Committee/Advisory Board Members

Isabel Bover, MD

Role: STUDY_DIRECTOR

Steering Committee/Advisory Board Members

Jacob Korach, MD

Role: STUDY_DIRECTOR

Steering Committee/Advisory Board Members

Locations

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Ballarat, , Australia

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Birtinya, , Australia

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Campbelltown, , Australia

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East Melbourne, , Australia

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Mandurah, Western Australia, , Australia

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South Brisbane, , Australia

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St Leonards, , Australia

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Victoria, , Australia

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Waratah, , Australia

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Edegem, , Belgium

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Namur, , Belgium

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Sint-Niklaas, , Belgium

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Alberta, , Canada

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Charlottetown, , Canada

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Mississauga, , Canada

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Montreal, , Canada

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Ottawa, , Canada

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Red Deer, , Canada

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Toronto, , Canada

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Vancouver, , Canada

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Aix-en-Provence, , France

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Ajaccio, , France

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Auxerre, , France

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Besançon, , France

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Béziers, , France

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Bordeaux, , France

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Bourg-en-Bresse, , France

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Brest, , France

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Caen, , France

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Chambéry, , France

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Colombes, , France

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Grenoble, , France

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Libourne, , France

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Longjumeau, , France

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Lyon, , France

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Marseille, , France

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Mont-de-Marsan, , France

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Montbéliard, , France

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Montpellier, , France

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Mulhouse, , France

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Nantes, , France

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Narbonne, , France

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Quimper, , France

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Rennes, , France

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Saint-Pierre-du-Mont, , France

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Strasbourg, , France

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Toulouse, , France

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Tours, , France

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Villejuif, , France

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Bad Godesberg, , Germany

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Berlin, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Düsseldorf, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Frankfurt am Main, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Karlsruhe, , Germany

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Kiel, , Germany

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Köthen, , Germany

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Leverkusen, , Germany

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München, , Germany

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Nuremberg, , Germany

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Osnabrück, , Germany

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Passau, , Germany

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Ratingen, , Germany

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Saarlouis, , Germany

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Stuttgart, , Germany

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Ulm, , Germany

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Velbert, , Germany

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Wetzlar, , Germany

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Afula, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Netanya, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Saint Holon, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Alessandria, , Italy

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Aosta, , Italy

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Ariano Irpino, , Italy

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Avellino, , Italy

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Bari, , Italy

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Brescia, , Italy

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Brindisi, , Italy

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Caltagirone, , Italy

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Candiolo, , Italy

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Carbonia, , Italy

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Castelfranco Veneto, , Italy

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Castellana Grotte, , Italy

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Castellaneta, , Italy

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Catania, , Italy

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Figline Valdarno, , Italy

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Franca, , Italy

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Genova, , Italy

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Gorizia, , Italy

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Gravina di Catania, , Italy

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Ivrea, , Italy

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Latina, , Italy

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Latisana, , Italy

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Lecce, , Italy

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Lido di Ostia, , Italy

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Manduria, , Italy

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Manerbi, , Italy

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Milan, , Italy

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Monselice, , Italy

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Monserrato, , Italy

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Monza, , Italy

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Napoli, , Italy

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Orbassano, , Italy

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Padua, , Italy

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Palmanova, , Italy

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Ponte A Niccheri, , Italy

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Portogruaro, , Italy

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Reggio Calabria, , Italy

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Rieti, , Italy

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Rionero in Vulture, , Italy

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Roma, , Italy

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San Gavino Monreale, , Italy

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Santorso VI, , Italy

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Seriate, , Italy

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Sesto San Giovanni, , Italy

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Solofra, , Italy

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Taranto, , Italy

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Torino, , Italy

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Trieste, , Italy

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Dordrecht, , Netherlands

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Enschede, , Netherlands

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Leiderdorp, , Netherlands

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Nijmegen, , Netherlands

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Purmerend, , Netherlands

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Barreiro, , Portugal

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Cascais, , Portugal

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Coimbra, , Portugal

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Covilha, , Portugal

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Lisbon, , Portugal

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Martinho Do Bispo, , Portugal

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Portimão, , Portugal

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Porto, , Portugal

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S. Martinho Do Porto, , Portugal

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Santa Maria da Feira, , Portugal

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Setúbal, , Portugal

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Vila Nova de Gaia, , Portugal

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Gyeonggi-do, , South Korea

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Seoul, , South Korea

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Alicante, , Spain

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Alzira, Valencia, , Spain

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Barcelona, , Spain

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Elche, , Spain

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Las Palmas, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Murcia, , Spain

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Ourense, , Spain

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Segovia, , Spain

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Seville, , Spain

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Terrassa, , Spain

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Toledo, , Spain

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Valencia, , Spain

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Aarau, , Switzerland

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Allschwil, , Switzerland

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Baden, , Switzerland

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Basel, , Switzerland

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Bern, , Switzerland

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Frauenfeld, , Switzerland

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Liestal, , Switzerland

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Lucerne, , Switzerland

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Rorschach, , Switzerland

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Sankt Gallen, , Switzerland

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Sion, , Switzerland

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Sursee, , Switzerland

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Wetzikon, , Switzerland

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Zurich, , Switzerland

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Basingstoke, , United Kingdom

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Bradford, , United Kingdom

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Brighton, , United Kingdom

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Bristol, , United Kingdom

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Cambridge, , United Kingdom

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Canterbury, , United Kingdom

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Glasgow, , United Kingdom

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Gloucester, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Oxford, , United Kingdom

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Plymouth, , United Kingdom

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Reading, , United Kingdom

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Sheffield, , United Kingdom

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Southend-on-Sea, , United Kingdom

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Taunton, , United Kingdom

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Wales, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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Australia Belgium Canada France Germany Israel Italy Netherlands Portugal South Korea Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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D0816R00004

Identifier Type: -

Identifier Source: org_study_id

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