Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test

NCT ID: NCT01644734

Last Updated: 2014-05-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-03-31

Brief Summary

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To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventions

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Spiriva HandiHaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
* Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),
* Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,
* Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.

Exclusion Criteria

* Uncooperative patients as judged by the physician,
* Patients with any conditions excluded as per Country specific package insert,
* Patients currently enrolled in any clinical trial,
* Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 236

Andrychów, , Poland

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Boehringer Ingelheim Investigational Site 170

Bialystok, , Poland

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Bialystok, , Poland

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Bialystok, , Poland

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Bialystok, , Poland

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Bialystok, , Poland

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Bielsko-Biala, , Poland

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Bielsko-Biala, , Poland

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Bielsko-Biala, , Poland

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Boehringer Ingelheim Investigational Site 79

Biskupiec, , Poland

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Bochnia, , Poland

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Brzesko, , Poland

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Brzesko, , Poland

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Brzeziny, , Poland

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Brzozów, , Poland

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Bydgoszcz, , Poland

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Bydgoszcz, , Poland

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Bydgoszcz, , Poland

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Bydgoszcz, , Poland

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Bydgoszcz, , Poland

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Chełm, , Poland

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Chełm, , Poland

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Chełmsko Śląskie, , Poland

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Chodzież, , Poland

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Chojnice, , Poland

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Chorzów, , Poland

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Chorzów, , Poland

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Ciechanów, , Poland

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Czarnków, , Poland

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Częstochowa, , Poland

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Częstochowa, , Poland

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Dąbrowa Górnicza, , Poland

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Domaradz, , Poland

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Dziergowice, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Gliwice, , Poland

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Gmina Jędrzejów, , Poland

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Gmina Końskie, , Poland

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Gmina Końskie, , Poland

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Gmina Sawin, , Poland

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Gmina Śrem, , Poland

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Gmina Śrem, , Poland

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Gmina Świecie, , Poland

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Gmina Uchanie, , Poland

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Gorzów Wielkopolski, , Poland

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Góra, , Poland

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Grodzisk Mazowiecki, , Poland

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Grodzisk Mazowiecki, , Poland

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Gryfice, , Poland

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Głuchołazy, , Poland

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Jarosław, , Poland

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Jasło, , Poland

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Jasło, , Poland

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Jasło, , Poland

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Jelenia Góra, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Kcynia, , Poland

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Kielce, , Poland

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Kielce, , Poland

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Kielce, , Poland

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Konin, , Poland

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Koszalin, , Poland

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Koszalin, , Poland

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Kołobrzeg, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Kraśnik, , Poland

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Kraśnik, , Poland

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Kraśnik, , Poland

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Krosno, , Poland

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Kutno, , Poland

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Kłodzko, , Poland

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Legionowo, , Poland

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Lędziny, , Poland

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Liśnik Duży, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lowicz, , Poland

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Lubań, , Poland

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Lubartów, , Poland

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Lubin, , Poland

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Lubin, , Poland

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Lubin, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Lubliniec, , Poland

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Luboń, , Poland

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Ludwikowo, , Poland

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Maków Mazowiecki, , Poland

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Malbork, , Poland

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Mielec, , Poland

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Milicz, , Poland

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Myszków, , Poland

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Mysłowice, , Poland

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Nisko, , Poland

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Nowy Dwór Gdański, , Poland

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Nowy Sącz, , Poland

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Olecko, , Poland

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Olsztyn, , Poland

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Opatów, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Oława, , Poland

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Pabianice, , Poland

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Papowo Biskupie, , Poland

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Pawonków, , Poland

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Pietrzykowice, , Poland

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Piotrkow Trybunalski, , Poland

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Piła, , Poland

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Pniewy, , Poland

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Poniatowa, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Prabuty, , Poland

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Proszowice, , Poland

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Pruszcz Gdański, , Poland

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Przemyśl, , Poland

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Płock, , Poland

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Rabka-Zdrój, , Poland

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Radom, , Poland

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Radom, , Poland

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Ruda Śląska, , Poland

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Ruda Śląska, , Poland

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Ruda Śląska, , Poland

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Ruda Śląska, , Poland

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Rumia, , Poland

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Rumia, , Poland

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Rumia, , Poland

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Rybnik, , Poland

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Rybnik, , Poland

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Rybnik, , Poland

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Rzeszów, , Poland

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Rzeszów, , Poland

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Sanok, , Poland

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Sejny, , Poland

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Siewierz, , Poland

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Skarżysko-Kamienna, , Poland

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Skawina, , Poland

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Skoczów, , Poland

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Skrzyszów, , Poland

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Sokołowsko, , Poland

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Sopot, , Poland

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Sosnowiec, , Poland

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Sosnowiec, , Poland

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Stalowa Wola, , Poland

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Starachowice, , Poland

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Starachowice, , Poland

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Stargard, , Poland

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Sucha Beskidzka, , Poland

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Supraśl, , Poland

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Suwałki, , Poland

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Suwałki, , Poland

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Syców, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Szczecin, , Poland

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Szczecinek, , Poland

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Sławno, , Poland

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Słubice, , Poland

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Słupca, , Poland

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Świdnik, , Poland

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Tarnobrzeg, , Poland

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Tarnobrzeg, , Poland

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Tarnowskie Góry, , Poland

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Tarnów, , Poland

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Tarnów, , Poland

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Torun, , Poland

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Torun, , Poland

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Torun, , Poland

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Trzcianka Lubuska, , Poland

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Twardogóra, , Poland

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Tychy, , Poland

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Tychy, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wałcz, , Poland

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Wejherowo, , Poland

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Wieliczna, , Poland

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Wieluń, , Poland

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Witonia, , Poland

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Wloc³awek, , Poland

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Wodzisław Śląski, , Poland

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Wołomin, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Zabrze, , Poland

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Zabrze, , Poland

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Ząbkowice Śląskie, , Poland

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Ząbkowice Śląskie, , Poland

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Zągoty, , Poland

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Zblewo, , Poland

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Zgierz, , Poland

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Zielona Góra, , Poland

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Zielona Góra, , Poland

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Zielonka k/Warszawy, , Poland

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Żyrardów, , Poland

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Łomża, , Poland

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Łomża, , Poland

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Łuków, , Poland

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Countries

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Poland

Other Identifiers

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205.502

Identifier Type: -

Identifier Source: org_study_id

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