Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296138
• Other study ID #: 1237.19
• Secondary ID: 2014-002275-28
• Status: Completed
• Phase: Phase 3
• Start date: January 13, 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: May 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7903
• Est. completion date: March 29, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Male or female patients, 40 years of age or older.

• Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1

• Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.

• Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.

• Current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria:

• Significant disease other than COPD.

• Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)

• Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma

• A diagnosis of thyrotoxicosis

• A history of myocardial infarction within 6 months of screening visit.

• Life-threatening cardiac arrhythmia.

• Known active tuberculosis.

• Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).

• A history of cystic fibrosis.

• Clinically relevant bronchiectasis.

• Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening

• A history of significant alcohol or drug abuse in the opinion of the investigator.

• Patients who have undergone thoracotomy with pulmonary resection

• Patients being treated with oral or patch ß-adrenergics.

• Patients being treated with oral corticosteroid medication at unstable doses

• Patients being treated with antibiotics for any reasons within 4 weeks of screening visit

• Patients being treated with PDE4 inhibitors within 3 months of screening visit

• Patients who have taken an investigational drug within one month or six half-lives

• Pregnant or nursing women.

• Women of childbearing potential not using a highly effective method of birth control.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• olodaterol
fixed dose combination
• tiotropium
fixed dose combination
• tiotropium

Locations

Country	Name	City	State
Argentina	1237.19.54015 Boehringer Ingelheim Investigational Site	Bahía Blanca
Argentina	1237.19.54014 Boehringer Ingelheim Investigational Site	Berazategui
Argentina	1237.19.54003 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1237.19.54004 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1237.19.54007 Boehringer Ingelheim Investigational Site	Capital Federal
Argentina	1237.19.54011 Boehringer Ingelheim Investigational Site	Ciudad de Buenos Aires
Argentina	1237.19.54018 Boehringer Ingelheim Investigational Site	Ciudad de Buenos Aires
Argentina	1237.19.54010 Boehringer Ingelheim Investigational Site	La Plata
Argentina	1237.19.54012 Boehringer Ingelheim Investigational Site	Mar del Plata
Argentina	1237.19.54017 Boehringer Ingelheim Investigational Site	Mar del Plata
Argentina	1237.19.54019 Boehringer Ingelheim Investigational Site	Mar del Plata
Argentina	1237.19.54005 Boehringer Ingelheim Investigational Site	Mendoza
Argentina	1237.19.54006 Boehringer Ingelheim Investigational Site	Quilmes
Argentina	1237.19.54013 Boehringer Ingelheim Investigational Site	Rosario
Argentina	1237.19.54016 Boehringer Ingelheim Investigational Site	San Isidro
Argentina	1237.19.54002 Boehringer Ingelheim Investigational Site	San Miguel de Tucuman
Argentina	1237.19.54001 Boehringer Ingelheim Investigational Site	Tucumán
Australia	1237.19.61013 Boehringer Ingelheim Investigational Site	Box Hill	Victoria
Australia	1237.19.61010 Boehringer Ingelheim Investigational Site	Cairns	Queensland
Australia	1237.19.61012 Boehringer Ingelheim Investigational Site	Campbelltown	New South Wales
Australia	1237.19.61006 Boehringer Ingelheim Investigational Site	Chermside	Queensland
Australia	1237.19.61001 Boehringer Ingelheim Investigational Site	Daw Park	South Australia
Australia	1237.19.61002 Boehringer Ingelheim Investigational Site	Kent Town	South Australia
Australia	1237.19.61011 Boehringer Ingelheim Investigational Site	Kogarah	New South Wales
Australia	1237.19.61003 Boehringer Ingelheim Investigational Site	Melbourne	Victoria
Australia	1237.19.61004 Boehringer Ingelheim Investigational Site	Murdoch	Western Australia
Australia	1237.19.61009 Boehringer Ingelheim Investigational Site	Parkville	Victoria
Australia	1237.19.61008 Boehringer Ingelheim Investigational Site	Randwick	New South Wales
Australia	1237.19.61007 Boehringer Ingelheim Investigational Site	Woodville	South Australia
Austria	1237.19.43006 Boehringer Ingelheim Investigational Site	Feldbach
Austria	1237.19.43004 Boehringer Ingelheim Investigational Site	Graz
Austria	1237.19.43003 Boehringer Ingelheim Investigational Site	Leoben
Austria	1237.19.43001 Boehringer Ingelheim Investigational Site	Linz
Austria	1237.19.70001 Boehringer Ingelheim Investigational Site	Ryazan
Austria	1237.19.43005 Boehringer Ingelheim Investigational Site	Salzburg
Austria	1237.19.43002 Boehringer Ingelheim Investigational Site	Wien
Belgium	1237.19.32001 Boehringer Ingelheim Investigational Site	Brussel
Belgium	1237.19.32007 Boehringer Ingelheim Investigational Site	Brussels
Belgium	1237.19.32006 Boehringer Ingelheim Investigational Site	Gilly
Belgium	1237.19.32004 Boehringer Ingelheim Investigational Site	Jambes
Belgium	1237.19.32003 Boehringer Ingelheim Investigational Site	Lebbeke
Belgium	1237.19.32002 Boehringer Ingelheim Investigational Site	Turnhout
Belgium	1237.19.32005 Boehringer Ingelheim Investigational Site	Zichem
Brazil	1237.19.55007 Boehringer Ingelheim Investigational Site	Belo Horizonte
Brazil	1237.19.55013 Boehringer Ingelheim Investigational Site	Botucatu
Brazil	1237.19.55011 Boehringer Ingelheim Investigational Site	Goiania
Brazil	1237.19.55002 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1237.19.55006 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1237.19.55010 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1237.19.55012 Boehringer Ingelheim Investigational Site	Porto Alegre
Brazil	1237.19.55014 Boehringer Ingelheim Investigational Site	Santo Andre
Brazil	1237.19.55005 Boehringer Ingelheim Investigational Site	Sao Paulo
Brazil	1237.19.55008 Boehringer Ingelheim Investigational Site	Sao Paulo
Brazil	1237.19.55001 Boehringer Ingelheim Investigational Site	São Paulo
Brazil	1237.19.55009 Boehringer Ingelheim Investigational Site	Vitoria
Bulgaria	1237.19.35905 Boehringer Ingelheim Investigational Site	Plovdiv
Bulgaria	1237.19.35902 Boehringer Ingelheim Investigational Site	Ruse
Bulgaria	1237.19.35903 Boehringer Ingelheim Investigational Site	Sofia
Bulgaria	1237.19.35904 Boehringer Ingelheim Investigational Site	Sofia
Bulgaria	1237.19.35906 Boehringer Ingelheim Investigational Site	Sofia
Bulgaria	1237.19.35907 Boehringer Ingelheim Investigational Site	Troyan
Bulgaria	1237.19.35901 Boehringer Ingelheim Investigational Site	Varna
Bulgaria	1237.19.35908 Boehringer Ingelheim Investigational Site	Vidin
Canada	1237.19.20018 Boehringer Ingelheim Investigational Site	Burlington	Ontario
Canada	1237.19.20011 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1237.19.20020 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1237.19.20035 Boehringer Ingelheim Investigational Site	Coquitlam	British Columbia
Canada	1237.19.20029 Boehringer Ingelheim Investigational Site	Corunna	Ontario
Canada	1237.19.20009 Boehringer Ingelheim Investigational Site	Courtice	Ontario
Canada	1237.19.20016 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1237.19.20025 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1237.19.20019 Boehringer Ingelheim Investigational Site	Grimsby	Ontario
Canada	1237.19.20017 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1237.19.20026 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1237.19.20038 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1237.19.20034 Boehringer Ingelheim Investigational Site	Kelowna	British Columbia
Canada	1237.19.20022 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1237.19.20004 Boehringer Ingelheim Investigational Site	Longueuil	Quebec
Canada	1237.19.20041 Boehringer Ingelheim Investigational Site	Maple Ridge	British Columbia
Canada	1237.19.20021 Boehringer Ingelheim Investigational Site	Moncton	New Brunswick
Canada	1237.19.20032 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1237.19.20040 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1237.19.20008 Boehringer Ingelheim Investigational Site	Point Claire	Quebec
Canada	1237.19.20014 Boehringer Ingelheim Investigational Site	Quebec
Canada	1237.19.20006 Boehringer Ingelheim Investigational Site	Saint John	New Brunswick
Canada	1237.19.20013 Boehringer Ingelheim Investigational Site	Saint John¿s	Newfoundland and Labrador
Canada	1237.19.20030 Boehringer Ingelheim Investigational Site	Sarnia	Ontario
Canada	1237.19.20002 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1237.19.20027 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1237.19.20031 Boehringer Ingelheim Investigational Site	St-Charles-Borromée	Quebec
Canada	1237.19.20023 Boehringer Ingelheim Investigational Site	Ste-Foy	Quebec
Canada	1237.19.20005 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1237.19.20037 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1237.19.20039 Boehringer Ingelheim Investigational Site	Trois-Rivieres	Quebec
Canada	1237.19.20010 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1237.19.20033 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1237.19.20036 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1237.19.20003 Boehringer Ingelheim Investigational Site	Victoriaville	Quebec
Canada	1237.19.20012 Boehringer Ingelheim Investigational Site	Waterloo	Ontario
Canada	1237.19.20007 Boehringer Ingelheim Investigational Site	Windsor	Ontario
Canada	1237.19.20015 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
Chile	1237.19.53004 Boehringer Ingelheim Investigational Site	Quillota
Chile	1237.19.53003 Boehringer Ingelheim Investigational Site	San Miguel
Chile	1237.19.53002 Boehringer Ingelheim Investigational Site	Santiago de Chile
Colombia	1237.19.57002 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1237.19.57004 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1237.19.57005 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1237.19.57003 Boehringer Ingelheim Investigational Site	Cali
Colombia	1237.19.57006 Boehringer Ingelheim Investigational Site	Medellín
Croatia	1237.19.38501 Boehringer Ingelheim Investigational Site	Rijeka
Croatia	1237.19.38502 Boehringer Ingelheim Investigational Site	Zagreb
Croatia	1237.19.38503 Boehringer Ingelheim Investigational Site	Zagreb
Czechia	1237.19.42001 Boehringer Ingelheim Investigational Site	Beroun
Czechia	1237.19.42010 Boehringer Ingelheim Investigational Site	Cesky Krumlov
Czechia	1237.19.42004 Boehringer Ingelheim Investigational Site	Hradec Kralove
Czechia	1237.19.42002 Boehringer Ingelheim Investigational Site	Jindrichuv Hradec
Czechia	1237.19.42006 Boehringer Ingelheim Investigational Site	Krnov
Czechia	1237.19.42007 Boehringer Ingelheim Investigational Site	Liberec
Czechia	1237.19.42003 Boehringer Ingelheim Investigational Site	Melnik
Czechia	1237.19.42005 Boehringer Ingelheim Investigational Site	Prague 8
Czechia	1237.19.42008 Boehringer Ingelheim Investigational Site	Praha
Czechia	1237.19.42009 Boehringer Ingelheim Investigational Site	Varnsdorf
Denmark	1237.19.45007 Boehringer Ingelheim Investigational Site	Aarhus
Denmark	1237.19.45004 Boehringer Ingelheim Investigational Site	Ålborg
Denmark	1237.19.45006 Boehringer Ingelheim Investigational Site	Holstebro
Denmark	1237.19.45002 Boehringer Ingelheim Investigational Site	Hvidovre
Denmark	1237.19.45005 Boehringer Ingelheim Investigational Site	Kolding
Denmark	1237.19.45001 Boehringer Ingelheim Investigational Site	Odense
Denmark	1237.19.45008 Boehringer Ingelheim Investigational Site	Roskilde
Denmark	1237.19.45003 Boehringer Ingelheim Investigational Site	Vaerløse
Finland	1237.19.35804 Boehringer Ingelheim Investigational Site	Helsinki
Finland	1237.19.35805 Boehringer Ingelheim Investigational Site	Oulu
Finland	1237.19.35801 Boehringer Ingelheim Investigational Site	Turku
Finland	1237.19.35803 Boehringer Ingelheim Investigational Site	Turku
France	1237.19.33016 Boehringer Ingelheim Investigational Site	Cannes
France	1237.19.33014 Boehringer Ingelheim Investigational Site	La Tronche
France	1237.19.33013 Boehringer Ingelheim Investigational Site	Marseille
France	1237.19.33020 Boehringer Ingelheim Investigational Site	MARSEILLE Cedex 08
France	1237.19.33003 Boehringer Ingelheim Investigational Site	Montpellier cedex 5
France	1237.19.33024 Boehringer Ingelheim Investigational Site	Nantes Cedex 01
France	1237.19.33017 Boehringer Ingelheim Investigational Site	Nice
France	1237.19.33019 Boehringer Ingelheim Investigational Site	Nîmes
France	1237.19.33018 Boehringer Ingelheim Investigational Site	Nîmes cedex 9
France	1237.19.33001 Boehringer Ingelheim Investigational Site	Paris
France	1237.19.33002 Boehringer Ingelheim Investigational Site	Pessac
France	1237.19.33006 Boehringer Ingelheim Investigational Site	Reims
France	1237.19.33021 Boehringer Ingelheim Investigational Site	Rennes Cedex 9
France	1237.19.33005 Boehringer Ingelheim Investigational Site	Saint Laurent du Var
France	1237.19.33012 Boehringer Ingelheim Investigational Site	Saint Pierre - La Réunion
France	1237.19.33022 Boehringer Ingelheim Investigational Site	Strasbourg
France	1237.19.33007 Boehringer Ingelheim Investigational Site	Toulouse cedex 9
France	1237.19.33023 Boehringer Ingelheim Investigational Site	TOURS Cedex 9
France	1237.19.33010 Boehringer Ingelheim Investigational Site	Vieux Condé
Germany	1237.19.49041 Boehringer Ingelheim Investigational Site	Ahlen
Germany	1237.19.49004 Boehringer Ingelheim Investigational Site	Aschaffenburg
Germany	1237.19.49059 Boehringer Ingelheim Investigational Site	Augsburg
Germany	1237.19.49042 Boehringer Ingelheim Investigational Site	Bad Wörishofen
Germany	1237.19.49072 Boehringer Ingelheim Investigational Site	Bamberg
Germany	1237.19.49024 Boehringer Ingelheim Investigational Site	Bergisch Gladbach
Germany	1237.19.49009 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49011 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49018 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49025 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49026 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49029 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49035 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49043 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49058 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49065 Boehringer Ingelheim Investigational Site	Berlin
Germany	1237.19.49076 Boehringer Ingelheim Investigational Site	Bielefeld
Germany	1237.19.49064 Boehringer Ingelheim Investigational Site	Bochum
Germany	1237.19.49048 Boehringer Ingelheim Investigational Site	Bonn
Germany	1237.19.49002 Boehringer Ingelheim Investigational Site	Düren
Germany	1237.19.49012 Boehringer Ingelheim Investigational Site	Essen
Germany	1237.19.49017 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1237.19.49019 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1237.19.49052 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1237.19.49062 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1237.19.49044 Boehringer Ingelheim Investigational Site	Fulda
Germany	1237.19.49057 Boehringer Ingelheim Investigational Site	Fürstenwalde
Germany	1237.19.49001 Boehringer Ingelheim Investigational Site	Großhansdorf
Germany	1237.19.49008 Boehringer Ingelheim Investigational Site	Gütersloh
Germany	1237.19.49028 Boehringer Ingelheim Investigational Site	Halle/Saale
Germany	1237.19.49038 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1237.19.49055 Boehringer Ingelheim Investigational Site	Hannover
Germany	1237.19.49077 Boehringer Ingelheim Investigational Site	Hannover
Germany	1237.19.49022 Boehringer Ingelheim Investigational Site	Heidelberg
Germany	1237.19.49056 Boehringer Ingelheim Investigational Site	Höchstädt
Germany	1237.19.49049 Boehringer Ingelheim Investigational Site	Kiel
Germany	1237.19.49005 Boehringer Ingelheim Investigational Site	Koblenz
Germany	1237.19.49034 Boehringer Ingelheim Investigational Site	Köln
Germany	1237.19.49073 Boehringer Ingelheim Investigational Site	Landsberg am Lech
Germany	1237.19.49003 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1237.19.49007 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1237.19.49030 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1237.19.49061 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1237.19.49063 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1237.19.49070 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1237.19.49010 Boehringer Ingelheim Investigational Site	Leverkusen
Germany	1237.19.49037 Boehringer Ingelheim Investigational Site	Lübeck
Germany	1237.19.49016 Boehringer Ingelheim Investigational Site	Mannheim
Germany	1237.19.49046 Boehringer Ingelheim Investigational Site	Mannheim
Germany	1237.19.49036 Boehringer Ingelheim Investigational Site	Marburg
Germany	1237.19.49054 Boehringer Ingelheim Investigational Site	Minden
Germany	1237.19.49006 Boehringer Ingelheim Investigational Site	München
Germany	1237.19.49013 Boehringer Ingelheim Investigational Site	München
Germany	1237.19.49047 Boehringer Ingelheim Investigational Site	Paderborn
Germany	1237.19.49014 Boehringer Ingelheim Investigational Site	Peine
Germany	1237.19.49074 Boehringer Ingelheim Investigational Site	Potsdam
Germany	1237.19.49045 Boehringer Ingelheim Investigational Site	Radebeul
Germany	1237.19.49053 Boehringer Ingelheim Investigational Site	Rheine
Germany	1237.19.49060 Boehringer Ingelheim Investigational Site	Rüdersdorf
Germany	1237.19.49050 Boehringer Ingelheim Investigational Site	Solingen
Germany	1237.19.49032 Boehringer Ingelheim Investigational Site	Teuchern
Germany	1237.19.49051 Boehringer Ingelheim Investigational Site	Wardenburg
Germany	1237.19.49040 Boehringer Ingelheim Investigational Site	Wiesloch
Germany	1237.19.49023 Boehringer Ingelheim Investigational Site	Witten
Greece	1237.19.30003 Boehringer Ingelheim Investigational Site	Athens
Greece	1237.19.30007 Boehringer Ingelheim Investigational Site	Athens
Greece	1237.19.30008 Boehringer Ingelheim Investigational Site	Athens
Greece	1237.19.30004 Boehringer Ingelheim Investigational Site	Heraklion
Greece	1237.19.30002 Boehringer Ingelheim Investigational Site	Nafplio
Greece	1237.19.30005 Boehringer Ingelheim Investigational Site	Serres
Greece	1237.19.30001 Boehringer Ingelheim Investigational Site	Thessaloniki
Greece	1237.19.30006 Boehringer Ingelheim Investigational Site	Thessaloniki
Guatemala	1237.19.50201 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1237.19.50202 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1237.19.50203 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1237.19.50204 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1237.19.50205 Boehringer Ingelheim Investigational Site	Guatemala
Hong Kong	1237.19.85201 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1237.19.85202 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1237.19.85203 Boehringer Ingelheim Investigational Site	Hong Kong
Hungary	1237.19.36006 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1237.19.36012 Boehringer Ingelheim Investigational Site	Budapest
Hungary	1237.19.36005 Boehringer Ingelheim Investigational Site	Debrecen
Hungary	1237.19.36015 Boehringer Ingelheim Investigational Site	Debrecen
Hungary	1237.19.36008 Boehringer Ingelheim Investigational Site	Edeleny
Hungary	1237.19.36011 Boehringer Ingelheim Investigational Site	Farkasgyepu
Hungary	1237.19.36002 Boehringer Ingelheim Investigational Site	Godollo
Hungary	1237.19.36014 Boehringer Ingelheim Investigational Site	Hajdunanas
Hungary	1237.19.36013 Boehringer Ingelheim Investigational Site	Kapuvar
Hungary	1237.19.36009 Boehringer Ingelheim Investigational Site	Komarom
Hungary	1237.19.36007 Boehringer Ingelheim Investigational Site	Nyiregyhaza
Hungary	1237.19.36003 Boehringer Ingelheim Investigational Site	Pecs
Hungary	1237.19.36004 Boehringer Ingelheim Investigational Site	Pecs
Hungary	1237.19.36010 Boehringer Ingelheim Investigational Site	Szazhalombatta
Hungary	1237.19.36001 Boehringer Ingelheim Investigational Site	Szeged
India	1237.19.91016 Boehringer Ingelheim Investigational Site	Ahmadabad
India	1237.19.91013 Boehringer Ingelheim Investigational Site	Ahmedabad
India	1237.19.91040 Boehringer Ingelheim Investigational Site	Ahmedabad
India	1237.19.91032 Boehringer Ingelheim Investigational Site	Bangalore
India	1237.19.91004 Boehringer Ingelheim Investigational Site	Coimbatore
India	1237.19.91033 Boehringer Ingelheim Investigational Site	Gurgaon
India	1237.19.91005 Boehringer Ingelheim Investigational Site	Hyderabad
India	1237.19.91019 Boehringer Ingelheim Investigational Site	Hyderabad
India	1237.19.91020 Boehringer Ingelheim Investigational Site	Hyderabad
India	1237.19.91025 Boehringer Ingelheim Investigational Site	Hyderabad
India	1237.19.91006 Boehringer Ingelheim Investigational Site	Jaipur
India	1237.19.91042 Boehringer Ingelheim Investigational Site	Jaipur
India	1237.19.91044 Boehringer Ingelheim Investigational Site	Jaipur
India	1237.19.91026 Boehringer Ingelheim Investigational Site	Karamsad
India	1237.19.91034 Boehringer Ingelheim Investigational Site	Kolkata
India	1237.19.91010 Boehringer Ingelheim Investigational Site	Ludhiana
India	1237.19.91007 Boehringer Ingelheim Investigational Site	Madurai
India	1237.19.91014 Boehringer Ingelheim Investigational Site	Mysore
India	1237.19.91021 Boehringer Ingelheim Investigational Site	Mysore
India	1237.19.91001 Boehringer Ingelheim Investigational Site	Nagpur
India	1237.19.91002 Boehringer Ingelheim Investigational Site	Nagpur
India	1237.19.91003 Boehringer Ingelheim Investigational Site	Nagpur
India	1237.19.91027 Boehringer Ingelheim Investigational Site	New Delhi
India	1237.19.91024 Boehringer Ingelheim Investigational Site	Panjim
India	1237.19.91023 Boehringer Ingelheim Investigational Site	Pune
India	1237.19.91035 Boehringer Ingelheim Investigational Site	Pune
India	1237.19.91008 Boehringer Ingelheim Investigational Site	Vellore
India	1237.19.91028 Boehringer Ingelheim Investigational Site	Vishakhapatnam
Ireland	1237.19.35301 Boehringer Ingelheim Investigational Site	Dublin 24
Ireland	1237.19.35302 Boehringer Ingelheim Investigational Site	Wilton
Italy	1237.19.39011 Boehringer Ingelheim Investigational Site	Cittadella (PD)
Italy	1237.19.39014 Boehringer Ingelheim Investigational Site	Ferrara
Italy	1237.19.39010 Boehringer Ingelheim Investigational Site	Messina
Italy	1237.19.39002 Boehringer Ingelheim Investigational Site	Milano
Italy	1237.19.39016 Boehringer Ingelheim Investigational Site	Milano
Italy	1237.19.39023 Boehringer Ingelheim Investigational Site	Milano
Italy	1237.19.39015 Boehringer Ingelheim Investigational Site	Monza
Italy	1237.19.39025 Boehringer Ingelheim Investigational Site	Padova
Italy	1237.19.39024 Boehringer Ingelheim Investigational Site	Palermo
Italy	1237.19.39006 Boehringer Ingelheim Investigational Site	Parma
Italy	1237.19.39005 Boehringer Ingelheim Investigational Site	Pavia
Italy	1237.19.39007 Boehringer Ingelheim Investigational Site	Perugia
Italy	1237.19.39008 Boehringer Ingelheim Investigational Site	Piacenza
Italy	1237.19.39001 Boehringer Ingelheim Investigational Site	Pisa
Italy	1237.19.39020 Boehringer Ingelheim Investigational Site	Pisa
Italy	1237.19.39013 Boehringer Ingelheim Investigational Site	Pordenone
Italy	1237.19.39003 Boehringer Ingelheim Investigational Site	Roma
Italy	1237.19.39004 Boehringer Ingelheim Investigational Site	Roma
Italy	1237.19.39012 Boehringer Ingelheim Investigational Site	Roma
Italy	1237.19.39021 Boehringer Ingelheim Investigational Site	San Pietro Vernotico (BR)
Italy	1237.19.39017 Boehringer Ingelheim Investigational Site	Sassari
Italy	1237.19.39019 Boehringer Ingelheim Investigational Site	Scafati (SA)
Japan	1237.19.81072 Boehringer Ingelheim Investigational Site	Aichi, Komaki
Japan	1237.19.81070 Boehringer Ingelheim Investigational Site	Aichi, Nagoya
Japan	1237.19.81073 Boehringer Ingelheim Investigational Site	Aichi, Nagoya
Japan	1237.19.81074 Boehringer Ingelheim Investigational Site	Aichi, Nagoya
Japan	1237.19.81071 Boehringer Ingelheim Investigational Site	Aichi, Obu
Japan	1237.19.81069 Boehringer Ingelheim Investigational Site	Aichi, Seto
Japan	1237.19.81030 Boehringer Ingelheim Investigational Site	Chiba, Chiba
Japan	1237.19.81031 Boehringer Ingelheim Investigational Site	Chiba, Kamogawa
Japan	1237.19.81061 Boehringer Ingelheim Investigational Site	Fukui, Fukui
Japan	1237.19.81116 Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka
Japan	1237.19.81112 Boehringer Ingelheim Investigational Site	Fukuoka, Kitakyushu-city
Japan	1237.19.81113 Boehringer Ingelheim Investigational Site	Fukuoka, Koga
Japan	1237.19.81111 Boehringer Ingelheim Investigational Site	Fukuoka, Kurume
Japan	1237.19.81114 Boehringer Ingelheim Investigational Site	Fukuoka, Yanagawa
Japan	1237.19.81115 Boehringer Ingelheim Investigational Site	Fukuoka, Yukuhashi
Japan	1237.19.81022 Boehringer Ingelheim Investigational Site	Fukushima, Fukushima
Japan	1237.19.81066 Boehringer Ingelheim Investigational Site	Gifu, Mizunami
Japan	1237.19.81065 Boehringer Ingelheim Investigational Site	Gifu, Ogaki
Japan	1237.19.81025 Boehringer Ingelheim Investigational Site	Gunma, Fujioka
Japan	1237.19.81027 Boehringer Ingelheim Investigational Site	Gunma, Maebashi
Japan	1237.19.81026 Boehringer Ingelheim Investigational Site	Gunma, Takasaki
Japan	1237.19.81101 Boehringer Ingelheim Investigational Site	Hiroshima, Fukuyama
Japan	1237.19.81104 Boehringer Ingelheim Investigational Site	Hiroshima, Hiroshima
Japan	1237.19.81102 Boehringer Ingelheim Investigational Site	Hiroshima, Kure
Japan	1237.19.81103 Boehringer Ingelheim Investigational Site	Hiroshima, Kure
Japan	1237.19.81010 Boehringer Ingelheim Investigational Site	Hokkaido, Asahikawa
Japan	1237.19.81007 Boehringer Ingelheim Investigational Site	Hokkaido, Chitose
Japan	1237.19.81012 Boehringer Ingelheim Investigational Site	Hokkaido, Hakodate
Japan	1237.19.81013 Boehringer Ingelheim Investigational Site	Hokkaido, Hakodate
Japan	1237.19.81009 Boehringer Ingelheim Investigational Site	Hokkaido, Obihiro
Japan	1237.19.81015 Boehringer Ingelheim Investigational Site	Hokkaido, Obihiro
Japan	1237.19.81016 Boehringer Ingelheim Investigational Site	Hokkaido, Otaru
Japan	1237.19.81001 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81002 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81004 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81006 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81008 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81011 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81014 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81017 Boehringer Ingelheim Investigational Site	Hokkaido, Sapporo
Japan	1237.19.81003 Boehringer Ingelheim Investigational Site	Hokkaido, Tomakomai
Japan	1237.19.81090 Boehringer Ingelheim Investigational Site	Hyogo, Himeji
Japan	1237.19.81093 Boehringer Ingelheim Investigational Site	Hyogo, Himeji
Japan	1237.19.81091 Boehringer Ingelheim Investigational Site	Hyogo, Kobe
Japan	1237.19.81092 Boehringer Ingelheim Investigational Site	Hyogo, Nishinomiya
Japan	1237.19.81024 Boehringer Ingelheim Investigational Site	Ibaraki, Hitachinaka
Japan	1237.19.81129 Boehringer Ingelheim Investigational Site	Ibaraki, Inashiki-gun
Japan	1237.19.81023 Boehringer Ingelheim Investigational Site	Ibaraki, Naka-gun
Japan	1237.19.81060 Boehringer Ingelheim Investigational Site	Ishikawa, Kanazawa
Japan	1237.19.81018 Boehringer Ingelheim Investigational Site	Iwate, Morioka
Japan	1237.19.81108 Boehringer Ingelheim Investigational Site	Kagawa, Sakaide
Japan	1237.19.81107 Boehringer Ingelheim Investigational Site	Kagawa, Takamatsu
Japan	1237.19.81109 Boehringer Ingelheim Investigational Site	Kagawa, Takamatsu
Japan	1237.19.81118 Boehringer Ingelheim Investigational Site	Kagoshima, Kagoshima
Japan	1237.19.81050 Boehringer Ingelheim Investigational Site	Kanagawa, Isehara
Japan	1237.19.81052 Boehringer Ingelheim Investigational Site	Kanagawa, Kawasaki
Japan	1237.19.81053 Boehringer Ingelheim Investigational Site	Kanagawa, Kawasaki
Japan	1237.19.81055 Boehringer Ingelheim Investigational Site	Kanagawa, Kawasaki
Japan	1237.19.81054 Boehringer Ingelheim Investigational Site	Kanagawa, Sagamihara
Japan	1237.19.81056 Boehringer Ingelheim Investigational Site	Kanagawa, Sagamihara
Japan	1237.19.81049 Boehringer Ingelheim Investigational Site	Kanagawa, Yokohama
Japan	1237.19.81051 Boehringer Ingelheim Investigational Site	Kanagawa, Yokohama
Japan	1237.19.81110 Boehringer Ingelheim Investigational Site	Kochi, Kochi
Japan	1237.19.81130 Boehringer Ingelheim Investigational Site	Kochi, Nankoku
Japan	1237.19.81077 Boehringer Ingelheim Investigational Site	Kyoto, Kyoto
Japan	1237.19.81076 Boehringer Ingelheim Investigational Site	Mie, Matsusaka
Japan	1237.19.81005 Boehringer Ingelheim Investigational Site	Miyagi, Sendai
Japan	1237.19.81019 Boehringer Ingelheim Investigational Site	Miyagi, Sendai
Japan	1237.19.81020 Boehringer Ingelheim Investigational Site	Miyagi, Sendai
Japan	1237.19.81038 Boehringer Ingelheim Investigational Site	Miyagi, Sendai
Japan	1237.19.81064 Boehringer Ingelheim Investigational Site	Nagano, Matsumoto
Japan	1237.19.81063 Boehringer Ingelheim Investigational Site	Nagano, Matumoto
Japan	1237.19.81117 Boehringer Ingelheim Investigational Site	Nagasaki, Isahaya
Japan	1237.19.81095 Boehringer Ingelheim Investigational Site	Nara, Ikoma
Japan	1237.19.81057 Boehringer Ingelheim Investigational Site	Niigata, Niigata
Japan	1237.19.81058 Boehringer Ingelheim Investigational Site	Niigata, Niigata
Japan	1237.19.81059 Boehringer Ingelheim Investigational Site	Niigata, Niigata
Japan	1237.19.81125 Boehringer Ingelheim Investigational Site	Okayama
Japan	1237.19.81100 Boehringer Ingelheim Investigational Site	Okayama, Okayama
Japan	1237.19.81119 Boehringer Ingelheim Investigational Site	Okinawa, Urasoe
Japan	1237.19.81120 Boehringer Ingelheim Investigational Site	Okinawa, Uruma
Japan	1237.19.81089 Boehringer Ingelheim Investigational Site	Osaka, Ikeda
Japan	1237.19.81082 Boehringer Ingelheim Investigational Site	Osaka, Kishiwada
Japan	1237.19.81079 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1237.19.81080 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1237.19.81086 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1237.19.81088 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1237.19.81078 Boehringer Ingelheim Investigational Site	Osaka, Osakasayama
Japan	1237.19.81083 Boehringer Ingelheim Investigational Site	Osaka, Sakai
Japan	1237.19.81081 Boehringer Ingelheim Investigational Site	Osaka, Takatsuki
Japan	1237.19.81085 Boehringer Ingelheim Investigational Site	Osaka, Toyonaka
Japan	1237.19.81087 Boehringer Ingelheim Investigational Site	Osaka, Yao
Japan	1237.19.81028 Boehringer Ingelheim Investigational Site	Saitama, Koshigaya
Japan	1237.19.81029 Boehringer Ingelheim Investigational Site	Saitama, Saitama
Japan	1237.19.81128 Boehringer Ingelheim Investigational Site	Shiga
Japan	1237.19.81098 Boehringer Ingelheim Investigational Site	Shimane, Izumo
Japan	1237.19.81099 Boehringer Ingelheim Investigational Site	Shimane, Izumo
Japan	1237.19.81067 Boehringer Ingelheim Investigational Site	Shizuoka, Hamamatsu
Japan	1237.19.81068 Boehringer Ingelheim Investigational Site	Shizuoka, Shizuoka
Japan	1237.19.81123 Boehringer Ingelheim Investigational Site	Tochigi, Shimotsuke
Japan	1237.19.81126 Boehringer Ingelheim Investigational Site	Tokyo
Japan	1237.19.81122 Boehringer Ingelheim Investigational Site	Tokyo,
Japan	1237.19.81075 Boehringer Ingelheim Investigational Site	Tokyo, Chiyoda-ku
Japan	1237.19.81036 Boehringer Ingelheim Investigational Site	Tokyo, Chuo-ku
Japan	1237.19.81040 Boehringer Ingelheim Investigational Site	Tokyo, Chuo-ku
Japan	1237.19.81039 Boehringer Ingelheim Investigational Site	Tokyo, Hachioji
Japan	1237.19.81035 Boehringer Ingelheim Investigational Site	Tokyo, Itabashi-ku
Japan	1237.19.81043 Boehringer Ingelheim Investigational Site	Tokyo, Itabashi-ku
Japan	1237.19.81046 Boehringer Ingelheim Investigational Site	Tokyo, Koto-ku
Japan	1237.19.81034 Boehringer Ingelheim Investigational Site	Tokyo, Meguro-ku
Japan	1237.19.81032 Boehringer Ingelheim Investigational Site	Tokyo, Minato-ku
Japan	1237.19.81047 Boehringer Ingelheim Investigational Site	Tokyo, Shinagawa-ku
Japan	1237.19.81033 Boehringer Ingelheim Investigational Site	Tokyo, Shinjuku-ku
Japan	1237.19.81041 Boehringer Ingelheim Investigational Site	Tokyo, Shinjuku-ku
Japan	1237.19.81042 Boehringer Ingelheim Investigational Site	Tokyo, Shinjuku-ku
Japan	1237.19.81044 Boehringer Ingelheim Investigational Site	Tokyo, Tachikawa
Japan	1237.19.81048 Boehringer Ingelheim Investigational Site	Tokyo, Toshima-ku
Japan	1237.19.81097 Boehringer Ingelheim Investigational Site	Wakayama, Hidaka-gun
Japan	1237.19.81096 Boehringer Ingelheim Investigational Site	Wakayama, Wakayama
Japan	1237.19.81124 Boehringer Ingelheim Investigational Site	Yamagata,
Japan	1237.19.81021 Boehringer Ingelheim Investigational Site	Yamagata, Yonezawa
Japan	1237.19.81106 Boehringer Ingelheim Investigational Site	Yamaguchi, Iwakuni
Japan	1237.19.81105 Boehringer Ingelheim Investigational Site	Yamaguchi, Ube
Japan	1237.19.81062 Boehringer Ingelheim Investigational Site	Yamanashi, Kofu
Korea, Republic of	1237.19.82004 Boehringer Ingelheim Investigational Site	Bucheon
Korea, Republic of	1237.19.82009 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1237.19.82006 Boehringer Ingelheim Investigational Site	Gwangju
Korea, Republic of	1237.19.82001 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1237.19.82002 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1237.19.82005 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1237.19.82007 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1237.19.82008 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1237.19.82010 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1237.19.82003 Boehringer Ingelheim Investigational Site	Wonju
Latvia	1237.19.37103 Boehringer Ingelheim Investigational Site	Daugavpils
Latvia	1237.19.37101 Boehringer Ingelheim Investigational Site	Riga
Latvia	1237.19.37105 Boehringer Ingelheim Investigational Site	Riga
Latvia	1237.19.37106 Boehringer Ingelheim Investigational Site	Riga
Latvia	1237.19.37104 Boehringer Ingelheim Investigational Site	Tukums
Latvia	1237.19.37102 Boehringer Ingelheim Investigational Site	Valmiera
Lithuania	1237.19.37002 Boehringer Ingelheim Investigational Site	Kaunas
Lithuania	1237.19.37003 Boehringer Ingelheim Investigational Site	Klaipeda
Lithuania	1237.19.37004 Boehringer Ingelheim Investigational Site	Klaipeda
Lithuania	1237.19.37001 Boehringer Ingelheim Investigational Site	Vilnius
Malaysia	1237.19.60006 Boehringer Ingelheim Investigational Site	Kota Bahru
Malaysia	1237.19.60002 Boehringer Ingelheim Investigational Site	Kuala Lumpur
Malaysia	1237.19.60004 Boehringer Ingelheim Investigational Site	Kuala Terengganu
Malaysia	1237.19.60001 Boehringer Ingelheim Investigational Site	Kuching
Mexico	1237.19.52006 Boehringer Ingelheim Investigational Site	Aguascalientes
Mexico	1237.19.52007 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1237.19.52005 Boehringer Ingelheim Investigational Site	León
Mexico	1237.19.52003 Boehringer Ingelheim Investigational Site	México
Mexico	1237.19.52001 Boehringer Ingelheim Investigational Site	Monterrey
Mexico	1237.19.52004 Boehringer Ingelheim Investigational Site	Tijuana
Netherlands	1237.19.31017 Boehringer Ingelheim Investigational Site	Alkmaar
Netherlands	1237.19.31015 Boehringer Ingelheim Investigational Site	Almelo
Netherlands	1237.19.31011 Boehringer Ingelheim Investigational Site	Amsterdam
Netherlands	1237.19.31014 Boehringer Ingelheim Investigational Site	Assen
Netherlands	1237.19.31001 Boehringer Ingelheim Investigational Site	Breda
Netherlands	1237.19.31003 Boehringer Ingelheim Investigational Site	EDE
Netherlands	1237.19.31002 Boehringer Ingelheim Investigational Site	Eindhoven
Netherlands	1237.19.31005 Boehringer Ingelheim Investigational Site	Groningen
Netherlands	1237.19.31010 Boehringer Ingelheim Investigational Site	Harderwijk
Netherlands	1237.19.31012 Boehringer Ingelheim Investigational Site	Hoofddorp
Netherlands	1237.19.31013 Boehringer Ingelheim Investigational Site	Hoorn
Netherlands	1237.19.31018 Boehringer Ingelheim Investigational Site	Leeuwarden
Netherlands	1237.19.31016 Boehringer Ingelheim Investigational Site	Leiden
Netherlands	1237.19.31008 Boehringer Ingelheim Investigational Site	Rotterdam
Netherlands	1237.19.31007 Boehringer Ingelheim Investigational Site	Sittard - Geleen
Netherlands	1237.19.31004 Boehringer Ingelheim Investigational Site	Zutphen
New Zealand	1237.19.64003 Boehringer Ingelheim Investigational Site	Auckland, New Zealand
New Zealand	1237.19.64002 Boehringer Ingelheim Investigational Site	Christchurch
New Zealand	1237.19.64004 Boehringer Ingelheim Investigational Site	Christchurch Central
New Zealand	1237.19.64007 Boehringer Ingelheim Investigational Site	Dunedin
New Zealand	1237.19.64008 Boehringer Ingelheim Investigational Site	Dunedin
New Zealand	1237.19.64001 Boehringer Ingelheim Investigational Site	Greenlane East Auckland NZ
New Zealand	1237.19.64005 Boehringer Ingelheim Investigational Site	Hamilton
New Zealand	1237.19.64009 Boehringer Ingelheim Investigational Site	Tauranga
Norway	1237.19.47002 Boehringer Ingelheim Investigational Site	Arendal
Norway	1237.19.47008 Boehringer Ingelheim Investigational Site	Hamar
Norway	1237.19.47001 Boehringer Ingelheim Investigational Site	Hønefoss
Norway	1237.19.47006 Boehringer Ingelheim Investigational Site	Kløfta
Norway	1237.19.47007 Boehringer Ingelheim Investigational Site	Lierskogen
Norway	1237.19.47004 Boehringer Ingelheim Investigational Site	Oslo
Norway	1237.19.47005 Boehringer Ingelheim Investigational Site	Skedsmokorset
Philippines	1237.19.63007 Boehringer Ingelheim Investigational Site	Angeles City
Philippines	1237.19.63001 Boehringer Ingelheim Investigational Site	Cebu City
Philippines	1237.19.63003 Boehringer Ingelheim Investigational Site	Dasmarinas
Philippines	1237.19.63008 Boehringer Ingelheim Investigational Site	Davao City
Philippines	1237.19.63006 Boehringer Ingelheim Investigational Site	Iloilo
Philippines	1237.19.63005 Boehringer Ingelheim Investigational Site	Manila
Philippines	1237.19.63002 Boehringer Ingelheim Investigational Site	Quezon City
Poland	1237.19.48009 Boehringer Ingelheim Investigational Site	Bialystok
Poland	1237.19.48026 Boehringer Ingelheim Investigational Site	Bialystok
Poland	1237.19.48031 Boehringer Ingelheim Investigational Site	Bialystok
Poland	1237.19.48010 Boehringer Ingelheim Investigational Site	Bydgoszcz
Poland	1237.19.48029 Boehringer Ingelheim Investigational Site	Chojnice
Poland	1237.19.48001 Boehringer Ingelheim Investigational Site	Katowice
Poland	1237.19.48024 Boehringer Ingelheim Investigational Site	Kielce
Poland	1237.19.48005 Boehringer Ingelheim Investigational Site	Krakow
Poland	1237.19.48007 Boehringer Ingelheim Investigational Site	Krakow
Poland	1237.19.48015 Boehringer Ingelheim Investigational Site	Libiaz
Poland	1237.19.48006 Boehringer Ingelheim Investigational Site	Lodz
Poland	1237.19.48008 Boehringer Ingelheim Investigational Site	Lodz
Poland	1237.19.48025 Boehringer Ingelheim Investigational Site	Lublin
Poland	1237.19.48011 Boehringer Ingelheim Investigational Site	Olsztyn
Poland	1237.19.48013 Boehringer Ingelheim Investigational Site	Ostow Wielkopolski
Poland	1237.19.48019 Boehringer Ingelheim Investigational Site	Ostroda
Poland	1237.19.48020 Boehringer Ingelheim Investigational Site	Piaseczno
Poland	1237.19.48002 Boehringer Ingelheim Investigational Site	Poznan
Poland	1237.19.48004 Boehringer Ingelheim Investigational Site	Poznan
Poland	1237.19.48014 Boehringer Ingelheim Investigational Site	Poznan
Poland	1237.19.48016 Boehringer Ingelheim Investigational Site	Skierniewice
Poland	1237.19.48021 Boehringer Ingelheim Investigational Site	Swidnik
Poland	1237.19.48017 Boehringer Ingelheim Investigational Site	Szczecin
Poland	1237.19.48030 Boehringer Ingelheim Investigational Site	Tarnobrzeg
Poland	1237.19.48022 Boehringer Ingelheim Investigational Site	Warszawa
Poland	1237.19.48003 Boehringer Ingelheim Investigational Site	Wolomin
Poland	1237.19.48023 Boehringer Ingelheim Investigational Site	Wroclaw
Poland	1237.19.48018 Boehringer Ingelheim Investigational Site	Zawadzkie
Poland	1237.19.48012 Boehringer Ingelheim Investigational Site	Zgierz
Portugal	1237.19.35010 Boehringer Ingelheim Investigational Site	Almada
Portugal	1237.19.35005 Boehringer Ingelheim Investigational Site	Amadora
Portugal	1237.19.35008 Boehringer Ingelheim Investigational Site	Aveiro
Portugal	1237.19.35009 Boehringer Ingelheim Investigational Site	Braga
Portugal	1237.19.35001 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	1237.19.35012 Boehringer Ingelheim Investigational Site	Guimarães
Portugal	1237.19.35002 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1237.19.35004 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1237.19.35003 Boehringer Ingelheim Investigational Site	Porto
Portugal	1237.19.35006 Boehringer Ingelheim Investigational Site	Vila Nova de Gaia
Romania	1237.19.40007 Boehringer Ingelheim Investigational Site	Bragadiru
Romania	1237.19.40003 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1237.19.40004 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1237.19.40005 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1237.19.40008 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1237.19.40002 Boehringer Ingelheim Investigational Site	Constanta
Romania	1237.19.40006 Boehringer Ingelheim Investigational Site	Timisoara
Russian Federation	1237.19.70004 Boehringer Ingelheim Investigational Site	Arkhangelsk
Russian Federation	1237.19.70028 Boehringer Ingelheim Investigational Site	Barnaul
Russian Federation	1237.19.70017 Boehringer Ingelheim Investigational Site	Chelyabinsk
Russian Federation	1237.19.70020 Boehringer Ingelheim Investigational Site	Ekaterinburg
Russian Federation	1237.19.70014 Boehringer Ingelheim Investigational Site	Gatchina
Russian Federation	1237.19.70051 Boehringer Ingelheim Investigational Site	Ivanovo
Russian Federation	1237.19.70050 Boehringer Ingelheim Investigational Site	Kazan
Russian Federation	1237.19.70006 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1237.19.70023 Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	1237.19.70031 Boehringer Ingelheim Investigational Site	Kirov
Russian Federation	1237.19.70007 Boehringer Ingelheim Investigational Site	Lomonosov
Russian Federation	1237.19.70002 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1237.19.70003 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1237.19.70032 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1237.19.70047 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1237.19.70024 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1237.19.70025 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1237.19.70034 Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	1237.19.70035 Boehringer Ingelheim Investigational Site	Omsk
Russian Federation	1237.19.70033 Boehringer Ingelheim Investigational Site	Penza
Russian Federation	1237.19.70021 Boehringer Ingelheim Investigational Site	Pskov
Russian Federation	1237.19.70052 Boehringer Ingelheim Investigational Site	Rosto-on-Don
Russian Federation	1237.19.70015 Boehringer Ingelheim Investigational Site	Rostov-na-Donu
Russian Federation	1237.19.70005 Boehringer Ingelheim Investigational Site	Saratov
Russian Federation	1237.19.70040 Boehringer Ingelheim Investigational Site	Saratov
Russian Federation	1237.19.70044 Boehringer Ingelheim Investigational Site	Saratov
Russian Federation	1237.19.70009 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70010 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70011 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70012 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70018 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70019 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70022 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70038 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70041 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70042 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70046 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70048 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70049 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1237.19.70008 Boehringer Ingelheim Investigational Site	Tomsk
Russian Federation	1237.19.70026 Boehringer Ingelheim Investigational Site	Tomsk
Russian Federation	1237.19.70037 Boehringer Ingelheim Investigational Site	Ulyanovsk
Russian Federation	1237.19.70030 Boehringer Ingelheim Investigational Site	Volgograd
Russian Federation	1237.19.70036 Boehringer Ingelheim Investigational Site	Yaroslavl
Serbia	1237.19.38101 Boehringer Ingelheim Investigational Site	Belgrade
Serbia	1237.19.38102 Boehringer Ingelheim Investigational Site	Belgrade
Serbia	1237.19.38105 Boehringer Ingelheim Investigational Site	Belgrade
Serbia	1237.19.38107 Boehringer Ingelheim Investigational Site	Belgrade
Serbia	1237.19.38104 Boehringer Ingelheim Investigational Site	Kragujevac
Serbia	1237.19.38108 Boehringer Ingelheim Investigational Site	Nis
Serbia	1237.19.38106 Boehringer Ingelheim Investigational Site	Sombor
Serbia	1237.19.38103 Boehringer Ingelheim Investigational Site	Sremska Kamenica
Singapore	1237.19.65001 Boehringer Ingelheim Investigational Site	Singapore
Singapore	1237.19.65002 Boehringer Ingelheim Investigational Site	Singapore
Slovakia	1237.19.42101 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	1237.19.42104 Boehringer Ingelheim Investigational Site	Humenne
Slovakia	1237.19.42102 Boehringer Ingelheim Investigational Site	Kosice
Slovakia	1237.19.42106 Boehringer Ingelheim Investigational Site	Martin
Slovakia	1237.19.42107 Boehringer Ingelheim Investigational Site	Poprad
Slovakia	1237.19.42103 Boehringer Ingelheim Investigational Site	Spisska Nova Ves
Slovakia	1237.19.42105 Boehringer Ingelheim Investigational Site	Vrable
Slovenia	1237.19.38601 Boehringer Ingelheim Investigational Site	Golnik
Slovenia	1237.19.38603 Boehringer Ingelheim Investigational Site	Pohorje
Slovenia	1237.19.38602 Boehringer Ingelheim Investigational Site	Topolsica
South Africa	1237.19.27006 Boehringer Ingelheim Investigational Site	Amanzimtoti
South Africa	1237.19.27001 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1237.19.27002 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1237.19.27003 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1237.19.27007 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1237.19.27009 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1237.19.27011 Boehringer Ingelheim Investigational Site	Morningside, Sandton
South Africa	1237.19.27010 Boehringer Ingelheim Investigational Site	Parow
South Africa	1237.19.27004 Boehringer Ingelheim Investigational Site	Pretoria
South Africa	1237.19.27008 Boehringer Ingelheim Investigational Site	Pretoria
Spain	1237.19.34017 Boehringer Ingelheim Investigational Site	Alicante
Spain	1237.19.34025 Boehringer Ingelheim Investigational Site	Aranjuez
Spain	1237.19.34024 Boehringer Ingelheim Investigational Site	Badalona
Spain	1237.19.34011 Boehringer Ingelheim Investigational Site	Barakaldo (Bilbao)
Spain	1237.19.34012 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1237.19.34021 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1237.19.34007 Boehringer Ingelheim Investigational Site	Cáceres
Spain	1237.19.34028 Boehringer Ingelheim Investigational Site	Centelles
Spain	1237.19.34015 Boehringer Ingelheim Investigational Site	Girona
Spain	1237.19.34027 Boehringer Ingelheim Investigational Site	Granollers (Barcelona)
Spain	1237.19.34003 Boehringer Ingelheim Investigational Site	L'Hospitalet Llobregat (bcn)
Spain	1237.19.34001 Boehringer Ingelheim Investigational Site	Liencres (Pielagos)
Spain	1237.19.34005 Boehringer Ingelheim Investigational Site	Madrid
Spain	1237.19.34020 Boehringer Ingelheim Investigational Site	Madrid
Spain	1237.19.34009 Boehringer Ingelheim Investigational Site	Malaga
Spain	1237.19.34019 Boehringer Ingelheim Investigational Site	Mérida
Spain	1237.19.34013 Boehringer Ingelheim Investigational Site	Palma de Mallorca
Spain	1237.19.34004 Boehringer Ingelheim Investigational Site	Pamplona
Spain	1237.19.34018 Boehringer Ingelheim Investigational Site	Pozuelo de Alarcón
Spain	1237.19.34023 Boehringer Ingelheim Investigational Site	Sabadell
Spain	1237.19.34014 Boehringer Ingelheim Investigational Site	Sevilla
Spain	1237.19.34006 Boehringer Ingelheim Investigational Site	Valencia
Spain	1237.19.34029 Boehringer Ingelheim Investigational Site	Valladolid
Spain	1237.19.34026 Boehringer Ingelheim Investigational Site	Vic
Spain	1237.19.34022 Boehringer Ingelheim Investigational Site	Vilanova i la Geltrú
Spain	1237.19.34002 Boehringer Ingelheim Investigational Site	Zaragoza
Sweden	1237.19.46002 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	1237.19.46008 Boehringer Ingelheim Investigational Site	Härnösand
Sweden	1237.19.46004 Boehringer Ingelheim Investigational Site	Höllviken
Sweden	1237.19.46001 Boehringer Ingelheim Investigational Site	Lund
Sweden	1237.19.46005 Boehringer Ingelheim Investigational Site	Rättvik
Sweden	1237.19.46007 Boehringer Ingelheim Investigational Site	Stockholm
Switzerland	1237.19.41004 Boehringer Ingelheim Investigational Site	Ascona
Switzerland	1237.19.41002 Boehringer Ingelheim Investigational Site	Bern
Switzerland	1237.19.41001 Boehringer Ingelheim Investigational Site	Liestal
Taiwan	1237.19.88010 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1237.19.88011 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1237.19.88012 Boehringer Ingelheim Investigational Site	Kaohsiung City
Taiwan	1237.19.88004 Boehringer Ingelheim Investigational Site	New Taipei
Taiwan	1237.19.88009 Boehringer Ingelheim Investigational Site	New Taipei City
Taiwan	1237.19.88001 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1237.19.88005 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1237.19.88008 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1237.19.88013 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1237.19.88007 Boehringer Ingelheim Investigational Site	Taipei City
Thailand	1237.19.66008 Boehringer Ingelheim Investigational Site	Dusit
Thailand	1237.19.66005 Boehringer Ingelheim Investigational Site	Hat Yai
Thailand	1237.19.66003 Boehringer Ingelheim Investigational Site	Maerim
Thailand	1237.19.66001 Boehringer Ingelheim Investigational Site	Muang
Thailand	1237.19.66002 Boehringer Ingelheim Investigational Site	Muang
Thailand	1237.19.66007 Boehringer Ingelheim Investigational Site	Patumwan
Thailand	1237.19.66004 Boehringer Ingelheim Investigational Site	Rajathevee
Turkey	1237.19.90006 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1237.19.90007 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1237.19.90015 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1237.19.90016 Boehringer Ingelheim Investigational Site	Ankara
Turkey	1237.19.90008 Boehringer Ingelheim Investigational Site	Antalya
Turkey	1237.19.90010 Boehringer Ingelheim Investigational Site	Bursa
Turkey	1237.19.90002 Boehringer Ingelheim Investigational Site	Denizli
Turkey	1237.19.90012 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1237.19.90013 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1237.19.90014 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1237.19.90003 Boehringer Ingelheim Investigational Site	Izmir
Turkey	1237.19.90004 Boehringer Ingelheim Investigational Site	Izmir
Turkey	1237.19.90005 Boehringer Ingelheim Investigational Site	Izmir
Turkey	1237.19.90011 Boehringer Ingelheim Investigational Site	Izmir
Turkey	1237.19.90001 Boehringer Ingelheim Investigational Site	Kocaeli
Turkey	1237.19.90009 Boehringer Ingelheim Investigational Site	Konya
Turkey	1237.19.90000 Boehringer Ingelheim Investigational Site	Mersin
Ukraine	1237.19.38009 Boehringer Ingelheim Investigational Site	Ivano-Frankivsk
Ukraine	1237.19.38001 Boehringer Ingelheim Investigational Site	Kharkiv
Ukraine	1237.19.38005 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1237.19.38007 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1237.19.38002 Boehringer Ingelheim Investigational Site	Kyiv
Ukraine	1237.19.38003 Boehringer Ingelheim Investigational Site	Kyiv
Ukraine	1237.19.38004 Boehringer Ingelheim Investigational Site	Kyiv
Ukraine	1237.19.38006 Boehringer Ingelheim Investigational Site	Kyiv
Ukraine	1237.19.38010 Boehringer Ingelheim Investigational Site	Odesa
Ukraine	1237.19.38008 Boehringer Ingelheim Investigational Site	Vinnytsya
United Kingdom	1237.19.44008 Boehringer Ingelheim Investigational Site	Bedford
United Kingdom	1237.19.44006 Boehringer Ingelheim Investigational Site	Birmingham
United Kingdom	1237.19.44001 Boehringer Ingelheim Investigational Site	Bradford
United Kingdom	1237.19.44002 Boehringer Ingelheim Investigational Site	Chertsey
United Kingdom	1237.19.44004 Boehringer Ingelheim Investigational Site	Coventry
United Kingdom	1237.19.44007 Boehringer Ingelheim Investigational Site	Doncaster
United Kingdom	1237.19.44003 Boehringer Ingelheim Investigational Site	South Shields
United States	1237.19.10091 Boehringer Ingelheim Investigational Site	Abingdon	Virginia
United States	1237.19.10039 Boehringer Ingelheim Investigational Site	Andalusia	Alabama
United States	1237.19.10075 Boehringer Ingelheim Investigational Site	Ann Arbor	Michigan
United States	1237.19.10117 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	1237.19.10009 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1237.19.10070 Boehringer Ingelheim Investigational Site	Boerne	Texas
United States	1237.19.10048 Boehringer Ingelheim Investigational Site	Bowling Green	Kentucky
United States	1237.19.10094 Boehringer Ingelheim Investigational Site	Brooklyn	New York
United States	1237.19.10035 Boehringer Ingelheim Investigational Site	Burlington	North Carolina
United States	1237.19.10014 Boehringer Ingelheim Investigational Site	Calabash	North Carolina
United States	1237.19.10054 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	1237.19.10098 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	1237.19.10131 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	1237.19.10031 Boehringer Ingelheim Investigational Site	Chesterfield	Missouri
United States	1237.19.10008 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	1237.19.10042 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	1237.19.10029 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1237.19.10106 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1237.19.10083 Boehringer Ingelheim Investigational Site	Columbia	Maryland
United States	1237.19.10086 Boehringer Ingelheim Investigational Site	Columbia	South Carolina
United States	1237.19.10127 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1237.19.10107 Boehringer Ingelheim Investigational Site	Corsicana	Texas
United States	1237.19.10121 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	1237.19.10148 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	1237.19.10005 Boehringer Ingelheim Investigational Site	Delaware	Ohio
United States	1237.19.10080 Boehringer Ingelheim Investigational Site	Duluth	Georgia
United States	1237.19.10037 Boehringer Ingelheim Investigational Site	Eagle	Idaho
United States	1237.19.10058 Boehringer Ingelheim Investigational Site	Easley	South Carolina
United States	1237.19.10041 Boehringer Ingelheim Investigational Site	East Providence	Rhode Island
United States	1237.19.10049 Boehringer Ingelheim Investigational Site	Elizabeth City	North Carolina
United States	1237.19.10129 Boehringer Ingelheim Investigational Site	Erie	Pennsylvania
United States	1237.19.10123 Boehringer Ingelheim Investigational Site	Everett	Washington
United States	1237.19.10027 Boehringer Ingelheim Investigational Site	Fall River	Massachusetts
United States	1237.19.10034 Boehringer Ingelheim Investigational Site	Farmington Hills	Michigan
United States	1237.19.10069 Boehringer Ingelheim Investigational Site	Flagstaff	Arizona
United States	1237.19.10077 Boehringer Ingelheim Investigational Site	Florence	Alabama
United States	1237.19.10108 Boehringer Ingelheim Investigational Site	Fort Mitchell	Kentucky
United States	1237.19.10153 Boehringer Ingelheim Investigational Site	Fort Worth	Texas
United States	1237.19.10043 Boehringer Ingelheim Investigational Site	Fridley	Minnesota
United States	1237.19.10023 Boehringer Ingelheim Investigational Site	Gaffney	South Carolina
United States	1237.19.10030 Boehringer Ingelheim Investigational Site	Gaffney	South Carolina
United States	1237.19.10011 Boehringer Ingelheim Investigational Site	Gainesville	Georgia
United States	1237.19.10154 Boehringer Ingelheim Investigational Site	Gastonia	North Carolina
United States	1237.19.10024 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	1237.19.10128 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	1237.19.10104 Boehringer Ingelheim Investigational Site	Hickory	North Carolina
United States	1237.19.10072 Boehringer Ingelheim Investigational Site	Hollywood	Maryland
United States	1237.19.10047 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1237.19.10087 Boehringer Ingelheim Investigational Site	Huntersville	North Carolina
United States	1237.19.10099 Boehringer Ingelheim Investigational Site	Indian Land	South Carolina
United States	1237.19.10115 Boehringer Ingelheim Investigational Site	Jasper	Alabama
United States	1237.19.10126 Boehringer Ingelheim Investigational Site	Johnston	Rhode Island
United States	1237.19.10147 Boehringer Ingelheim Investigational Site	Kettering	Ohio
United States	1237.19.10111 Boehringer Ingelheim Investigational Site	Killeen	Texas
United States	1237.19.10059 Boehringer Ingelheim Investigational Site	Kingwood	Texas
United States	1237.19.10157 Boehringer Ingelheim Investigational Site	Lafayette	Colorado
United States	1237.19.10137 Boehringer Ingelheim Investigational Site	Larchmont	New York
United States	1237.19.10112 Boehringer Ingelheim Investigational Site	Lawrenceville	Georgia
United States	1237.19.10110 Boehringer Ingelheim Investigational Site	Lincoln	California
United States	1237.19.10118 Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	1237.19.10076 Boehringer Ingelheim Investigational Site	Lynchburg	Virginia
United States	1237.19.10081 Boehringer Ingelheim Investigational Site	Marlton	New Jersey
United States	1237.19.10061 Boehringer Ingelheim Investigational Site	McKinney	Texas
United States	1237.19.10021 Boehringer Ingelheim Investigational Site	Medford	Oregon
United States	1237.19.10097 Boehringer Ingelheim Investigational Site	Missoula	Montana
United States	1237.19.10001 Boehringer Ingelheim Investigational Site	Morgantown	West Virginia
United States	1237.19.10144 Boehringer Ingelheim Investigational Site	Mount Pleasant	South Carolina
United States	1237.19.10122 Boehringer Ingelheim Investigational Site	Muncie	Indiana
United States	1237.19.10071 Boehringer Ingelheim Investigational Site	Myrtle Beach	South Carolina
United States	1237.19.10109 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1237.19.10138 Boehringer Ingelheim Investigational Site	North Dartmouth	Massachusetts
United States	1237.19.10133 Boehringer Ingelheim Investigational Site	Norwalk	Connecticut
United States	1237.19.10130 Boehringer Ingelheim Investigational Site	O'Fallon	Illinois
United States	1237.19.10140 Boehringer Ingelheim Investigational Site	Oaks	Pennsylvania
United States	1237.19.10095 Boehringer Ingelheim Investigational Site	Opelousas	Louisiana
United States	1237.19.10020 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	1237.19.10085 Boehringer Ingelheim Investigational Site	Peoria	Arizona
United States	1237.19.10003 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	1237.19.10019 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	1237.19.10006 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1237.19.10136 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1237.19.10151 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	1237.19.10074 Boehringer Ingelheim Investigational Site	Poway	California
United States	1237.19.10007 Boehringer Ingelheim Investigational Site	Rapid City	South Dakota
United States	1237.19.10060 Boehringer Ingelheim Investigational Site	Reno	Nevada
United States	1237.19.10040 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	1237.19.10089 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	1237.19.10065 Boehringer Ingelheim Investigational Site	River Forest	Illinois
United States	1237.19.10096 Boehringer Ingelheim Investigational Site	Rochester	Minnesota
United States	1237.19.10025 Boehringer Ingelheim Investigational Site	Rock Hill	South Carolina
United States	1237.19.10101 Boehringer Ingelheim Investigational Site	Saint Charles	Missouri
United States	1237.19.10051 Boehringer Ingelheim Investigational Site	Saint Louis	Missouri
United States	1237.19.10084 Boehringer Ingelheim Investigational Site	Saint Louis	Missouri
United States	1237.19.10000 Boehringer Ingelheim Investigational Site	Saint Petersburg	Florida
United States	1237.19.10135 Boehringer Ingelheim Investigational Site	Saint Petersburg	Florida
United States	1237.19.10050 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1237.19.10053 Boehringer Ingelheim Investigational Site	Shelby	North Carolina
United States	1237.19.10113 Boehringer Ingelheim Investigational Site	Shreveport	Louisiana
United States	1237.19.10139 Boehringer Ingelheim Investigational Site	Shreveport	Louisiana
United States	1237.19.10033 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	1237.19.10036 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	1237.19.10120 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1237.19.10093 Boehringer Ingelheim Investigational Site	Stamford	Connecticut
United States	1237.19.10143 Boehringer Ingelheim Investigational Site	Syracuse	New York
United States	1237.19.10092 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	1237.19.10145 Boehringer Ingelheim Investigational Site	Tamarac	Florida
United States	1237.19.10066 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1237.19.10055 Boehringer Ingelheim Investigational Site	Toledo	Ohio
United States	1237.19.10063 Boehringer Ingelheim Investigational Site	Topeka	Kansas
United States	1237.19.10082 Boehringer Ingelheim Investigational Site	Traverse City	Michigan
United States	1237.19.10146 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	1237.19.10010 Boehringer Ingelheim Investigational Site	Union	South Carolina
United States	1237.19.10016 Boehringer Ingelheim Investigational Site	West Allis	Wisconsin
United States	1237.19.10142 Boehringer Ingelheim Investigational Site	Wheat Ridge	Colorado
United States	1237.19.10062 Boehringer Ingelheim Investigational Site	Wilmington	North Carolina
United States	1237.19.10032 Boehringer Ingelheim Investigational Site	Winter Park	Florida
United States	1237.19.10103 Boehringer Ingelheim Investigational Site	Worcester	Massachusetts
Vietnam	1237.19.84003 Boehringer Ingelheim Investigational Site	Ha Noi
Vietnam	1237.19.84001 Boehringer Ingelheim Investigational Site	Ho Chi Minh
Vietnam	1237.19.84002 Boehringer Ingelheim Investigational Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  India,  Ireland,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.	Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.	From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary	Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.	Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.	From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary	Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.	Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.	From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary	Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.	Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.	From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary	Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.	Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.	From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days

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