The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung funtion over time in patients with COPD.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: tiotropium	Phase III

Further Study Details: 

Primary Outcomes: The co-primary endpoints are:yearly rate of decline in pre and post bronchodilator FEV1 from day 30 (steady state) until completion of double-blind treatment.
Secondary Outcomes: Rate of decline in pre & post bronchodilator FEV1, FVC & SVC from day 1 until 30 days post treatment, rate of decline in pre & post bronchodilator FVC & SVC day 30 until completion of treatment, exacerbations/hospitalizations, SGRQ total score, mortality
Expected Total Enrollment:  6000

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria: patients >= 40 years of age, with smoking history of >= 10 pack-years, a diagnosis of COPD, FEV1 <= 70% of predicted normal and FEV1 <=70% of FVC Exclusion criteria: significant diseases other than COPD, recent MI (,6 mo.), unstable/lifethreatening arrhythmia or cardiac arrhythmia requiring change in therapy in past year, hospitalization for class III or IV heart failure in past year, asthma, cystic fibrosis, interstitial lung disease, bronchiectasis or pulmonary thromboembolic disease, thoracotomy with pulmonary resection, malignancy in past 5 years, planned lung transplant or LVRS, respiratory infection or exacerbation in 4 weeks preceding screening, moderate to severe renal impairment, narrow angle glaucome, significant symptomatic BPH or bladder neck obstruction, supplemental oxygen >12 hours/day, hypersensitivity to anticholinergic drugs or components of the delivery system.

Alabama
      Boehringer Ingelheim Investigational Site, Jasper,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Birmingham,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Anniston,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Birmingham,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Mobile,  Alabama,  United States
Arizona
      Boehringer Ingelheim Investigational Site, Phoenix,  Arizona,  United States
California
      Boehringer Ingelheim Investigational Site, San Diego,  California,  United States
      Boehringer Ingelheim Investigational Site, Los Angeles,  California,  United States
      Boehringer Ingelheim Investigational Site, Los Angeles,  California,  United States
      Boehringer Ingelheim Investigational Site, Carmichael,  California,  United States
      Boehringer Ingelheim Investigational Site, Los Angeles,  California,  United States
      Boehringer Ingelheim Investigational Site, Escondito,  California,  United States
      Boehringer Ingelheim Investigational Site, San Diego,  California,  United States
      Boehringer Ingelheim Investigational Site, Orange,  California,  United States
      Boehringer Ingelheim Investigational Site, Rancho Mirage,  California,  United States
      Boehringer Ingelheim Investigational Site, Los Angeles,  California,  United States
      Boehringer Ingelheim Investigational Site, Lakewood,  California,  United States
      Boehringer Ingelheim Investigational Site, Palo Alto,  California,  United States
      Boehringer Ingelheim Investigational Site, Long Beach,  California,  United States
      Boehringer Ingelheim Investigational Site, Sylmar,  California,  United States
      Boehringer Ingelheim Investigational Site, Stockton,  California,  United States
      Boehringer Ingelheim Investigational Site, San Diego,  California,  United States
      Boehringer Ingelheim Investigational Site, La Jolla,  California,  United States
      Boehringer Ingelheim Investigational Site, Long Beach,  California,  United States
      Boehringer Ingelheim Investigational Site, Sepulveda,  California,  United States
Colorado
      Boehringer Ingelheim Investigational Site, Denver,  Colorado,  United States
      Boehringer Ingelheim Investigational Site, Wheat Ridge,  Colorado,  United States
Connecticut
      Boehringer Ingelheim Investigational Site, Hartford,  Connecticut,  United States
      Boehringer Ingelheim Investigational Site, Norwalk,  Connecticut,  United States
      Boehringer Ingelheim Investigational Site, West Haven,  Connecticut,  United States
      Boehringer Ingelheim Investigational Site, Hartford,  Connecticut,  United States
Florida
      Boehringer Ingelheim Investigational Site, Panama City,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Largo,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Brandon,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Bay Pines,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Melbourne,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Melbourne,  Florida,  United States
      Boehringer Ingelheim Investigational Site, West Palm Beach,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Sarasota,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Tampa,  Florida,  United States
Georgia
      Boehringer Ingelheim Investigational Site, Atlanta,  Georgia,  United States
      Boehringer Ingelheim Investigational Site, Atlanta,  Georgia,  United States
      Boehringer Ingelheim Investigational Site, Stockbridge,  Georgia,  United States
      Boehringer Ingelheim Investigational Site, Augusta,  Georgia,  United States
Idaho
      Boehringer Ingelheim Investigational Site, Coeur D Alene,  Idaho,  United States
Illinois
      Boehringer Ingelheim Investigational Site, Normal,  Illinois,  United States
Indiana
      Boehringer Ingelheim Investigational Site, Indianapolis,  Indiana,  United States
Iowa
      Boehringer Ingelheim Investigational Site, Dubuque,  Iowa,  United States
Kansas
      Boehringer Ingelheim Investigational Site, Olathe,  Kansas,  United States
Kentucky
      Boehringer Ingelheim Investigational Site, Lexington,  Kentucky,  United States
Louisiana
      Boehringer Ingelheim Investigational Site, Shreveport,  Louisiana,  United States
      Boehringer Ingelheim Investigational Site, New Orleans,  Louisiana,  United States
Maine
      Boehringer Ingelheim Investigational Site, Auburn,  Maine,  United States
Maryland
      Boehringer Ingelheim Investigational Site, Baltimore,  Maryland,  United States
Massachusetts
      Boehringer Ingelheim Investigational Site, Boston,  Massachusetts,  United States
Michigan
      Boehringer Ingelheim Investigational Site, Livonia,  Michigan,  United States
      Boehringer Ingelheim Investigational Site, Ann Arbor,  Michigan,  United States
      Boehringer Ingelheim Investigational Site, Detroit,  Michigan,  United States
Minnesota
      Boehringer Ingelheim Investigational Site, Rochester,  Minnesota,  United States
      Boehringer Ingelheim Investigational Site, Minneapolis,  Minnesota,  United States
      Boehringer Ingelheim Investigational Site, Minneapolis,  Minnesota,  United States
Missouri
      Boehringer Ingelheim Investigational Site, Chesterfield,  Missouri,  United States
      Boehringer Ingelheim Investigational Site, Kansas City,  Missouri,  United States
      Boehringer Ingelheim Investigational Site, St. Louis,  Missouri,  United States
New Hampshire
      Boehringer Ingelheim Investigational Site, Lebanon,  New Hampshire,  United States
New Jersey
      Boehringer Ingelheim Investigational Site, Summit,  New Jersey,  United States
      Boehringer Ingelheim Investigational Site, Cherry Hill,  New Jersey,  United States
New York
      Boehringer Ingelheim Investigational Site, Bayshore,  New York,  United States
      Boehringer Ingelheim Investigational Site, Rochester,  New York,  United States
      Boehringer Ingelheim Investigational Site, Larchmont,  New York,  United States
      Boehringer Ingelheim Investigational Site, Manhasset,  New York,  United States
      Boehringer Ingelheim Investigational Site, Bronx,  New York,  United States
      Boehringer Ingelheim Investigational Site, New York,  New York,  United States
      Boehringer Ingelheim Investigational Site, Albany,  New York,  United States
      Boehringer Ingelheim Investigational Site, Mineola,  New York,  United States
North Carolina
      Boehringer Ingelheim Investigational Site, Winston Salem,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Burlington,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Durham,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Chapel Hill,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Elizabath City,  North Carolina,  United States
Ohio
      Boehringer Ingelheim Investigational Site, Cincinnati,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Cleveland,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Cincinnati,  Ohio,  United States
Oklahoma
      Boehringer Ingelheim Investigational Site, Tulsa,  Oklahoma,  United States
Oregon
      Boehringer Ingelheim Investigational Site, Portland,  Oregon,  United States
      Boehringer Ingelheim Investigational Site, Portland,  Oregon,  United States
Pennsylvania
      Boehringer Ingelheim Investigational Site, Philadelphia,  Pennsylvania,  United States
      Boehringer Ingelheim Investigational Site, Hershey,  Pennsylvania,  United States
Rhode Island
      Boehringer Ingelheim Investigational Site, Providence,  Rhode Island,  United States
Texas
      Boehringer Ingelheim Investigational Site, El Paso,  Texas,  United States
      Boehringer Ingelheim Investigational Site, San Antonio,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Houston,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Houston,  Texas,  United States
Utah
      Boehringer Ingelheim Investigational Site, Salt Lake City,  Utah,  United States
Virginia
      Boehringer Ingelheim Investigational Site, Salem,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Richmond,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Lynchburg,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Fredericksburg,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Richmond,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Danville,  Virginia,  United States
Washington
      Boehringer Ingelheim Investigational Site, Spokane,  Washington,  United States
Wisconsin
      Boehringer Ingelheim Investigational Site, La Crosse,  Wisconsin,  United States
Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aies,  Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aires,  Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aires,  Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aires,  Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aires,  Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aires,  Argentina
      Boehringer Ingelheim Investigational Site, Buenos Aires,  Argentina
      Boehringer Ingelheim Investigational Site, Parque Velez Sarlfield - Córdoba,  Argentina
      Boehringer Ingelheim Investigational Site, Rosario - Argentina,  Argentina
      Boehringer Ingelheim Investigational Site, Vicente López- Prov.Buenos Aires,  Argentina
Australia, New South Wales
      Boehringer Ingelheim Investigational Site, Bankstown,  New South Wales,  Australia
      Boehringer Ingelheim Investigational Site, Concord,  New South Wales,  Australia
      Boehringer Ingelheim Investigational Site, Westmead,  New South Wales,  Australia
Australia, Queensland
      Boehringer Ingelheim Investigational Site, Cairns,  Queensland,  Australia
      Boehringer Ingelheim Investigational Site, Redcliffe,  Queensland,  Australia
Australia, South Australia
      Boehringer Ingelheim Investigational Site, Port Lincoln,  South Australia,  Australia
Australia, Victoria
      Boehringer Ingelheim Investigational Site, Box Hill,  Victoria,  Australia
      Boehringer Ingelheim Investigational Site, Geelong,  Victoria,  Australia
Austria
      Boehringer Ingelheim Investigational Site, Graz,  Austria
      Boehringer Ingelheim Investigational Site, Innsbruck,  Austria
      Boehringer Ingelheim Investigational Site, Leoben,  Austria
      Boehringer Ingelheim Investigational Site, Wien,  Austria
      Boehringer Ingelheim Investigational Site, Wien,  Austria
Belgium
      Boehringer Ingelheim Investigational Site, Anderlecht,  Belgium
      Boehringer Ingelheim Investigational Site, Baudour,  Belgium
      Boehringer Ingelheim Investigational Site, Brugge,  Belgium
      Boehringer Ingelheim Investigational Site, Brussel,  Belgium
      Boehringer Ingelheim Investigational Site, BRUXELLES,  Belgium
      Boehringer Ingelheim Investigational Site, BRUXELLES,  Belgium
      Boehringer Ingelheim Investigational Site, Dendermonde,  Belgium
      Boehringer Ingelheim Investigational Site, Edegem,  Belgium
      Boehringer Ingelheim Investigational Site, Gent,  Belgium
      Boehringer Ingelheim Investigational Site, Herentals,  Belgium
      Boehringer Ingelheim Investigational Site, Ieper,  Belgium
      Boehringer Ingelheim Investigational Site, Kortrijk,  Belgium
      Boehringer Ingelheim Investigational Site, Leuven,  Belgium
      Boehringer Ingelheim Investigational Site, Menen,  Belgium
      Boehringer Ingelheim Investigational Site, Merksem,  Belgium
      Boehringer Ingelheim Investigational Site, Middelheim,  Belgium
      Boehringer Ingelheim Investigational Site, Mons,  Belgium
      Boehringer Ingelheim Investigational Site, Namur,  Belgium
      Boehringer Ingelheim Investigational Site, Neerpelt,  Belgium
      Boehringer Ingelheim Investigational Site, Nobressart (ATTERT),  Belgium
      Boehringer Ingelheim Investigational Site, Oostende,  Belgium
      Boehringer Ingelheim Investigational Site, Tournai,  Belgium
      Boehringer Ingelheim Investigational Site, TURNHOUT,  Belgium
      Boehringer Ingelheim Investigational Site, TURNHOUT,  Belgium
      Boehringer Ingelheim Investigational Site, Yvoir,  Belgium
Brazil
      Boehringer Ingelheim Investigational Site, Florianópolis-SC,  Brazil
      Boehringer Ingelheim Investigational Site, Juiz de Fora - MG,  Brazil
      Boehringer Ingelheim Investigational Site, Porto Alegre-RS,  Brazil
      Boehringer Ingelheim Investigational Site, Porto Alegre-RS,  Brazil
      Boehringer Ingelheim Investigational Site, Porto Alegre-RS,  Brazil
      Boehringer Ingelheim Investigational Site, Porto Alegre-RS,  Brazil
      Boehringer Ingelheim Investigational Site, Porto Alegre-RS,  Brazil
      Boehringer Ingelheim Investigational Site, Rio de Janeiro - RJ,  Brazil
      Boehringer Ingelheim Investigational Site, Rio de Janeiro - RJ,  Brazil
      Boehringer Ingelheim Investigational Site, Salvador - BA,  Brazil
      Boehringer Ingelheim Investigational Site, Santo André-SP,  Brazil
      Boehringer Ingelheim Investigational Site, São Paulo-SP,  Brazil
      Boehringer Ingelheim Investigational Site, São Paulo-SP,  Brazil
      Boehringer Ingelheim Investigational Site, São Paulo-SP,  Brazil
      Boehringer Ingelheim Investigational Site, São Paulo-SP,  Brazil
Czech Republic
      Boehringer Ingelheim Investigational Site, Benesov,  Czech Republic
      Boehringer Ingelheim Investigational Site, Beroun,  Czech Republic
      Boehringer Ingelheim Investigational Site, Brno,  Czech Republic
      Boehringer Ingelheim Investigational Site, Brno,  Czech Republic
      Boehringer Ingelheim Investigational Site, Cesky Tesin,  Czech Republic
      Boehringer Ingelheim Investigational Site, HRADEC KRALOVE,  Czech Republic
      Boehringer Ingelheim Investigational Site, Jablonec nad Nisou,  Czech Republic
      Boehringer Ingelheim Investigational Site, Jaromer,  Czech Republic
      Boehringer Ingelheim Investigational Site, Kromeriz,  Czech Republic
      Boehringer Ingelheim Investigational Site, Kyjov,  Czech Republic
      Boehringer Ingelheim Investigational Site, Lovosice,  Czech Republic
      Boehringer Ingelheim Investigational Site, Marianske Lazne,  Czech Republic
      Boehringer Ingelheim Investigational Site, Plzen,  Czech Republic
      Boehringer Ingelheim Investigational Site, Plzen,  Czech Republic
      Boehringer Ingelheim Investigational Site, Prague 5,  Czech Republic
      Boehringer Ingelheim Investigational Site, Praha 4,  Czech Republic
      Boehringer Ingelheim Investigational Site, Praha 4,  Czech Republic
      Boehringer Ingelheim Investigational Site, Praha 5,  Czech Republic
      Boehringer Ingelheim Investigational Site, Praha 5 - Nove Butovice,  Czech Republic
      Boehringer Ingelheim Investigational Site, Praha-8,  Czech Republic
      Boehringer Ingelheim Investigational Site, Prerov,  Czech Republic
      Boehringer Ingelheim Investigational Site, Pribor,  Czech Republic
      Boehringer Ingelheim Investigational Site, Strakonice,  Czech Republic
      Boehringer Ingelheim Investigational Site, Tabor,  Czech Republic
      Boehringer Ingelheim Investigational Site, Usti nad Orlici,  Czech Republic
      Boehringer Ingelheim Investigational Site, Znojmo,  Czech Republic
Denmark
      Boehringer Ingelheim Investigational Site, Aalborg,  Denmark
      Boehringer Ingelheim Investigational Site, Aalborg SV,  Denmark
      Boehringer Ingelheim Investigational Site, Copenhagen,  Denmark
      Boehringer Ingelheim Investigational Site, Copenhagen K,  Denmark
      Boehringer Ingelheim Investigational Site, Copenhagen Nv,  Denmark
      Boehringer Ingelheim Investigational Site, Frederikshavn,  Denmark
      Boehringer Ingelheim Investigational Site, Frederikssund,  Denmark
      Boehringer Ingelheim Investigational Site, Fåborg,  Denmark
      Boehringer Ingelheim Investigational Site, Hellerup,  Denmark
      Boehringer Ingelheim Investigational Site, Hellerup,  Denmark
      Boehringer Ingelheim Investigational Site, Helsingor,  Denmark
      Boehringer Ingelheim Investigational Site, Hillerød,  Denmark
      Boehringer Ingelheim Investigational Site, Hobro,  Denmark
      Boehringer Ingelheim Investigational Site, Holbæk,  Denmark
      Boehringer Ingelheim Investigational Site, Holstebro,  Denmark
      Boehringer Ingelheim Investigational Site, Hvidovre,  Denmark
      Boehringer Ingelheim Investigational Site, Kalundborg,  Denmark
      Boehringer Ingelheim Investigational Site, Kolding,  Denmark
      Boehringer Ingelheim Investigational Site, Nykobing F.,  Denmark
      Boehringer Ingelheim Investigational Site, Næstved,  Denmark
      Boehringer Ingelheim Investigational Site, Odense C,  Denmark
      Boehringer Ingelheim Investigational Site, Randers,  Denmark
      Boehringer Ingelheim Investigational Site, SILKEBORG,  Denmark
      Boehringer Ingelheim Investigational Site, Skive,  Denmark
      Boehringer Ingelheim Investigational Site, Skive,  Denmark
      Boehringer Ingelheim Investigational Site, Skive,  Denmark
      Boehringer Ingelheim Investigational Site, Slagelse,  Denmark
      Boehringer Ingelheim Investigational Site, Svendborg,  Denmark
      Boehringer Ingelheim Investigational Site, Værløse,  Denmark
Finland
      Boehringer Ingelheim Investigational Site, Helsinki,  Finland
      Boehringer Ingelheim Investigational Site, Kinkomaa,  Finland
      Boehringer Ingelheim Investigational Site, Kotka,  Finland
      Boehringer Ingelheim Investigational Site, Lahti,  Finland
      Boehringer Ingelheim Investigational Site, Pori,  Finland
France
      Boehringer Ingelheim Investigational Site, Albi,  France
      Boehringer Ingelheim Investigational Site, Albi,  France
      Boehringer Ingelheim Investigational Site, Bourges,  France
      Boehringer Ingelheim Investigational Site, Barbezieux St Hilaire,  France
      Boehringer Ingelheim Investigational Site, Chauny,  France
      Boehringer Ingelheim Investigational Site, Cholet,  France
      Boehringer Ingelheim Investigational Site, Chamalières,  France
      Boehringer Ingelheim Investigational Site, La Teste,  France
      Boehringer Ingelheim Investigational Site, Montauban,  France
      Boehringer Ingelheim Investigational Site, Nantes,  France
      Boehringer Ingelheim Investigational Site, Nice,  France
      Boehringer Ingelheim Investigational Site, Paris,  France
      Boehringer Ingelheim Investigational Site, Provins,  France
      Boehringer Ingelheim Investigational Site, Strasbourg,  France
      Boehringer Ingelheim Investigational Site, Tarbes,  France
      Boehringer Ingelheim Investigational Site, Toulouse,  France
Germany
      Boehringer Ingelheim Investigational Site, Berlin,  Germany
      Boehringer Ingelheim Investigational Site, Berlin,  Germany
      Boehringer Ingelheim Investigational Site, Brake,  Germany
      Boehringer Ingelheim Investigational Site, Braunschweig,  Germany
      Boehringer Ingelheim Investigational Site, Bruchsal,  Germany
      Boehringer Ingelheim Investigational Site, Hannover,  Germany
      Boehringer Ingelheim Investigational Site, Kaufbeuren,  Germany
      Boehringer Ingelheim Investigational Site, Lörrach,  Germany
      Boehringer Ingelheim Investigational Site, LÜBECK,  Germany
      Boehringer Ingelheim Investigational Site, München,  Germany
      Boehringer Ingelheim Investigational Site, München,  Germany
      Boehringer Ingelheim Investigational Site, Ulm,  Germany
      Boehringer Ingelheim Investigational Site, Weyhe,  Germany
      Boehringer Ingelheim Investigational Site, Wiesloch,  Germany
Greece
      Boehringer Ingelheim Investigational Site, Athens,  Greece
      Boehringer Ingelheim Investigational Site, Athens,  Greece
      Boehringer Ingelheim Investigational Site, Heraklion,  Greece
      Boehringer Ingelheim Investigational Site, Kavala,  Greece
      Boehringer Ingelheim Investigational Site, Larissa,  Greece
      Boehringer Ingelheim Investigational Site, Patra,  Greece
      Boehringer Ingelheim Investigational Site, Patra,  Greece
      Boehringer Ingelheim Investigational Site, THESSALONIKI,  Greece
      Boehringer Ingelheim Investigational Site, THESSALONIKI,  Greece
      Boehringer Ingelheim Investigational Site, THESSALONIKI,  Greece
Hong Kong
      Boehringer Ingelheim Investigational Site, Hong Kong,  Hong Kong
      Boehringer Ingelheim Investigational Site, Hong Kong,  Hong Kong
      Boehringer Ingelheim Investigational Site, Hong Kong,  Hong Kong
      Boehringer Ingelheim Investigational Site, Kowloon,  Hong Kong
Hungary
      Boehringer Ingelheim Investigational Site, Budapest,  Hungary
      Boehringer Ingelheim Investigational Site, Budapest,  Hungary
      Boehringer Ingelheim Investigational Site, Budapest,  Hungary
      Boehringer Ingelheim Investigational Site, Budapest,  Hungary
      Boehringer Ingelheim Investigational Site, Budapest,  Hungary
      Boehringer Ingelheim Investigational Site, Budapest,  Hungary
      Boehringer Ingelheim Investigational Site, Debrecen,  Hungary
      Boehringer Ingelheim Investigational Site, Deszk,  Hungary
      Boehringer Ingelheim Investigational Site, Erd,  Hungary
      Boehringer Ingelheim Investigational Site, Farkasgyepü,  Hungary
      Boehringer Ingelheim Investigational Site, Gyula,  Hungary
      Boehringer Ingelheim Investigational Site, Kiskunhalas,  Hungary
      Boehringer Ingelheim Investigational Site, Miskolc,  Hungary
      Boehringer Ingelheim Investigational Site, Mosonmagyarovar,  Hungary
      Boehringer Ingelheim Investigational Site, Pecs,  Hungary
      Boehringer Ingelheim Investigational Site, Sopron,  Hungary
      Boehringer Ingelheim Investigational Site, Szombathely,  Hungary
      Boehringer Ingelheim Investigational Site, Tatabanya,  Hungary
      Boehringer Ingelheim Investigational Site, Törökbalint,  Hungary
      Boehringer Ingelheim Investigational Site, Veszprem,  Hungary
Ireland
      Boehringer Ingelheim Investigational Site, Cork,  Ireland
      Boehringer Ingelheim Investigational Site, Dublin,  Ireland
      Boehringer Ingelheim Investigational Site, Dublin,  Ireland
      Boehringer Ingelheim Investigational Site, Dublin,  Ireland
Italy
      Boehringer Ingelheim Investigational Site, Alessandria,  Italy
      Boehringer Ingelheim Investigational Site, Avellino,  Italy
      Boehringer Ingelheim Investigational Site, Bologna,  Italy
      Boehringer Ingelheim Investigational Site, Busto Arsizio (VA),  Italy
      Boehringer Ingelheim Investigational Site, CASSANO D''''ADDA (Milano),  Italy
      Boehringer Ingelheim Investigational Site, Cagliari,  Italy
      Boehringer Ingelheim Investigational Site, Carrara (Massa),  Italy
      Boehringer Ingelheim Investigational Site, Chieti,  Italy
      Boehringer Ingelheim Investigational Site, Erice (Trapani),  Italy
      Boehringer Ingelheim Investigational Site, Firenze,  Italy
      Boehringer Ingelheim Investigational Site, Ferrara,  Italy
      Boehringer Ingelheim Investigational Site, Firenze,  Italy
      Boehringer Ingelheim Investigational Site, Genova,  Italy
      Boehringer Ingelheim Investigational Site, Gubbio (Perugia),  Italy
      Boehringer Ingelheim Investigational Site, Iglesias (Cagliari),  Italy
      Boehringer Ingelheim Investigational Site, L''''Aquila,  Italy
      Boehringer Ingelheim