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SUPPLEMENTARY FILE 1. LIST OF INVESTIGATORS AND IECS/IRBS FOR STUDY 117115

|Investigator |Investigator no./center |Description of research facility, hospital/ |Name of IEC/IRB committee, address, |

| |no. |institution, and address |committee chair |

|Bulgaria | | | |

|Dimov, Dimo M. MD, PhD|227054/200066 |MHAT "Prof. Stoyan Kirkovich", 11, Armeiska |Ethics Committee for Multicenter |

| | |Street, Stara Zagora, 6003, Bulgaria |Clinical Trials, 5, Sveta Nedelya |

| | | |Square, Sofia, 1000, Bulgaria |

| | | |Chairperson: Stoykov, Anastas |

|Dudevska, Tsvetomila |225221/200067 |SHATPulmD Troyan, 253, Vassil Levski street, |Ethics Committee for Multicenter |

|Vasileva. MD | |Troyan, 5600, Bulgaria |Clinical Trials, 5, Sveta Nedelya |

| | | |Square, Sofia, 1000, Bulgaria |

| | | |Chairperson: Stoykov, Anastas |

|Hodzhev, Vladimir A. |009942/200087 |MHAT ''Sveti Georgi", Department of Respiratory |Ethics Committee for Multicenter |

|MD, PhD | |Diseases, 66 Peshtersko Shose, Plovdiv, 4002, |Clinical Trials, 5, Sveta Nedelya |

| | |Bulgaria |Square, Sofia, 1000, Bulgaria |

| | | |Chairperson: Stoykov, Anastas |

|Ivanov, Yavor J. MD |027904/200062 |Multiprofile Hospital for Active Treatment "Dr. |Ethics Committee for Multicenter |

| | |Georgi Stranski", Clinic of Pneumology and |Clinical Trials, 5, Sveta Nedelya |

| | |Phtisiatry, 81, Vladimir Vazov Street, Pleven, |Square, Sofia, 1000, Bulgaria |

| | |5800, Bulgaria |Chairperson: Stoykov, Anastas |

|Nova -Gocheva, Ivanka |151752/200064 |Multiprofile Hospital for Active Treatment |Ethics Committee for Multicenter |

|Dinkova. MD | |"Sveta Ekaterina", 29, Hristo Botev Street, |Clinical Trials, 5, Sveta Nedelya |

| | |Dimitrovgrad, 6400, Bulgaria |Square, Sofia, 1000, Bulgaria |

| | | |Chairperson: Stoykov, Anastas |

|Metev, Hristo. PhD |009842/200063 |Specialized hospital for active treatment of |Ethics Committee for Multicenter |

| | |pneumophthisiatric diseases 1, Aleja Lilia |Clinical Trials, 5, Sveta Nedelya |

| | |Street, Rousse, 7000, Bulgaria |Square, Sofia, 1000, Bulgaria |

| | | |Chairperson: Stoykov, Anastas |

|Peneva, Marinka T. MD,|009937/200086 |DCC Mladost M -Varna, 15, Republika boulevard, |Ethics Committee for Multicenter |

|PhD | |Varna, 9000, Bulgaria |Clinical Trials, 5, Sveta Nedelya |

| | | |Square, Sofia, 1000, Bulgaria |

| | | |Chairperson: Stoykov, Anastas |

| | | | |

|Canada | | | |

|Belle-Isle, Jasmin. |030764/106138 |Alpha Recherche Clinique, 1147 boul Pie XI Nord,|Institutional Review Board Services, |

|MD, LMCC, CCFP | |Suite 207, Quebec, Québec, G3K 2P8, Canada |Suite 300, 372 Hollandview Trail, |

| | | |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Fera, Tharwat AE. MD, |003994/106153 |Office of Tharwat Fera, Suite 910, 943 West |Institutional Review Board Services, |

|MBChB, FRCP, FCCP | |Broadway, Vancouver, British Columbia, V5Z 4E1, |Suite 300, 372 Hollandview Trail, |

| | |Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Girard, Ginette. MD, |006272/106144 |Diex Recherche Sherbrooke Inc., Suite 120, 731, |Institutional Review Board Services, |

|CPI, LMCC | |Galt Ouest,, Sherbrooke, Québec, J1H 1Z1, Canada|Suite 300, 372 Hollandview Trail, |

| | | |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Greenspoon, Allen. MD |004047/106145 |Office of Allen Greenspoon, Suite M1, 414 |Institutional Review Board Services, |

| | |Victoria Avenue North, Hamilton, Ontario, L8L |Suite 300, 372 Hollandview Trail, |

| | |5G8, Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Killorn, W.Patrick. |201769/106140 |Burlington Lung Clinic, Suite 401, 3155 |Institutional Review Board Services, |

|MD, FRCPC, FCCP, LMCC | |Harvester Road, Burlington, Ontario, L7N 3V2, |Suite 300, 372 Hollandview Trail, |

| | |Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Landry, Daniel. MD |004135/106142 |G.A. Research Associates Ltd/Ltee, Suite 206, |Institutional Review Board Services, |

| | |1789 Mountain Road, Moncton, New Brunswick, E1G |Suite 300, 372 Hollandview Trail, |

| | |1A7, Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Lasko, Benjamin H. MD,|011985/106134 |Manna Research, Suite 117B, 2291 Kipling Avenue,|Institutional Review Board Services, |

|LMCC, CCFP, MB ChB | |Toronto, Ontario, M9W 4L6, Canada |Suite 300, 372 Hollandview Trail, |

| | | |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Maleki-Yazdi, M. Reza.|057618/106141 |Pulmonary Care Clinic and Research Centre, Suite|Institutional Review Board Services, |

|MD, FRCPC, FCCP, LMCC | |608, 790 Bay Street, Toronto, Ontario, M5G 1N8, |Suite 300, 372 Hollandview Trail, |

| | |Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Mazza, Giuseppe. MD, |004198/106136 |Recherche GCP Research, Suite 200, 1021 |Institutional Review Board Services, |

|LMCC | |Jean-Talon est, Montreal, Québec, H2R 1V6, |Suite 300, 372 Hollandview Trail, |

| | |Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Pek, Bonavuth. MD, |220890/106139 |Clinique de pneumologie et du sommeil |Institutional Review Board Services, |

|FRCP, LMCC | |Lanaudière, Suite 307, 28 Chemin du Golf est, |Suite 300, 372 Hollandview Trail, |

| | |St-Charles-Borromée, Québec, J6E 2B4, Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Pliamm, Lew. MD |050085/106143 |Canadian Phase Onward Inc., Unit 5, 4646 |Institutional Review Board Services, |

| | |Dufferin Street, Toronto, Ontario, M3H 5S4, |Suite 300, 372 Hollandview Trail, |

| | |Canada |Aurora, Ontario, L4G 0A5, Canada |

| | | |Chairperson: Blajchman, Morris |

|Germany | | | |

|Ballenberger, Sabine. |189718/200026 |Ballenberger, Freytag, Wenisch-Institut fuer |Ethik-Kommission der Landesaerztekammer|

| | |klinische Forschung GmbH, Robert-Koch-Strasse 7,|Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |Neu-Isenburg, Hessen, 63263, Germany |Hessen, 60488, Germany |

| | | |Chairperson: Harder, Sebastian. Dr.med |

|Degtyareva, Elizaveta.|131201/200027 |Synexus Clinical Research, Klinisches |Ethik-Kommission der Landesaerztekammer|

| | |Prüfzentrum Leipzig, Johannisplatz 1, Leipzig, |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |Sachsen, 04103, Germany |Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Eich, Andreas. Dr.med |122917/200035 |IKF Pneumologie GmbH and Co. KG, Institut fuer |Ethik-Kommission der Landesaerztekammer|

| | |klinische Forschung Pneumologie, Schaumainkai |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |101-103 , Stresemannallee3, Frankfurt, Hessen, |Hessen, 60488, Germany Chairperson: |

| | |60596, Germany |Harder, Sebastian. Dr.med |

|Hoheisel, Gerhard. |006423/200036 |Praxis Dr. med. Gerhard Hoheisel, |Ethik-Kommission der Landesaerztekammer|

|Dr.med. MD | |AugustBebel-Strasse 69, Leipzig, Sachsen, 04275,|Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |Germany |Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Jandl, Margret. Dr.med|116973/200083 |Hamburger Institut fuer Therapieforschung GmbH, |Ethik-Kommission der Landesaerztekammer|

| | |Colonnaden 72, Hamburg, Hamburg, 20354, Germany |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | | |Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Schaper, Lennart. |121671/200037 |Studienpraxis Berlin-Brandenburg, Arztehaus |Ethik-Kommission der Landesaerztekammer|

| | |Torstrasse, Torstrasse 117, Berlin, Berlin, |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |10119, Germany |Hessen, 60488, Germany |

| | | |Chairperson: Harder, Sebastian. Dr.med |

|Schenkenberger, |042792/200061 |KFB-Klinsche Forschung Berlin, Ansbacher Strasse|Ethik-Kommission der Landesaerztekammer|

|Isabelle. Dr.med. MD | |17-19, Berlin, Berlin, 10787, Germany |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | | |Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Tyler, Kerstin. Dr.med|055882/200057 |POLIKUM Institut MVZ(Medizinische |Ethik-Kommission der Landesaerztekammer|

| | |Versorgungszentrum) GmbH, Standort Friedenau, |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |Rubenstrasse 119, Berlin, Berlin, 12157, Germany|Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Voges, Ole. Dr.med |243642/200058 |ABX-CRO Advanced Pharmaceutical |Ethik-Kommission der Landesaerztekammer|

| | |Forschungsgesellschaft mBH Services, Blasewitzer|Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |Strasse 78-80, Dresden, Sachsen, 01307, Germany |Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Zachgo, Wolfgang. |006248/200059 |Pneumologisches Forschungsinstitut Hohegeest |Ethik-Kommission der Landesaerztekammer|

|Dr.med. MD | |GbR, Bohnenstrasse 1, Geesthacht, |Hessen, Im Vogelsgesang 3, Frankfurt, |

| | |Schleswig-Holstein, 21502, Germany |Hessen, 60488, Germany Chairperson: |

| | | |Harder, Sebastian. Dr.med |

|Hungary | | | |

|Gömöri, Katalin. MD |145400/107713 |Dr. Kenessey Albert Kórház és, Pulmonologia, |Egészségügyi Tudományos Tanács, |

| | |Rendelőintézet, Rákóczi utca 125-127, |Klinikai Farmakologiai Etikai |

| | |Balassagyarmat, 2660, Hungary |Bizottság, Arany János u. 6- |

| | | |8, Budapest, 1051, Hungary Chairperson:|

| | | |Fürst, Zsuzsanna |

|Mucsi, János. MD |220776/200141 |Erzsébet Gondozó Ház Kft., Légszesz u. 6., |Egészségügyi Tudományos Tanács, |

| | |Gödöllő, 2100, Hungary |Klinikai Farmakologiai Etikai |

| | | |Bizottság, Arany János u. 68, Budapest,|

| | | |1051, Hungary Chairperson: Fürst, |

| | | |Zsuzsanna |

|Száraz, Éva. MD |223432/200138 |Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa |Egészségügyi Tudományos Tanács, |

| | |András Oktató Kórház, Egeszsegugyi Nonprofit |Klinikai Farmakologiai Etikai |

| | |Kft., Pulmonológiai Osztaly, Sóstói út 62., |Bizottság, Arany János u. 68, Budapest,|

| | |Nyíregyháza, 4400, Hungary |1051, Hungary Chairperson: Fürst, |

| | | |Zsuzsanna |

|Szentpéteri, Imre. MD |141233/107721 |CRU Hungary Kft, Kassai út 45-49., Szikszó, |Egészségügyi Tudományos Tanács, |

| | |3800, Hungary |Klinikai Farmakologiai Etikai |

| | | |Bizottság, Arany János u. 6- |

| | | |8, Budapest, 1051, Hungary Chairperson:|

| | | |Fürst, Zsuzsanna |

|Szilasi, Mária. MD, |001951/107715 |Debreceni Egyetem Orvos-es Egeszsegtudomanyi |Egészségügyi Tudományos Tanács, |

|PhD | |Centrum Tudogyogyaszati Klinika, Nagyerdei Krt. |Klinikai Farmakologiai Etikai |

| | |98, Debrecen, 4032, Hungary |Bizottság, Arany János u. 68, Budapest,|

| | | |1051, Hungary Chairperson: Fürst, |

| | | |Zsuzsanna |

|Udud, Katalin. MD |063501/200140 |Medical-Diag System Kft, Szabadság utca 14, |Egészségügyi Tudományos Tanács, |

| | |Budaörs, 2040, Hungary |Klinikai Farmakologiai Etikai |

| | | |Bizottság, Arany János u. 68, Budapest,|

| | | |1051, Hungary Chairperson: Fürst, |

| | | |Zsuzsanna |

|Romania | | | |

|Cirstoniu, Mihaela |189956/106575 |Spitalului Clinic de Pneumoftiziologie “Leon |Comisia Naţională de Etică, Strada |

|Carmen. | |Daniello” Cluj, Strada B. P. Hasdeu nr 6, Cluj |Aviator Sănătescu 48, Bucureşti, |

| | |Napoca, 400371, Romania |011478, Romania Chairperson: |

| | | |Dumitrescu, Sava |

|Filip, Livia. MD, PhD |229636/106576 |Spitalul Clinic de Pneumoftiziologie "Leon |Comisia Naţională de Etică, Strada |

| | |Daniello", Strada B.P. Hasdeu nr. 6, |Aviator Sănătescu 48, Bucureşti, |

| | |Cluj-Napoca, jud.Cluj, 400371, Romania |011478, Romania Chairperson: |

| | | |Dumitrescu, Sava |

|Gica, Cristina. MD |222543/106579 |Spitalul Clinic Prof. Dr. Dimitrie Gerota-MAI, |Comisia Naţională de Etică, Strada |

| | |Strada Dionisie Lupu Nr.63, sect 1, Bucuresti, |Aviator Sănătescu 48, Bucureşti, |

| | |70000, Romania |011478, Romania Chairperson: |

| | | |Dumitrescu, Sava |

|Nemes, Roxana. MD, PhD|075037/106577 |Institutului de Pneumoftiziologie “Marius |Comisia Naţională de Etică, Strada |

| | |Nasta”, Sos Viilor 90, Bucuresti, 050159, |Aviator Sănătescu 48, Bucureşti, |

| | |Romania |011478, Romania Chairperson: |

| | | |Dumitrescu, Sava |

|Petrui, Ioan-Dorin. MD|150574/106581 |SC Medical Center SRL, Pneumology Consulting |Comisia Naţională de Etică, Strada |

| | |Room, Speciality Ambulatory Of The County |Aviator Sănătescu 48, Bucureşti, |

| | |Hospital Deva, 22 December Street Nr.58. Deva. |011478, Romania Chairperson: |

| | |COD, Hunedoara County, 330084, Romania |Dumitrescu, Sava |

|Rascu, Agripina. MD, |030081/106578 |Spitalul Clinic Colentina, Sos. Stefan cel Mare |Comisia Naţională de Etică, Strada |

|PhD | |Street, nr.19-21, Bucharest, 020125, Romania |Aviator Sănătescu 48, Bucureşti, |

| | | |011478, Romania Chairperson: |

| | | |Dumitrescu, Sava |

|Tom, Mihai Alexandru. |229637/106580 |SC Impatiens SRL, Internal Medicine, Strada |Comisia Naţională de Etică, Strada |

|MD | |Lunga nr. 174, Codlea, 505100, Romania |Aviator Sănătescu 48, Bucureşti, |

| | | |011478, Romania Chairperson: |

| | | |Dumitrescu, Sava |

|Russian Federation | | | |

|Esip, Valeria V. MD |205012/107131 |Saint-Petersburg State Budget Healthcare |Local Ethics Committee of St. |

| | |Institution "Consultative-Diagnostic Center |Petersburg State Healthcare |

| | |No.85", builing 3, Liter A, 89, prospekt |Institution, "Consultative-Diagnostic |

| | |Veteranov, Saint-Petersburg, 198260, Russian |Center No.85", builing 3, Liter A, 89, |

| | |Federation |prospekt Veteranov, Saint-Petersburg, |

| | | |198260, Russian Federation Chairperson:|

| | | |Varga, Elena V |

|Khurkhurova, |187440/107134 |Municipal Budgetary Healthcare Institution "City|Municipal Healthcare Institution City |

|Natalia V. MD | |Clinical Hospital No.2 of Pyatigorsk" Pulmonolgy|Hospital No. 2, Pulmonolgy department, |

| | |department, Admiralskogo Strada, 6, Pyatigorsk, |Admiralskogo str., 6, Pyatigorsk, |

| | |357538, Russian Federation |357538, Russian Federation Chairperson:|

| | | |Temirov, Igor E |

|Martynenko, |001106/107137 |Municipal Clinical Hospital No.5, Altai Regional|Local Ethics Committee of the |

|Tatiana I. MD, | |Pulmonary Center, Zmeinogorsky Highway, 75, |Municipal Clinical Hospital No.5, |

|PhD | |Barnaul, 656045, Russian Federation |Altai Regional Pulmonary Center, |

| | | |Zmeinogorsky Highway, 75, Barnaul, |

| | | |656045, Russian Federation Chairperson:|

| | | |Kovchina, Svetlana V |

|Mikhaylov, Sergey E. |076944/107132 |Central Railway Clinical Hospital No. 1 RZHD, |Non-state Healthcare Institution |

|MD | |Pulmonology department, Volokolamskoe shosse, |“Central Clinical Hospital No.1 OAO |

| | |84, Moscow, 125367, Russian Federation |RZD”, 84, Volokolamskoe shosse, Moscow,|

| | | |125367, Russian Federation Chairperson:|

| | | |Dmitriev, Andrey A |

|Ovchinnikova, Elena A.|061978/107133 |Out-patients’ clinic No. 1 of President of |Out-patients’ clinic No. 1 of President|

|MD, PhD Oskina, Elena.| |Russian Federation, 26/28, Sivtsev Vrazhek |of Russian Federation, 26/28, Sivtsev |

|MD, PhD (FPI) | |pereulok, Moscow, 119002, Russian Federation |Vrazhek pereulok, Moscow, 119002, |

| | | |Russian Federation Chairperson: |

| | | |Polubentseva, Elena I |

|Romashok, Nadezhda F. |137722/107135 |Multiprofile Clinical Hospital No. 2, d, 6, |Multiprofile Clinical Hospital No. 2, |

|MD | |korp.2, Ul. Krasnyh Partizan, Krasnodar, 350012,|d, 6, korp.2, Ul. Krasnyh Partizan, |

| | |Russian Federation |Krasnodar, 350012, Russian Federation |

| | | |Chairperson: Veselenko, Marina I |

|Shaporova, Natalia L. |027334/107130 |St.Petersburg State Healthcare Institution “City|Local Ethics Comittee of Saint |

|MD, PhD | |Consultative Diagnostic Center No. 1”, 10 |Petersburg State Medical University n. |

| | |Sikeyrosa street, 10, Saint-Petersburg, 194354, |a. I. P. Pavlov, Roentgena strada 10, |

| | |Russian Federation |Saint Petersburg, 197101, Russian |

| | | |Federation Chairperson: Yagmurov, Oraz |

| | | |Murat DJ |

|Smolko, Tatiana A. MD |243049/107136 |Belgorod Regional Clinical Hospital, 08/09/2013,|Belgorod Regional Clinical Hospital, |

| | |Nekrasova strada, Belgorod, 308007, Russian |08/09/2013, Nekrasova strada, Belgorod,|

| | |Federation |308007, Russian Federation Chairperson:|

| | | |Afanasiev, Yury I |

|Spain | | | |

|Cordero Rodríguez, |224295/107159 |Hospital 9 de Octubre, Pneumology Department, C/|(Current) Hospital Universario La Fe, |

|Pedro José. MD | |Valle Avda de la Ballestera, 59, Valencia, |Servicio de Medicina Interna, Avda |

| | |46015, Spain |Campanar 21, Valencia, |

| | | |46009, Spain Chairperson: Montalar, |

| | | |Joaquin (Initial) Clínica Mediterránea |

| | | |de Neurociencias, Camino Viejo |

| | | |Alicante-Elche s/n, Alicante, 03114, |

| | | |Spain Chairperson: Antón Fructuoso, |

| | | |Pedro |

|De Teresa Parreño, |010692/107157 |Instituto de Ciencias Médicas, C/ Poeta |(Initial) Clínica Mediterránea de |

|Luis. MD, PhD | |Quintana, 56, Alicante, 03004, Spain |Neurociencias, Camino Viejo |

| | | |Alicante-Elche s/n, Alicante, 03114, |

| | | |Spain Chairperson: Antón Fructuoso, |

| | | |Pedro |

|Pérez Fernández, |227568/107158 |Hospital de Mérida, Pneumology Department, |(Current) Hospital Infanta Cristina, |

|Antonio Manuel. MD | |Poligono Nueva Ciudad s/n, Mérida (Badajoz), |Departamento de Farmacología de la |

| | |06800, Spain |Facultad de Medicina, Avenida de Elvás,|

| | | |s/n Badajoz, 06008, Spain Chairperson: |

| | | |Márquez Pérez, Francisca Lourdes |

| | | |Hospital Universario La Fe, Servicio de|

| | | |Medicina Interna, Avda |

| | | |Campanar 21, Valencia, 46009, Spain |

| | | |Chairperson: Montalar, Joaquin |

| | | |(Initial) Clínica Mediterránea de |

| | | |Neurociencias, Camino Viejo |

| | | |Alicante-Elche s/n, Alicante, 03114, |

| | | |Spain Chairperson: Antón Fructuoso, |

| | | |Pedro |

|Roldán Sánchez, Juan. |230601/107160 |Servei Pneumologia, Hospital Santa Caterina Parc|(Current) Hospital Universario La Fe, |

| | |Hospitalari Martí i Julià Calle Dr. Castany, |Servicio de Medicina Interna, Avda |

| | |s/n, Salt, Girona, 17190, Spain |Campanar 21, Valencia, 46009, Spain |

| | | |Chairperson: Montalar, Joaquin |

| | | |Institut d'Assistència Sanitària. C/ |

| | | |Doctor Castany, s/n., Salt (Girona), |

| | | |17190, Spain Chairperson: Gabriel, Coll|

| | | |De Tuero (Initial) Clínica Mediterránea|

| | | |de Neurociencias, Camino Viejo |

| | | |Alicante-Elche s/n, Alicante, 03114, |

| | | |Spain Chairperson: Antón Fructuoso, |

| | | |Pedro |

|United States | | | |

|Abboy, Chandar. MD |194755/105617 |Greenville Pharmaceutical Research, 2 Roper |Chesapeake Research Review, Inc., 7063 |

| | |Corner Circle, Greenville, South Carolina, |Columbia Gateway Drive, Suite 110, |

| | |29615, United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Alleyne, II, |243786/105525 |CU Pharmaceutical Research, Suite 115, 223 |Chesapeake Research Review, |

|William F. MD | |South Herlong Avenue, Rock Hill, South Carolina,|Inc., 7063 Columbia Gateway Drive, |

| | |29732, United States |Suite 110, Columbia, Maryland, 21046, |

| | | |United States Chairperson: Cavagnaro, |

| | | |Joy. PhD, DABT, RAC |

|Boscia, III, |067189/105306 |CU Pharmaceutical Research, 1005 Thompson |Chesapeake Research Review, |

|Joseph A. MD, | |Boulevard, Union, South Carolina, 29379, United |Inc., 7063 Columbia Gateway |

|CPI | |States |Drive, Suite 110, Columbia, Maryland, |

| | | |21046, United States Chairperson: |

| | | |Cavagnaro, Joy. PhD, DABT, RAC |

|Bouda, David W. MD |017708/105310 |Heartland Clinical Research, Inc., Suite |Chesapeake Research Review, Inc., 7063 |

| | |125-126, 2201 North 90th Street, Omaha, |Columbia Gateway Drive, Suite 110, |

| | |Nebraska, 68134, United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Covelli, Henry D. MD |012387/105308 |Henry D. Covelli, MD, Suite 300, 700 Ironwood |Chesapeake Research Review, Inc., 7063 |

| | |Drive, Coeur D'Alene, Idaho, 83814, United |Columbia Gateway Drive, Suite 110, |

| | |States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Erb, David R. MD, CPI |067190/105524 |Gaffney Pharmaceutical Research, 1529 North |Chesapeake Research Review, Inc., 7063 |

| | |Limestone Street, Gaffney, South Carolina, |Columbia Gateway Drive, Suite 110, |

| | |29340, United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Fogarty, Charles M. |009363/105311 |Spartanburg Medical Research, 485 Simuel Road, |Chesapeake Research Review, Inc., 7063 |

|MD, CPI | |Spartanburg, South Carolina, 29303, United |Columbia Gateway Drive, Suite 110, |

| | |States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Hill, John M. MD, RRT,|088550/105313 |Avail Clinical Research, LLC, 860 Peachwood |Chesapeake Research Review, Inc., 7063 |

|CPI | |Drive, DeLand, Florida, 32720, United States |Columbia Gateway Drive, Suite 110, |

| | | |Columbia, Maryland, 21046, United |

| | | |States |

| | | |Chairperson: Cavagnaro, Joy. PhD, DABT,|

| | | |RAC |

|Johnson Jr., Frank P. |009254/105314 |MultiSpecialty Clinical Research, Suite 6, 313 |Chesapeake Research Review, Inc., 7063 |

|MD | |Princeton Road, Johnson City, Tennessee, 37601, |Columbia Gateway Drive, Suite 110, |

| | |United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Kaelin, Jr., Thomas D.|017720/105315 |Lowcountry Lung and Critical Care, P.A., 9150 B |Chesapeake Research Review, Inc., 7063 |

|DO | |Medcom Street, Charleston, South Carolina, |Columbia Gateway Drive, Suite 110, |

| | |29406-7108, United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Keiser, Stephen. MD |267030/105616 |Easley Clinical Research, 201 Richards Street, |Chesapeake Research Review, Inc., 7063 |

| | |Easley, South Carolina, 29640, United States |Columbia Gateway Drive, Suite 110, |

| | | |Columbia, Maryland, 21046, United |

| | | |States |

| | | |Chairperson: Cavagnaro, Joy. PhD, DABT,|

| | | |RAC |

|Moriarty, Timothy G. |015684/105317 |Emerald Coast Research Associates, Suite B, 221 |Chesapeake Research Review, Inc., 7063 |

|MD | |East 23rd Street, Panama City, Florida, 32405, |Columbia Gateway Drive, Suite 110, |

| | |United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Patel, Amit I. MD |012037/105318 |Integrated Research Group, Suites |Chesapeake Research Review, Inc., 7063 |

| | |101/201/202/203/302, 4646 Brockton Avenue, |Columbia Gateway Drive, Suite 110, |

| | |Riverside, California, 92506, United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Pudi, Krishna Kumar. |009410/105319 |Upstate Pharmaceutical Research, 30 Pointe |Chesapeake Research Review, Inc., 7063 |

|MD | |Circle, Greenville, South Carolina, 29615, |Columbia Gateway Drive, Suite 110, |

| | |United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Ramsdell, Joe W. MD |031467/105320 |University of California, San Diego (UCSD) |University of California, San Diego, |

| | |Airway Research and Clinical Trials Center, 210 |Human Research Protections Program, |

| | |Dickinson Street, CTF-A. RM 102, San Diego, |9500 Gilman Drive, Mail Code 0052,La |

| | |California, 92103-8415, United States |Jolla, California, 92093-0052, United |

| | | |States Chairperson: Caligiuri, Michael.|

| | | |PhD |

|Shen, Wei. MD |198044/105312 |Southern Arizona VA Health Care System (SA |Southern Arizona VA Health Care System |

| | |VAHCS), 1-111A, 3601 South 6th Avenue, Tucson, |Institutional Review Board, Bldg 77, |

| | |Arizona, 85723, United States |3601 South, 6th Avenue (0-151), Tucson,|

| | | |Arizona, 85723, United States |

| | | |Chairperson: Babcock-Parziale, Judith |

| | | |L. PhD |

|Siler, Thomas M. MD |008864/105321 |Midwest Chest Consultants, PC, Suite 470, 330 |Chesapeake Research Review, Inc., 7063 |

| | |First Capital Drive, St. Charles, Missouri, |Columbia Gateway Drive, Suite 110, |

| | |63301, United States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

|Zeno, Brian R. MD |180519/105324 |Remington-Davis Clinical Research, Suite 106 A, |Chesapeake Research Review, Inc., 7063 |

| | |1335 Dublin Road, Columbus, Ohio, 43215, United |Columbia Gateway Drive, Suite 110, |

| | |States |Columbia, Maryland, 21046, United |

| | | |States Chairperson: Cavagnaro, Joy. |

| | | |PhD, DABT, RAC |

IEC, independent ethics committee; IRB, institutional review board.

SUPPLEMENTARY FILE 2. INCLUSION AND EXCLUSION CRITERIA

Inclusion criteria

Subjects eligible for enrollment in the study must have met all of the following criteria:

1. Type of subject: Outpatient.

2. Informed Consent: A signed and dated written informed consent prior to study participation.

3. Age: Subjects 40 years of age or older at Visit 1.

4. Gender: Male or female subjects.

A female was eligible to enter and participate in the study if she was of:

• Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who was postmenopausal or surgically sterile). Surgically sterile females were defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Postmenopausal females were defined as being amenorrhoeic for more than 1 year with an appropriate clinical profile, eg, age appropriate, >45 years, in the absence of hormone replacement therapy

• Childbearing potential, had a negative pregnancy test at Screening, and agreed to one of the following acceptable contraceptive methods used consistently and correctly (ie, in accordance with the approved product label and the instructions of the physician for the duration of the study – Screening to Follow-up contact):

• Abstinence

• Oral contraceptive, either combined or progestogen alone

• Injectable progestogen

• Implants of levonorgestrel

• Estrogenic vaginal ring

• Percutaneous contraceptive patches

• Intrauterine device or intrauterine system that met the Standard Operating Procedure effectiveness criteria as stated in the product label

• Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male was the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records

• Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).

5. Diagnosis: An established clinical history of chronic obstructive pulmonary disease (COPD) in accordance with the definition by the American Thoracic Society (ATS)/European Respiratory Society [1] as follows:

“Chronic obstructive pulmonary disease is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.”

6. Smoking history: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day/20) x number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers were defined as those who had stopped smoking for at least 6 months prior to Visit 1.

7. Severity of disease: A pre and post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of ................
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