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A Randomized Clinical Trial Supplementary Online Content Benowitz NL, Pipe A, West R, et al. Cardiovascular safety of varenicline, bupropion, and nicotine patch in smokers: a randomized clinical trial. JAMA Intern Med. Published online April 9, 2018. doi:10.1001/jamainternmed.2018.0397 eFigure. Study Overview eAppendix. Independent Ethics Committee or Institutional Review Board eTable 1. Hazard Ratios for Time to Occurrence of MACE and MACE+ eTable 2. Cardiovascular Deaths eTable 3. MACE and MACE+ Until End of Study Stratified by Baseline Framingham Cardiovascular Risk This supplementary material has been provided by the authors to give readers additional information about their work. © 2018 American Medical Association. All rights reserved. 1 Downloaded From: https://jamanetwork.com/ on 09/28/2021 eFigure 1. Study Overview Treatment phase Non-treatment follow-up Extension non-treatment phase (EAGLES) (EAGLES) (EAGLES extension trial) Varenicline 1 mg twice daily EAGLES Bupropion baseline 150 mg twice daily randomization Screening NRT visit 21 mg/d patch with tapering Placebo EAGLES extension trial initiation visit Study visits (wk) 0 1 2 3 4 5 6 8 10 12 13 16 20 24 28 32 36 40 44 48 52 Study endpoint During treatment time intervals (wk) (EAGLES) During treatment and until 30 days’ follow-up (EAGLES) During treatment, 12 weeks’ follow-up and until end of study (EAGLES or EAGLES extension trial)* * End of study refers to last visit in the EAGLES extension trial, or in EAGLES for those subjects not enrolled into the EAGLES extension trial. © 2018 American Medical Association. All rights reserved. 2 Downloaded From: https://jamanetwork.com/ on 09/28/2021 eAppendix. Independent Ethics Committee or Institutional Review Board Country Independent Ethics Committee or Institutional Review Board Address(es) Argentina – Comite Independiente de Etica para Ensayos en Farmacologia Clinica Av. Cabildo 1536-5°Piso_Dep B Buenos Aires, Buenos Aires C1426ABP, Argentina – Comite de Etica en Investigacion Clinica (CEIC) "Dr Carlos A. Barclay" Larrea # 1381 3o "A" Ciudad de Buenos Aires, Buenos Aires C1117ABK, Argentina Australia – Alfred Hospital, Alfred Hospital Ethics committee 55 Commercial Road, The Alfred Hospital Research and Ethics Unit Melbourne, VIC 3004, Australia Brazil – Sanatorio Sao Paulo Ltda Ladeira do Aquidaban, 91 Santo Antonio Salvador, Bahia 40301-500, Brazil – Comitê de Ética em Pesquisa da Maternidade Climério de Oliveira Rua do Limoeiro, 137 Nazaré, Salvador, Bahia 40055-150, Brazil – Comissão Nacional de Ética em Pesquisa CONEP Unidade II, Ministério da Saúde SEPN 510 Norte, Bloco A 1º Subsolo, Brasília, Distrito Federal 70750-521, Brazil – Comitê de Ética em Pesquisa do Instituto Dante Pazzanese de Cardiologia Dante Pazzanese, 500, Ibirapuera São Paulo, São Paulo 04012-909, Brazil – Comite de Etica em Pesquisa com Seres Humanos da PUC Campinas Rod. Dom Pedro I, km 136, Parque das Universidades Campinas, São Paulo 13086-900, Brazil – Comitê de Ética em Pesquisa da Pontifícia Universidade Católica do Rio Grande do Sul Prédio 60, sala 314, Avenida Ipiranga, 6690 Porto Alegre, Rio Grande do Sul/Porto Alegre 90610-000, Brazil Bulgaria – Ethics Committee at MC "Sveti Naum" Ltd. 1 Lyuben Rusev Str, Sofia 1113, Bulgaria – Ethics Committee for Multicenter Trials 5 "Sveta Nedelya" Sq, Sofia 1000, Bulgaria – Ethics Committee at UMHAT Sveti Georgi Ltd. 15A Vasil Aprilov Blvd, Plovdiv 4002, Bulgaria – Ethics Committee at MHAT Dr. Hristo Stambolski Ltd. 16 Starozagorska Str, Kazanlak 6100, Bulgaria – Ethics Committee at UMHAT Dr. Georgi Stranski Ltd. 8A Georgi Kochev Str, Pleven 5800, Bulgaria – Ethics Committee at SHATPPD Ruse Ltd. 1 Aleya Lilia Str, Ruse 7002, Bulgaria – Ethics Committee at Mental Health Center Ruse Ltd. 20 Tutrakan Blvd, Ruse 7004, Bulgaria – Ethics Committee at SHATPD Troyan Ltd. 253 Vasil Levski Str, Troyan 5600, Bulgaria – Ethics Committee at Mental Health Center "Prof Dr Ivan Temkov – Bourgas" Ltd. Complex "Lazur", Park "Ezero", Bourgas 8000, Bulgaria – Ethics Committee at NPH Sv. Ivan Rilski Hristo Botev Str, Novi Iskar 1282, Bulgaria Canada – Ottawa Health Science Network Research Ethics Board Ottawa Hospital, Civic Campus, LOEB Building, 725 Parkdale Avenue, Civic Box 411 Ottawa, ON K1Y 4E9, Canada – Centre for Addiction and Mental Health 33 Russell Street, Research Ethics Board Toronto, ON M5S 2S1, Canada – IRB Services 372 Hollandview Trail, Suite 300 Aurora, ON L4G 0A5, Canada Chile – Comité de Etico Cientifica Servicio de Salud Maule Uno Norte 936, Oficina 215, 2° Piso Talca, VII Region, Chile – Comite Etico Cientifico del Servicio de Salud Vina-Quillota © 2018 American Medical Association. All rights reserved. 3 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Calle Limache 1307, Hospital Dr Gustavo Fricke, Viña del Mar, V Region 2570017, Chile Denmark – De Videnskabsetiske Komitéer for Region Hovedstaden Kongens Vaenge 2, Regionsgaarden, Hillerød 3400, Denmark Finland – TUKIJA Valtakunnallinen lääketieteellinen tutkimuseettinen toimikunta (National Committee on Medical Research Ethics) Lintulahdenkuja 4, Helsinki 00530, Finland Germany – Ethik-Kommission der Medizinischen Fakultaet der Eberhard-Karls-Universitaet Tuebingen und am Universitaetsklinikum Tuebingen Gartenstrasse 47 Tuebingen, Baden-Wuerttemberg 72074, Germany Mexico – Comite Bioetico para la Investigacion Clinica SC Puebla 422-4, Colonia Roma Sur, Delegacion Cuauhtemoc, Mexico DF 06700, Mexico New – Health and Disability Ethics Committees Health and Disability Ethics Committees Zealand Ministry of Health Ethics Department 20 Aitken Street, No 1 The Terrace, Freyburg Building Reception-Ground Floor Wellington 6011, New Zealand Russian – Independent Interdisciplinary Committee for Ethical Expert Evaluation of Clinical Federation Studies 51 Leningradskiy prospect, Moscow 125468, Russian Federation – Ethics Council at the Ministry of Healthcare of Russian Federation 3 Rakhmanovskij pereulok, Moscow 127994, Russian Federation – Local Ethics Committee of FSBI "Saint-Petersburg Scientific Research" 3 Bekhtereva ul, Psychoneurological Institute na VM Bechterev" of MoH of RF, Saint-Petersburg, 192019 Russian Federation – Local Ethics Committee of FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine" 3 Poteshnaya ul, of the Ministry of Health, Moscow 107076, Russian Federation – Local Ethics Committee of MSPHI Mental Clinical Hospital #1 na NA Alexeeva of Moscow Healthcare 2 Zagorodnoe shosse, Moscow 117152, Russian Federation – Ethics Committee of LLC "Arte Med Assistance" Room ln/1, liter A, 55 Pionerskaya ul, Saint-Petersburg 197110, Russian Federation Slovakia – Eticka komisia Bratislavskeho samospravneho kraja, Sabinovska 16, PO Box 106, Bratislava 25, 820 05, Slovakia – Eticka komisia Kollarova 2, Univerzitna nemocnica Martin, Martin 036 59, Slovakia – Eticka Komisia Rázusova 2A, Nitriansky samosprávny kraj, Nitra 949 01, Slovakia – Eticka komisia Nemocnica s poliklinikou sv Barbory Roznava as, Spitalska 1, Roznava 048 01, Slovakia – Eticka komisia Namestie SNP 23, Banskobystricky samospravny kraj, Banska Bystrica 974 01, Slovakia South – Pharma Ethics Africa 123 Amcor Road, Lyttelton Manor, Centurion, Gauteng 0157, South Africa Spain – Hospital Universitari Vall d'Hebron Passeig de la Vall d'Hebron, 119-129, Agencia de Ensayos Clínicos, Edifici Institut de Recerca, 3ª Planta Barcelona, Barcelona 08035, Spain – Comite Etico de Investigacion Clinica, Hospital de la Santa Creu i Sant Pau Avenida Sant Antoni Mª Claret 167 Barcelona, Barcelona 08025, Spain – Comite Etico de Investigacion Clinica, Hospital Clinic de Barcelona C/ Villarroel 170, Escalera 6B Sotano., Agencia de Ensayos Clinicos, Servicio de © 2018 American Medical Association. All rights reserved. 4 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Farmacia, Fundacio Clinic per la Recerca Biomedica, Barcelona, 08036, Spain – Comite Etico de Investigacion, Hospital San Pedro Alcantara Avenida de España 2, Hospital Nuestra Sra de la Montaña, Caceres 10004, Spain – Unidad Especializada en Tabaquismo de la Comunidad de Madrid, Hospital Clinico San Carlos C/ Profesor Martin Lagos s/n, Secretaria Administrativa, Agencia de Ensayos Clínicos, Unidad de Coordinación de Ensayos Clínicos, Madrid 28040, Spain – Secretaría Comité Ético de Investigación Clinica de Aragón Avenida San Juan Bosco 13, Zaragoza 50009, Spain United – Mayo Clinic Institutional Review Board and Office for Human Research Protection States 200 First St Sw, Bldg 201, Rm 4-60 Rochester, MN 55905, USA – Schulman Associates Institutional Review Board, Incorporated 4445 Lake Forest Dr, Ste 300 Cincinnati, OH 45242, USA – Western Institutional Review Board, Inc. 1019 39th Ave SE, Ste 120 Puyallup, WA 98374-2115, USA – Western Institutional Review Board 3535 Seventh Ave, Sw Olympia, WA 98502-5010, USA – Partners Human Research Committee 116 Huntington Ave, Partners Human Research Ofc, Ste 1002 Boston, MA 02116, USA – Human Research Protection Program, University of Minnesota 420 Delaware St Se, MMC 820 Minneapolis, MN 55455-0392, USA – Institutional Review Board The University of Texas M.D. Anderson Cancer Center 1400 Pressler Unit 1437 Houston, TX 77030, USA – University of California, San Diego 9500 Gilman Dr, Human Research Protections Program, Mail Code 0052, La Jolla, CA 92093-0052, USA – Institutional Review Board 0690 SW Bancroft St, Mail Code L106I0, Portland, OR 97239, USA – Crescent City Institutional Review Board 2820 Canal St, New Orleans, LA 70119, USA © 2018 American Medical Association. 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