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Article History

Received: 11 February 2022

Accepted: 14 September 2022

First Online: 8 February 2023

Declarations

:

: All studies were conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines. Study protocols were approved by the Institutional Review Boards and/or independent ethics committees at each of the investigational centers participating in the studies, or a central Institutional Review Board (Australia: Eastern Health Research and Ethics Committee; Royal Adelaide Hospital Research Ethics Committee; Sydney Local Health District Human Research Ethics Committee—CRGH; Monash Health Human Research Ethics; ACT Health Human Research Ethics Committee; and Ethics Review Committee of the Sydney Local Health District (SLHD) (RPAH ZONE); Austria: Ethik Kommission der Medizinischen Universitaet Wien; Belgium: Commisse Medische Ethiek van Universitaire Ziekenhuizen K.U; Brazil: Comite de Etica em Pesquisa do Hospital de Clinicas de Porto Alegre—HCPA/UFRGS; CONEP—Comissao Nacional de Etica em Pesquisa; and Comite de Etica em Pesquisa do Hospital Universitario Clementino Fraga Filho/UFRJ; Canada: Comite d'ethique de la recherche de I'hopital Maisonneuve-Rosemont; Montreal General Hospital—McGill University Health Centre; Western University Health Sciences Research Ethics Board; University of Saskatchewan BioMedical Research Ethics Board (Bio-REB); Hamilton Integrated Research Ethics Board; University of Alberta-Health Research Ethics Board; and Conjoint Health Research Ethics Board; Colombia: Comite de Etica en Investigación en el Area de la Salud de la Universidad del Norte; Comite de Investigaciones y Etica en Investigaciones del Hospital Pablo Tobon Uribe; and Comite de Estudios Medicos S.A.S.—CREIMED S.A.S.; Croatia: Agency for Medicinal Products and Medical Devices of Croatia, Central Ethics Committee, RoC; Czech Republic: Eticka komise IKEM a TN; Eticka komise Nemocnice Strakonice, a.s.; Eticka komise klinickeho centra ISCARE; Eticka komise Krajska zdravotni, a.s.—Masarykova nemocnice v Usti nad Labem, o.z.; and Etická komise Fakultni nemocnice Hradec Kralove; Denmark: Den Videnskabsetiske Komité for Region Syddanmark; Estonia: Tallinn Medical Research Ethics Committee; France: Comite de Protection des Personnes Ile de France VIII; Germany: Ethik Kommission Kiel der Medizinischen Fakultaet der Christian-Albrechts-Universitaet zu Kiel; Hungary: Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga; Israel: Helsinki Committee-The Edith Wolfson Medical Center; Helsinki Committee Rabin Medical Center; Helsinki Committee Rambam Health Care Campus; Helsinki Committee Tel Aviv Sourasky Medical Center; and Helsinki Committee Kaplan Medical Center; Italy: Comitato Etico Indipendente del Centro di Riferimento Oncologico di Aviano; Comitato Etico Istituto Clinico Humanitas IRCCS; Comitato Etico Palermo 2; and Comitato Etico Azienda Ospedaliera Universitaria “Mater Domini”; Japan: National Hospital Organization CRB; Osaka City University Hospital IRB; Osaka Medical College Hospital Institutional Review Board; Japan Community Health care Organization Tokyo Yamate Medical Center Institutional Review Board; Tokai University Hospital Institutional Review Board; Institutional Review Board of Keio University Hospital; Kitasato University Kitasato Institute Hospital Institutional Review Board; Chiba University Hospital IRB; National Hospital Organization Central Review Board; Aichi Medical University Hospital IRB; Kurume University Hospital Institutional Review Board; Keiaikai Institutional Review Board; Kyoto University Hospital Institutional Review Board; Jikei University Hospital Institutional Review Board; Showa University Hospital Institutional Review Board; Fukuoka University Chikushi Hospital Institutional Review Board; The Hospital of Hyogo College of Medicine IRB; Toho University Sakura Medical Center Institutional Review Board; Hiroshima University Hospital Institutional Review Board; Yokohama minoru medical Clinic IRB; NTT Medical Center Tokyo Institutional Review Board; Sapporo-Kosei General Hospital IRB; Tokyo Medical And Dental University Hospital, Faculty of Medicine Institutional Review Board; Shiga University of Medical Science Hospital Institutional Review Board; and Yokohama minoru medical Clinic IRB; Korea: Gachon University Gil Medical Center IRB; Hanyang University Guri Hospital Institutional Review Board; Kyung Hee University Hospital Institutional Review Board; Seoul National University Hospital IRB; Severance Hospital, Yeonsei University Health System; Samsung Medical Center; IRB of Pusan National University Hospital; Asan Medical Center Institutional Review Board; and CHA Bundang Medical Center, CHA University Institutional Review Board; Latvia: EC for Clinical Research at Development Society; Netherlands: Medisch Ethische Toetsingscommissie (METC); New Zealand: Southern Health and Disability Ethics Committee; Poland: Komisja Etyki i Nadzoru nad Badaniami na Ludziach i Zwierzetach Centralnego Szpitala Klinicznego MSWiA w Warszawie; Komisja Bioetyczna przy Okregowej Izbie Lekarskiej; and Diagnostyka Sp. z o.o.; Romania: Ministerul Sanatatii, Comisia Nationala de Etica pentru Studiul Clinic al Medicamentuli; and Comisia Nationala de Bioetica a Medicamentului; Russian Federation: Ethics Committee at State budget Institution of Healthcare; Ethics Council of Ministry of Health and Social Development of the Russian Federation; Independent Ethics Committee attached to Moscow regional scientific research clinical institute named after M.F. Vladimirsky; Ethics Committee attached to FSBI “State scientific centre of coloproctology” of Ministry of Health of Russian Federation; Ethics Committee of Yaroslavl State Medical Academy; Ethics committee attached to SBIH of Yaroslavl region Regional clinical hospital; Ethics committee attached to Municipal Budget Institution of Healthcare “Central City Hospital of Pyatigorsk”; Institution of Higher Professional Education “Saratov State Medical University named after V.I. Razumovsky”; Ethics Committee of State Budget Educational of Healthcare City Hospital No 26; Ethics Committee of State Budget Educational institution of Higher Professional Education; Ethics Committee at 7A, Myagi str., Limited Liability Company Medical Company “Hepatolog”; and Biomedical EC of FSBI of PFM of the SD of RAMS; Serbia: Ethics Committee of Clinical Centre of Vojvodina; Ethics Com. Clinical Hospital Centre Zvezdara; Ethics Committee of Clinical Centre of Serbia; Ethics Committee Clinical Centre of Nis; Ethics Committee of General Hospital “Djordje Joanovic”; Ethics Committee of Military Medical Academy; Ethics Committee, General Hospital Subotica; and Ethics Committee of Clinical Centre of Kragujevac; Slovakia: MEC: Eticka Komisia, Urad Nitrianskeho samospravneho kraja; LEC: Eticka komisia, NsP Nove Mesto; MEC/LEC Eticka Komisia,Urad Nitrianskeho samospravneho kraja; Urad Bratislavskeho samospravneho kraja, Eticka komisia; Eticka komisia UN Bratislava Nemocnica Stare Mesto; Eticka komisia Trencianskeho samospravneho kraja; Eticka komisia Presovskeho samospravneho kraja; South Africa: Pharma-Ethics [Pty] Ltd; and University of the Witwatersrand Human Research Ethics committee; Spain: CEIC Hospital Clinic I Provincial de Barcelona; and CEIC Area 7. Hospital Clinico San Carlos; Taiwan: Research Ethics Committee of National Taiwan University Hospital; Ukraine: Ethics Commission of Vinnytsia; LEC of Municipal Healthcare Institution “Kharkiv City Clinical Hospital #2”; The Central Ethics Commission of the Ministry of Health of Ukraine; Commission of Ethic Questions of Kyiv Municipal Clinical Hospital #18; LEC of the State Institution “L.T. Malaya Therapy Institute of National Academy Department of Liver and Gastro-Intestinal Tract Diseases of Medical Sciences of Ukraine”; Ethics Commission at Kyiv City Clinical Hospital#8; E.C. of C. R. I. “Clinical Territorial Medical Community” “University Clinic”; Local Ethics Commission of Regional Municipal I; Ethics Commission at State Institution Railway Hos; Ethics Commission of State Institution “Institute of Gastroenterology of the Academy of Medical Sciences of Ukraine”; LEC of the Municipal Institution City Hospital #7; LEC of S.I. “District Clinical Hospital” “Lviv Railway”; Ethics Commission of Municipal Institution “Odesa Regional Clinical Hospital”; and Local Ethics Commission of Regional Municipal Institution Chernivtsi Regional Clinical Hospital; UK: NRES Committee London—Riverside; and USA: Baylor College of Medicine; Quorum Institutional Review Board; Quorum Institutional Review Board; The IRB of The Guthrie Clinic; IRBMED; Western Institutional Review Board; Mayo Clinic Institutional Review Board; Program for the Protection of Human Subjects Mount Sinai Medical Center; Cedars Sinai Office of Research Compliance; Human Research Protections Program (HRPP); Aurora IRB; University of California San Francisco Committee on Human Research; Human Research Protection Office, Washington University School in St. Louis; Cleveland Clinic Foundation Institutional Review Board; Yale University Human Research Protection Program; Chesapeake Institutional Review Board; Human Research Protection Program; Saint Joseph Mercy Health System IRB and Research Compliance; and Columbia University Medical Center IRB). All the patients provided written informed consent.

: Not applicable.

: SDL has received consulting fees from Cornerstones, Eli Lilly, Janssen, Pfizer Inc, and UCB Pharma; and grant support from AbbVie, Arena, Atlantic, Celgene, Gilead Sciences, Janssen, Pfizer Inc, Salix, Shield, Takeda, Tetherex, and UCB Pharma. JRA has received consulting fees from Artugen, Bacainn, Bristol-Myers Squibb, Celgene, Finch Therapeutics, Iterative Scopes, Janssen, Morphic, Pandion, and Pfizer Inc; and grant support from Merck. FS has served as an advisory board member for Pfizer Inc; and has received consulting fees and speaker fees from AbbVie, Amgen, Eurofarma, Ferring Pharmaceuticals, Janssen, Novartis, Sandoz, Takeda, and UCB Pharma. SBC and NL are employees and stockholders of Pfizer Inc. JP is an employee of Syneos Health, which was a paid contractor to Pfizer in connection with the development of this manuscript and related statistical analysis. KBG has received grant support from Celltrion and Pfizer Inc; and personal fees from AbbVie, Arena, Celltrion, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Immunic, Janssen, Novartis, Pfizer Inc, Roche, Samsung Bioepis, Takeda, and Tillotts.