Blevins, Thomas C.
Raiter, Yaron
Sun, Bin
Donnelly, Charles
Shapiro, Roxann
Chullikana, Anoop
Rao, Anita
Vashishta, Laxmikant
Ranganna, Gopinath http://orcid.org/0000-0001-9974-3354
Barve, Abhijit
Article History
Accepted: 23 August 2022
First Online: 17 September 2022
Declarations
:
: The study was sponsored by Mylan GmbH, Switzerland (now Viatris), and Biocon Biologics Ltd, Bengaluru, India.
: Thomas C. Blevins has received clinical research support from AstraZeneca, Eli Lilly, Lexicon, Merck, Mylan, Novo Nordisk, Sanofi, Mannkind, Medtronic, and Tandem and speaker fees from Amgen, AstraZeneca, Boehringer-Ingelheim, Janssen, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Bin Sun, Charles Donnelly, Roxann Shapiro, Gopinath Ranganna, and Abhijit Barve are employees of Viatris Inc. and may hold stock or stock options in the company. Yaron Raiter is an ex-employee of Viatris Inc and currently associated with GE Healthcare. Anoop Chullikana and Anita Rao are Biocon Biologics Ltd employees and may hold stock or stock options in the company. Laxmikant Vashishta is an ex-employee of Biocon Biologics Ltd. and currently a full-time employee of Alvogen Pharma India Pvt. Ltd.
: The conduct of this study was in accordance with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the appropriate regulatory requirements in the countries in which the study was conducted. The protocol and its amendments and informed consent documentation were reviewed and approved by the institutional review board(s) or independent ethics committee(s) at each study site.
: All participants voluntarily consented to participate and signed an Institutional Review Board/Independent Ethics Committee approved informed consent form prior to study inclusion.
: Not applicable.
: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
: Not applicable.
: TCB, YR, BS, CD, RS, AC, GR, and AB contributed to the conception and design of the study; acquisition, analysis, and interpretation of data; and critically revising the manuscript for important intellectual content. YR and GR contributed to the analysis and interpretation of data; drafting of the manuscript; and critically revising the manuscript for important intellectual content. CD, AR, and LV contributed to acquisition, analysis, and interpretation of data. All authors reviewed and approved the manuscript for publication.