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Deodhar, Subramanian Loganathan and Elena Wolff-Holz are employees of Biocon Biologics Limited (BBL) and hold stocks\/stock options of BBL. Ramesh Kadadanamari Subbarama Reddy, Gopinath M. Ranganna, Shiyao Liu and Matthew A. Hummel are employees of Mylan Pharmaceuticals Pvt Ltd (A Viatris Company) and hold stocks\/stock options of Viatris. Stefan Daniluk was the principal investigator of the clinical trial center at ClinicMed Daniluk, Nowak Sp.k, Poland. He declares no conflict of interest with the study sponsor and the study conduct. Anna Hanczewska was the principal investigator of the clinical trial center at Ai Centrum Medyczne Sp, Poznan, Poland. She has received research\/consulting support from Galapagos and Gilead Sciences. Kamelia Vekovska was the principal investigator of the clinical trial center at Medical Center Medconsult Pleven OOD, Pleven, Bulgaria. She has received research\/consulting support from GSK and Biogen. Maria Zegadlo-Mylik was the principal investigator of the clinical trial center at ETG Warszawa ul, Belgradzka, Warszawa, Poland. She has received research\/consulting support from Samsung Bioepis and Takeda. Grazyna Pulka was the principal investigator of the clinical trial center a Centrum Medyczne All-med Badania Kliniczne, Krakow, Poland. She has received research\/consulting support from Samsung Bioepis, Takeda, Chugai Pharmaceuticals and Ichnos Biosciences.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The protocol was approved by the applicable independent ethics committee or institutional review board at each participating site, and the trial was performed in accordance with Good Clinical Practice and the Declaration of Helsinki. Written informed consent was obtained from all patients before their participation.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}