Received: 28 November 2019
Accepted: 18 March 2020
First Online: 4 June 2020
Ethics approval and consent to participate
: This study was conducted in compliance with the ICH Tripartite guideline regarding Good Clinical Practice and Declaration of Helsinki (Brazil, October 2013), and Schedule Y (amended Drug & Cosmetic Act 2013), and Guidelines for Similar Biologics 2016, India along with subsequent amendments and Indian regulatory laws governing biomedical research in human patients. The study was commenced with approval from institutional ethics committee. Prior to conducting any study-related screening procedure, written informed consent was obtained from each patient before enrolling them in the study. The study was registered at Clinical Trial Registry-India (CTRI: CTRI/2016/04/006884) prior to initiation of patient screening.<b><i>Ethics committee name and address.</i></b>OrderedList removed
: Not applicable.
: SS, BR, VKB, SC, PT, and LT are the employees of Hetero Biopharma Limited, India and involved from conception of study to the approval of the manuscript. All the authors declare no other competing interests.