Mohan, M. V. T. Krishna
Prajapati, Arpitkumar
Kothari, Rushabh
Mandal, Srikrishna
Rao Srikanth, Ranganatha
Nagarkar, Rajnish
Khane, Shriram
Santa, Ayyagari
Dadke, Disha
Article History
Accepted: 3 June 2024
First Online: 27 June 2024
Declarations
:
: This study, study drugs, and study-related material were sponsored by CuraTeQ Biologics Private Limited, India.
: Arpitkumar Prajapati and Disha Dadke are employees of CuraTeQ Biologics Pvt Ltd. Rushab Kothari has received honoraria from Zydus Pharmaceuticals, AstraZeneca, Glenmark, Novartis, Emcure, Fresenius Kabi, Bard Peripheral Vascular, Pfizer, Alkem Laboratories, and Roche; has received institutional honoraria from Cipla, Merck, Celon Pharma, and Bristol Myers Squibb Foundation; served in a consulting/advisory role for MSD; and has received institutional research funding from Zydus Pharmaceuticals, Lambda Therapeutic Research, Axis Clinicals, and Reliance Life Sciences. M.V.T. Krishna Mohan, Rushabh Kothari, Srikrishna Mandal, R Srikanth, Rajnish Nagarkar, Shriram Khane, A Santa have no conflicts of interest that are directly relevant to the content of this article.
: This study was conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH Guideline E6-R2), following all ethical principles having their origin in the Declaration of Helsinki, as well as adhering to all relevant local ethical regulations. The protocol, its amendments, and informed consent documents were reviewed and approved by the institutional ethics committee of each study site.
: Patients provided written informed consent prior to study enrollment.
: Not applicable.
: The data that support the findings of this study are available from the corresponding author upon reasonable request.
: Not applicable.
: MVTKM: formal analysis; data curation; writing: review and editing, visualization. AP: methodology; software; validation; formal analysis; resources; data curation; writing: review and editing; visualization; project administration. RK: investigation; writing: review and editing. SM: investigation; writing: review and editing. RS: investigation; writing: review and editing. RN: investigation; writing: review and editing. SK: investigation; writing: review and editing. AS: investigation; writing: review and editing. DD: conceptualization; methodology; resources; writing: review and editing; visualization; funding acquisition. All authors: approval of the final version of the manuscript.