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Authors
Abdulakutty, Jabir https://orcid.org/0000-0002-6970-6461
Abhyankar, Atul
Seth, Sandeep https://orcid.org/0000-0002-4380-0230
Sharma, Kamal https://orcid.org/0000-0001-5866-2566
Aggarwal, Rakesh Kumar
Bhalani, Nirav
Vijan, Vinod
Bansal, Sandeep
Jain, Rajendra Kumar Premchand https://orcid.org/0000-0003-0918-5251
Banerjee, Suvro https://orcid.org/0000-0002-7881-6849
Chopra, V. K. https://orcid.org/0000-0001-9512-1718
Oomman, Abraham https://orcid.org/0000-0002-0520-3566
Kahale, Pravin
Sodhi, Priyanka
Gawde, Ashish
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Funding
Funding for this research was provided by:
Bayer AG
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Article History
Received: 10 September 2025
Accepted: 26 November 2025
First Online: 30 December 2025
Declarations
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: Dr. Jabir Abdulakutty, Dr. Atul Abhyankar, Dr. Sandeep Seth, Dr. Kamal Sharma, Dr. Rakesh Kumar Aggarwal, Dr. Nirav Bhalani, Dr. Vinod Vijan, Dr. Sandeep Bansal, Dr. Rajendra Kumar Premchand Jain, Dr. Suvro Banerjee, Dr. V. K. Chopra, Dr. Abraham Oomman, and Dr. Pravin Kahale declare no competing interests. Dr. Ashish Gawde and Dr. Priyanka Sodhi are employees of Bayer Pharmaceuticals Pvt Ltd.
: This study was carried out in alignment with the protocol and established ethical principles based on international guidelines, including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, relevant International Council for Harmonisation’s Good Clinical Practice (ICH GCP) Guidelines, and other applicable laws and regulations. Approval was obtained from the independent ethics committee (IEC) at each participating site (see Supplementary Material for site names and numbers). All the subjects provided informed consent to participate in the study, and also provided consent for publication.
