Ghosh, Asim K.
Nikumbh, Usha S.
Shukla, Chaitanya K.
Laul, Rohit S.
Dixit, Abhishek
Mahapatra, Santosh K.
Nayak, Sameera
Shah, Urmil M.
Parwal, Sandeep
Venkatapathy, Narendran
Radhakrishnan, Natasha
Kelgaonkar, Anup
Saxena, Sandeep
Mishra, Divyansh
Dave, Vivek Pravin
Khan, Perwez
Saswade, Manojkumar R.
Shantilal, Malli S.
Ramasamy, Kim
Sreekanta, Smitha
Rajurkar, Mandodari http://orcid.org/0000-0002-5513-0545
Doshi, Maulik
Behera, Sapan
Patel, Piyush
Dhawan, Shilpi
Lakhwani, Lalit
Funding for this research was provided by:
Sun Pharma
Article History
Received: 5 December 2023
Accepted: 4 January 2024
First Online: 26 March 2024
Declarations
:
: Authors Asim Ghosh, Usha Nikumbh, Chaitanya Shukla, Rohit Laul, Abhishek Dixit, Santosh Mahapatra, Sameera Nayak, Urmil Shah, Sandeep Parwal, Narendran Venkatapathy, Natasha Radhakrishnan, Anup Kelgaonkar, Sandeep Saxena, Divyansh Mishra, Vivek Dave, Perwez Khan, Manojkumar Saswade, Malli Shantilal, Kim Ramasamy, and Smitha Sreekanta were the study investigators and they received grants from the sponsor for conducting the study at their respective sites and declare no conflict of interest. Mandodari Rajurkar is a full-time employee of Sun Pharma Laboratories Limited. Maulik Doshi, Sapan Behera, Piyush Patel, Shilpi Dhawan, and Lalit Lakhwani were affiliated with Sun Pharma Laboratories Limited during the conduct of the study and are no longer part of the organisation and declare no conflict of interest.
: The study was approved by the Drug Controller General of India and the IEC at each participating study site. The list of study sites and their respective IEC details is provided in the Supplementary Material. All patients provided written informed consent before participation in the study. The study was performed in accordance with the Declaration of Helsinki 1964 and its later amendments. All patients provided informed consent to participate in the study.