Document is current

Article History

Accepted: 28 June 2023

First Online: 18 July 2023

Change Date: 26 June 2024

Change Type: Update

Change Details: Supplementary material is missing and it has been included

Declarations

:

: Funding for this study was provided by Hetero Labs Limited, Hyderabad, India.

: Shubhadeep D. Sinha, Mohan Reddy Bandi, Sreenivasa Chary Sriramadasu, Abhilash Sankerneni, Muralidher Panapakam, Venkata Narayana Reddy Vemireddy and Srinivas Reddy Devireddy are the employees of Hetero Labs Limited. Ramya Vattipalli is a former employee of Hetero Labs Limited. All other authors have no conflict of interest to declare.

: The data supporting the results reported in the article, which are not available in the article, are available on request if appropriate.

: This study was conducted after approval by the institutional review board/ethics committee at each participating site (Supplementary Material) and in accordance with good clinical practice (GCP) guidelines issued by the Central Drugs Standard Control Organization (CDSCO), New Drugs and Clinical Trials Rules (2019), Indian Council of Medical Research (ICMR) and ethical guidelines for biomedical research on human patients. This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki (2013), that are consistent with GCP in accordance with International Conference on Harmonization guidelines (ICH-GCP E6), the applicable regulatory requirements, and applicable standard operating procedures (SOPs).

: All patients signed written informed consent prior to the initiation of study-related procedures for screening.

: Not Applicable.

: Not Applicable.

: Conceptualisation: SDS and SCS; Methodology: SCS and AS; Formal analysis and investigation: AR, RKK, S.S, SH, MP, VNRV and MRB; Writing—original draft preparation: SRD; Writing—review and editing: SCS, SRD, SDS; Supervision: SDS, SCS, and MRB.