Methods
Our study was a single-center, single-arm, open-label, phase 2 clinical trial with enrolment from July 2020 to December 2021. The trial was approved by the institutional ethics committee (JIP/IEC/2020/059) and the Clinical Trials Registry of India (CTRI/2020/09/027547). It was conducted in accordance with the Declaration of Helsinki and the Indian Council of Medical Research (ICMR) Guidelines for Good Clinical Practice. All patients provided written informed consent.