Soman, Raunak Jay
Swamy, Malisetty Venkat
Article History
Accepted: 24 September 2019
First Online: 4 November 2019
Compliance with ethical standards
: Before participation in the study, all subjects provided written informed consent. This study was performed in compliance with International Conference on Harmonisation (ICH E6[R2]) “Guidance on Good Clinical Practice,” Declaration of Helsinki; Indian Good Clinical Practices Guideline; National Ethical Guidelines for Biomedical and Health Research involving human participants, Indian Council of Medical Research 2017; and, relevant standard operating protocols of Jehangir Clinical Development Centre, Pune, Maharashtra, India. This study was approved by the institutional review board of Jehangir Clinical Development Centre, Pune, Maharashtra, India, and was registered in the Clinical Trials Registry of India (CTRI/2018/05/014071).
: R J Soman and M V Swamy are employees of Sanzyme Biologics Pvt Ltd. The authors have no other conflict of interest to declare with respect to this authored publication.