Shrikhande, Shailesh V.
Verma, Manish
Funding for this research was provided by:
Sanofi India
Article History
Received: 24 May 2019
Accepted: 27 January 2021
First Online: 1 March 2021
Declarations
:
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the study.
: Gastro-intestinal disease management group of Tata Memorial Hospital received honorarium for conducting this study. Manish Verma is an employee of Sanofi.
: Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found atExternalRef removed.