Ahmad, Sundus Shafat
Verma, Reena
Commons, Robert J.
Nitika,
Singh-Phulgenda, Sauman
Chhajed, Rutuja
Bharti, Praveen K.
Behera, Beauty
Naser, Syed Mohammad
Pal, Salil Kumar
Ranjit, Parinita Halder
Baharia, Rajendra Kumar
Solanki, Bhavin
Upadhyay, K. J.
Guerin, Philippe J.
Sharma, Amit
Price, Ric N.
Rahi, Manju
Thriemer, Kamala http://orcid.org/0000-0001-7536-7497
Article History
Received: 24 November 2023
Accepted: 15 February 2024
First Online: 29 February 2024
Declarations
:
: ICMR- National Institute of Malaria Research has obtained approval from the Institutional Ethics Committee (IEC) with relevant documents after Scientific Advisory Committee (SAC) approval. Ethics approval has been obtained from both site ethics committees as well. The proposal has also been submitted for the Health Ministry Screening Committee’s (HMSC) approval. The trial has been registered online prospectively through the Clinical Trial Registry of India (CTRI) after obtaining the approval of the IEC and receiving exemption from the Drug Controller General of India. The study will be conducted in accordance with Good Clinical Practice (GCP), all applicable subject privacy requirements, and the ethical principles that are outlined in the Declaration of Helsinki 2008.
: This manuscript does not contain individual personal data from patients they will be presented in reports of the trial results. Informed consent materials are available, on request, from the corresponding author.
: The authors declare they have no competing interests.