Mvalo, Tisungane
McCollum, Eric D.
Fitzgerald, Elizabeth
Kamthunzi, Portia
Schmicker, Robert H.
May, Susanne
Phiri, Melda
Chirombo, Claightone
Phiri, Ajib
Ginsburg, Amy Sarah
Article History
Received: 19 May 2021
Accepted: 20 December 2021
First Online: 10 January 2022
Declarations
:
: The ITIP project was conducted under the International Conference on Harmonization Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. Ethical approvals were received from the Western Institutional Review Board in the USA and the Malawi College of Medicine Research Ethics Committee prior to commencement of study procedures. The ITIP1 and ITIP2 clinical trials also received regulatory approval from the Malawi Pharmacy Medicines and Poisons Board. Written informed consent from parents or caregivers was obtained prior to any study procedures. ITIP1, ITIP2, and ITIP3 were registered with ClinicalTrials.gov (NCT02760420, NCT02678195, and NCT02960919, respectively).
: Not applicable.
: The authors declare that they have no competing interests.