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Authors
Gu, Helen
Abla, Nada
Venishetty, Vinay Kumar
Schoeberl, Birgit
Zack, Julia
Einolf, Heidi J.
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Funding
Funding for this research was provided by:
Novartis/Medicines for Malaria Venture/PAMAfrica consortium/European & Developing Countries Clinical Trials Partnership (RIA2018SD-2306, RIA2018SD-2306, RIA2018SD-2306, RIA2018SD-2306, RIA2018SD-2306, RIA2018SD-2306)
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Article History
Received: 12 May 2025
Accepted: 1 August 2025
First Online: 25 August 2025
Declarations
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: The study was conducted according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E6 Guidelines for Good Clinical Practice that have their origin in the Declaration of Helsinki. The study protocol was reviewed and approved by the institutional ethics committee or review board for each center and by national health authorities. The study design was also discussed and agreed with SwissMedic, the WHO, and with some malaria-endemic countries via a Marketing Authorisation for Global Health Products consultation. Informed consent was obtained from the legally acceptable representative, i.e. parent or legal guardian, of each patient.
: Not applicable.
: H.G., V.K.V., B.S., J.Z., and H.J.E. are employees of Novartis; H.G. and J.Z. are Novartis stockholders. N.A.G. is an employee of Medicines for Malaria Venture.
