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Article History

Received: 12 May 2025

Accepted: 13 October 2025

First Online: 6 November 2025

Declarations

:

: 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 centre 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.

: I.D., C.W., C.R., S.H., G.H., Z.Q., G.S., J.Z., M.C., V.K.V., S.S., and P.G. are employees and/or stockholders of Novartis. K.C.R. was an employee of Novartis at the time of the study and is a Novartis stockholder. M.E.G. is an employee of Medicines for Malaria Venture. A.C.M. is an employee of Medicines for Malaria Venture and a stockholder of Novartis, Idorsia and Alcon. G.W., B.O., I.S., C.M, A.B.T., Q.B., S.S. and B.K. have no interests to declare.