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If inclusion criteria are met, informed consent will be obtained and the patient will be informed that participation is voluntary and that withdrawal of informed consent is possible at any time.
A total of 46 patients (10%) dropped out for different reasons (e.g. withdrawal of informed consent, retrospective violation of inclusion criteria, incomplete information).
After the treatment assessment at week 18, patients will receive the ARG-Vx001 or placebo every 12 weeks starting from week 27 until disease progression, unacceptable toxicity, withdrawal of informed consent, or death.
Patients were excluded during follow-up for use of antimalarial drugs outside of the study, serious adverse events requiring a change in treatment, withdrawal of informed consent, or loss of follow-up (not located within 24 h Days 1 3 or 48 h Days 4 42).
Participants were withdrawn for change of school, withdrawal of informed consent, or noncompliance with study procedures.
Apart from active withdrawal of informed consent, we do not maintain any specific criteria for dropouts.
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