Created at Source Raw Value Validated value
June 25, 2024, noon usa

* unwilling or unable to provide informed consent/assent * the participant is judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results * inability/unlikely to be in the study area for the duration of the 28-day follow-up period * pregnant or lactating women * severe disease requiring parenteral treatment * currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine * received chloroquine in the last three days * inability/unlikely to be in the study area for the duration of the 42-day follow-up period * known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms * known chronic kidney disease (signs or symptoms of stage iv renal impairment or receiving dialysis) * known liver cirrhosis (child-pugh class b or greater) or signs or symptoms of severe hepatotoxicity

* unwilling or unable to provide informed consent/assent * the participant is judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results * inability/unlikely to be in the study area for the duration of the 28-day follow-up period * pregnant or lactating women * severe disease requiring parenteral treatment * currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine * received chloroquine in the last three days * inability/unlikely to be in the study area for the duration of the 42-day follow-up period * known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms * known chronic kidney disease (signs or symptoms of stage iv renal impairment or receiving dialysis) * known liver cirrhosis (child-pugh class b or greater) or signs or symptoms of severe hepatotoxicity

Jan. 6, 2021, 12:31 a.m. usa

- unwilling or unable to provide informed consent/assent - the participant is judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results - inability/unlikely to be in the study area for the duration of the 28-day follow-up period - pregnant or lactating women - severe disease requiring parenteral treatment - currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine - received chloroquine in the last three days - inability/unlikely to be in the study area for the duration of the 42-day follow-up period - known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms - known chronic kidney disease (signs or symptoms of stage iv renal impairment or receiving dialysis) - known liver cirrhosis (child-pugh class b or greater) or signs or symptoms of severe hepatotoxicity

- unwilling or unable to provide informed consent/assent - the participant is judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results - inability/unlikely to be in the study area for the duration of the 28-day follow-up period - pregnant or lactating women - severe disease requiring parenteral treatment - currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine - received chloroquine in the last three days - inability/unlikely to be in the study area for the duration of the 42-day follow-up period - known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms - known chronic kidney disease (signs or symptoms of stage iv renal impairment or receiving dialysis) - known liver cirrhosis (child-pugh class b or greater) or signs or symptoms of severe hepatotoxicity