Trial Outcomes & Findings for To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria (NCT NCT02497612)

NCT ID: NCT02497612

Last Updated: 2022-03-24

Results Overview

ACPR: negative parasitemia at Day 28, irrespective of axillary temperature(AT), in participants not meeting any criteria of early therapy failure (ETF):Danger signs (DS)/severe malaria (SM) at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \>Day 0 irrespective of AT; or parasitemia at Day 3 with AT \>=37.5 degree Celsius (°C); or parasite count on Day 3\>=25 percent (%) on Day 0, or late clinical failure(LCF):DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT\>=37.5°C between Day 4 and 28, or late parasitological failure (LPF):presence of parasitemia between Day 7 and 28 and AT\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection. In data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 377 participants
• Primary outcome timeframe: Day 28
• Results posted on: 2022-03-24

Participant Flow

Study conducted at 12 active sites in 7 countries. Total of 806 participants were screened between 25 July 2015 and 22 July 2019, of which 377 were randomized to 1 of 4 treatment arms (via Integrated Web Recognition System using permuted block randomization schedules). 429 participants failed screening mainly due to meeting exclusion criteria.

In each arm, participants were divided in 4 cohorts (C):C1 (greater than [>] 14 years (yrs) to less than [<] 70 yrs); C2 (>5 yrs to less than or equal to [<=] 14 yrs );C3 (>2 yrs to <=5 yrs); C4 (>6 months to <=2 yrs). Day 0 (drug administration day, per protocol) was Day 1 for safety reporting as per Clinical Data Interchange Standards Consortium.

Participant milestones

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) On Day 0, based on the body weight (BW), participants received orally a single dose of ferroquine (FQ) capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of artefenomel (OZ439) (maximum dose up to 800 milligrams \[mg\]) oral suspension as follows: BW greater than or equal to (\>=) 35 kilograms (kg): FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Overall Study STARTED	93	94	97	93
Overall Study Treated	92	94	96	91
Overall Study Cohort 1: >14 Years to <70 Years	14	15	18	16
Overall Study Cohort 2: >5 Years to <=14 Years	6	5	6	5
Overall Study Cohort 3: >2 Years to <=5 Years	66	66	67	65
Overall Study Cohort 4: >6 Months to <=2 Years	7	8	6	7
Overall Study COMPLETED	27	37	48	46
Overall Study NOT COMPLETED	66	57	49	47

Reasons for withdrawal

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) On Day 0, based on the body weight (BW), participants received orally a single dose of ferroquine (FQ) capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of artefenomel (OZ439) (maximum dose up to 800 milligrams \[mg\]) oral suspension as follows: BW greater than or equal to (\>=) 35 kilograms (kg): FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Overall Study Met >=1 anti-malarial treatment criteria	57	51	39	41
Overall Study Participant's request	2	3	4	1
Overall Study Investigator's judgement	1	0	0	2
Overall Study Adverse Event	3	1	4	1
Overall Study Lost to Follow-up	1	1	0	1
Overall Study Other unspecified	1	1	2	0
Overall Study Not eligible	1	0	0	1

Baseline Characteristics

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Baseline characteristics by cohort

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=94 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=97 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg	Total n=377 Participants Total of all reporting groups
Age, Continuous	7.34 years STANDARD_DEVIATION 9.94 • n=5 Participants	6.97 years STANDARD_DEVIATION 8.97 • n=7 Participants	7.61 years STANDARD_DEVIATION 9.60 • n=5 Participants	7.68 years STANDARD_DEVIATION 10.44 • n=4 Participants	7.40 years STANDARD_DEVIATION 9.71 • n=21 Participants
Age, Customized >6 months to <=2 years	7 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	28 Participants n=21 Participants
Age, Customized >2 to <=5 years	66 Participants n=5 Participants	66 Participants n=7 Participants	67 Participants n=5 Participants	65 Participants n=4 Participants	264 Participants n=21 Participants
Age, Customized >5 to <=14 years	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	22 Participants n=21 Participants
Age, Customized >14 to <18 years	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Age, Customized >=18 years	8 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	41 Participants n=21 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	46 Participants n=7 Participants	43 Participants n=5 Participants	56 Participants n=4 Participants	182 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	48 Participants n=7 Participants	54 Participants n=5 Participants	37 Participants n=4 Participants	195 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	89 Participants n=5 Participants	89 Participants n=7 Participants	91 Participants n=5 Participants	87 Participants n=4 Participants	356 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 28

Population: African \<=5 years PP28: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.

ACPR: negative parasitemia at Day 28, irrespective of axillary temperature(AT), in participants not meeting any criteria of early therapy failure (ETF):Danger signs (DS)/severe malaria (SM) at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count >Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5 degree Celsius (°C); or parasite count on Day 3>=25 percent (%) on Day 0, or late clinical failure(LCF):DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT>=37.5°C between Day 4 and 28, or late parasitological failure (LPF):presence of parasitemia between Day 7 and 28 and AT<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection. In data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=51 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=60 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=57 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=60 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) at Day 28: African <=5 Years Per Protocol Population at Day 28 (PP28)	78.4 percentage of participants Interval 64.7 to 88.7	85.0 percentage of participants Interval 73.4 to 92.9	89.5 percentage of participants Interval 78.5 to 96.0	91.7 percentage of participants Interval 81.6 to 97.2

SECONDARY outcome

Timeframe: Day 28

Population: African \>5 years PP28: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.

ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=11 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=10 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=12 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=10 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: African >5 Years Per Protocol Population at Day 28 (A5PP28)	72.7 percentage of participants Interval 39.0 to 94.0	100 percentage of participants Interval 69.2 to 100.0	100 percentage of participants Interval 73.5 to 100.0	90.0 percentage of participants Interval 55.5 to 99.7

SECONDARY outcome

Timeframe: Day 28

Population: Asian PP28 population: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.

ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: Asian PP Population at Day 28 (APP28)	25.0 percentage of participants Interval 0.6 to 80.6	25.0 percentage of participants Interval 0.6 to 80.6	40.0 percentage of participants Interval 5.3 to 85.3	20.0 percentage of participants Interval 0.5 to 71.6

SECONDARY outcome

Timeframe: Day 42

Population: African \<=5 years PP42: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 42, excluding those who received rescue treatment due to vomiting during drug administration.

ACPR: negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT >=37.5°C between Day 4 and 42, or LPF: presence of parasitemia between Day 7 and 42 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=43 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=55 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=50 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=57 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP Population at Day 42 (PP42)	69.8 percentage of participants Interval 53.9 to 82.8	81.8 percentage of participants Interval 69.1 to 90.9	84.0 percentage of participants Interval 70.9 to 92.8	87.7 percentage of participants Interval 76.3 to 94.9

SECONDARY outcome

Timeframe: Day 63

Population: African \<=5 years PP63: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 63, excluding those who received rescue treatment due to vomiting during drug administration.

ACPR: negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT >=37.5°C between Day 4 and 63, or LPF: presence of parasitemia between Day 7 and 63 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=39 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=43 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=44 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=47 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP Population at Day 63 (PP63)	64.1 percentage of participants Interval 47.2 to 78.8	76.7 percentage of participants Interval 61.4 to 88.2	81.8 percentage of participants Interval 67.3 to 91.8	87.2 percentage of participants Interval 74.3 to 95.2

SECONDARY outcome

Timeframe: Day 28

Population: Analysis was performed on African \<=5 years PP28 population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.

ACPR was defined as negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28 or, LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish re-infection (new clone of parasite) or recrudescence.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=67 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=63 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=62 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28: African <=5 Years PP28 Population	49.3 percentage of participants Interval 37.0 to 61.6	71.6 percentage of participants Interval 59.3 to 82.0	76.2 percentage of participants Interval 63.8 to 86.0	87.1 percentage of participants Interval 76.1 to 94.3

SECONDARY outcome

Timeframe: Day 42

Population: Analysis was performed on African \<=5 years PP42 population.

ACPR was defined as negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT >=37.5°C between Day 4 and 42 or, LPF: presence of parasitemia between Day 7 and 42 and AT <37.5°C or having rescue therapy for malaria PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=65 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=59 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=61 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP42 Population	39.1 percentage of participants Interval 27.6 to 51.6	50.8 percentage of participants Interval 38.1 to 63.4	61.0 percentage of participants Interval 47.4 to 73.5	68.9 percentage of participants Interval 55.7 to 80.1

SECONDARY outcome

Timeframe: Day 63

Population: Analysis was performed on African \<=5 years PP63 population.

Crude ACPR was defined as negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT >=37.5°C between Day 4 and 63 or, LPF: presence of parasitemia between Day 7 and 63 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=68 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=65 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=59 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=60 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP63 Population	35.3 percentage of participants Interval 24.1 to 47.8	46.2 percentage of participants Interval 33.7 to 59.0	57.6 percentage of participants Interval 44.1 to 70.4	58.3 percentage of participants Interval 44.9 to 70.9

SECONDARY outcome

Timeframe: Up to Day 63

Population: African \<=5 years modified Intent-To-Treat (mITT) population: all randomized African participants \<=5 years with parasitological confirmed Plasmodium falciparum (P. falciparum) malaria at baseline, who received the single administration of OZ439/FQ and excluding participants who required rescue treatment due to vomiting during drug administration.

Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Re-emergence was confirmed by microscopy (positive blood smear). Kaplan-Maier method was used for estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=73 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=70 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Time to Re-emergence	36.0 days Interval 24.0 to 63.0	61.0 days Interval 43.0 to Upper limit of 95% confidence interval (CI) was not estimable due to very low number of participants with the events.	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	64.0 days Interval 63.0 to 65.0

SECONDARY outcome

Timeframe: Up to Day 63

Population: Analysis was performed on African \<=5 years mITT population. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=73 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=70 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Time to Recrudescence	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	NA days Median and 95% CI was not estimable due to very low number of participants with the events.

SECONDARY outcome

Timeframe: Up to Day 63

Population: Analysis was performed on African \<=5 years mITT population. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differs from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=73 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=70 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Time to Re-infection	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	NA days Median and 95% CI was not estimable due to very low number of participants with the events.	65.0 days 95% CI was not estimable due to very low number of participants with the events.

SECONDARY outcome

Timeframe: From the start of study drug administration up to the time of the first negative film (up to Day 63)

Population: African\<=5years PP population participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violation impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration

PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, in the data table "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=69 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=67 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=63 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=62 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Parasite Clearance Time (PCT): African <=5 Years PP Population	36.0 hours Interval 24.23 to 36.07	36.0 hours Interval 35.93 to 36.1	36.1 hours Interval 36.0 to 48.0	36.1 hours Interval 24.25 to 36.42

SECONDARY outcome

Timeframe: From the start of study drug administration up to the time of the first negative film (up to Day 63)

Population: African \>5years PP population participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violation impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration

PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=11 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=11 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=12 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=10 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Parasite Clearance Time: African >5 Years PP Population	24.0 hours Interval 18.0 to 24.18	24.3 hours Interval 18.07 to 36.0	24.3 hours Interval 12.23 to 36.0	27.2 hours Interval 6.15 to 36.17

SECONDARY outcome

Timeframe: From the start of study drug administration up to the time of the first negative film (up to Day 63)

Population: Asian PP population: participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration.

PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Parasite Clearance Time: Asian PP Population	82.0 hours Interval 79.97 to Upper limit of 95% CI was not estimable due to very low number of participants with the events.	75.1 hours Interval 53.93 to 95.82	79.8 hours Interval 36.0 to Upper limit of 95% CI was not estimable due to very low number of participants with the events.	72.2 hours Interval 60.08 to 79.98

SECONDARY outcome

Timeframe: From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)

Population: Analyzed performed on African \<=5 years PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had event, plus those who were censored.

FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first assessment. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=3 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Fever Clearance Time (FCT): African <=5 Years PP Population	1.0 hours Interval 1.0 to 24.0	1.0 hours Interval 1.0 to 18.0	1.0 hours 95% CI was not estimable as all 4 participants had the same value.	1.0 hours Interval 1.0 to 12.0

SECONDARY outcome

Timeframe: From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)

Population: Analysis was performed on African \>5 years PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had event, plus those who were censored.

FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=3 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=1 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=2 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=1 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Fever Clearance Time: African >5 Years PP Population	1.0 hours Interval 1.0 to 18.0	1.0 hours	1.5 hours Interval 1.0 to 2.0	2.0 hours

SECONDARY outcome

Timeframe: From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)

Population: Analysis was performed on Asian PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, '0' in "overall number of participants analyzed"=no participants were evaluable since they had paracetamol within 96 hours of study drug administration.

FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=1 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=1 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Fever Clearance Time: Asian PP Population	18.0 hours	—	—	36.0 hours

SECONDARY outcome

Timeframe: 24 and 48 hours post dose

Population: Analysis was performed on African \<=5 years PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.

The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=63 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=57 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=58 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=53 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Parasite Reduction Ratio (PRRlog10) at 24 Hours and 48 Hours: African <=5 Years PP Population PRR24 (log10)	2.867 ratio Interval 1.19 to 5.35	3.011 ratio Interval 1.1 to 5.63	2.397 ratio Interval 1.25 to 4.75	2.587 ratio Interval 1.52 to 5.24
Parasite Reduction Ratio (PRRlog10) at 24 Hours and 48 Hours: African <=5 Years PP Population PRR48 (log10)	5.734 ratio Interval 2.39 to 10.69	6.023 ratio Interval 2.2 to 11.27	4.794 ratio Interval 2.5 to 9.5	5.174 ratio Interval 3.04 to 10.48

SECONDARY outcome

Timeframe: 24 and 48 hours post dose

Population: Analysis was performed on African \>5 years PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.

The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=7 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=9 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=10 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=8 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Parasite Reduction Ratio at 24 Hours and 48 Hours: African >5 Years PP Population PRR24 (log10)	2.979 ratio Interval 2.41 to 4.3	4.069 ratio Interval 2.16 to 5.0	3.288 ratio Interval 2.3 to 4.81	3.054 ratio Interval 1.76 to 5.59
Parasite Reduction Ratio at 24 Hours and 48 Hours: African >5 Years PP Population PRR48 (log10)	5.957 ratio Interval 4.83 to 8.6	8.137 ratio Interval 4.32 to 10.0	6.577 ratio Interval 4.61 to 9.63	6.108 ratio Interval 3.52 to 11.17

SECONDARY outcome

Timeframe: 24 and 48 hours post dose

Population: Analysis was performed on Asian PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.

The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=5 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=4 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Parasite Reduction Ratio at 24 Hours and 48 Hours: Asian PP Population PRR24 (log10)	1.167 ratio Interval 1.01 to 1.28	1.125 ratio Interval 1.0 to 1.44	1.688 ratio Interval 1.07 to 3.12	1.353 ratio Interval 1.1 to 1.65
Parasite Reduction Ratio at 24 Hours and 48 Hours: Asian PP Population PRR48 (log10)	2.335 ratio Interval 2.03 to 2.56	2.250 ratio Interval 1.99 to 2.88	3.377 ratio Interval 2.14 to 6.24	2.705 ratio Interval 2.21 to 3.31

SECONDARY outcome

Timeframe: From Baseline up to Day 63

Population: Analyzed on safety population which included all randomized participants who received at least 1 dose or part of a dose of the study medication.

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of the first dose of double-blind drug administration up to the Day 63. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=92 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=94 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=96 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=91 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) Any TEAE	84 Participants	87 Participants	85 Participants	81 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) Any treatment-emergent SAE	0 Participants	2 Participants	4 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) Any treatment-emergent AESI	5 Participants	8 Participants	9 Participants	11 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) Any TEAE led to treatment discontinuation	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) Any TEAE led to death	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Analysis was performed on the PK population for OZ439 which included all participants who received OZ439 and had at least one evaluable blood sample for PK and with adequate documentation of dosing date and sampling date.

Cmax is the maximum observed plasma concentration of artefenomel.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=88 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=90 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Artefenomel	1072 nanograms per milliliter Geometric Coefficient of Variation 95	936.7 nanograms per milliliter Geometric Coefficient of Variation 91	771.8 nanograms per milliliter Geometric Coefficient of Variation 92	797.8 nanograms per milliliter Geometric Coefficient of Variation 119

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Analysis was performed on PK population for OZ439.

Area under the plasma concentration versus time curve from time zero to infinity.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=88 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=90 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Pharmacokinetics: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Artefenomel	14.24 micrograms*hour per milliliter Geometric Coefficient of Variation 124	12.41 micrograms*hour per milliliter Geometric Coefficient of Variation 127	9.621 micrograms*hour per milliliter Geometric Coefficient of Variation 130	9.605 micrograms*hour per milliliter Geometric Coefficient of Variation 147

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and pharmacodynamic \[PD\]). Since clearance was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.

Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since volume of distribution was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Analysis was performed on the PK population for FQ which included all participants who received FQ and had at least one evaluable blood sample for PK and with adequate documentation of dosing date and sampling date. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Cmax is the maximum observed plasma concentration of Ferroquine.

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=88 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=90 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine (Cmax)	148.1 nanograms per milliliter Geometric Coefficient of Variation 52	222.8 nanograms per milliliter Geometric Coefficient of Variation 66	350 nanograms per milliliter Geometric Coefficient of Variation 55	467.6 nanograms per milliliter Geometric Coefficient of Variation 80

SECONDARY outcome

Timeframe: 2, 4, 6, 8, 12, 24, 48, 168, 336 and 672 hours postdose

Population: Analysis was performed on PK population for FQ. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.

Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours).

Outcome measures

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=88 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=93 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=90 Participants On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Pharmacokinetics: Area Under the Curve From Time 0 to Day 28 (AUC0-day28) of Ferroquine	14.92 micrograms*hour per milliliter Geometric Coefficient of Variation 40	22.56 micrograms*hour per milliliter Geometric Coefficient of Variation 48	33.84 micrograms*hour per milliliter Geometric Coefficient of Variation 48	46.4 micrograms*hour per milliliter Geometric Coefficient of Variation 52

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since clearance was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.

Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since volume of distribution was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose

Population: Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since blood plasma ratio of active drug and metabolite was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.

Outcome measures

Outcome data not reported

Adverse Events

Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)

Serious events: 0 serious events

Other events: 77 other events

Deaths: 0 deaths

Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)

Serious events: 2 serious events

Other events: 79 other events

Deaths: 0 deaths

Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)

Serious events: 4 serious events

Other events: 77 other events

Deaths: 0 deaths

Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)

Serious events: 2 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=92 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=94 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=96 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=91 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Infections and infestations Malaria	0.00% 0/92 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.1% 1/94 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.0% 1/96 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/91 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Infections and infestations Hepatitis A	0.00% 0/92 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/94 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/96 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.1% 1/91 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Infections and infestations Pharyngitis	0.00% 0/92 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.1% 1/94 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/96 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/91 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/92 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/94 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/96 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.1% 1/91 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Hepatobiliary disorders Drug-Induced Liver Injury	0.00% 0/92 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/94 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.0% 1/96 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/91 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Investigations Alanine Aminotransferase Increased	0.00% 0/92 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/94 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	2.1% 2/96 • Number of events 2 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	0.00% 0/91 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.

Other adverse events

Measure	Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) n=92 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg.	Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) n=94 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg.	Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) n=96 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg.	Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) n=91 participants at risk On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg.
Infections and infestations Malaria	59.8% 55/92 • Number of events 75 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	53.2% 50/94 • Number of events 65 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	41.7% 40/96 • Number of events 49 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	45.1% 41/91 • Number of events 45 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	7.6% 7/92 • Number of events 9 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	6.4% 6/94 • Number of events 8 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	17.7% 17/96 • Number of events 18 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	11.0% 10/91 • Number of events 10 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Infections and infestations Bronchitis	3.3% 3/92 • Number of events 3 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.3% 5/94 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	4.2% 4/96 • Number of events 4 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.5% 5/91 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Infections and infestations Rhinitis	4.3% 4/92 • Number of events 4 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	3.2% 3/94 • Number of events 4 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	1.0% 1/96 • Number of events 1 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	7.7% 7/91 • Number of events 8 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Metabolism and nutrition disorders Decreased Appetite	5.4% 5/92 • Number of events 6 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	8.5% 8/94 • Number of events 8 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.2% 5/96 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.5% 5/91 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Nervous system disorders Headache	6.5% 6/92 • Number of events 6 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	7.4% 7/94 • Number of events 8 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	7.3% 7/96 • Number of events 8 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.5% 5/91 • Number of events 6 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Cough	10.9% 10/92 • Number of events 13 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	7.4% 7/94 • Number of events 9 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	15.6% 15/96 • Number of events 16 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	16.5% 15/91 • Number of events 17 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	29.3% 27/92 • Number of events 29 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	28.7% 27/94 • Number of events 28 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	35.4% 34/96 • Number of events 37 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	37.4% 34/91 • Number of events 37 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	10.9% 10/92 • Number of events 10 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	11.7% 11/94 • Number of events 12 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	7.3% 7/96 • Number of events 9 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	12.1% 11/91 • Number of events 13 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain	7.6% 7/92 • Number of events 7 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.3% 5/94 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.2% 5/96 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	6.6% 6/91 • Number of events 6 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
General disorders Pyrexia	7.6% 7/92 • Number of events 9 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	2.1% 2/94 • Number of events 3 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	9.4% 9/96 • Number of events 12 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	11.0% 10/91 • Number of events 10 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Investigations Electrocardiogram Qt Prolonged	6.5% 6/92 • Number of events 6 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	5.3% 5/94 • Number of events 5 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	6.2% 6/96 • Number of events 7 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.	8.8% 8/91 • Number of events 8 • From Baseline up to Day 63 Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.

Additional Information

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