Table 1.

Data Collection and Assessment Schedule

Assessments	In-patient assessment (day)							Follow-up (months)
	BL	1	2,3,4,5	7	14	21	30	3	6
Clinical assessment (BP, body temperature, weight, height1, spleen size)	X			X	X	X	X	X	X
Haematology (HB, WBC, Platelet)	X			X	X	X	X	X	X
Biochemistry2 (Urea, creatinine, ALT, AST, Na+, K+, Mg2+)	X		X	X	X	X	X	X	X
CARPA	X	X		X	X
Pharmacodynamic Assessment	X		X	X	X		X	X	X
Urinalysis (blood, protein, glucose)	X		X	X	X	X	X
Parasitology (splenic, LN, BM aspirates)3	X						X	X	X
HIV test	X
Electrocardiogram Examination4	X			X	X	X	X		X
Pregnancy test	X
Dosing - including monitoring of vital signs5		X	X		X	X
Adverse events6	X	X	X	X	X	X	X	X	X

BL = Baseline, BP = blood pressure, HB = Haemoglobin, WBC = white blood cell count, AST = aspartate aminotransferase, ALT = Alanine transaminase, Na⁺= Sodium, K⁺ = Potassium, Mg²⁺ = Magnesium, CARPA = complement activation related pseudo allergy products, LN = lymph node, BM = bone marrow, HIV = Human immunodeficiency virus

¹ Body height measurements on Day 0 only

² Day 3 only

³ Parasitological investigations to be undertaken in the event of clinically significant abnormalities at 3 months follow-up

⁴ ECG if clinically indicated

⁵ Single-dose arm monitoring on day 1 only

⁶ Treatment emergent adverse events have onset at anytime between day 1 and day 60 for each patient