Table 2 Summary of the inclusion and exclusion criteria at screening
Inclusion criteria | Exclusion criteria |
|---|---|
Hemoglobin SS genotype | Chronic transfusion program as defined by participating in a scheduled (pre-planned) series of transfusions for prophylactic purposes or a hemoglobin A level >20 % of the total hemoglobin |
Age ≥18 years and living in Dar es Salaam | Haemoglobin <4.0 g/dL |
Male or female (post-menopausal, sterile, or using an acceptable method of contraception) | HIV positive |
Negative urine pregnancy test at Screening and a negative urine pregnancy test (dipstick) prior to randomization and dosing | Female planning to become pregnant during the study period |
Absolute neutrophil count >1500/uL | Serious mental (including psychosis) or physical illness, which, in the opinion of the investigators would compromise participation in the study (e.g. impaired mental capacity, alcoholism) |
Platelet count >95,000/uL | Any condition which the investigators judge to preclude safe participation in the study or to confound the evaluation of the study outcome |
Serum creatinine <100 μmol/L (1.2 mg/dL) | |
Alanine transaminase less than two times the upper limit of normal | |
Being able and willing to record and submit videos electronically. |