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Table 1 Summary of inclusion and exclusion criteria

From: A phase I trial to evaluate the safety and pharmacokinetics of low-dose methotrexate as an anti-malarial drug in Kenyan adult healthy volunteers

Inclusion Criteria Exclusion Criteria
Male aged ≥18 -≤55 years old;
Weighing 50-75 kg
Haemoglobin ≥10 g/dl
HIV negative
Written informed consent from the study subject.
Severe underlying conditions such as malnutrition, clinically suspected cardiac, renal, or hepatic diseases, suspected AIDS, or severe injury.
Presence of any concomitant illnesses such as malaria, lower respiratory tract infections (LRTI), acute bloody or non-bloody diarrhoeas, or other acute infections.
History of treatment with antimalarial drugs within the last 2 weeks.
History of treatment with aspirin or any non-steroidal-anti-inflammatory agent or trimethoprim and co-trimoxazole within the last 7 days.
Any ongoing medication.
Abnormal clinical chemistry or hematological finding.
Alcohol/drugs intake.
Any other reason in the recruiting clinician's opinion that makes the individual unsuitable for taking part in a clinical trial.