Screen failures are defined as subjects who consent to participate in the clinical trial but are never subsequently dosed. In order to ensure transparent reporting of screen failure subjects, meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements, and respond to queries from Regulatory authorities, a minimal set of screen failure information will be reported including Demography, Screen Failure details (including G6PD results), Eligibility Criteria, and any Serious Adverse Events.