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Written informed consent for participation was not required from the participants or the participants legal guardians/next of kin because data were obtained from administrative datasets encompassing primary, secondary, and tertiary care for Brazilian patients across all five geographic regions (North, Northeast, Central-West, South, and Southeast)

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This suggests that the dose-escalation schedule used for the 36 mg arm may have been somewhat better optimized to mitigate nausea than the schedule for the 12 mg arm, or that the higher dose groups achieved better gastrointestinal adaptation during the titration period