Stopped: Sponsor Decision
The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.
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Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Timeframe: Through study completion, an average of 10 weeks