Endpoints
ADVERSE EVENTS, SECONDARY
The primary efficacy endpoint was definitive cure at 12 months after treatment onset, defined as clinical cure (100% lesion resolution) and no additional PKDL treatment between end of therapy and 12-month follow-up assessment. Safety endpoints were serious adverse events (SAEs) from the start of treatment to 12 months follow-up, frequency and severity of adverse events (AEs) that lead to treatment discontinuation, and frequency and severity of all AEs from the start of treatment through 12 months follow-up. A secondary pharmacokinetic endpoint was to assess the maximum drug concentration in the blood plasma at the end of treatment (Day 42) and the maximal accumulation of PM, total amphotericin B, and MF in the skin at the end of treatment (Day 42), and to correlate these values.