Assessments
SKIN, DISEASE, LENS
Physical examination and vital signs, haematological, biochemical, and safety assessments were carried out in the screening period (day -30 to day 0) and on days 1, 3, 7, 14, and 28. A first clinical assessment for efficacy was made at D42 (+2 days). All patients had follow-up visits at 3 months (±7 days), 6 months (±7 days), and 12 months (±14 days) after the onset of treatment, to assess safety and efficacy. Plasma samples for PK analysis were collected on Days 1, 7, 14, 28, and 42, and at 3 months (sparse and intensive sampling). Skin biopsies (2 mm) were taken for PK analysis on Days 7 and 28 for patients in arm 2, or Days 14 and 42 for patients in arm 1. See Table A in PKDL diagnosis was confirmed in a skin slit smear by direct microscopy (material from the PKDL lesion was smeared on glass slides, air dried, fixed in methanol, stained with Giemsa, and examined microscopically using a 100× oil immersion lens for visualization of the amastigote form of the leishmania parasite) or by PCR using a validated method [Clinical evolution was systematically recorded using the PKDL grading to assess disease severity by lesion distribution and density (see Text A in 