Primary efficacy outcome of definitive cure at 12 months by treatment arm–mITT and PP sets.
hypersensitivity
HYPERSENSITIVITY
LAmB = Liposomal amphotericin B; CI = Confidence interval; MF = Miltefosine; mITT = Modified intention-to-treat; PM = Paromomycin; PP = Per-protocol. In this primary analysis, missing efficacy outcome at 12 months are defined as treatment failure.Treatment failure was reported in 7 patients in arm 2, all of whom received rescue treatment: 5 due to relapse at 12 months follow-up, 1 absence of cure, and 1 patient with an AE of hypersensitivity related to LAmB who received rescue treatment after treatment discontinuation. Four remaining patients were assigned as failure in the mITT analysis in arm 2 due to withdrawal of consent during treatment (1 patient), withdrawal of consent during follow-up (1 patient) and loss to follow-up (2 patients). In arm 1 the only case of failure in the mITT analysis was 1 patient lost to follow-up.A Kaplan-Meier analysis of the time to complete cure is presented in the mITT set by treatment arm and overall in 