Safety data
deaths, haemolysis, fever
Ten serious AEs occurred in three participants in the placebo group and none in the IVIG group. None of the SAEs were judged to be related to the study treatment. One participant in the IVIG group reported an AE of special interest; the participant developed a fever during the IVIG infusion; however, this was judged to be unrelated to the study treatment. None of the participants experienced haemolysis following receipt of two doses of study treatment. No deaths occurred during the study period.