Safety and tolerability
deaths, dry mouth, diarrhea
DRY MOUTH
In the active formulation group, one participant reported one AE of diarrhea that was rated as severe. The AE started on day 2 of study formulation consumption and resolved on day 3; the participant completed the study. In the placebo group, two participants reported one AE each, both of which were rated as mild. One participant reported dry mouth that started on day 2 of placebo formulation consumption and resolved on day 3; the participant completed the study. Another participant reported an eye rash/swollen eye that started on day 2 of placebo formulation consumption; this participant withdrew from the study on day 3, citing problems with transportation to study visits. There were no SAEs, no formulation-related AEs leading to treatment discontinuation, and no deaths in either group.The rate of compliance with study formulation consumption was 100% among the 38 completed participants. The two participants who discontinued the study self-reported 100% compliance with study formulation until the point of study discontinuation.