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Eight subjects received one dose of study drug or placebo.
The safety analysis set included all randomized patients who received at least one dose of study drug.
All subjects provided written informed consent prior to the administration of study drug or any study procedure.
All patients who received at least one dose of study drug were included in all analyses.
A total of 13 subjects (46.4 %) experienced adverse events that led to discontinuation of study drug.
The safety dataset included participants who received at least one dose of study drug.
In 14 236 participants who received at least 1 dose of study drug, 4692 (33%) experienced TI.
Safety assessment was the frequency and severity of AEs (medical occurrences during the study period after the first dose of study drug was administered) in the safety cohort, which included participants who received at least one dose of study drug.
a Defined as the last measurement on or before the day of the first dose of study drug.
Safety parameters were evaluated in all patients who received ≥1 dose of study drug using descriptive statistics.
Participants were seen on days 1 (first day of study drug), 15 and 29 (end of study drug and unblinding) for clinical evaluation and study procedures.
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