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The flowchart illustrates participant disposition across study populations. Off ADMs refers to participants who were not treated with ADMs at any point during the study. The ITT population includes all randomized participants. The mITT population consists of ITT participants who received at least one dose of the study drug and had valid TFC scores at baseline and at least one post-baseline visit. The SP population includes randomized participants who received at least one dose of the study drug. The PP population represents the combined analysis set of the W65PP and W78PP subsets. The W65PP and W78PP subsets include mITT participants with valid TFC scores at weeks 65 and 78, at least 80% compliance with the study drug and no major protocol deviations. W65PP, per protocol week 65 population; W78PP, per protocol week 78 population. a Patients who did not receive ADM treatment at any point during the study; b the analysis set consisting of patients from both W65PP and W78PP.
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