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Table S1. Regions, countries, number of centres and patients participating in EDGE.

Table S2A. Number and reasons for discontinuations by cohort (ITT population).

Table S2B. Deviations from protocol requiring exclusion from the PP population by cohort.

Table S3. Index medication (ITT population).

Table S4. Adverse events by primary System Organ Class (SOC) and cohort (ITT population).

Table S5. Serious adverse events by SOC and cohort (ITT population).

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