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Safety Incidences of AE of all grades are summarised in table 2. The table shows the number of AEs recorded in the study and the number of patients affected by at least one AE. At least one AE was reported in 98/214 participants, and most of them were mild in severity. AEs of moderate grade were reported in 13/104 patients in SOC+L group and 9/110 patients in SOC group.
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