Safety analysis set: all randomised participants who were exposed to at least one dose of study product 1G first generation, 2G second generation, AE adverse event, E number of events, n number of participants, PT preferred term, SAE serious adverse event, SOC system organ class, TEAE treatment-emergent adverse event Group 1 Overall, 186 (83.8%) of 222 participants reported a total of 904 TEAEs (Table 4)
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