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40 [95% CI 2.12-5.48]; RR 2.40 [95% CI 1.36-4.23]; RR 2.80 [95% CI 1.66-4.73]), but disappeared thereafter. The AP absolute risk in MMI users during the first 18 months of treatment was less than 0.4% in all sex and age classes. Our results support the EMA warning, suggesting an increased risk of AP associated with MMI use. However, such an increase seems limited to the first months of MMI treatment. Moreover, in absolute terms, the probability of AP is low among patients, well below 1%. Our results support the EMA warning, suggesting an