Adverse reactions reported as more than an isolated case are listed as follows, by system organ class and by frequency. Frequency categories are defined using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100),
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Adverse reactions and their frequencies reported in Table 3 are based on the main registration studies. (See Table 3.)
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