Tabulated List of Adverse Reactions: Adverse reactions reported are presented in the table as follows. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Frequencies were defined as follows: Common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (can not be estimated from the available data). (See Table 2.)

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