 All adverse events were summarized by system organ class, preferred term, and treatment. A list of subjects who had serious adverse events SAEs and who discontinued from the study due to an adverse event was provided. The number and percentage of subjects who experienced at least 1 treatment-emergent adverse event TEAE were presented for each system organ class and for each preferred term by treatment. Treatment-emergent adverse events that were considered by the Investigator to be related to study drug were summarized in the same manner. Serious adverse events and adverse events leading to discontinuation from the study were listed separately. 