Unsolicited AEs considered by the investigator to be causally related to the IP were toothache and restless leg syndrome (n = 1, Group-A10), headache and nausea (n = 1, Group-A10), prothrombin time prolonged (n = 1, Group-A10), neutrophil count decreased (n = 1, Group-A30), and hyperhidrosis (n = 1, Group-APbo); all were Grade 1 in intensity and resolved. This evidence concerns the gene F2 and Hyperhidrosis.