definiens: or . Theseriousness of an event is defined according to the applicable regulations and generally refers to the outcome of anevent . A SAE is defined as any untoward medical occurrence that at any dose : • [ * * * ] [ * * * ] VBL Page 45 of 60Confidential Information Protocol version 1.1, 21 Aug 2012Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by[***].Protocol VB-201 - 064 VB-201 • [ * * * ] [ * * * ] 11.3Reporting and DocumentationThe Investigator must report all directly observed AEs and all spontaneously reported AEs . At each visit theInvestigator will ask the subject a nonspecific question ( e.g., ) to assess whether any AEs have been experienced since the last report or visit . AEs will be identified anddocumented on the AE page of the eCRF in appropriate medical terminology . Details of the event must includeseriousness, severity, relationship to study drug, duration, action taken, and outcome