Serious adverse events will include those that require medical intervention such as additional monitoring by the subject’s primary physician or medical hospitalization. All significant adverse events (such as those listed above or any side effect with an intensity level of 4) will be reviewed with the treating psychiatrist and the independent medical reviewers. Each site will have two independent medical reviewers (one internist, one psychiatrist) to examine any serious or significant adverse events and determine if the subject should be withdrawn from the study. The two reviewers will not be directly connected to the research group and will not be investigators in the protocol.