Subjects will be encouraged to complete the study; however they may voluntarily withdraw at any time. The investigator must provide written documentation of the reason for discontinuation on the appropriate study form. Regardless of the reason for or source of withdrawal, all subjects will be asked to undergo an end of therapy evaluation and a 45+-day after completing the study medication. Additionally, subjects who discontinue study drug for any reason, without meeting any of the criteria listed above, may continue in the study. Such subjects will have no further efficacy evaluations following the last study drug dose, but will continue all safety assessments through the 10 days of follow-up. Subjects who withdraw or are withdrawn will not be replaced under this protocol.