Note regarding the blinding of this study: the subject, investigators, and assessor are all blinded to which treatment arm (Fenzian or sham) the subject is assigned. However, the treatment coordinator, who administers the Fenzian (or sham) treatments, is unblinded. Therefore, the design of this study does not neatly fit into either the "single blind" or the "double blind" category. We would call this study design "subject and observer blinded" because no one involved in any assessment of study outcomes is unblinded. Unfortunately, the clinicaltrials.gov system for posting does not allow us to both indicate "single blind" AND check multiple masked roles. For this reason, this explanation should accompany any discussion of the blinding; subject, investigator, an assessor are all blinded (but cannot be checked).