Methods
This feasibility study was a prospective, randomized, double-masked, placebo-controlled crossover design of 6 months duration with 12 patients from the private practice of the principal investigator (author R.Z.S.). Institutional Review Board (IRB) Approval was provided by Western IRB, as was an Investigational New Drug (IND) Exemption. Clinical trial registration information is publicly available at clinicaltrials.gov, under the identifier NCT04423341.