I wonder where TSOI published if not on clinicaltrials.gov Since
"Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject (para. 35). "Researchers have a duty to make publicly available the results of their research on human subjects.
to be approved by the FDA
FDA's inspection of clinical investigators is not limited to the United States (U.S.). International inspections are generally conducted when the studies are part of a marketing application submitted to FDA and provide data critical to decision-making on product approval.
Alpha Male always Caribbean Wolf Pack StrongThe Society of Slayers...
to be approved by the FDA 
