The following link goes into detail of the study they performed and the results. From what I can see it was a single study with 32 horses. Not bad for 5 years exclusivity, although no doubt horse trainers will most likely just do what they've always done and use other forms of PPS.
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13249
The following link goes into detail of the study they performed...
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