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Challenges : Regulatory scrutiny around efficacy claims

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Therefore, more studies in humans are needed to support the findings in animals, with a unique methodology, specifying the exact proteins/isoenzymes analyzed, with an adequate number of participants involved, a clear distinction of infertile and fertile men from infertile couples, with defined type of infertility (according to seminogram characteristics, confirmed after two semen analyses), careful control of possible confounding, and elimination of other possible known reasons for male infertility

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