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Initial clinical trials only tested a gap of less than six months between doses, but unexpected popularity and resulting shortages caused further testing to validate wider spacing of the two doses

However, like other Khavinson peptides , Pinealon faces skepticism - most research conducted in Russia with limited Western replication, no FDA approval or large-scale international trials, mechanisms not fully elucidated despite decades of study, optimal dosing based on Russian protocols without rigorous dose-finding studies, and long-term safety data from clinical use rather than controlled trials

It is classified as an unapproved new drug , meaning it cannot be legally marketed, sold, or prescribed as a therapeutic agent

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