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Conflict of interest The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest

B., Rominger, F

The FDAs concerns go beyond simply the absence of trials

Why Standardizing Decision-Making Matters The real question isn't "What dose should we use?" It's, "How do we create a safe, compliant process?" That looks like: Written protocols Clear eligibility criteria Strong informed consent forms Set follow-up checks Adverse event reporting Staff training Standard workflows protect your patients, your providers, and your spa