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The most responsible framing is: Short-term tolerability is not the same as long-term safety Manufacturing quality heavily affects risk People with medical conditions or those taking medications should talk to a clinician before considering unapproved substances

The adjustment period typically lasts two to four weeks, during which mild side effects may occur before resolving

It is not intended for human or veterinary use, administration, diagnosis, treatment, or therapeutic application.

Eisai submitted a new drug application in May 2015 but the Pharmaceuticals and Medical Devices Agency (PMDA) indicated that additional clinical trials were necessary