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Primary mitochondrial disease and secondary mitochondrial dysfunction: importance of distinction for diagnosis and treatment

Several factors combine: absence of active patent (thus little pharmaceutical incentive to finance trials), ambiguous regulatory status in most countries, high cost of a phase I to III clinical trial (several million to tens of million euros), difficulty in defining a precise indication acceptable to a regulatory authority

Possible side effects may include mild discomfort at the injection site or temporary redness and swelling

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