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Description

Bourdais, G

These limited reports suggest good tolerability, though the small sample sizes, lack of standardized safety monitoring, and retrospective or uncontrolled study designs limit definitive safety conclusions

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Regulatory Approval by the TGA Once clinical trials are successfully completed, the treatment developer, also known as the sponsor, will use its scientifically robust data regarding the medicines quality, safety and efficacy, to apply for registration from the Therapeutic Goods Administration (TGA), Australias regulatory authority for therapeutic goods

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