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Cardona L (2016) Food and feeding of Mugilidae

Even in asymptomatic patients, up to 70% will develop symptoms of AIH (or cirrhosis, the consequence of its progression) within 10 years, and those not treated will have a decreased 10-year survival compared to symptomatic patients with AIH who start treatment

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You can read the regulatory guidelines on the website of the EMA and the first in human clinical trials guidelines FDA here

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