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BIT Science Discussion, page-248

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    Phase II is to determine safety and the optimal dosage. What BIT have shown in a small number of individuals (27 from memory) dosed at 200mg for 12 weeks that there were now side effects so major as to have anyone drop out. This is a long way from showing safety - you both need many more people and much longer treatment times.

    This of course assuming that 200mg is high enough to be effective which is yet to be shown.
 
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