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.
BIT Science Discussion, page-248
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