Ann: Operational Update, page-14

If there is severe adverse effect is reported the trial may be discontinued or put on hold. Data Review committee will get involved too. If some adverse effect seen (undedirable side effects) it will be consider by Data Review comittee and that does not have to be at the end of each phase. If side effects are those seen in previous stages, by definition they are acceptable and trial goes on but Data Review will still look at it (again). There will also be a Data Rebiew even I'd there is no adverse effect and of by some point there is sufficient statistics to say there is no statistically significant advantage, the company itself may decide not to continue (as it will be a waste or resources) but regardless, the data again go to Data Review ... all this means, "No news, is good news".