definiens: means the d etermination by Charles River, in its professional judgment based on its review of standardized serial photographs, that all of the following conditions have been met in the Pre - Clinical Study : ( i ) an Objective Res ponse rate of greater than 80 % in each of the 1mM a nd 10mM arms and less than 20 % in the vehicle arm ; ( ii ) a N ear Complete Response rate of greater than 50 % in e ach of the 1mM and 10mM arms and 0 % in the vehicle arm ; and ( i ii ) a dose response as evidenced by an Objective Response rate in the 100uM dose group that is great er than that for the vehicle group, but less than t hat for the 1mM group, and a Near Complete Response rate in the 100uM dose group that is less than that for the 1 m M group