The second phase (Cycle 2): EW02 at 700mg tid daily versus placebo group are given at the beginning of Cycle 2 for 15 consecutive days. 60 subjects will be randomized 2:1 to two groups in pre-stratified permuted blocks of six with four subjects assigned to Group 1 (EW02) while two subjects assigned to Group 2 (Placebo). Group 1 will receive EW02 for 15 consecutive days during the second cycle and Group 2 will receive 15 consecutive days of Placebo.