 4. Subjects presenting with a CGI-S score of 6 severely ill at two consecutive visits after week 2 will be dropped from the study i.e. A subject with a CGI of 6 at hisher week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit. Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary. 