PRE-REGISTRATION INCLUSION CRITERIA:Xx_NEWLINE_xXREGISTRATION INCLUSION CRITERIA:Xx_NEWLINE_xXPRE-REGISTRATIONXx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIA:Xx_NEWLINE_xXPRE-REGISTRATION ELIGIBILITY CRITERIAXx_NEWLINE_xX