- Cases which do not meet exact inclusion or exclusion criteria but questioned as appropriate by the site PI will be reviewed by the multi-site STAART protocol committee for final decision about study eligibility. The protocol committee will take care to insure that the exception 1) is consistent with the subject's welfare and 2) does not compromise the scientific purpose of the study. Such exceptions will be coded as an approved protocol deviation and will be communicated to the local Institutional Review Board in a timely manner.