 Subject Identification Code. The following series of numbers will comprise the subject identification code SIC: protocol acronym ADAPTHRO, and 2-digit subject number e.g., 01...02 reflecting the order of enrollment i.e., signing the informed consent form. For example, the third subject who signed an informed consent form will be identified as ADAPTHRO-03. All study documents e.g., CRFs, clinical documentation, etc. will be identified with the SIC. 