hCG Treatment for Rehabilitation From a TBI

Inclusion Criteria: * Male subjects aged 18-65 * Subject is 1-month but \< 6-month post-TBI with a msTBI defined as Glasgow Coma Scale (GCS) 4-12 (inclusive) at the time of the TBI, and/or at the time of screening (Visit 1) * Stable doses of any medication, supplement or medical food that may affect brain function, unless deemed medically necessary by the patient's physician for optimal healthcare * Fluent in English * Reasonable expectation of availability to receive the 24-week course of therapy and be available for follow up evaluations Exclusion Criteria: * Significantly depressed (Geriatric Depression Scale \> 10) * Patients considered to be at risk for suicidality or homicidality according to the Columbia Suicide Severity Rating Scale (CSSRS) * Primary hypogonadism (unrelated to trauma) * Renal disease; Asthma; known endocrine or germ cell tumor * Taking other medications known to affect serum sex hormone or gonadotropin concentrations such as testosterone for hormone replacement therapy, goserelin or danazol, in the past three (3) months * Presence of significant systemic illness likely to interfere with participation in or completion of the study or to affect study results * Receiving other investigational drugs within 30 d or 5 half-lives prior to randomization, whichever longer * Male patients with known/documented elevated PSA levels, or a PSA level of 4ng/mL at screening * History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) * Clinically sign…