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. 2018 Sep 10;9:520. doi: 10.3389/fendo.2018.00520

Table 1.

Inclusion and exclusion criteria.

Inclusion criteria Exclusion criteria
1. Non-penetrating TBI 1. History of pre-existing neurologic disease
(such as brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
2. Age 16–65 years 2. History of premorbid disabling condition that interfere with outcome assessments
3. Randomization within 2–24 weeks of injury. 3. Contraindication to rhGH therapy
(hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)
4. Rancho Los Amigos Rating IV or better at the time of randomization. Should not be at Rancho IV level for more than 18 weeks before randomization 4. Penetrating traumatic brain injury
5. Availability of caregiver to oversee administration of medications 5. Discharged from rehabilitation on insulin therapy and/or hypoglycemic agents
6. Reasonable expectation for completion of outcome measures 6. Obesity (BMI > 35)
7. Residence inside the United States 7. Active infection
8. Hypothyroidism or Adrenal Insufficiency
9. Previous diagnosis of renal or hepatic failure
10. Active malignant disease
11. Acute critical illness, heart failure, or acute respiratory failure
12. Membership in a vulnerable population (prisoner)
13. Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy
14. Lactating females