Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Brief Summary: The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.


Options:
A: Inclusion Criteria:

1. Subjects were to have completed Study CLAR-09007.
2. Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
3. Subjects were required to remain off all forms of T except for study medication throughout the entire study.
4. Subjects voluntarily gave written informed consent to participate in this study.

Subjects meeting any of the following criteria were not eligible for participation in this study:

1. Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness developed during the Phase III study that would, in the opinion of the Investigator, require exclusion from this study.
2. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
3. Serum transaminases \>2 times upper limit of normal (ULN), serum bilirubin \>2.0 mg/dL and serum creatinine \>2.0 mg/dL at the final visit for Study CLAR 09007.
4. Abnormal prostate digital rectal examination (palpable nodule\[s\]) or elevated PSA (serum PSA \>4 ng/mL) at the final visit for Study CLAR-09007.
5. Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or dehydroepiandrosterone (DHEA).
6. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors (e.g., orlistat \[Xenical\]) and bile acid-binding resins (e.g., cholestyramine \[Questran\], colestipol \[Colestid\]).
7. Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
8. Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g., barbiturates, glucocorticoids \[pharmacologic doses of glucocorticoids for replacement therapy were not exclusionary\]) and potent CYP3A4 inhibitors (e.g., human immunodeficiency virus \[HIV\] antivirals \[indinavir, nelfinavir, ritonavir, saquinavir, delaviridine\], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note: Short-term ciprofloxacin administration completed more than 7 days prior to study visits was not exclusionary during the study.)
B: Inclusion Criteria:

* Type 2 diabetes
* Testosterone less than 10 nmol/L

Exclusion Criteria:

* Contraindication to
* Testosterone or
* IM injection
C: Inclusion Criteria:

* Subjects were at least 50 years of age
* A body mass index (BMI) between 18 and 34 kg/m\^2
* Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
* Calculated free testosterone measurement of \<0.26 nmol/L in the morning

Exclusion Criteria:

* History or current diagnosis of breast or prostate cancer
* any clinically significant abnormal finding on physical examination including the prostate
* Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) \>14)
* Prostate specific antigen (PSA) level \> 4 ng/mL at screening
* Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
* Hyperprolactinaemia or treatment with prolactin-lowering drugs
* History of known chronic polycythemia and/or hematocrit \>50% at screening
* History or presence of severe sleep apnea
* Unstable or untreated endocrine disorders
* History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
* Use of medication that would interfere with the efficacy and safety objectives of the trial
D: Inclusion Criteria:

* Male gender age 50-70
* Bioavailable testosterone \< 7,3 nmol/L
* Metformin treatment of T2DM for 3 months or more

Exclusion Criteria:

* HbA1c \> 9,0 %, BMI \> 40 kg/m2, Haematocrit \> 50%,
* Known malignant disease, PSA \> 3 ug/L, Nycturia \> 3 times,
* Abnormal routine blood samples,
* Severe hypertension,
* Significant EKG-changes,
* Wish of parenthood,
* Active mental illness,
* former or present abuse,
* Severe illness of heart-, lung- or kidney,
* Primary or secondary hypogonadism.

Answer: A