Please select the eligibility criteria that correspond to the clinical trial below.
Title: Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.
Brief Summary: The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.


Options:
A: Inclusion Criteria:

* Women aged greater than or equal (\>=) 18 years
* Fibromyalgia diagnosed at least one year before
* History of generalized pain and at least 16 positive tender points (1990 American College of Rheumatology \[ACR\] criteria)
* Body Mass Index (BMI) less than or equal to(=\<) 32
* Normal GH stimulation test (insulin)
* Stable (\>= 3 months unchanged) standard treatment with amitriptyline (10-50 milligram per day \[mg/day\]) plus selective serotonin reuptake inhibitor (10-40 mg/day) plus tramadol (25-400 mg/day)
* Active rehabilitation program during the previous year (at least 30 minutes/day)
* Fibromyalgia Impact Questionnaire (FIQ) score \>=75
* IGF-1 serum level =\< 150 nanogram/milliliter (ng/mL) otherwise =\< 2 SD of the local lab normality)
* Normal response to IGF-1 generation test
* Chronic Fatigue Symptoms (Multidimensional Assessment of Fatigue \[MAF\])
* Effective anti-conception
* Willingness to comply with the protocol
* Written Informed consent

Exclusion Criteria:

* Major psychiatric condition
* Rheumatic disease, including systemic lupus erythematosus (SLE)
* Previous or current malignancies, active or inactive
* Clinical history intracranial space occupying lesion
* Reactive or secondary (rheumatoid arthritis \[RA\], osteoarthritis) fibromyalgia syndrome (FMS)
* Antinuclear antibody (ANA) greater than or equal 1:80
* Abnormal Creatine phosphokinase (CPK) or aldolase serum levels
* Not controlled thyroid disease in the last 3 months (free Thyroxine \[T4\] and Thyrotrophin-stimulating hormone \[TSH\] serum levels)
* Diabetes mellitus
* Adrenal gland disease (any abnormal cortisolemia, will be confirmed by 24-hour cortisoluria)
* Pregnancy or breast feeding
* Known to be hypersensitive to somatotropin or any of the excipients
B: Inclusion Criteria:

* Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1 levels included in a rehabilitation and psychological program and stable under standard intensive treatment for at least 6 months.
* All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level \<250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and body surface according to laboratory reference value).
* Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ \> 75.
* The study was conducted in accordance with the Declaration of Helsinki and received the local institutional review board and Spanish Drug Agency (nº03-0456) approvals. All patients gave written informed consent prior to their inclusion in the study.

Exclusion Criteria:

* Disabling physical or mental status
* Previous or current malignancies, either active or inactive
* Intracranial space occupying lesion
* Any relevant endocrine disorder including diabetes mellitus
* History of another pituitary disorder
* Previous treatment with growth hormone
* Other systemic or joint inflammatory rheumatic conditions; and
* Known to be hypersensitive to somatropin or any of the excipients.
* Pregnant women, nursing mothers, or women with childbearing potential not using adequate contraceptive methods were also excluded.
C: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
D: Inclusion Criteria:

* ACR criteria for fibromyalgia
* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications

Answer: A