Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
Brief Summary: There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.


Options:
A: Inclusion Criteria:

* Age: 35-65 years.
* Meeting the American College of Rheumatology criteria: widespread pain for more than 3 months, and pain with 4 kg/cm of pressure reported for 11 or more of 18 tender points.
* Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q ).
* Not to be engaged in regular physical activity \>20 minutes on \>3 days/week.
* Planning to stay in the same Association during the study.
* Able to ambulate, with or without assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Acute or terminal illness.
* Myocardial infarction in the past 3 months.
* Not capable to ambulate.
* Unstable cardiovascular disease or other medical condition.
* Upper or lower extremity fracture in the past 3 months.
* Severe dementia (MMSE\<10).
* Unwillingness to either complete the study requirements or to be randomised into control or training group.
* Presence of neuromuscular disease or drugs affecting neuromuscular function.
B: Inclusion Criteria:

* Criteria diagnosis according ACR 1990
* Wash-out of medication specific for fibromyalgia for 1 month
* Only paracetamol 750mg will be allowed during the period of study.

Exclusion Criteria:

* Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation
C: Inclusion Criteria:

* Age greater than or equal to 18 years
* A diagnosis of fibromyalgia according to American College of Rheumatology criteria
* Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity
* Pain medications must have been stable for at least 14 days.
* Ability to follow the protocol (with reference to cognitive and situational conditions, (e.g. stable housing, ability to attend follow-up visits, motivation and commitment to self practice of CFQ Qigong for 45-60 minutes per day).
* Willing and able to give written informed consent

Exclusion Criteria:

* Presence of clinically significant medical disorder on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
* Already practicing CFQ Qigong on a regular basis
* Unable to commit to 45-60 minutes of CFQ Qigong practice per day
D: 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.

Answer: D