Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Iron Deficient Patients With Fibromyalgia
Brief Summary: This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days.


Options:
A: Inclusion Criteria:

* Male or female subject's ≥ 18 years of age, able to give informed consent to the study.
* Fibromyalgia diagnosis based on The 2011 modification of the American College of Rheumatology (ACR) 's 2010 preliminary criteria for diagnosing fibromyalgia (2011ModCr)
* A baseline score ≥ 60 on the FIQR
* Subject's current medications to treat fibromyalgia, including pain medicines, anti-depressants, sleep medications must be on a stable dose for at least 30 days.
* Subject's current narcotic medication must be on a stable dose for at least 30 days prior to randomization
* Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.

Exclusion Criteria:

* Parenteral iron use within 4 weeks prior to screening.
* History of \> 10 blood transfusions in the past 2 years.
* Anticipated need for blood transfusion during the study.
* Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
* Current or acute or chronic infection other than viral upper respiratory tract infection
* Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).
* Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
* Pregnant or lactating women.
* Severe peripheral vascular disease with significant skin changes.
* Seizure disorder currently being treated with medication.
* Baseline ferritin ≥ 50 ng/mL.
* Baseline TSAT ≥ 20%.
* History of hemochromatosis or hemosiderosis or other iron storage disorders.
* Known positive hepatitis with evidence of active disease.
* Hemoglobin greater than the upper limit of normal.
* Calcium or phosphorous outside the normal range.
* Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).
* Known positive HIV-1/HIV-2 antibodies (anti-HIV)
* Received an investigational drug within 30 days before randomization.
* Chronic alcohol or drug abuse within the past 6 months.
* Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.
* Subject unable to comply with the study requirements.
B: SLR ARM

Inclusion Criteria:

* sea level natives of lowland ancestry
* generally in good health
* detectable tricuspid regurgitation on echocardiography

Exclusion Criteria:

* any significant medical problem
* known susceptibility to high altitude pulmonary or cerebral oedema
* taking medications or iron supplements

CMS ARM

Inclusion Criteria:

* diagnosis of chronic mountain sickness
* no recent venesection therapy (within 1 year)
* detectable tricuspid regurgitation on echocardiography

Exclusion Criteria:

* any other significant medical problem
C: Inclusion Criteria:

* Female, 18 to 45 years old,
* Serum Ferritin levels \<20 µg/L,
* Normal body Mass Index (18.5-25 kg/m2),
* Body weight \<65 kg,
* Signed informed consent

Exclusion Criteria:

* Anaemia (Hb \< 11.7 g/dL),
* Elevated c-reactive protein or alpha1 glycoprotein concentrations \>5.0 mg/L, \>1.0 g/L, respectively,
* Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
* Continuous/long-term use of medication during the whole studies (except for contraceptives),
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration,
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months,
* Earlier participation in a study using stable iron isotopes,
* Known hypersensitivity or allergy to iron supplements,
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the studies,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present studies,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
D: Inclusion Criteria:

* Age 18 to 100
* To be receiving intravenous iron

Exclusion Criteria:

* Age \< 18
* Hemodialysis
* Previous exposure to intravenous iron
* Unable to provide written consent

Answer: A