Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease
Brief Summary: This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.


Options:
A: Inclusion Criteria:

* GH nadir during a standard 75 g OGTT \>= 5.0 mmol/L.
* Pituitary tumor by MRI-scan.

Exclusion Criteria:

* Immediate surgery indicated by usual clinical criteria.
* Pregnant.
* Known adverse effects of octreotide.
* Unfit for participation by any other reason.
B: Inclusion criteria:

* Patients with active acromegaly (based on elevated GH and IGF-1 levels)
* Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
* Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

Exclusion criteria:

* Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
* Patients with compression of the optic chiasm causing any visual field defect
* Patients who have received pituitary irradiation within the last ten years prior to visit 1
* Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply
C: Inclusion Criteria:

* Written voluntary informed consent.
* Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
* Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
* Baseline (mean of 3 samples) GH level \> 2 µg/L.
* Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.

Other protocol-defined inclusion/exclusion criteria applied to the study.
D: Inclusion Criteria:

* The patient has given written informed consent prior to any study related procedures
* The patient is male or female and is aged between 18 and 75 years, inclusive,
* Diagnosis of acromegaly defined by i) GH nadir \> 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level \> 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the age- and sex-matched normal range for diabetic and non diabetic patients (central laboratory results),
* The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading,
* The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement:

  * Not related to the pituitary adenoma
  * Clinically stable condition not presumed to change during the study period
  * Not modifying the ability to evaluate visual field changes related to the macroadenoma

Exclusion Criteria:

* The patient has a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure,
* The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study,
* The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the study protocol,
* The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,
* The patient is pregnant or lactating,
* The patient has a history of, or known current, problems with alcohol abuse,
* The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
* The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study,
* The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry,
* The patient has previously been treated with a somatostatin analogue,
* The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry,
* The patient is expected to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period,
* Patients with suspected associated prolactinoma: prolactin level \> 100 ng/mL (central laboratory results),
* Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2),
* Patient known by Investigator, to have congenital or acquired optic nerve disease or any visual abnormality with risk of worsening during the course of the study (e.g glaucoma), influencing ability to evaluate Visual Field changes related to the macroadenoma.

Answer: C