-  Participation in other interventional trials that could interfere with the present<br/>             study<br/><br/>          -  International Prostate Symptom Score (IPPS) > 18<br/><br/>          -  History of radiation or chemotherapy<br/><br/>          -  History of transurethral prostate resection<br/><br/>          -  unable to provide informed consent<br/><br/>          -  unwillingness to storage and forwarding of pseudonymous data<br/>
-  Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;<br/><br/>          -  Stage III or IV endometriosis (endometriomas);<br/><br/>          -  Hydrosalpinx;<br/><br/>          -  History of past poor response to COH resulting in canceling ART;<br/><br/>          -  Use of thawed/donated oocytes;<br/><br/>          -  Use of thawed/donated embryos;<br/><br/>          -  Patients affected by pathologies associated with any contraindication of being<br/>             pregnant;<br/><br/>          -  Hypersensitivity to study medication;<br/><br/>          -  Uncontrolled adrenal or thyroid dysfunction;<br/><br/>          -  Undiagnosed vaginal bleeding;<br/><br/>          -  History of arterial disease;<br/><br/>          -  Patients with hepatic impairment;<br/><br/>          -  Neoplasias (current) or history of neoplasia that may be responsive to progesterone;<br/><br/>          -  High grade cervical dysplasia;<br/><br/>          -  Active thrombophlebitis or thromboembolic disorders, or a history of<br/>             hormone-associated thrombophlebitis or thromboembolic disorders;<br/><br/>          -  History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages<br/>             wherein pregnancy developed to a minimum of a gestational sac on TVUS;<br/><br/>          -  Participation in a concurrent clinical trial or another trial within the past 2<br/>             months;<br/><br/>          -  Use of concomitant medications that might interfere with the study evaluation;<br/><br/>          -  Pre-implantation genetic diagnosis/screening.<br/>
1. latent or overt thyroid dysfunction<br/>2. serum potassium levels below 4 mmol/l<br/>3. clotting inhibitionout of range<br/>4. Detection of left atrial thrombus or tumor<br/>5. Lack of patient's competence
-  Cannot currently be catheterizing as a way to control incontinence<br/><br/>          -  Must not have used botulinum toxin type A or any other botulinum toxin previously for<br/>             any condition<br/>
-  Prior targeted therapy for hepatocellular carcinoma.<br/>
-  Existent pregnancy including ectopic pregnancy;<br/><br/>          -  Identification of other causes for the discomfort;<br/><br/>          -  Chronic diseases, except endometriosis, which require continuous pain therapy;<br/><br/>          -  Previous application of GnRH analogues 6 month prior to study;<br/><br/>          -  Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;<br/><br/>          -  Planned additional general surgical procedures during the operation for removal of<br/>             the endometriotic lesions;<br/><br/>          -  Absence of endometriosis at laparoscopy;<br/><br/>          -  Partial resection of the bowel or urinary bladder for removal of endometriosis<br/>
-  Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone<br/>             (GnRH) agonists or antagonists within the last 12 months preceding the study or<br/>             concomitant treatment with one or more of these substance(s)<br/><br/>          -  Any current use or within 6 months prior to treatment start of medications which are<br/>             known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,<br/>             aminoglutethimide, oestrogens and progesterone<br/><br/>          -  Patient at risk of spinal cord compression or ureter obstruction<br/><br/>          -  Prior hypophysectomy or adrenalectomy<br/>
-  EGFR mutations<br/><br/>          -  ALK translocations<br/><br/>          -  Predominantly squamous, adenosquamous or unclear histologic type<br/><br/>          -  Active or untreated CNS metastases<br/><br/>          -  Active malignancies other than NSCLC within the last 5 years with the exception of<br/>             adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or<br/>             squamous cell carcinoma of the skin<br/><br/>          -  Serious cardiac illness or medical conditions<br/><br/>          -  Pregnant or lactating women<br/><br/>          -  Uncontrolled intercurrent illness<br/>
-  More than two prior cytotoxic chemotherapy regimens<br/><br/>          -  Prior Ketoconazole for prostate cancer<br/><br/>          -  Prior abiraterone acetate or other CYP17 inhibitor or investigational agents<br/>             targeting the androgen receptor for prostate cancer<br/><br/>          -  Uncontrolled hypertension<br/><br/>          -  Active or symptomatic viral hepatitis or chronic liver disease<br/><br/>          -  History of pituitary or adrenal dysfunction<br/><br/>          -  Clinically significant heart disease<br/><br/>          -  Other malignancy<br/><br/>          -  Known brain metastasis<br/><br/>          -  GI disorder affecting absorption<br/><br/>          -  Not willing to use contraception<br/>
Exclusion criteria:<br/><br/>          -  Prior treatment with bisphosphonates within 6 months before study start, and during<br/>             treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other<br/>             bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <<br/>             8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)<br/><br/>          -  Current/active dental problems including<br/><br/>          -  infection of the teeth or jawbone<br/><br/>          -  dental or fixture trauma<br/><br/>          -  current or previous osteonecrosis of the jaw<br/><br/>          -  exposed bone in the mouth<br/><br/>          -  slow healing after dental procedures<br/><br/>          -  recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)<br/><br/>          -  Patients with clinically symptomatic brain metastases. Severe physical or<br/>             psychological concomitant diseases expected to impair compliance with the provisions<br/>             of the study protocol or impair the assessment of drug of patient safety<br/><br/>          -  Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant<br/>             pathologic findings in ECG<br/><br/>          -  History of diseases with influence on bone metabolism such as Paget´s disease and<br/>             primary hyperparathyroidism and with need of treatment for osteoporosis (defined<br/>             according to DVO, T-Score ≤2.5).<br/><br/>          -  Previous radiation therapy to bone (including therapeutic radioisotopes such as<br/>             strontium 89) within 1 month<br/><br/>        Additional protocol-defined inclusion/exclusion criteria may apply<br/>
-  History or current evidence of retinal vein occlusion (RVO) or current risk factors<br/>             for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of<br/>             hyperviscosity or hypercoagulability syndromes).<br/><br/>          -  Prior therapy with a MEK or BRAF inhibitor.<br/><br/>          -  History of Gilbert's syndrome.<br/><br/>          -  Impaired cardiovascular function or clinically significant cardiovascular diseases.<br/><br/>          -  Uncontrolled or symptomatic brain metastases that are not stable or require steroids,<br/>             are potentially life-threatening or have required radiation within 28 days prior to<br/>             first dose of study treatment.<br/><br/>          -  Concomitant malignancies or previous malignancies with less than a 5-year<br/>             disease-free interval at the time of first dose of study treatment; patients with<br/>             adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ<br/>             of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of<br/>             diagnosis.<br/><br/>          -  Known positive serology for the human immunodeficiency virus (HIV), active hepatitis<br/>             B and/or active hepatitis C.<br/><br/>          -  Prior randomization into this clinical study.<br/><br/>          -  Additional criteria exist.<br/>
-  Subjects with significant acute or chronic bleeding, such as overt gastrointestinal<br/>             bleeding<br/><br/>          -  Active hemolysis or diagnosis of hemolytic syndrome<br/><br/>          -  History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure<br/>             red-cell aplasia (PRCA)<br/><br/>          -  History of hemosiderosis or hemochromatosis<br/><br/>          -  Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)<br/><br/>          -  Aplastic anemia<br/><br/>          -  Chronic lymphoproliferative diseases<br/><br/>          -  Proliferative choroidal or retinal disease, such as neovascular age-related macular<br/>             degeneration or proliferative diabetic retinopathy that is likely to require invasive<br/>             treatment (intraocular injections or laser photocoagulation) during the study<br/><br/>          -  Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus<br/>             erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in<br/>             remission<br/><br/>          -  Known hypersensitivity to the study drugs (active substances or excipients of the<br/>             preparations)<br/><br/>          -  Uncontrolled and symptomatic hyperparathyroidism<br/><br/>          -  Uncontrolled active infection<br/><br/>          -  Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell<br/>             carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively<br/>             treated > 3 years prior to randomization<br/><br/>          -  Any allograft (including renal allograft) in place and on immunosuppressive therapy<br/>             or a scheduled kidney transplant within the next 16 weeks (being on a waiting list<br/>             does not exclude the subject)<br/>
-  History of acute metabolic complications<br/><br/>          -  Uncontrolled Hypertension<br/><br/>          -  History of Hypersensitivity to Exenatide<br/><br/>          -  Cardiovascular Disease<br/><br/>          -  History of Acute or chronic pancreatitis<br/><br/>          -  Personal or family history of Multiple endocrine neoplasia type 2<br/><br/>          -  History of Medullary thyroid cancer<br/><br/>          -  Severe renal failure, End stage renal disease or dialysis<br/>
-  Planned for a full-dose allogeneic transplant<br/>
-  no description of the R- status after resection of the tumour<br/><br/>          -  implanted metal in the radiation field<br/><br/>          -  pregnancy<br/><br/>          -  no written informed consent<br/><br/>          -  lack of histological confirmation<br/><br/>          -  no squamous cell carcinoma<br/><br/>          -  distant metastases<br/><br/>          -  interval between first and second irradiation < 6 months at secondary tumor or <1<br/>             year when local recurrence of previously irradiated tumor<br/><br/>          -  no previous dental treatment<br/><br/>          -  simultaneous participation in another intervention study , if further treatment must<br/>             be carried out<br/>
•Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.<br/>•History of thrombosis. <br/>•Chronic infection or acute infection or fever within the last 8 weeks prior to the start of drug administration. <br/>•Subjects with a splenomegaly.<br/>•Participation in another clinical study within three months prior to the start of drug administration. <br/>•Blood donation (>100 ml) or a comparable blood loss within three months prior to the start of drug administration.<br/>•Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason.<br/>•Subjects having already received G-CSF in the past.<br/>
- patients who have undergone a recent, or current attempt to revascularize (for example: lysis therapy)<br/>- patients with a known A. poplitea aneurysma in the limb concerned<br/>- patients with severe heart failure (NYHA IV) <br/>- patients with terminal kidney failure (creatinine > 10mg/dl) or undergoing dialysis, kidney transplant <br/>- allopurinol intolerance<br/>- allergy to any of the components in the reperfusion solution<br/>- current participation in a clinical trial (or within the last 30 days)<br/>- pregnant patients, or those currently breastfeeding<br/>- other conditions or circumstances likely to lead to poor treatment adherence (i.e., drug dependency, no fixed abode)
-  Pregnant or breastfeeding women<br/><br/>          -  Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the<br/>             Summary of Product Characteristics<br/><br/>          -  No Herceptin treatment for early breast cancer in the adjuvant setting<br/>
Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation,<br/>        undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal<br/>        preparations within one month prior to inclusion<br/>
Group 1 (sepsis patients): neuromuscular diseases, alcohol abuse, steroid therapy for asthma, COPD and patients likely to die within less than 24 hours, patients after tonsillectomy<br/>Group 2 and 3 (chronic tonsillitis and tonsil hyperplasia): sepsis, immunodeficiency, severe chronic diseases in the medical history<br/>
Patients younger than 18 years or with contraindication to a contrast-enhanced CT scan.
<18 years; operational coronary heart disease; acute myocardial infarction; TIA, PRIND, Apoplex in the last 6 months, no patient consent
Patients with ST-elevation myocardial infarction (STEMI)<br/>Continuing chest pain or recurrent episodes of chest pain under therapy<br/>High-risk patients with suspected ACS who need to be hospitalized for reasons independent of their initial troponin result <br/>Patients who need to be hospitalized for other medical reasons <br/>Patients in need of urgent life-saving interventions <br/>Patients under 18 years of age<br/>Patients with a life expectancy < 6 months<br/>Patients with any condition that leads the treating physician to not consider the patient eligible for the trial<br/>
none
hearing problems
pregnancy, acute myocardial infarction or stroke within 14 days before the examination
is not able to give consent ot take part in that study, is not able to understand and/or fill in the questionaire SF-36 and other forms
- lack of consentability <br/>- lack of consent for participation <br/>- incomplete or nonevaluable data<br/>- preoperative spontaneous resorption of the calcification<br/>- relevant additional intraoperative pathologies <br/>- reoperation
1. Mucosal or ocular melanoma melanoma<br/>2. Intransitmetastasen<br/>3. Other adjuvant therapy (systemic therapy with an immunomodulator of a previous operation is allowed, provided that the last dose at least 30 days earlier; prior radiotherapy before lymphadenectomy is allowed)<br/>4. Autoimmune disorders (vitiligo außgenommen)<br/>5. Immunodeficiency<br/>6. Other malignancies (excluding carcinoma in situ of the cervix or remission over 5 years)<br/>7. Uncontrolled bleeding
Patients who<br/>have a known allergy to constituents of the materials used, are addicted to medication, alcohol and/ or drugs, are suffering from infectious diseases (hepatitis, HIV, tuberculosis), are suffering from malignant tumors, are undergoing or have undergone radiotherapy, are pregnant or breast feeding, are not giving informed consent, are applying for renewal of a telescopic denture, that is already present
Exclusion criteria were contraindications to the use of electrical stimulation such as the presence of cardiac pacemakers or other implanted electronic devices, severe<br/>cardiac arrhythmia, osteosyntheses, malignant tumors, neurological diseases, peripheral vascular diseases, pregnancy, breastfeeding women, haemophilia, skin or soft tissue disease or chronic pain syndromes such as migraine or back pain. Previous experience with electrical stimulation methods was also an exclusion criteria inorder to avoid an expectation bia
presence of multiple defects which cannot adequately covered by implantation of one device, current participation in another ongoing clinical device or drug trial, recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF), active bacterial and/or viral infection, evidence of intra-cardiac thrombi on echocardiography, any existent disorder that, in opinion of the investigator, might interfere with the conduct of the trial<br/>
No documented triple-class resistance, medical illness that does not allow safe blood draw, age under 18 years, cognitive impairment leading to inability to fill out the questionnaires and/or to give informed assent or consent.
Students who did not pass one of those courses in the first attempt and therefore repeat it.
Age under 18; no intervention or no surgery during hospitalisation
Hospitals without intensive care units
oncological patients who are hospitalized with suspected ADR/ME and who have been hospitalized in the previous 4 weeks for oncological<br/>treatment
• Patients under 18 years<br/>• Polytoxicomania<br/>• Allergies to the various herbal ingredients of EUSANO formulation (food intolerance)<br/>• Pregnancy
no ability of giving consent;<br/>aphasia, dementia, confusion of the patient;<br/><br/>for incidence study only: place of residences out of Essen and surrounding area
- Pretreatment with Klacid<br/>- Transfer from another hospital
lack of consent<br/>preexisting severe lung disease (COPD, asthma)<br/>gravidity
hormone replacement therapy; history of breast cancer; serious health problems related to nutrient absorption, digestion, metabolism or excretion; women taking nutritional supplements or on medication during the past 3 months, which may interact with study parameters; participants who are supposed to be not complient;
<br/>Knee arthrosis Grade 2 (Kellgren and Lawrence system)<br/>Chronic drug abuse<br/>Patients carrying, artifical heart waves, heart pacemaker, other ferromagnetic implants
not German-speaking, not member of the rehabilitation team, age <18 years
GERD, non-conpliance<br/>
revocation of consent and underage patients
- Body weight above 120kg <br/>- Orthopedic problems and spasticity which make it impossible to walk with EB   <br/>- cardio-pulmonary not tenable<br/>- patients with aphasia, who don’t understand instructions<br/>- patients with neglect  <br/><br/>
Pregnancy, breast feeding, skin diseases, diseases of the peripheral nervous system, intake of antihistamines, NSAIDs, local anesthetics or mast cell stabilizers within 5 days prior to testing, intake of antideppressants within 14 days prior to testing, intake of steroids (topical or systemic) within 7 days prior to testing.
Unrealistic expectations <br/>• limitations that are inherent in clinical study<br/>• Unwillingness or inability of / the candidate concerning the experimental requirements<br/>• Additional disadvantages which would limit the participation in the audiological tests
Patient is eligible for and receives IV tPA according to licensing criteria<br/>Patient with an INR of >3<br/>Patient is an active participant in another drug or device treatment trial for any disease state,<br/>or patient is expected to start participation in another drug or device treatment trial while<br/>enrolled in this protocol, unless approved by Sponsor.<br/>Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.<br/>Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.<br/>Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)<br/>Patient has history of contraindication for contrast medium.<br/>Patient is known to have infective endocarditis<br/>CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on<br/>unenhanced CT and CBV drop on CBV maps on CTP, or, alternatively as per institutional<br/>standard, restricted diffusion on DWI with an ASPECT score of 6 or less<br/>Female of childbearing potential who is known to be pregnant and/or lactating or who has a<br/>positive pregnancy test on admission.<br/>Patients anticipated life expectancy is less than 6 Months.
known cardiocirculatory diseases, known lung diseases, pregnancy, active implants
Patients with evidence for a gemistocytic histology.
CDR memory value ≥ 2 or MMSE ≤ 9; severe Alzheimer's disease, frontotemporal dementia, levy body dementia, dementia in Parkinson's disease, other rare forms of dementia (corticobasal degeneration, Korsakoff's disease, Creutzfeldt-Jakob disease, PCA), severe psychiatric illness or previous illness (drug or alcohol abuse / - looking for the last 5 years, acute suicidality), brain tumor, cerebral hemorrhage, stroke, traumatic brain injury, acute inflammatory diseases of the CNS, hydrocephalus
•	Contraindication to adenosine administration<br/>•	Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel<br/>
Persons aged under 18, Wound infection before surgery, missing informed consent
other illness of lower extremity; other neurological or psychiatric desease; no independent walking or sit to stand before; cardiorespiratory instability at T0; need for vasopressive support, severe illness of lumbar, thoracic or cervical spine, severe open wounds (abdomial, legs, pelvis), PAD >2, amputations upper limb, transfer to an other rehabilitation or intensiv care unit in the first 3 Weeks after adission; palliative care; dialyses more than 3 times/week, BMI: >35kg/m2
Patients who have:<br/><br/>          -  not given informed consent<br/><br/>          -  known iodine allergy<br/><br/>          -  high grade renal insuffiency (eGFR < 30ml/min) not on dialysis<br/><br/>          -  overt hyperthyreoidism<br/><br/>          -  singular metastases <1cm in diameter<br/><br/>          -  an increase of their baseline creatine levels of >20% between CT examinations<br/>
(1) cognitive impairment indicating a possible dementia, (2) the presence of uncontrolled cardiac illness, (3) functional relevant disease (e.g. neurological and/or orthopedic), which significantly influences walking performance or leg extension, and (4) terminal illness
none
-  non-secretory multiple myeloma<br/><br/>          -  previous treatment with bortezomib<br/><br/>          -  allogenic stem cell transplantation<br/><br/>          -  other co-existing malignancy beside basaliome<br/><br/>          -  peripheral neuropathy<br/><br/>          -  epilepsia<br/><br/>          -  other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious<br/>             etc.)<br/><br/>          -  history of allergic reactions to bortezomib or mannitol<br/><br/>          -  expected life expectancy of less than 3 months<br/>
Psychotic Disorder (acute or lifetime); Self-endangerment; current substance disorder; current personality disorder except avoidant, compulsive or dependent personality disorder; organically caused mental disorder; serious physical illness; current psychotherapeutic or psychopharmacological treatment<br/><br/>
Individuals for whom adequate CRC related screening measures already exist are excluded from the study. In particular, patients with an increased risk of CRC due to a known disease (family history of adenomatous polyposis, chronic inflammatory bowel diseases (ulcerative colitis, Chron's disease)) or with a  previous diagnosis of CRC will be excluded, as well as patients over 50 years of age for whom CRC screening already exists.  <br/>
-  Subjects with significant acute or chronic bleeding, such as overt gastrointestinal<br/>             bleeding<br/><br/>          -  Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus<br/>             erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in<br/>             remission<br/><br/>          -  Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell<br/>             carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively<br/>             treated > 3 years prior to randomization<br/><br/>          -  Subjects treated with any ESA within the 8 weeks before randomization<br/><br/>          -  Red blood cell (RBC) containing transfusion within the 8 weeks before randomization<br/><br/>          -  History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial<br/>             infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary<br/>             embolism) within the last 6 months from initial screening visit<br/><br/>          -  Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial<br/>             fibrillation or flutter, prolonged QT > 500 msec, second or third degree<br/>             atrioventricular [AV] block)<br/><br/>          -  New York Heart Association Class III or IV congestive heart failure<br/><br/>          -  Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate<br/>             aminotransferase [AST], or gamma glutamyl transferase [GGT] > 3 x the upper limit of<br/>             normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis,<br/>             in the investigator's opinion<br/>
-  Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,<br/>             primary peritoneal or fallopian tube cancer<br/><br/>          -  Previous abdominal and/or pelvic external beam radiotherapy<br/><br/>          -  History of central nervous metastasis<br/><br/>          -  History of arterial or venous thromboembolism within 12 months prior to randomization<br/><br/>          -  Clinically significant cardiovascular disease within 12 months prior to randomization<br/>
1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as:<br/>a. On an organ transplantation list or has received an organ transplant. <br/>b. Renal crisis within 1 year. <br/>c. Lung disease requiring constant oxygen treatment.<br/>d. Pulmonary hypertension requiring constant oxygen treatment.<br/>e. Malabsorption or gastrointestinal dysmotility requiring total parenteral nutrition.<br/>2. Any of the following values for laboratory tests at Screening:<br/>a) A positive pregnancy test in women of childbearing potential.<br/>b) Hemoglobin < 9 g/dL for males and < 8 g/dL for females.<br/>c) Neutrophils < 1.0 ×109/L. <br/>d) Platelets < 75 ×109/L. <br/>e) Creatinine clearance in blood < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation. Creatinine clearance may be assessed in a 24 hour urine collection to confirm eligibility (creatinine clearance ≥ 50 ml/min) if screening blood test is < 50 mL/min.<br/>f) Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.<br/>3. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening.<br/>4. Oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1.<br/>5. A positive test for anti-centromere antibody at Screening.<br/>6. Significant diseases or conditions other than SSc or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.