['scleroderma, systemic']
['nintedanib', 'placebo']

        Inclusion criteria:

          -  Age >= 18 years

          -  2013 American College of Rheumatology (ACR) / EULAR classification criteria for SSc
             fulfilled

          -  SSc disease onset (defined by first non-Raynaud symptom) within 7 years

          -  SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography
             (HRCT); Extent of fibrotic disease in the lung >= 10%

          -  FVC >= 40% of predicted normal

          -  Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal

        Exclusion criteria:

          -  Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) >1.5 x ULN

          -  Bilirubin >1.5 x ULN

          -  Creatinine clearance <30 mL/min

          -  Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC
             <0.7)

          -  Other clinically significant pulmonary abnormalities

          -  Significant Pulmonary Hypertension (PH)

          -  Cardiovascular diseases

          -  More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring
             hospitalization or severe other ulcers

          -  Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose
             anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central
             nervous system (CNS) event within last year

          -  international normalised ratio (INR) >2, prolongation of prothrombin time (PT) and
             partial thromboplastin time (PTT) by >1.5 x ULN)

          -  History of thrombotic event within last year

          -  Clinical signs of malabsorption or needing parenteral nutrition

          -  Previous treatment with nintedanib or pirfenidone

          -  Treatment with prednisone >10 mg/day, azathioprine, hydroxychloroquine, colchicine,
             D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept,
             leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and
             cyclosporine A, potassium para-aminobenzoate

          -  Unstable background therapy with either mycophenolate mofetil or methotrexate

          -  Previous or planned hematopoietic stem cell transplantation

          -  Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
      