 evidence of severe retinopathy e.g. cytomegalovirus retinitis, macular degeneration or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension; thyroid dysfunction not adequately controlled; patients tested positively with Thyroglobulin antibody and or TPOAb at screening; documented autoimmune disease at screening or in the medical history; history or presence of depression requiring treatment with antidepressant; any risk of suicide at screening or previous suicide attempts; 