9. A n y dia g n osis of a ut oi m m u ne disease ( c o nfir me d b y me dical r ec or ds or a p pr o priate la b or at or y testi n g) 1 0. Has k n o w n hist or y of, or a n y e vi de nce of acti ve, n o n-i nfecti o us p ne u m o nitis. 1 1. Has a n acti ve i nfecti o n re q uiri n g s yste mic t her a p y. 1 2. Has a hist or y or c urre nt e vi de nce of a n y c o n diti o n, t hera p y, or la b or at or y a b n or malit y t hat mi g ht c o nf o u n d t he r es ults of t he trial, i nterfere wit h t he s u bject’s partici pati o n f or t he f ull d urati o n of t he trial, or is n ot i n t he best i nterest of t he s u bject t o partici pate, i n t he o pi ni o n of t he treati n g i n vesti gat or. 1 3. Has k n o w n ps yc hiatric or s u bsta nce a b use dis or d ers t hat w o ul d i nterfer e wit h c o o perati o n wit h t he r e q uire me nts of t he trial. 1 4. Is pr e g na nt or br eastfee di n g, or e x pecti n g t o c o ncei ve or f at her c hil dr e n wit hi n t he pr ojecte d d ur ati o n of t he trial, starti n g wit h t he pre -s cree ni n g or scree ni n g visit t hr o u g h 1 2 0 d a ys after t he last d ose of trial treat me nt. 1 5. Has a k n o w n hist or y of H u ma n I m m u n o deficie n c y Vir us ( HI V) ( HI V 1/ 2 a nti b o dies). 1 6. Has k n o w n acti ve He patitis B (e. g., H Bs A g r eacti ve) or He p atitis C (e. g., H C V R N A [ q ualitati ve] is detecte d). 1 7. Has recei ve d a li ve vacci ne wit hi n 3 0 da ys of pla n ne d start of st u d y t hera p y. N O T E : Se as o n al i nfl ue nz a v acci nes f or i njecti o n are ge ner ally i n activ ate d fl u v acci nes a n d are all o we d; h o wever i ntr a n as al i nfl ue nz a v acci nes (e. g., Fl u -Mist ®) are live atte n u ate d v a cci nes, a n d are n ot all o we d. 5.