ࡱ> _a^ bjbj *XEEEEEYYY8$Y)lll')))))))))))))f+.))Elllll))EE>)lEE')l')O'|(Pa~Y*')T)0)'.&.$(.E(Llllllll))))lll)llll.lllllllll : All Questions must be answered YES for the subject to be enrolled in the study. INCLUSION CRITERIACOMMENTYES (Y) or NO (N)1. Male or Female 18 yrs and olderY N2. Body weight of ( 40kgY N3. Currently have a diagnosis of XXX that is either: related to . related to . OR associated with .Y NHave a documented / confirmed history of XXXY NIf on XXX, must be at the maximal dose of XXmg BID for a minimum of 12 Weeks prior to screening and have a screening AST/ALT < 3 times ULNY NHave a chest X-Ray within 6 months of Screening that shows clear lung fields or no more than mild patchy (not diffuse) interstitial infiltrates. Y NHave no evidence of significant lung disease as evidenced by pulmonary function tests within 6 months of screening showing total lung capacity ( 60% predicted.Y NHave a XX test results of XXX. Y NHave a XXXY NA female subject of childbearing potential must have a negative serum pregnancy test at the screening visit and agree to use two medically reliable methods of contraception until study end.Y NWritten informed consent (and written assent for minors) will be obtained prior to any study procedures being performed. Y NINCLUSION Comments: ________________________________________________________________________ ______________________________________________________________________ All Questions must be answered NO for the subject to be enrolled in the study. EXCLUSION CRITERIACOMMENTYES (Y) or NO (N)Is patient pregnant or nursing?Y NHave related to conditions other than specified in inclusion criteria, including but not limited to XXX.Y NResting arterial oxygen saturation (SaO2) < 88% on room air at screening. 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