definiens: shall mean a human clinical trial that includes ( i ) a control arm ( placebo or standard of care ), ( ii ) a minimum of one hundred ( 100 ) patients per indication ( except ( x ) if the indication is an orphan indication as determined under Applicable Law, in which case there shall be no such minimum, or ( y ) if the clinical trial is intended to explore multiple indi cations in the same arm or arms of - 12 - such clinical trial, in which case a minimum of one hundred ( 100 ) total patients, irrespective of indication, shall apply ), and ( iii ) a minimum duration of dosing for each patient of five ( 5 ) months from the initial dose until the last dose, regardless of how frequently any such patients are dosed, for which the primary endpoints include a determination of dose ranges or a preliminary determination of efficacy in patients being studied, as described in 21 C.F.R. § 312.21(b ) ( FDCA ), as amended from time to time, and the foreign equivalent thereof