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[(subject)-333.1(had)-336.1(to)-325.5(give)-333.3(voluntary)-331.1(written)-333.1(permission)-330.2(to)-331.8(participate)-332.8(in)]TJ 0 -1.2203 TD [(the)-188.3(study,)-189.1(and)-184.3(the)-188.3(subject)-187.7(had)-190.6(to)-186.4(give)-181.5(written)-194(or)-185(oral)-184.1(approval)-190.9(before)]TJ T* [(participating)-289.2(in)-274.9(the)-283.2(study.)]TJ 1.1128 -1.2266 TD [(New)-292.1(su)12.4(bje)14(ct)13.5(s)-297.9(had)-285.5(to)-293.9(mee)12.1(t)]TJ /F11 1 Tf 10.7047 0 TD [(Dia)13.1(gn)13.6(os)12.4(tic)-293.5(an)13.6(d)-296.7(Sta)16.4(tis)17.5(tic)16.3(al)-293.9(Man)18.3(ual)-287.1(of)]TJ -11.8175 -1.2203 TD [(Ment)18.7(al)-199.1(Dis)11.9(or)12.4(der)16.8(s,)-199.6(Fif)12.6(th)-199.1(Edi)16.6(tio)12.4(n)]TJ /F7 1 Tf 12.6901 0 TD [(\(Ame)15.4(ri)13.3(can)-199.4(Ps)13.8(ych)18(iat)16.3(ric)-197.3(Ass)14.8(oci)14(ati)16.3(on)13.6(,)]TJ -12.6901 -1.2203 TD [(201)14.1(3\),)-301.7(cri)17.7(ter)11.4(ia)-309(for)-300.9(a)-311.7(pri)13.8(mar)18.2(y)-315.7(dia)14(gn)13.6(os)12.4(is)-307.7(of)-311.4(AD)13.3(HD)-309.1(\(co)15.4(mbi)12.9(ned)18(,)-312.7(ina)14(t-)]TJ 0 -1.2266 TD [(ten)14(tiv)12.4(e,)-289.4(or)-292.5(hy)13.6(per)15.4(act)11.6(iv)15.9(e/i)16.3(mpul)19.7(siv)15.2(e)-299.1(pre)15.4(sen)16.8(ta)13.5(tio)12.4(n\))-292.5(per)-281.8(cli)16.3(nic)14(al)-290(eval)18.4(ua-)]TJ 0 -1.2203 TD [(tio)12.4(n)-518(and)-506.8(con)18(rm)15.7(ed)-513.6(by)-517.5(th)15.9(e)-520.4(Min)15.7(i)-522(Int)20.1(ern)15.4(ati)16.3(onal)-504(Neu)14.7(rop)17.8(sy)12.4(chi)14(atr)11.4(ic)]TJ T* [(Int)13.8(erv)15.4(iew)-305.5(for)-307.2(Chi)18(ldr)13.8(en)-311.3(and)-304.5(Ado)17.1(les)12.8(cen)15.6(ts.)-304.3(New)-311.1(su)12.4(bje)14(ct)13.5(s)-316.8(als)12.8(o)-315.7(had)-304.5(to)]TJ T* [(have)-281.1(a)-292.8(sco)16.8(re)-288.6(of)-286.2(at)-283.7(lea)11.6(st)-282.4(3)-296.7(\()0(m)13.8(ild)18.7(ly)-287.6(ill)14.7(\))-293(o)0(n)-283.6(the)-283.2(cl)13.5(ini)12.4(ci)13.5(an-)15.4(adm)14.5(ini)12.4(st)14.7(ere)13(d)]TJ 0 -1.2266 TD [(Cli)14(nic)14(al)-315.3(Gl)12.6(ob)13.6(al)-315.3(Imp)14.3(res)14.2(si)14.7(ons)12.9(S)15(ever)19.8(ity)-310.1(\(C)12.6(GI-)11.9(S\))-310(sca)14.4(le)-315.3(at)-315.3(the)-308.5(st)14.7(art)-311.1(of)]TJ 0 -1.2203 TD [(the)-264.2(DO)-271.2(phas)17.3(e)-273.8(o)0(r)-267.2(aft)11.4(er)-269.6(me)14(dic)14(at)13.5(ion)-268.1(wa)14.2(sho)12.9(ut,)-265.2(if)-264.9(appl)20.8(ica)11.6(bl)15.9(e.)]TJ 1.1128 -1.2203 TD [(Subjects)-249(were)-255.4(excluded)-247.6(if)-245.9(they)-251.1(had)-247.5(any)-247.5(diagnosis)-248.7(of)-248.2(bipolar)-249.9(I)-248.7(o)0(r)]TJ -1.1128 -1.2266 TD [(II)-693.4(disorder,)-688.4(major)-693(depressive)-694.2(disorder,)-688.4(conduct)-694.6(disorder,)-688.4(or)]TJ 0 -1.2203 TD [(obsessive-compulsive)-275.8(disorder)-274.5(or)-267.2(any)-272.8(history)-274(of)-267.2(psychosis,)-274.1(autism)]TJ T* [(spectrum)-347.4(disorder,)-347(disruptive)-342.2(mood)-343(dysregulation)-343.1(disorder,)-347(intel-)]TJ 0 -1.2266 TD [(lectual)-192.9(disability,)-186.1(Tourette)-194.8(syndrome,)-185.8(or)-185(conrmed)-189(genetic)-188.9(disorder)]TJ 0 -1.2203 TD [(with)-369.8(cognitive)-372.9(and/or)-366.5(behavioral)-373.4(disturbances.)-371.4(Subjects)-369.2(with)-369.8(op-)]TJ T* [(positional)-406.8(deant)-396.5(disorder)-407.3(were)-400.8(permitted)-398(to)-401.4(enroll)-402.2(in)-401.4(the)-397(study)]TJ T* [(provided)-277(that)-274.1(it)-278.9(was)-271(not)-274.4(the)-276.9(primary)-277.3(focus)-269.3(of)-279.8(treatment)-274(and,)-275.8(in)-274.9(the)]TJ 0 -1.2266 TD [(opinion)-346.1(of)-336.7(the)-340.1(investigator,)-344.2(was)-340.6(mild)-344.7(to)-338.2(moderate)-342.3(and)-342.4(as)-344.1(long)-337.2(as)]TJ 0 -1.2203 TD [(eligible)-288.9(subjects)-289.6(with)-287.6(oppositional)-285.7(deant)-282.7(disorder)-287.1(were)-287(appropri-)]TJ T* [(ate)-285.6(and)-279.2(cooperative)-286.8(during)-275.6(screening.)]TJ /F10 1 Tf 0 -2.447 TD [(Study)-338.6(design)]TJ /F7 1 Tf 1.1128 -1.8336 TD [(The)-316.9(study)-318.9(design)-314.5(consisted)-320.7(of)-317.8(a)-318.1(30-day)-318.2(screening)-320.5(phase,)-316.3(a)-318.1(D)0(O)]TJ -1.1128 -1.2267 TD [(phase)-256.5(\(for)-252.5(new)-250.8(subjects\),)-250.3(a)-254.8(360-day)-248.2(treatment)-255(phase,)-253.1(and)-247.6(a)-254.8(follow-)]TJ 0 -1.2203 TD [(up)-593.4(visit.)-595.4(Subjects)-590.5(who)-589.9(successfully)-597.3(completed)-596.1(the)-593(laboratory)]TJ T* [(classroom)-512.5(study)-502.3(were)-508.3(rolled)-509.6(over)-502.6(into)-505.6(the)-504.5(current)-510.2(trial)-507.8(within)]TJ T* [(45)-201.4(days)-204(of)-197.6(their)-200.3(last)-205.7(dose)-197.7(of)-204(SDX/d-MPH)-199.7(in)-199.1(the)-201(previous)-202.3(study.)-201.7(The)]TJ 0 -1.2266 TD [(rollover)-308.9(subjects)-308.5(bypassed)-306.8(the)-308.5(screening)-307.8(and)-304.5(DO)-302.8(phases)-307.8(and)-304.5(con-)]TJ 0 -1.2203 TD [(tinued)-374.3(into)-366.5(the)-371.7(360-day)-368.3(treatment)-375.1(phase.)-366.9(These)-376.4(rollover)-365.8(subjects)]TJ T* [(were)-261.7(entered)-250.7(into)-252.7(this)-253.9(trial)-254.9(on)-251.9(the)-257.9(same)-254.2(day)-253.9(as)-255.5(their)-250.9(follow-up)-258.8(visit)]TJ 0 -1.2266 TD [(in)-306.5(the)-308.5(previous)-309.8(study)-306.3(or)-305.1(up)-308.8(to)-306.5(45)-302.5(days)-311.5(later.)-306.8(The)-310.6(starting)-305.2(dose)-305.1(for)]TJ 0 -1.2203 TD [(these)-355.4(subjects)-352.8(in)-357.1(the)-352.7(treatment)-349.8(phase)-357.7(was)-353.2(the)-352.7(same)-355.4(as)-350.4(their)-352.1(opti-)]TJ T* [(mized)-281.8(dose)-286.2(from)-278.7(the)-283.2(previous)-278.2(study.)]TJ 1.1128 -1.2266 TD [(New)-197.2(sub)12.9(je)13.5(cts)-202.2(wer)18.4(e)-210.6(de)13.1(ned)-197(as)-205(th)15.9(ose)-198.2(who)-197.8(did)-198.6(no)13.6(t)-212.2(par)15.4(tic)16.3(ipa)14(te)-201.5(in)-199.1(the)]TJ -1.1128 -1.2203 TD [(pre)15.4(vio)16.4(us)-177.3(stu)15.2(dy)-176.1(or)-172.3(ent)14(ere)13(d)-182.9(t)0(h)15.9(e)-185.3(tr)13.3(ial)]TJ /F8 1 Tf 13.2149 0 TD (>)Tj /F7 1 Tf .5438 0 TD [(45)-176.1(days)-166.1(aft)11.4(er)-174.8(the)14(ir)-176.4(la)13.5(st)-175(dos)12.9(e)-179(i)0(n)-173.8(the)]TJ -13.7587 -1.2203 TD [(pre)15.4(vio)16.4(us)-341.7(st)14.7(udy)14.1(.)-338(New)-336.4(su)12.4(bje)14(ct)13.5(s)-342.1(und)14.1(erw)18.4(ent)-333.8(scr)14.2(een)15.6(ing)16.4(.)-344.4(F)0(o)15(r)-343.6(bo)13.6(th)-338.2(rol)13.8(l-)]TJ T* [(over)-268.6(and)-279.2(new)-269.8(sub)12.9(je)13.5(cts)12.8(,)-281.1(the)-276.9(do)13.6(se)-280.8(of)-279.8(SDX)15.2(/d-)13.8(MP)14.3(H)-287.3(cou)18(ld)-281.3(be)-279.7(cha)15.6(ng)13.6(ed)]TJ 0 -1.2266 TD [(base)14.9(d)-258.8(o)0(n)-251.9(t)0(h)15.9(eir)-254.2(in)15.9(div)16.4(idu)16.4(al)-252.1(res)14.2(pon)14.1(se)-255.6(and)-247.5(to)15.9(ler)11.4(abi)14(lit)21(y)-258.8(t)0(o)-256(the)-245.2(tre)11.4(at)13.5(men)14.5(t.)]TJ 1.1128 -1.2203 TD [(During)-215.7(the)-219.9(DO)-214.3(phase)-218.6(\(for)-214.5(new)-219.2(subjects)-213.7(only\),)-215.8(subjects)-220(titrated)-215.6(to)]TJ -1.1128 -1.2203 TD [(their)-257.2(optimized)-262.6(dose)-254.6(based)-256.5(on)-251.9(their)-257.2(individual)-260.2(tolerability)-253.3(and)-260.2(best)]TJ 0 -1.2266 TD [(response)-341(to)-331.8(the)-340.1(treatment)-337.2(in)-331.8(the)-340.1(opinion)-333.4(of)-336.7(the)-333.8(investigator.)-337.9(New)]TJ 0 -1.2203 TD [(subjects)-295.9(started)-285.1(treatment)-292.9(with)-287.6(39.2/7.8)-171.3(mg)-287.1(SDX/d-MPH)-288.2(daily)-286.2(for)]TJ T* [(7)-341(days.)-339.7(Dose)-333.7(adjustments,)-342.8(if)-340.8(needed,)-336(were)-337.6(performed)-340.6(at)-340.6(approxi-)]TJ 0 -1.2266 TD [(mately)-342.3(weekly)-344.3(intervals.)-341.7(The)-342.2(investigator)-341.3(evaluated)-348.4(the)-340.1(subjects)]TJ 0 -1.2203 TD [(therapeutic)-531.1(response)-530.7(and)-525.8(tolerability)-531.5(to)-521.5(treatment)-533.2(and)-525.7(decided)]TJ /F4 1 Tf -27.9978 77.2217 TD (2)Tj 45.3353 0 TD [(CHILDRESS)-336.6(ET)-338.7(AL.)]TJ ET endstream endobj 42 0 obj <>stream /GS1 gs BT /F7 1 Tf 8.9663 0 0 8.9663 59.7543 725.7825 Tm 0 0 0 rg 0 Tc 0 Tw [(wh)16.6(et)19.8(he)17.5(r)-470(t)0(h)22.2(e)-469.8(cu)17.5(rr)21.1(en)17.5(t)-471.4(S)14.6(DX)13.3(/d)22.2(-M)16.6(P)14.6(H)-470.7(do)19.9(se)-464.2(sh)25.1(ou)19.9(ld)-464.6(b)13.1(e)-469.8(in)15.9(cr)21.2(ea)15.1(se)22.7(d,)-457.7(de)17.5(-)]TJ 0 -1.2203 TD [(cr)14.9(ea)21.4(se)16.3(d)13.1(,)-217.9(o)13.1(r)-217.1(re)21.2(ma)14(i)15.4(n)-214.5(th)15.9(e)-216.9(s)0(a)22.7(m)0(e)-207.3(f)0(o)23.7(r)-217.1(th)15.9(e)-210.6(n)0(e)17.5(x)13.1(t)-218.5(w)0(e)20.5(e)0(k)-203.8(o)0(f)-210.3(d)13.1(os)18.8(in)22.3(g.)-204.8(Th)20.1(e)-216.9(d)0(o)19.9(s)0(e)-205(a)0(t)]TJ 0 -1.2266 TD [(th)15.9(e)-299.1(e)0(n)17.5(d)-303(o)13.1(f)-305.6(th)22.2(e)-305.4(t)0(h)22.2(i)0(r)19.6(d)-303(we)20.5(ek)-292.3(wa)14.2(s)-297.9(a)0(s)16.3(s)0(i)21.1(g)0(n)19.9(e)0(d)-292.3(a)0(s)-293.5(t)0(h)15.9(e)-299.1(op)19.9(ti)18.2(mi)18.7(ze)21.4(d)-303(d)0(o)19.9(s)0(e)-293.5(c)0(o)17.5(n)13.1(-)]TJ 0 -1.2203 TD [(si)14.7(st)21.1(in)22.2(g)-189.2(o)0(f)-178.7(2)0(6)19.9(.)0(1)22.9(/)0(5)15.9(.)0(2)22.9(,)-192.6(3)13.1(9)0(.)22.9(2)0(/)15.9(7)13.1(.8)16.5(,)-186.3(o)0(r)-178.7(5)13.1(2.)16.5(3)13.1(/)0(1)15.9(0)13.1(.4)-147.9(mg)-179.6(SD)18.1(X/)18.9(d)13.1(-)0(M)16.6(P)14.6(H)-192.5(d)13.1(ai)19.8(ly)15.9(.)-186.3(T)0(h)20.1(e)]TJ T* [(st)14.7(ar)21.2(ti)18.2(n)13.1(g)-366.2(d)13.1(o)0(s)18.8(e)-362.3(du)19.9(ri)19.6(ng)-353.1(th)15.9(e)-362.3(t)0(r)19.6(e)0(a)21.4(t)0(m)18.7(e)0(n)17.5(t)-363.9(p)13.1(h)0(a)17.5(s)0(e)-356.7(w)0(a)20.5(s)-361.1(th)15.9(e)-362.3(o)13.1(pt)15.9(im)18.7(iz)19.8(ed)-355.5(S)14.6(D)0(X)19.7(/)]TJ 0 -1.2266 TD [(d-)17.3(M)12.4(P)0(H)-196.9(d)13.1(os)18.8(e)-204.3(a)0(t)-195.1(t)15.4(he)-197.4(en)23.9(d)-201.8(o)0(f)-197.6(t)0(h)22.2(e)-204.3(DO)-189(ph)19.9(as)16.3(e.)-194.5(Du)23(ri)19.6(ng)-195(th)22.2(e)-204.3(t)0(r)19.6(e)0(a)15.1(t)15.4(me)14(n)13.1(t)-205.9(p)13.1(h)0(a)17.5(s)0(e)22.7(,)]TJ 0 -1.2203 TD [(al)13.5(l)-269.1(s)0(u)18.8(b)13.1(je)19.8(ct)19.8(s)-272.6(c)0(o)17.5(n)13.1(ti)18.2(n)13.1(u)0(e)17.5(d)-271.4(th)22.2(ei)19.8(r)-274(o)13.1(pt)15.9(im)18.7(i)15.4(z)0(e)15.1(d)-271.4(d)13.1(o)0(s)18.8(e)-273.8(o)13.1(f)-267.7(SD)18.1(X/)18.9(d-)17.3(M)12.4(P)0(H)-260.1(d)0(a)17.5(i)0(l)18.2(y)13.1(.)]TJ /F10 1 Tf 0 -2.447 TD [(Safety)-335.8(assessments)]TJ /F7 1 Tf 1.1128 -1.8336 TD [(All)-465.1(baseline)-461.5(and)-462.5(safety)-465(data)-462.2(were)-464(analyzed)-465(using)-464.3(the)-460.2(safety)]TJ -1.1128 -1.2203 TD [(population.)-417.2(The)-411.8(safety)-414.4(population)-414.3(included)-413.6(all)-413.7(enrolled)-416.2(subjects)]TJ T* [(who)-229.5(received)-233.7(at)-233.1(least)-232.9(one)-228.6(dose)-229.3(of)-229.3(study)-230.4(medication)-232.9(and)-234.9(had)-228.6(at)-226.8(least)]TJ 0 -1.2266 TD [(one)-285.5(postdose)-276.8(safety)-281.6(assessment.)]TJ 1.1128 -1.2203 TD [(AEs)-426.5(were)-432.4(assessed)-431.7(and)-424.6(recorded)-432.2(from)-424.1(the)-428.6(rst)-428.1(day)-430.9(of)-425.3(SDX/)]TJ -1.1128 -1.2203 TD [(d-MPH)-274.6(administration)-278.3(through)-268.8(the)-276.9(end)-272.8(of)-273.5(the)-270.5(study)-274.7(through)-275.1(either)]TJ T* [(follow-up)-442.1(or)-444.2(early)-439(termination.)-448.2(Both)-436.7(rollover)-441.7(and)-443.6(new)-440.5(subjects)]TJ 0 -1.2266 TD [(completed)-336.9(a)-324.4(follow-up)-334.6(visit)]TJ /F12 1 Tf 11.6278 0 TD (*)Tj /F7 1 Tf .999 0 TD [(3)-328.3(days)-330.4(after)-334.1(the)-327.4(last)-332.2(dose)-330.4(of)-330.4(SDX/)]TJ -12.6269 -1.2203 TD [(d-MPH.)-252.3(A)-249.4(complete)-255.2(medical)-249.4(history)-248.7(was)-252(obtained)-255.6(at)-245.7(the)-251.6(screening)]TJ T* [(visit.)-348.8(Physical)-343.9(examinations,)-349.9(clinical)-348.2(laboratory)-348.3(assessments,)-347.1(and)]TJ 0 -1.2266 TD [(ECGs)-247.3(were)-242.7(performed)-239.4(at)-239.4(screening,)-247.5(after)]TJ /F12 1 Tf 16.6166 0 TD (*)Tj /F7 1 Tf .999 0 TD [(6)-239.8(months)-239.8(of)-241.9(treatment,)]TJ -17.6156 -1.2203 TD [(and)-386.7(at)-384.8(the)-390.7(end)-380.3(of)-387.3(the)-384.3(treatment)-387.8(phase.)-385.9(Vital)-388.4(signs)-389.7(\(sitting)-382.7(blood)]TJ T* [(pressure,)-384.5(pulse)-378.2(rate,)-379.2(respiratory)-376.9(rate,)-379.2(and)-380.3(oral)-373.8(temperature\))-383.6(were)]TJ 0 -1.2267 TD [(assessed)-286.3(at)-283.7(each)-277.2(study)-281(visit.)]TJ 1.1128 -1.2203 TD [(For)-341.2(safety)-338.5(assessments,)-347.1(descriptive)-340.2(statistics)-339.8(were)-343.9(reported)-338.9(for)]TJ -1.1128 -1.2203 TD [(continuous)-424.1(and)-424.6(categorical)-426.1(data.)]TJ /F11 1 Tf 13.8725 0 TD (Z)Tj /F7 1 Tf .5564 0 TD [(-score)-419.3(was)-429.1(used)-419(to)-420.4(analyze)-427.6(a)]TJ -14.4289 -1.2203 TD [(subjects)-196.8(weight)-187.9(and)-190.6(height)-190.9(against)-187.7(a)-191.6(reference)-192.5(population)-193(using)-192.5(the)]TJ 0 -1.2266 TD [(United)-440.8(States)-433.4(2000)-434.3(Centers)-437.6(for)-433.7(Disease)-437.2(Control)-435.6(Growth)-433.9(Charts)]TJ 0 -1.2203 TD [(\(ages)-208.5(2)-201.8(t)0(o)]TJ /F8 1 Tf 4.0087 0 TD (<)Tj /F7 1 Tf .5501 0 TD [(20)-207.7(years\))-204.3(as)-205(the)-201(reference)-211.5(\(Kuczmarski)-208.8(et)-201.5(al,)-204.4(2002\).)-205.4(The)]TJ -4.5588 -1.2203 TD [(modied)-744.9(abbreviated)-748.4(Childrens)-750.2(Sleep)-744.8(Habits)-745.5(Questionnaire)]TJ 0 -1.2266 TD [(\(CSHQ\))-397.9(was)-391.1(used)-393.7(to)-388.7(assess)-398.7(sleep)-393.3(behavior)-393.3(during)-389.4(the)-397(treatment)]TJ 0 -1.2203 TD [(phase.)-442.8(Of)-434.9(a)-438.2(total)-442(score)-436.1(of)-437.9(99,)-438.2(the)-434.9(clinical)-443.1(cutoff)-438.7(indicating)-439.7(the)]TJ T* [(presence)-237.2(of)-235.6(sleep)-235.2(disorders)-230.9(is)-231.9(a)-235.9(CSHQ)-229.3(score)-240.1(of)]TJ /F8 1 Tf 18.8802 0 TD ()Tj /F7 1 Tf .5501 0 TD [(41.)-235.9(A)-230.4(reduction)-232.4(in)]TJ -19.4303 -1.2267 TD [(CSHQ)-267.2(scores)-259.8(indicates)-262.7(improvement)-263.8(in)-262.3(sleep)-266.8(\(Owens)-262.8(et)-258.4(al,)-261.3(2000\).)]TJ /F10 1 Tf 0 -2.4406 TD [(Efcacy)-339(assessments)]TJ /F7 1 Tf 1.1128 -1.8336 TD [(All)-465.1(efcacy)-469(analyses)-465(and)-462.5(CSHQ)-469.5(assessments)-470.6(were)-464(analyzed)]TJ -1.1128 -1.2266 TD [(using)-217.7(the)-220(efcacy)-216.1(population.)-214.9(This)-218(population)-218.3(included)-217.6(all)-211.3(enrolled)]TJ 0 -1.2203 TD [(subjects)-314.8(who)-311.7(received)-315.9(at)-315.3(least)-315.1(30)-308.8(days)-317.8(of)-311.4(study)-312.6(medication)-315.1(in)-312.9(the)]TJ T* [(treatment)-274(phase,)-272.1(who)-267.4(had)-266.5(adequate)-275.3(data)-266.1(to)-268.6(assess)-272.2(the)-270.5(change)-269.9(from)]TJ 0 -1.2267 TD [(baseline)-328.7(of)-324.1(the)-327.4(efcacy)-329.9(parameters,)-325.2(and)-323.4(who)-330.6(had)-323.4(no)-321.5(protocol)-325.3(de-)]TJ 0 -1.2203 TD [(viations)-283.6(that)-280.4(could)-282.2(affect)-285.4(the)-276.9(efcacy)-285.6(parameters.)]TJ 1.1128 -1.2203 TD [(For)-195.7(new)-193.9(subjects,)-191.3(during)-193.4(the)-194.7(DO)-195.3(phase,)-189.9(the)-194.7(ADHD)-194.6(Rating)-195.6(Scale-)]TJ -1.1128 -1.2203 TD [(5)-347.3(\(ADHD-RS-5\),)-353.3(CGI-S)-350.8(scale,)-348(and)-348.7(Clinical)-350.5(Global)-352.3(Impressions)]TJ 0 -1.2266 TD [(Improvement)-420.4(scale)-414.7(were)-413.5(used)-419(to)-414(guide)-415(DO)-410.3(in)-414(conjunction)-416.2(with)]TJ 0 -1.2203 TD [(tolerability)-379.8(and)-380.3(safety)-376.4(\(Busner)-376.8(and)-374(Targum,)-375.1(2007;)-381(DuPaul)-372.1(et)-378.5(al,)]TJ T* [(2016\).)-325.6(ADHD-RS-5)-327.2(is)-320.4(an)-323.9(18-item)-323(scale)-326.2(based)-326(on)]TJ /F11 1 Tf 20.4546 0 TD [(Diagnostic)-323.9(and)]TJ -20.4546 -1.2266 TD [(Statistical)-357.5(Manual)-351(of)-350.8(Mental)-351.1(Disorders,)-360.8(Fifth)-350.9(Edition)]TJ /F7 1 Tf 22.3768 0 TD (\(American)Tj -22.3768 -1.2203 TD [(Psychiatric)-307.2(Association,)-311(2013\))-303.7(criteria)-305.1(of)-305.1(ADHD)-308.4(that)-305.7(rates)-307.4(symp-)]TJ T* [(toms)-221.8(on)-220.3(a)-223.2(4-point)-222.2(scale,)-221.6(ranging)-226.9(from)-221.8(0)-214.5(\(no)-222.4(symptoms\))-226.7(to)-218(3)-220.8(\(severe)]TJ 0 -1.2266 TD [(or)-279.8(frequent)-282(symptoms\))-283.6(\(DuPaul)-279.4(et)-283.7(al,)-280.3(2016\).)]TJ 1.1128 -1.2203 TD [(The)-196.8(CGI-S)-199.1(is)-200.2(a)-197.9(clinician-rated)-207.1(scale)-199.7(that)-198.2(measures)-201.5(the)-194.7(severity)-202.4(of)]TJ -1.1128 -1.2203 TD [(psychopathology)-215.4(\(ADHD)-209.4(symptoms)-211.9(in)-205.4(the)-213.6(study\))-207.2(on)-207.7(a)-210.6(scale)-212.3(from)-209.1(1)]TJ T* [(\(not)-403(at)-403.8(all)-401(ill\))-398.4(to)-401.4(7)-404.2(\(among)-397.6(the)-403.3(most)-398.8(extremely)-402.7(ill\))-404.7(\(Busner)-402.1(and)]TJ 0 -1.2266 TD [(Targum,)-292.9(2007\).)-293.9(During)-291.5(the)-289.5(treatment)-292.9(phase,)-297.4(the)-289.5(ADHD-RS-5)-295.5(and)]TJ 0 -1.2203 TD [(CGI-S)-458.3(scale)-452.6(assessments)-458(were)-451.4(used)-456.9(to)-452(evaluate)-450.1(the)-453.9(changes)-453.9(in)]TJ T* [(ADHD)-428.6(symptoms)-426.9(and)-424.6(severity)-423.7(over)-426.7(time)-429.3(and)-424.6(could)-421.3(be)-425.1(used)-425.3(in)]TJ 0 -1.2266 TD [(conjunction)-258.1(with)-256(tolerability)-259.7(and)-253.9(safety)-256.3(to)-256(adjust)-255.3(the)-257.9(dose)-254.6(of)-254.5(SDX/)]TJ 0 -1.2203 TD [(d-MPH.)-302.8(Wilcoxon)-299.3(signed-rank)-300.7(test)-300.5(was)-296.3(used)-298.8(to)-300.2(assess)-297.5(the)-302.1(signi-)]TJ T* [(cance)-348.7(of)-343.1(changes)-340.1(from)-341.9(baseline)-347.7(through)-338.3(follow-up)-347.3(visits)-340.3(\(signi-)]TJ 0 -1.2266 TD [(cance)-310.7(level)-307.6(of)-305.1(0.05\).)-303.7(A)-306.3(last-observation-carried-forward)-309.8(approach)]TJ 0 -1.2203 TD [(was)-283.7(used)-279.9(for)-282(missing)-282.4(data.)]TJ /F4 1 Tf 28.0042 74.5598 TD (Results)Tj /F10 1 Tf 0 -1.8336 TD [(Subject)-333.7(disposition)-338.1(and)-329.4(dosing)]TJ /F7 1 Tf 1.1128 -1.8336 TD [(Of)-251.5(the)-251.6(323)-257.8(subjects)-251.6(screened,)-259.1(282)-251.5(were)-261.7(enrolled)-251.8(in)-256(the)-251.6(study,)-258.6(of)]TJ -1.1128 -1.2203 TD [(whom)-359(70)-353.1(were)-362.9(rollover)-359.5(subjects)-359.1(and)-361.4(212)-352.6(were)-362.9(new)-358.3(subjects)-359.1(\(in-)]TJ 0 -1.2266 TD [(cluding)-354.8(24)-359.4(enrolled)-359.3(as)-356.7(new)-358.3(subjects)-359.1(from)-354.5(the)-359.1(previous)-360.4(study)-356.8(be-)]TJ 0 -1.2203 TD [(cause)-239.9(their)-238.2(last)-243.6(completed)-235.7(dose)-241.9(in)-237(the)-238.9(previous)-240.3(study)-236.7(was)]TJ /F8 1 Tf 23.0407 0 TD (>)Tj /F7 1 Tf .5564 0 TD [(45)-233(days)]TJ -23.5971 -1.2203 TD [(before)-190.5(the)-188.3(rst)-187.8(dose)-191.3(in)-186.4(the)-194.7(current)-187.7(study;)-189.7(Fig.)-187.4(1\).)-187.9(Of)-194.6(the)-188.3(282)-188.2(enrolled)]TJ 0 -1.2266 TD [(subjects,)-279.8(254)-283.1(entered)-288.7(the)-283.2(treatment)-280.3(phase,)-284.7(which)-285.5(included)-280.9(70)-283.6(roll-)]TJ 0 -1.2203 TD [(over)-477.3(subjects)-485.6(and)-481.5(184)-479.1(new)-484.8(subjects.)-482.2(Of)-479.1(the)-485.5(282,)-475.7(155)-485.4(subjects)]TJ T* [(completed)-292.6(treatment)-299.3(and)-291.8(127)-295.7(discontinued)-296.8(early.)-296.5(Reasons)-293(for)-294.6(dis-)]TJ T* [(continuation)-514.6(were)-520.9(lost)-513.1(to)-515.2(follow-up)-518(\()]TJ /F11 1 Tf 16.0539 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(51,)-514.1(18.1%\),)-513.9(withdrew)]TJ -17.4386 -1.2266 TD [(consent)-215.3(\()]TJ /F11 1 Tf 3.6104 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(28,)-216.9(9.9%\),)-217.3(noncompliance)-217.2(\()]TJ /F11 1 Tf 11.0335 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(17,)-216.9(6.0%\),)-217.3(AEs)-217.8(\()]TJ /F11 1 Tf 6.6201 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD (11,)Tj -25.4181 -1.2203 TD [(3.9%\),)-451.2(lack)-455.8(of)-456.9(efcacy)-456.4(\()]TJ /F11 1 Tf 10.496 0 TD (n)Tj /F8 1 Tf .6702 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(2,)-451.4(0.7%\),)-451.2(protocol)-458.1(deviation)-455.1(\()]TJ /F11 1 Tf 12.6458 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD (1,)Tj -25.9176 -1.2203 TD [(0.4%\),)-248.9(and)-247.5(other)-253.2(\()]TJ /F11 1 Tf 7.2587 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(17,)-248.5(6.0%\).)-248.9(Two)-248.2(hundred)-248.2(thirty-eight)-255.8(subjects)]TJ -8.6434 -1.2266 TD [(were)-280.7(in)-281.3(the)-283.2(treatment-phase)-279.7(safety)-287.9(population.)]TJ 1.1128 -1.2203 TD [(On)-432.3(day)-430.9(0,)-432.4(the)-428.6(mean)-436.4(\(standard)-434.5(deviation)-436.1([SD]\))-430.9(daily)-431.6(dose)-431.6(of)]TJ -1.1128 -1.2203 TD [(d-MPH)-451.7(HCl)-446.9(equivalent)-457(was)-448(32.54)-165.4(mg)-451.5(\(7.28)-168(mg\),)-450.2(or)-450.6(0.94)-165.8(mg/kg)]TJ 0 -1.2266 TD [(\(0.35)-168(mg/kg\))-291.8(of)-298.8(body)-301.5(weight.)-298.3(At)-297.2(6)-296.7(months)-296.7(of)-298.8(treatment,)-302.2(the)-295.8(mean)]TJ 0 -1.2203 TD [(daily)-330.5(dose)-324.1(of)-330.4(d-MPH)-331.5(HCl)-326.7(equivalent)-330.6(was)-327.9(33.56)-171.7(mg)-325(\(7.11)-168(mg\),)-323.7(or)]TJ T* [(0.94)-165.8(mg/kg)-277(\(0.36)-161.6(mg/kg\).)-282(At)-271.9(the)-276.9(last)-281.6(dispensing)-273.5(visit,)-279.3(day)-279.2(330,)-273.3(the)]TJ T* [(mean)-714.6(daily)-716.2(dose)-716.1(of)-716.1(d-MPH)-717.2(HCl)-718.7(equivalent)-716.3(was)-719.9(35.08)-165.4(mg)]TJ 0 -1.2266 TD [(\(6.38)-168(mg\),)-279.5(or)-279.8(0.95)-165.9(mg/kg)-277(\(0.34)-168(mg/kg\))-279.1(of)-279.8(body)-282.6(weight.)]TJ /F10 1 Tf 0 -2.447 TD [(Baseline)-331.5(and)-335.7(demographic)-334.7(characteristics)]TJ /F7 1 Tf 8.9663 0 0 8.9663 320.8251 446.3432 Tm [(The)-304.3(mean)-303.6(age)-306.9(of)-305.1(subjects)-308.5(was)-302.6(9.1)-305.4(years,)-306.3(and)-310.8(most)-304(\(61%\))-302.1(were)]TJ -1.1128 -1.2266 TD [(male)-307.6(\(Table)-305.5(1\).)-308(Nineteen)-305.5(percent)-314(were)-306(of)-305.1(Hispanic)-310.6(or)-305.1(Latino)-304.5(eth-)]TJ 0 -1.2203 TD [(nicity.)-223.1(The)-222.1(racial)-223.6(makeup)-220.4(of)-222.9(the)-226.3(subjects)-220(was)-226.7(predominantly)-225.3(White)]TJ T* [(\(48%\))-365.3(and)-367.7(Black/African)-370(American)-364.6(\(47%\).)-368.2(At)-366.8(baseline,)-369.6(subjects)]TJ 0 -1.2266 TD [(in)-293.9(the)-302.1(efcacy)-298.3(population)-300.5(had)-298.1(a)-299.1(mean)-297.3(\(SD\))-296(ADHD-RS-5)-301.9(score)-303.4(of)]TJ 0 -1.2203 TD [(41.5)-355.5(\(7.7\))-360.3(and)-355(a)-356(mean)-360.5(CGI-S)-357.1(score)-360.3(of)-355.7(4.7)-362.3(\(0.7\).)-356.9(The)-354.8(mean)-360.5(\(SD\))]TJ T* [(score)-278.1(on)-283.6(the)-276.9(CSHQ)-286.2(at)-277.3(baseline)-284.5(was)-283.6(53.5)-279.7(\(6.0\).)]TJ /F10 1 Tf 0 -2.447 TD [(Safety)-335.8(results)]TJ /F7 1 Tf 1.1128 -1.8336 TD [(In)-532.8(the)-542.4(DO)-543.1(phase)-534.7(\(safety)-542.9(population,)]TJ /F11 1 Tf 16.2815 0 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(208\),)-534.7(113)-542.3(subjects)]TJ -18.779 -1.2203 TD [(\(54.3%\))-525.8(experienced)-538.1(at)-530.3(least)-530.1(one)-532.1(TEAE)-531.9(\(Table)-526.8(2\).)-529.3(The)-531.9(most)]TJ 0 -1.2266 TD [(common)-208.9(TEAEs)-210.1(in)-211.7(the)-213.6(DO)-208(phase)-212.2(were)-211.1(decreased)-220.1(appetite)-211.4(\(18.8%\),)]TJ 0 -1.2203 TD [(followed)-353.9(by)-359.4(insomnia)-352.7(and)-361.4(irritability)-358.7(\(both)-351.9(6.7%\),)-356.4(and)-361.4(initial)-354.2(in-)]TJ T* [(somnia)-210.6(\(5.3%\))-210.1(\(Table)-217(2\).)-213.2(In)-210.3(the)-207.3(treatment)-217.1(phase)-212.2(\(safety)-214.2(population,)]TJ /F11 1 Tf 0 -1.2267 TD (n)Tj /F8 1 Tf .6639 0 TD (=)Tj /F7 1 Tf .7208 0 TD [(238\),)-376.6(26)-378.4(subjects)-378.1(were)-375.5(optimized)-382.8(to)-376.1(26.1/5.2)-165(mg,)-378.5(86)-378.4(subjects)]TJ -1.3847 -1.2203 TD [(were)-223.8(optimized)-224.7(to)-224.3(39.2/7.8)-171.3(mg,)-220.5(and)-222.3(126)-226.2(subjects)-226.3(were)-230.1(optimized)-224.7(to)]TJ T* [(52.3/10.4)-164.5(mg)-217.5(SDX/d-MPH)-212.3(daily)-216.7(\(Fig.)-214.8(1\).)-219.5(Of)-213.6(the)-220(238)-213.5(subjects)-213.7(in)-218(the)]TJ T* [(treatment)-274(phase,)-272.1(143)-276.7(\(60.1%\))-272.9(experienced)-272.6(at)-277.3(least)-270.9(one)-279.2(TEAE,)-269.3(and)]TJ 0 -1.2266 TD [(36)-485.9(\(15.1%\))-487.9(experienced)-493.9(mild)-490.2(TEAEs,)-491.3(95)-492.2(\(39.9%\))-487.9(experienced)]TJ 0 -1.2203 TD [(moderate)-595.2(TEAEs,)-598.8(and)-595.3(12)-599.7(\(5.0%\))-595.8(experienced)-601.4(severe)-596.1(TEAEs)]TJ T* [(\(Table)-299.2(2\).)-295.4(The)-291.6(most)-297.6(common)-297.4(TEAEs)-298.7(in)-293.9(the)-295.8(treatment)-299.3(phase)-294.4(were)]TJ 0 -1.2266 TD [(decreased)-675.4(appetite)-673(\(18.5%\),)-674.1(upper)-672.8(respiratory)-680.4(tract)-670.6(infection)]TJ 0 -1.2203 TD [(\(9.7%\),)-320.5(nasopharyngitis)-324.4(\(8.0%\),)-320.5(decreased)-321.3(weight)-327(\(7.6%\),)-320.5(and)-317.1(ir-)]TJ T* [(ritability)-391(\(6.7%\).)-396.4(There)-390.5(were)-400.8(no)-391(life-threatening)-396.5(or)-393.6(fatal)-392.4(TEAEs)]TJ 0 -1.2266 TD (reported.)Tj 1.1128 -1.2203 TD [(All)-250.2(AEs)-255.8(leading)-249.7(to)-256(discontinuation)-252.8(of)-248.2(study)-255.7(drug)-253.6(during)-250.3(the)-251.6(DO)]TJ -1.1128 -1.2203 TD [(phase)-345(and)-342.4(treatment)-343.5(phase)-345(were)-350.2(classied)-347(as)-344.1(TEAEs.)-345.8(During)-342.1(the)]TJ T* [(DO)-517.8(phase,)-525(four)-515.4(subjects)-523.5(\(1.9%\))-520(with)-521.5(at)-517.6(least)-523.8(one)-519.4(TEAE)-519.3(dis-)]TJ 0 -1.2266 TD [(continued)-210.8(treatment)-210.7(because)-209.8(of)-210.3(an)-210.1(AE.)-213.7(TEAEs)-210.1(leading)-211.8(to)-205.4(treatment)]TJ 0 -1.2203 TD [(discontinuation)-562.6(in)-565.8(the)-561.4(DO)-568.4(phase)-560(were)-565.2(aggression,)-568.3(irritability,)]TJ T* [(psychotic)-319.5(disorder,)-321.7(and)-323.4(nausea)-321.7(\(each)]TJ /F11 1 Tf 15.3267 0 TD (n)Tj /F8 1 Tf .6702 0 TD (=)Tj /F7 1 Tf .7145 0 TD [(1\).)-320.7(Irritability,)-322.3(psychotic)]TJ -16.7115 -1.2266 TD 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