1. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 
Jun 3.

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H,
Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K,
Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf 
RM; IMPROVE-IT Investigators.

Collaborators: Musliner T, Tershakovec A, Gurfinkel E, Aylward P, Tonkin A,
Maurer G, Van de Werf F, Nicolau JC, Theroux P, Genest J, Armstrong P, Corbalan
R, Isaza D, Spinar J, Grande P, Voitk J, Kesaniemi A, Bassand JP, Farnier M,
Darius H, Keltai M, Mathur A, Mittal S, Reddy K, Lewis B, De Ferrari GM, Ophuis
TO, Jukema J, White H, Pedersen T, Britto F, Ruzyllo W, Carrageta M, Duris T,
Dalby A, Seung KB, Lopez-Sendon J, Dellborg M, Mach F, Guneri S, Parkhomenko A,
Brady A, Cannon C, Blazing M, Ballantyne C, de Lemos J, Kleiman N, McGuire DK,
Gurfinkel E, Centeno E, Casalins M, Cartasegna L, Beltrano MC, Guerrero R,
Fanuele M, Berra F, Egido J, Colombo H, Dellatorre M, Terns P, Blumberg E, Reges 
P, Azize G, Ramos H, Fernandez R, Carlessi C, Milesi R, Schmuck R, Duronto E,
Gurfinkel E, Procopio G, Carlevaro O, Maffeo H, Beloscar J, Viso M, Hominal M,
Castoldi M, Bluguermann J, Mauro D, Macin S, Cocco N, Ruiz N, Ricart J, Lozada A,
Nani S, Turri D, Fernandez H, Caruso O, Zarandon R, Bono J, Arias V, Allall O,
Marino J, Cusimano S, Schygiel P, Buzetti C, Penaloza N, Berli M, Aylward P,
Worthley S, Roach A, Chew D, Wright T, Leitch J, Hicks E, Rankin J, Venn-Edmonds 
C, Lehman R, Morrison H, Shaw J, Mak V, Hii C, Smith K, Cross D, Lilwall L,
Nelson G, Loxton A, Horowitz J, Rose J, Maurer G, Steinwender C, Leisch F,
Kammler J, Brussee H, Zweiker R, Niederl E, Weihs W, Giorgio G, Maurer G, Lang I,
Drexel H, Zanolin D, Hoppe U, Atzenhofer-Baumgartner K, Pichler M, Hainzer D,
Eber B, Pichler F, Foeger B, Wechselberger T, Mayr H, Hofer J, Stockenhuber F,
Warlits B, Huber K, Egger F, Weidinger F, Ziegler B, Jirak P, Metzler B,
Pachinger O, Wanitschek M, Auer J, Grabscheit G, Podczeck-Schweighofer A,
Priesnitz T, Frank H, Van de Werf F, El Allaf D, Marechal P, Roosen J, Joly E,
Lefebvre P, Arend C, Sinnaeve P, De Velder L, Hellemans S, Vanhauwaert B, Van
Dorpe A, Van Dorpe A, Heyse A, Vantomme C, Striekwold H, Van Den Broeck D,
Lancellotti P, Schoors D, Lemoine I, Taeymans Y, De Wolf L, Brike C, Vercauteren 
S, Tahon S, Vervoort G, Mestdagh I, Pirenne B, Cardinal F, Lips S, Dujardin K,
Debrouwer K, Dhooghe G, Holvoet G, van de Borne P, Renard M, De Clippel M,
Lesseliers H, Van Miert N, Nicolau JC, Saraiva J, Vicente C, Rossi P, Dos Santos 
LB, Duda N, Tognon AP, Serrano C, Nicolau JC, Gomes FL, Manenti ER, Silveira DS, 
Maia L, Mouco OM, Paiva M, Antonangelo A, de Souza J, Lino EA, Leães P, Blacher
MG, Kormann A, Ultramari FT, Dutra O, Mendelski AM, Morgado S, Ardito W, Greque
G, Ardito RV, Pimentel Filho P, Zucchetti C, Alves A, Seabra AM, Mattos M,
Miranda LF, Silva D, Uehara RM, Marin Neto J, Schmidt A, Braga J, Rodrigues A,
Abrantes J, Pinheiro L, Bodanese L, Magedanz ÉH, Piegas L, Dos Santos ES,
Wainstein M, Ribeiro J, Stein R, Marino R, Machado VM, Moraes Junior J, Guimarães
S, da Costa FA, Ferraz RF, Albuquerque D, Rocha RM, de Carvalho Moreira R,
Dohmann H, Dohmann H, Costantini C, Tarastchuk JC, Coelho O, Cirillo W, Sousa A, 
Almeira AS, Stefanini E, Silva F, Teixeira M, da Cunha C, Précoma D, Facchi TL,
Theroux P, Rupka D, Thiessen S, Warnica J, Smith B, Della Siega A, Klinke P,
Nelson S, Dion D, Gilbert N, Hui W, Kvill L, Sussex B, Luther A, Dupuis R, Ouimet
F, Pandey A, Clarus S, Senaratne M, Ferdinandis H, Mukherjee A, Bozek B, Vizel S,
Markov G, Zimmermann R, Stephens W, Tremblay B, Wong G, Uchida N, Brossoit R,
Peck C, Van Kieu C, Forgione M, Bata I, Cossett J, Kostuk W, Arnold M, Bone C,
Grondin F, Bilodeau N, Gosselin G, David M, Giannoccaro J, Beresford P, Polasek
P, Roberts P, Doucet M, Beaudry M, Cheung S, Cleveland T, Bhargava R, McCallum A,
Ma P, Theroux P, Morrissette J, Cleveland D, Chadwyn D, Nigro F, Weeks A,
Cryderman C, Leader R, Houde G, Rousseau S, Pearce M, Radyk M, Lonn E, Magi A,
Lefkowitz C, Sandrin F, Coffin N, Lubelsky B, Coldwell J, Habot J, McPherson C,
De Larochelliere R, Roy M, Haichin R, Barber C, Bhesania T, Kitagawa H, To T,
Donnelly B, Tymchak W, Harris L, Kouz S, Roy M, Huynh T, St Jacques B, Lamy A,
Rizzo A, Stein J, Childs C, Wong B, Poirier R, Gupta M, Dela Cruz C, Constance C,
Gauthier M, Ervin F, Ouellette M, Kokis A, Lemay C, Kwok K, Leung C, Lee D,
Nesmith J, Renton J, Syan G, Turek M, Hogan D, Griffin P, Lipson A, Winestock J, 
Abramson B, Fogel A, Gagne C, Bergeron J, Clarke A, Slipp S, Darcel I,
Carling-Chambers L, Kannampuzha P, Pallie S, Krekorian S, Vertes G, Roth S, Lai
K, Heath J, Corbalan R, Perez L, Arriagada G, Castro P, Villa F, Rodríguez M,
Ramos G, Baraona F, Núñez A, García M, Jofre C, Silva P, Lamich R, Yovaniniz P,
Escobar E, Dussaubat A, Arriagada G, Segura E, Ramirez M, Lapostol C, Ramirez M, 
Palma A, Encina L, Zapata M, Baeza N, Varela P, Pérez L, Isaza D, Jaramillo C,
Ruiz S, Sanchez G, Perdomo I, Manzur F, Cohen LE, Velasquez J, Arana C, Alvarez
Y, Triana M, Balaguera J, de Salazar D, Rendon N, Botero R, Ruiz A, Saaibi J,
Saaibi J, Medina J, Jaramillo M, Calderón MJ, Delgado J, Bohorquez R, Medina MF, 
Herrera M, Rosales D, Mendoza F, Martinez S, Ternera A, Castro R, Baiz A,
Martinez M, Orozco A, Suarez M, Fonseca Y, Beltran R, Cepeda M, Jaramillo C,
Jaramillo N, Isaza D, Valenzuela C, Gutierrez M, Sanchez A, Spinar J, Vitovec J, 
Hlinomaz O, Spinar J, Poloczek M, Mayer O, Veselka J, Vejvoda J, Soucek M, Spac
J, Novobilsky K, Srp V, Francek L, Branny M, Sknouril L, Motovska Z, Rohac F,
Stankova A, Fiala T, Holub M, Zeman K, Pohludkova L, Pospisilova E, Tuma P,
Cihalik C, Oral I, Podpera I, Stepanovova R, Uricar M, Solar M, Pelouch R, Porzer
M, Grussmannova K, Stipal R, Reichert P, Hradec J, Kral J, Sejkova B, Janek B,
Pitha J, Linhart A, Polacek P, Grande P, Koeber L, Clemmensen P, Grande P, Hebin 
CH, Schmidt E, Pedersen MS, Roseva-Nielsen N, Kristensen K, Bang-Hansen T, Jensen
J, Laage-Petersen J, Nielsen H, Stokholm E, Thayssen P, Cappelen H, Jensen T,
Winther-Friis B, Klausen I, Hedegaard B, May O, Andersen M, Bottzauw J, Lush A,
Markenvard J, Vestager KM, Bronnum-Schou J, Hempel H, Petersen J, Nielsen AJ,
Thomsen K, Nielsen T, Nygaard A, Sykulski R, Jensen BS, Ralfkiaer N, Gottschalck 
H, Rasmussen S, Pedersen LR, Dodt K, Skovsbøl M, Andersen O, Tuxen C, Meier AW,
Kristensen T, Rasmussen O, Lopez J, Salazar D, Sanchez L, Rosero F, Penaherrera
E, Duarte YC, Marmol R, Andrade G, Guzman E, Morillo A, Voitk J, Aug L, Loogna I,
Voitk J, Laanmets P, Kesaniemi A, Mustonen J, Mäntylä P, Kesäniemi A, Ukkola O,
Kervinen H, Juhela S, Juvonen J, Toppinen A, Jarvenpaa J, Syvanne M, Svahn T,
Voutilainen S, Huotari A, Nikkila M, Raiskinmäki S, Kotila M, Rajala A, Laukkanen
J, Hiltunen P, Melin J, Nyman K, Luukkonen J, Kosonen P, Huttunen M, Seppänen V, 
Airaksinen J, Juonala M, Lehto S, Savolainen K, Halkosaari M, Sia J, Palomaki A, 
Luoma J, Utriainen S, Valpas S, Tiensuu T, Lilleberg J, Kainulainen R, Bassand
JP, Schiele F, Bassand J, Meneveau N, Galinier M, Jean M, Martelet M, Mouallem J,
Elbaz M, Puel J, Carrié D, Coisne D, Varroud-Vial N, Jaboureck O, Dujardin J,
Leroy F, Mansourati J, Funck F, Jourdain P, Guillard N, Coviaux F, Gay A,
Dourmap-Collas C, Froger-Bompas C, Paillard F, Tricot O, Maquin-Mavier I,
Dubois-Rande JL, Pongas D, Paris AP, Delahaye F, Ovize M, Benyahya L, Bonnet J,
Belle L, Mangin L, Lafitte B, Zemour G, Doux N, Agraou B, El Mansour N, Traisnel 
G, El Jarroudi M, Ohlmann P, Diadema B, Escande M, Legros G, Demarcq JM, Haftel
Y, Alsagheer S, Dambrine P, Cottin Y, Ghostine S, Caussin C, Gacem A, Bouvier JM,
Poulard J, Davy J, Furber A, Prunier F, Darius H, Muenzel T, Genth-Zotz S, Appel 
K, Kretzschmar D, Ferrari M, Terres W, Uher T, Schulze H, Ochs H, Morbach S,
Duengen H, Gross M, Oezcelik C, Tahirovic E, Heuer H, Laschewski B, Kadel C, Rahn
G, Steiner S, Kreuzer J, Tsoy I, Zeiher A, Muegge A, Hanefeld C, Boehm S,
Boudriot E, Hodenberg E, Lippe B, Darius H, Hausdorf C, Sydow K, Baldus S,
Schlesner C, Tiroch K, Haltern G, Guelker H, Wilhelm J, Dietz S, Ebelt H, Buerke 
M, Rupprecht H, Rittgen J, Schaeufele T, Meinhardt G, Schieber M, Honold M,
Sieprath S, Nienaber C, Hacker J, Butter C, Lapp H, Hirn S, Pauschinger M, Zahn
R, Scheffler U, Schaefer A, Schieffer B, Tebbe U, Kriete M, Mudra H, Raeder T,
Braun P, Schmidt E, Zeymer U, Kouraki K, Reppel M, Schunkert H, Weil J, Olbrich
H, Schwaiger P, Mueller O, Blessing E, Buss I, Bohlscheid V, Kaddatz J, Skowasch 
D, Nickenig G, Twelker K, Osterhues H, Varghese T, Burghard S, Kaeaeb S, Klauss
V, Sohn HY, Hauptmann K, Schulze M, Gall K, Felix S, Doerr M, Mante J, Gulba D,
Freick M, Werner G, Kleinertz K, Buerke M, Hobbach HP, Halbach M, Mueller-Ehmsen 
J, Mueller ME, Mitrovic V, Peil A, Laufs U, vom Dahl J, Baumanns S, Scholtz W,
Wiemer M, Haude M, Van de Loo A, Pistorius K, Schaefer J, Schwinger R, Goeing O, 
Jung W, Birkemeyer R, Lee W, Kong S, Yu C, Chui K, Keltai M, Merkely B, Szelényi 
Z, Polgár P, Svab S, Herczeg B, Bajcsi É, Vértes A, Davidovits S, Nagy A, Király 
C, Lupkovics G, Kenéz A, Poór F, Takács J, Kirschner R, Simonyi G, Koncz J, Édes 
I, Gergely S, Katona A, Nagy E, Kovács Z, Gyetvai I, Salamon C, Kolman É, Sitkei 
É, Csapó K, Molnar K, Mező I, Sereg M, Mathur A, Mittal S, Reddy K, Reddy P,
Manjunath C, Narayanappa S, Kumar S, Sinha N, Kapoor A, Christopher J, Reddy G,
Rani M, Oomman A, Ramamurthee K, Kumar N, Pasha SS, Rao C, Murty GS, Chopra A,
Kapila D, Bali H, Chattree K, Mathur A, Hasan O, Suryaprakash G, Rao D, Babu R,
Bhargavi M, Naik S, Khan S, Chopra V, Sapra R, Kumar S, Kaul U, Ghose T, Menon R,
Battikadi S, Mullasari A, Subban VK, Dani S, Iby M, Chandra P, Sethi S, Bhargava 
M, Arora P, Tyagi G, Padmanabhan T, Malhotra S, Talwar K, Shafiq N, Kasliwal R,
Bansal M, Lewis B, Eldar M, Berger M, Shechter M, Atar S, Roguin N, Kilimnik M,
Hayek T, Hamoud S, Katz A, Plaev T, Shotan A, Vazan A, Weiss A, Leibowitz D,
Zimlichman R, Ben-Aharon J, Hammerman H, Dragu R, Rozenman Y, Witzling V, Tzivoni
D, Moriel M, Halkin A, Sheps D, Bogomolny N, Mosseri M, Khudyak Y, Lewis B,
Halabi S, Uziel-Iunger K, Yuval R, Shimoni S, Caspi A, Botwin S, Gavish D,
Sandler A, Pollak A, Kreisberg B, Hussein O, Jabal K, Henkin Y, Grosbard A,
Rosenschein U, Rivlin E, Zeltser D, Platner N, Porter A, Harel N, Lishner M, Elis
A, Karny M, Fuchs S, Stein G, Grossman E, Gealel Z, Schlaeffer F, Liberty I,
Golik A, Tzuman O, De Ferrari G, De Ferrari G, Pavesi C, Poggio L, Damiano S,
Pazzano AS, Mennuni M, Paloscia L, Mascellanti M, Piovaccari G, Grosseto D,
Mascia F, Vetrano A, Zingarelli A, Mazzantini S, Visconti L, Terzi G, Senni M,
Gavazzi A, Scuri P, Carmelo M, De Caterina R, Conti M, Novo S, Graceffa A, Arvigo
L, Lunetta M, Filardi P, Chiariello M, Scala O, Pirozzi E, Musella F, Moretti L, 
Testa M, Vicentini A, De Feo S, Biasucci L, Cardillo MT, Puccioni E, Galli M,
Menegato A, Margheri M, Maresta A, Gatti C, Guarini P, Damiano M, Golino P, Porcu
M, Fele N, Gensini G, Lombardi A, Ciuti G, Bernardi D, Mariani P, Paolini E,
Marenzi G, Moltrasio M, Terrosu P, Chessa P, Guglielmino G, Miccoli F, Oldoino E,
Ragni M, Poli M, Basso V, Rapezzi C, Branzi A, Gallelli I, Perna G, Guazzarotti
F, Marra S, Usmiani T, Olivari Z, Calzolari D, Santoro G, Minneci C, Achilli A,
Nassiacos D, Sommariva L, Romeo F, Fedele F, Foschi ML, Bruno N, Centurion C,
Patrizi G, De Maria E, Gonnelli S, Vichi V, Cassadonte F, Rotella G, Capucci A,
Villani G, Gaspardone A, Ferrante R, Scollo V, Pancaldi L, Saccà S, Gabrielli D, 
Ciliberti D, Savini E, Porcu M, Binaghi G, Di Biase M, Ieva R, Fattore L, Cicia
G, Cavallini C, Tamburino C, Sacco A, Mafrici A, Di Pasquale G, Pavesi PC, Scioli
R, Lioy E, Occhiuzzi E, Matino MG, Russo V, Moscogiuri MG, Cuccia C, Forgione C, 
Volpe M, Palano F, Tamburino C, Branca G, Rossi R, Modena M, Olaru IA, Zanini R, 
Cianflone D, Cristell N, Pantaleoni M, Guiducci U, Menozzi C, Gaddi O, Fasulo A, 
Indolfi C, Emanuele V, Capucci A, Guerra F, Iliceto S, Marotta C, Morocutti G,
Presbitero P, Rossi M, Zanini R, Bonatti S, Grieco A, Chiodi L, Betti I,
Zuppiroli A, Fanelli R, Stanco G, Azzolini P, Ruggieri C, Bocconcelli P, Airoldi 
F, Tavano D, Brunelli C, Caso P, Scalzone A, Brunelli C, Ghigliotti G, Fanelli R,
Facciorusso A, Stanco G, Grieco A, Bocconcelli P, Sim K, Kiam O, Chee K, Bin
Ismail O, Zambahari R, Ophuis T, Jukema J, van Nes E, Werter CJ, Ophuis AJ,
Troquay RP, Hamer BJ, Lenderink T, Feld RJ, van Hessen MW, Viergever EP, van der 
Sluis A, Lok DJ, Badings EA, Nierop PR, Danse IY, Hermans WR, Holwerda NJ,
Thijssen HJ, Theunissen LJ, van der Zwaan C, Van Den Berg BJ, Hendriks IH, Ronner
E, Withagen AJ, Dijkshoorn-Giesen AH, Ezechiels JP, Kuijper AF, Den Hartog FR,
Van Kalmthout PM, Buijs EM, van der Zeijst M, Zwart PA, Zuidgeest JA, van Eck M, 
Daniels MC, van der Ven-Elzebroek N, Van 't Hof A, van Boven AJ, van der Weerdt
A, Dunselman PH, Alings MA, van Es RF, The SH, Gurlek C, Liem AH, van Lennep HW, 
Van Vlies B, Kalkman C, Swart HP, van der Bij P, Taverne R, Ciampricotti R, van
Dam C, Spierenburg H, van Ruijven I, van Kempen LH, Willems FF, Dirkali A, Stoel 
I, Plomp J, Veldmeijer S, Tjeerdsma G, Nijmeijer R, Van Hal JM, Bartels GL, Posma
JL, Linssen GC, Fauser CG, Waalewijn RA, Groenemeijer BE, Pos L, Fast JH, Droste 
HT, Westenburg J, Veenstra W, Koolen J, van Loo LW, Smits W, Milhous JG, van
Rossum P, Stuij S, White H, Scott R, Richards AM, Morrison Z, Devlin G, Fisher R,
Stewart R, Benetar J, Voss J, Wong S, Scott D, Luke R, Tang E, Davidson L, Hamer 
A, Wilson S, Price R, Hart H, Turner A, Pedersen T, Jortveit J, Calic S,
Gundersen T, Brunvand H, Fosse L, Nygaard O, Gjellefall B, Gravdal SA, Ringstad
R, Atar D, Clausen H, Hysing J, Arvesen K, Topper M, Flagstad E, Graven T, Haug
HH, Dalin L, Al-Ani R, Otterstad J, Ausen K, Aaser E, Olufsen M, Halvorsen S,
Clausen H, Gullestad L, Stueflotten W, Waage K, Stødle RM, Hall C, Aase O,
Nordeng J, Soyland E, Fageraas ER, Lied A, Aske R, Raouf N, Johansson J,
Herrscher T, Skogrand E, Bjornstad H, Aagnes I, Arntsen BI, Vegsundvaag J, Skjold
ME, Velle H, Aambakk MB, Skjetne O, Byfuglien A, Britto F, Rodriguez J, Galvez D,
Medina F, Hernandez HA, Chavez V, Morales R, Huapalla E, Velasquez D, Torres F,
Morales R, Britto F, Aguirre O, Yanez L, Andrade M, Campos C, Arce R, Mogrovejo
W, Osores F, Bustamante G, Rodriguez M, Berrospi P, Garcia C, Talledo M, Navarro 
P, Horna M, Herrera V, Ruzyllo W, Ruzyllo W, Kadziela J, Rybicka-Musialik A,
Trusz-Gluza M, Berger-Kucza A, Musial W, Tycinska A, Gil R, Gziut A, Gorny J,
Tyllo M, Reszka Z, Mickiewicz-Pawlowska M, Wrzosek B, Kosior J, Staneta P,
Korzeniak R, Kalarus Z, Markowicz E, Miekus P, Konarzewski M, Kleinrok A, Puzniak
M, Grajek S, Janus M, Krzyzanowski M, Hoffmann A, Muzalewski P, Polonski L, Kazik
A, Nowalany-Kozielska E, Wojciechowska C, Ponikowski P, Nawrocka S, Filipiak K,
Serafin A, Dubiel J, Mielecki W, Ogorek M, Kopcik D, Jaworska K, Skonieczny G,
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BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol
levels and the risk of cardiovascular events, but whether the addition of
ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can
reduce the rate of cardiovascular events further is not known.
METHODS: We conducted a double-blind, randomized trial involving 18,144 patients 
who had been hospitalized for an acute coronary syndrome within the preceding 10 
days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6
mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per
deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering
therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg)
(simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo
(simvastatin monotherapy). The primary end point was a composite of
cardiovascular death, nonfatal myocardial infarction, unstable angina requiring
rehospitalization, coronary revascularization (≥30 days after randomization), or 
nonfatal stroke. The median follow-up was 6 years.
RESULTS: The median time-weighted average LDL cholesterol level during the study 
was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe
group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the
simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the
primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as
compared with 34.7% in the simvastatin-monotherapy group (absolute risk
difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 
0.89 to 0.99; P=0.016). Rates of prespecified muscle, gallbladder, and hepatic
adverse effects and cancer were similar in the two groups.
CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental
lowering of LDL cholesterol levels and improved cardiovascular outcomes.
Moreover, lowering LDL cholesterol to levels below previous targets provided
additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number,
NCT00202878.).

DOI: 10.1056/NEJMoa1410489 
PMID: 26039521  [Indexed for MEDLINE]