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Week 96 efficacy an...
Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1
- Article/chapterEnglish2019
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LIBRIS-ID:oai:gup.ub.gu.se/285580
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https://gup.ub.gu.se/publication/285580URI
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https://doi.org/10.1016/j.antiviral.2019.104543DOI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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© 2019 The Authors Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL < 50 copies/mL (virologic suppression) and ≥50 copies/mL (VF) (FDA-snapshot analysis). Of 1141 randomized patients, 1080 continued in the extension phase. Few patients had PDVR (D/C/F/TAF: 3.1%, 24/763 cumulative through week 96; late-switch: 2.3%, 8/352 week 52–96). Week 96 virologic suppression was 90.7% (692/763) (D/C/F/TAF) and 93.8% (330/352) (late-switch). VF was 1.2% and 1.7%, respectively. No darunavir, primary PI, tenofovir or emtricitabine resistance-associated mutations were observed post-baseline. No patients discontinued for efficacy-related reasons. Few discontinued due to adverse events (2% D/C/F/TAF arm). Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the late-switch arm, with small increases in total cholesterol/high-density-lipoprotein-cholesterol ratio. A study limitation was the lack of a control arm in the week 96 analysis. Through 96 weeks, D/C/F/TAF resulted in low PDVR rates, high virologic suppression rates, very few VFs, and no resistance development. Late-switch results were consistent with D/C/F/TAF week 48 results. EMERALD week 96 results confirm the efficacy, high genetic barrier to resistance and safety benefits of D/C/F/TAF.
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Orkin, C.
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Cunningham, Douglas
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Pulido, Federico
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Post, Frank A.
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De Wit, Stéphane
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Lathouwers, E.
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Hufkens, Veerle
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Jezorwski, John
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Petrovic, Romana
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Brown, Kimberley
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Van Landuyt, E.
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Opsomer, M.
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De Wit, S.
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Florence, E.
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Moutschen, M.
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Van Wijngaerden, E.
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Vandekerckhove, L.
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Vandercam, B.
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Brunetta, J.
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Conway, B.
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Klein, M.
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Murphy, D.
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Rachlis, A.
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Shafran, S.
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Walmsley, S.
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Ajana, F.
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Cotte, L.
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Girardy, P. M.
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Katlama, C.
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Molina, J. M.
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Poizot-Martin, I.
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Raffi, F.
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Rey, D.
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Reynes, J.
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Teicher, E.
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Yazdanpanah, Y.
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Gasiorowski, J.
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Halota, W.
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Horban, A.
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Piekarska, A.
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Witor, A.
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Arribas, J. R.
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Perez-Valero, I.
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Berenguer, J.
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Casado, J.
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Gatell, J. M.
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Gutierrez, F.
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Galindo, M. J.
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Gutierrez, M. D.M.
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Iribarren, J. A.
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Knobel, H.
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Negredo, E.
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Pineda, J. A.
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Podzamczer, D.
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Sogorb, J. Portilla
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Pulido, F.
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Ricart, C.
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Rivero, A.
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Santos Gil, I.
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Blaxhult, A.
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Flamholc, L.
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Gisslén, Magnus,1962Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine(Swepub:gu)xgissm
(author)
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Thalme, A.
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Fehr, J.
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Rauch, A.
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Stoeckle, M.
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Clarke, A.
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Gazzard, B. G.
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Johnson, M. A.
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Orkin, C.
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Ustianowski, A.
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Waters, L.
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Bailey, J.
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Benson, P.
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Bhatti, L.
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Brar, I.
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Bredeek, U. F.
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Brinson, C.
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Crofoot, G.
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Cunningham, D.
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DeJesus, E.
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Dietz, C.
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Dretler, R.
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Eron, J.
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Felizarta, F.
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Fichtenbaum, C.
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Gallant, J.
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Gathe, J.
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Hagins, D.
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Henn, S.
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Henry, W. K.
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Huhn, G.
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Jain, M.
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Lucasti, C.
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Martorell, C.
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McDonald, C.
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Mills, A.
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Morales-Ramirez, J.
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Göteborgs universitetInstitutionen för biomedicin, avdelningen för infektionssjukdomar
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In:Antiviral Research: Elsevier BV1700166-35421872-9096
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Eron, Joseph J.
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Orkin, C.
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Cunningham, Doug ...
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Pulido, Federico
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Post, Frank A.
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De Wit, Stéphane
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Lathouwers, E.
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Hufkens, Veerle
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Jezorwski, John
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Petrovic, Romana
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Brown, Kimberley
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Van Landuyt, E.
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Opsomer, M.
-
De Wit, S.
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Florence, E.
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Moutschen, M.
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Van Wijngaerden, ...
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Vandekerckhove, ...
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Vandercam, B.
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Brunetta, J.
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Conway, B.
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Klein, M.
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Murphy, D.
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Rachlis, A.
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Shafran, S.
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Walmsley, S.
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Ajana, F.
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Cotte, L.
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Girardy, P. M.
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Katlama, C.
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Molina, J. M.
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Poizot-Martin, I ...
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Raffi, F.
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Rey, D.
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Reynes, J.
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Teicher, E.
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Yazdanpanah, Y.
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Gasiorowski, J.
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Halota, W.
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Horban, A.
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Piekarska, A.
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Witor, A.
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Arribas, J. R.
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Perez-Valero, I.
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Berenguer, J.
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Casado, J.
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Gatell, J. M.
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Gutierrez, F.
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Iribarren, J. A.
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Knobel, H.
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Negredo, E.
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Pulido, F.
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Ricart, C.
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Rivero, A.
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Santos Gil, I.
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Blaxhult, A.
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Flamholc, L.
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Gisslén, Magnus, ...
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Thalme, A.
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Fehr, J.
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Rauch, A.
-
Stoeckle, M.
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Clarke, A.
-
Gazzard, B. G.
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Johnson, M. A.
-
Ustianowski, A.
-
Waters, L.
-
Bailey, J.
-
Benson, P.
-
Bhatti, L.
-
Brar, I.
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Bredeek, U. F.
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Brinson, C.
-
Crofoot, G.
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Cunningham, D.
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DeJesus, E.
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Dietz, C.
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Dretler, R.
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Eron, J.
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Felizarta, F.
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Fichtenbaum, C.
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Gallant, J.
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Gathe, J.
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Hagins, D.
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Henn, S.
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Henry, W. K.
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Huhn, G.
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Jain, M.
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Lucasti, C.
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Martorell, C.
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McDonald, C.
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Morales-Ramirez, ...
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