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Quadrivalent vaccin...
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
- Article/chapterEnglish2007
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LIBRIS-ID:oai:lup.lub.lu.se:f908378b-b855-4501-b82d-2d917663712c
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https://lup.lub.lu.se/record/667293URI
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https://doi.org/10.1056/NEJMoa061741DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:1953048URI
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Perez, Gonzalo
(author)
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Kjaer, Susanne K.
(author)
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Paavonen, Jorma
(author)
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Lehtinen, Matti
(author)
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Munoz, Nubia
(author)
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Sigurdsson, Kristjan
(author)
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Hernandez-Avila, Mauricio
(author)
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Skjeldestad, Finn Egil
(author)
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Thoresen, Steinar
(author)
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Garcia, Patricia
(author)
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Majewski, Slawomir
(author)
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Dillner, JoakimKarolinska Institutet,Lund University,Lunds universitet,Klinisk mikrobiologi, Malmö,Forskargrupper vid Lunds universitet,Clinical Microbiology, Malmö,Lund University Research Groups(Swepub:lu)mikr-jdi
(author)
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Olsson, Sven-EricKarolinska Institutet
(author)
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Tay, Eng Hseon
(author)
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Bosch, F. Xavier
(author)
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Ault, Kevin A.
(author)
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Brown, Darron R.
(author)
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Ferris, Daron G.
(author)
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Koutsky, Laura A.
(author)
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Kurman, Robert J.
(author)
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Myers, Evan R.
(author)
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Barr, Eliav
(author)
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Boslego, John
(author)
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Bryan, Janine
(author)
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Esser, Mark T.
(author)
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Gause, Christine K.
(author)
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Hesley, Teresa M.
(author)
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Lupinacci, Lisa C.
(author)
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Sings, Heather L.
(author)
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Taddeo, Frank J.
(author)
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Thornton, Annemarie R.
(author)
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Boulos, M.
(author)
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Cox, J. T.
(author)
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Langmark, F.
(author)
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Modlin, J.
(author)
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Munoz, A.
(author)
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Odlind, V.
(author)
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Wilkinson, E.
(author)
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Ferenczy, A.
(author)
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Kurman, R.
(author)
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Ronett, B.
(author)
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Stoler, M.
(author)
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Andreoni, G.
(author)
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Bahamondes, L.
(author)
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Camargos, A.
(author)
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Costa, R.
(author)
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De Andrade, R.
(author)
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Fedrizzi, E.
(author)
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Ferriani, R.
(author)
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Goncalves, M.
(author)
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Laginha, F.
(author)
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Mendonca, J.
(author)
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Moreira, E., Jr.
(author)
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Nonnenmacher, B.
(author)
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Taborda, W.
(author)
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Zanetta, D.
(author)
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Ardila, J.
(author)
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Balcazar, N.
(author)
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Maldonado, I.
(author)
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Revollo, F.
(author)
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Ruiz, A.
(author)
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Andersen, E. S.
(author)
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Djursing, H.
(author)
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Hansen, T.
(author)
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Jorgensen, J. J.
(author)
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Nilas, L.
(author)
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Ottesen, B.
(author)
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Petersen, L. K.
(author)
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Thomsen, S. G.
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Toftager-Larsen, K.
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Apter, D.
(author)
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Kekki, M.
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Kuortti, M.
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Lahti, L.
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Lindroos, Y.
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Lunnas, T.
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Paavonen, J.
(author)
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Palmroth, J.
(author)
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Sigurdsson, K.
(author)
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Lazcano, E.
(author)
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Zertuche, J.
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Dalaker, K.
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Eriksen, B.
(author)
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Erno, L. E.
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Fiane, B.
(author)
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Hesla, K.
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Isachsen, M. Myhre
(author)
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Iversen, O. E.
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Kasin, K.
(author)
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Kristoffersen, M.
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Lunde, T.
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Nordmark, P. T.
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Nygaard, T.
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Onsrud, M.
(author)
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Riis-Johannessen, G.
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Schiotz, H.
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Skjeldestad, F. E.
(author)
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Sundhagen, H.
(author)
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Sviggum, O.
(author)
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Trosterud, K. A.
(author)
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Garcia, P.
(author)
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Penny, M.
(author)
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Vivar, A.
(author)
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Basta, A.
(author)
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Czajkowski, K.
(author)
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Knapp, P.
(author)
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Spaczynski, M.
(author)
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Barnes, R.
(author)
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Tay, E. H.
(author)
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Elfgren, K.
(author)
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Hardmeier, E.
(author)
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Hellsten, C.
(author)
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Hofte, C.
(author)
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Jensen, P.
(author)
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Johannisson, G.
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Loewhagen, G. -B.
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Olsson, S. -E.
(author)
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Steinwall, M.
(author)
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Tamsen, L.
(author)
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Varnauskas, T.
(author)
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Wikstroem, A.Karolinska Institutet
(author)
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Crawford, G.
(author)
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Allen, B.
(author)
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Ault, K.
(author)
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Brown, D.
(author)
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Edwards, R.
(author)
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Comerci, J.
(author)
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Giuliano, A.
(author)
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Greer, S.
(author)
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Hatch, K.
(author)
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Kriesel, J.
(author)
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Lalezari, J.
(author)
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Partridge, E.
(author)
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Sperling, R.
(author)
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Spruance, S.
(author)
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Stapleton, J.
(author)
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Wright, P.
(author)
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Zedler, P.
(author)
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McCarroll, K.
(author)
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Zhang, L.
(author)
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Zhou, H.
(author)
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Klinisk mikrobiologi, MalmöForskargrupper vid Lunds universitet
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In:New England Journal of Medicine356:19, s. 1915-19270028-47931533-4406
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Villa, Luisa L.
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Paavonen, Jorma
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Lehtinen, Matti
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Langmark, F.
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Modlin, J.
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Munoz, A.
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Odlind, V.
-
Wilkinson, E.
-
Ferenczy, A.
-
Kurman, R.
-
Ronett, B.
-
Stoler, M.
-
Andreoni, G.
-
Bahamondes, L.
-
Camargos, A.
-
Costa, R.
-
De Andrade, R.
-
Fedrizzi, E.
-
Ferriani, R.
-
Goncalves, M.
-
Laginha, F.
-
Mendonca, J.
-
Moreira, E., Jr.
-
Nonnenmacher, B.
-
Taborda, W.
-
Zanetta, D.
-
Ardila, J.
-
Balcazar, N.
-
Maldonado, I.
-
Revollo, F.
-
Ruiz, A.
-
Andersen, E. S.
-
Djursing, H.
-
Hansen, T.
-
Jorgensen, J. J.
-
Nilas, L.
-
Ottesen, B.
-
Petersen, L. K.
-
Thomsen, S. G.
-
Toftager-Larsen, ...
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Apter, D.
-
Kekki, M.
-
Kuortti, M.
-
Lahti, L.
-
Lindroos, Y.
-
Lunnas, T.
-
Paavonen, J.
-
Palmroth, J.
-
Sigurdsson, K.
-
Lazcano, E.
-
Zertuche, J.
-
Dalaker, K.
-
Eriksen, B.
-
Erno, L. E.
-
Fiane, B.
-
Hesla, K.
-
Isachsen, M. Myh ...
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Iversen, O. E.
-
Kasin, K.
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Kristoffersen, M ...
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Lunde, T.
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Nordmark, P. T.
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Nygaard, T.
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Onsrud, M.
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Riis-Johannessen ...
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Schiotz, H.
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Skjeldestad, F. ...
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Sundhagen, H.
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Sviggum, O.
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Trosterud, K. A.
-
Garcia, P.
-
Penny, M.
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Vivar, A.
-
Basta, A.
-
Czajkowski, K.
-
Knapp, P.
-
Spaczynski, M.
-
Barnes, R.
-
Tay, E. H.
-
Elfgren, K.
-
Hardmeier, E.
-
Hellsten, C.
-
Hofte, C.
-
Jensen, P.
-
Johannisson, G.
-
Loewhagen, G. -B ...
-
Olsson, S. -E.
-
Steinwall, M.
-
Tamsen, L.
-
Varnauskas, T.
-
Wikstroem, A.
-
Crawford, G.
-
Allen, B.
-
Ault, K.
-
Brown, D.
-
Edwards, R.
-
Comerci, J.
-
Giuliano, A.
-
Greer, S.
-
Hatch, K.
-
Kriesel, J.
-
Lalezari, J.
-
Partridge, E.
-
Sperling, R.
-
Spruance, S.
-
Stapleton, J.
-
Wright, P.
-
Zedler, P.
-
McCarroll, K.
-
Zhang, L.
-
Zhou, H.
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