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Items: 18

1.

Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16-26 years: a randomised, double-blind trial.

Huh WK, Joura EA, Giuliano AR, Iversen OE, de Andrade RP, Ault KA, Bartholomew D, Cestero RM, Fedrizzi EN, Hirschberg AL, Mayrand MH, Ruiz-Sternberg AM, Stapleton JT, Wiley DJ, Ferenczy A, Kurman R, Ronnett BM, Stoler MH, Cuzick J, Garland SM, Kjaer SK, Bautista OM, Haupt R, Moeller E, Ritter M, Roberts CC, Shields C, Luxembourg A.

Lancet. 2017 Nov 11;390(10108):2143-2159. doi: 10.1016/S0140-6736(17)31821-4. Epub 2017 Sep 5.

PMID:
28886907
2.

Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials.

Petersen LK, Restrepo J, Moreira ED Jr, Iversen OE, Pitisuttithum P, Van Damme P, Joura EA, Olsson SE, Ferris D, Block S, Giuliano AR, Bosch X, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Hyatt D, Maansson R, Moeller E, Qi H, Roberts C, Luxembourg A.

Papillomavirus Res. 2017 Jun;3:105-115. doi: 10.1016/j.pvr.2017.03.002. Epub 2017 Mar 16.

4.

Deconstructing the measure of vaccine efficacy against disease irrespective of HPV in HPV vaccine clinical trials.

Bautista OM, Luxembourg A.

Contemp Clin Trials. 2016 Mar;47:254-8. doi: 10.1016/j.cct.2016.01.002. Epub 2016 Jan 18.

PMID:
26795674
5.

A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women.

Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study.

N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.

6.

End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age.

Castellsagué X, Muñoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A.

Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31.

7.

Re: Longitudinal study of human papillomavirus persistence and cervical intraepithelial neoplasia grade 2/3: critical role of duration of infection.

Bautista OM, Saah A, Muñoz N.

J Natl Cancer Inst. 2011 Jan 19;103(2):158; author reply 158-9. doi: 10.1093/jnci/djq468. Epub 2010 Nov 29. No abstract available.

PMID:
21115883
8.

Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women.

Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM.

Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001.

PMID:
18313445
9.

Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines.

Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators.

Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.

PMID:
18164106
10.

Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials.

Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J.

Lancet. 2007 May 19;369(9574):1693-702.

PMID:
17512854
11.

Parametric survival models for interval-censored data with time-dependent covariates.

Sparling YH, Younes N, Lachin JM, Bautista OM.

Biostatistics. 2006 Oct;7(4):599-614. Epub 2006 Apr 5.

PMID:
16597670
12.

Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo.

Crawford ED, Wilson SS, McConnell JD, Slawin KM, Lieber MC, Smith JA, Meehan AG, Bautista OM, Noble WR, Kusek JW, Nyberg LM, Roehrborn CG; MTOPS RESEARCH Group.

J Urol. 2006 Apr;175(4):1422-6; discussion 1426-7.

PMID:
16516013
13.

Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial.

Mao C, Koutsky LA, Ault KA, Wheeler CM, Brown DR, Wiley DJ, Alvarez FB, Bautista OM, Jansen KU, Barr E.

Obstet Gynecol. 2006 Jan;107(1):18-27. Erratum in: Obstet Gynecol. 2006 Jun;107(6):1425.

PMID:
16394035
14.

The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

McConnell JD, Roehrborn CG, Bautista OM, Andriole GL Jr, Dixon CM, Kusek JW, Lepor H, McVary KT, Nyberg LM Jr, Clarke HS, Crawford ED, Diokno A, Foley JP, Foster HE, Jacobs SC, Kaplan SA, Kreder KJ, Lieber MM, Lucia MS, Miller GJ, Menon M, Milam DF, Ramsdell JW, Schenkman NS, Slawin KM, Smith JA; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group.

N Engl J Med. 2003 Dec 18;349(25):2387-98.

15.

Group sequential large sample T2-like chi2 tests for multivariate observations.

Lachin JM, Greenhouse SW, Bautista OM.

Stat Med. 2003 Nov 15;22(21):3357-68.

PMID:
14566920
16.

Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial.

Bautista OM, Kusek JW, Nyberg LM, McConnell JD, Bain RP, Miller G, Crawford ED, Kaplan SA, Sihelnik SA, Brawer MK, Lepor H.

Control Clin Trials. 2003 Apr;24(2):224-43.

PMID:
12689743
17.

A flexible stochastic curtailing procedure for the log-rank test.

Bautista OM, Bain RP, Lachin JM.

Control Clin Trials. 2000 Oct;21(5):428-39.

PMID:
11018561
18.

Stratified-adjusted versus unstratified assessment of sample size and power for analyses of proportions.

Lachin JM, Bautista OM.

Cancer Treat Res. 1995;75:203-23. Review. No abstract available.

PMID:
7640164

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