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Rapid improvements in MADRS with zuranolone in major depressive disorder and postpartum depression: results from the LANDSCAPE/NEST clinical development programmes

European psychiatry, 2023-03, Vol.66 (S1), p.S93-S94

2023

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Some comments on frequently used multiple endpoint adjustment methods in clinical trials

Statistics in medicine, 1997-11, Vol.16 (22), p.2529-2542

1997

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Multiple Co-primary Endpoints: Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of America

Drug information journal, 2007-01, Vol.41 (1), p.31-46

2007

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Interim Analyses: An Update of an FDA Reviewer's Experience and Perspective

Drug information journal, 1999, Vol.33 (1), p.165-176

Sankoh, A. J.

1999

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Clinical Efficacy of a 2-Week Treatment Course of Zuranolone for the Treatment of Major Depressive Disorder and Postpartum Depression: Outcomes From the Clinical Development Program

European psychiatry, 2022-06, Vol.65 (S1), p.S97-S98

2022

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An Overview of Practical Approaches for Handling Missing Data in Clinical Trials

Journal of biopharmaceutical statistics, 2009-11, Vol.19 (6), p.1055-1073

2009

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Global Two-Group Multiple Endpoint Adjustment Methods Applied to Clinical Trials

Drug information journal, 1999, Vol.33 (1), p.119-140

1999

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Interim Analyses: An FDA Reviewer's Experience and Perspective

Drug information journal, 1995, Vol.29 (2), p.729-737

Sankoh, A. J.

1995

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A note on the conservativeness of the confidence interval approach for the selection of non-inferiority margin in the two-arm active-control trial

Statistics in medicine, 2008-08, Vol.27 (19), p.3732-3742

Sankoh, Abdul J.

2008

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A reviewer's perspective on multiple endpoint issues in clinical trials

Journal of biopharmaceutical statistics, 1997, Vol.7 (4), p.545-564

1997

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Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues

Statistics in medicine, 2003-10, Vol.22 (20), p.3133-3150

2003

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ON THE UTILITY OF THE DIRICHLET DISTRIBUTION FOR META-ANALYSIS OF CLINICAL STUDIES

Journal of biopharmaceutical statistics, 1999-05, Vol.9 (2), p.289-306

1999

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Prognostic Variables in Clinical Trials

Methods and Applications of Statistics in Clinical Trials, 2014, p.789-798

2014

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A Note on O'Brien's OLS and GLS Tests

Biometrics, 1995-12, Vol.51 (4), p.1580-1581

1995

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Small-sample properties of finite population ratios

Communications in statistics. Simulation and computation, 1995-01, Vol.24 (4), p.897-909

Sankoh, Abdul J.

1995

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Bayesian optimal stratified sampling design

Communications in statistics. Theory and methods, 1992-01, Vol.21 (11), p.3185-3196

Sankoh, Abdul J.

1992

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The utility of mixed-effects covariate analysis in rapid selection of doses in pediatric subjects: A case study with fexofenadine hydrochloride

Biopharmaceutics & drug disposition, 2004-12, Vol.25 (9), p.373-387

2004

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Some comments on: Frequently used multiple endpoint adjustment methods in clinical trials by Bauer, P. et al

Statistics in medicine, 1997, Vol.16 (22), p.2529-2542

1997

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Reflections on the global burden of disease 2010 estimates

PLoS medicine, 2013-07, Vol.10 (7), p.e1001477-e1001477

2013

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Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis

The New England journal of medicine, 2013-08, Vol.369 (8), p.699-710

2013

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Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

The New England journal of medicine, 2013-08, Vol.369 (8), p.711-721

2013

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Trial of SAGE-217 in Patients with Major Depressive Disorder

The New England journal of medicine, 2019-09, Vol.381 (10), p.903-911

2019

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Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

The journal of clinical psychiatry, 2023-02, Vol.84 (2)

2023

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Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials

The Lancet (British edition), 2018-09, Vol.392 (10152), p.1058-1070

2018

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Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial

JAMA psychiatry (Chicago, Ill.), 2021-09, Vol.78 (9), p.951

2021

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Rapid improvements in MADRS with zuranolone in major depressive disorder and postpartum depression: results from the LANDSCAPE/NEST clinical development programmes

Some comments on frequently used multiple endpoint adjustment methods in clinical trials

Multiple Co-primary Endpoints: Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of America

Interim Analyses: An Update of an FDA Reviewer's Experience and Perspective

Clinical Efficacy of a 2-Week Treatment Course of Zuranolone for the Treatment of Major Depressive Disorder and Postpartum Depression: Outcomes From the Clinical Development Program

An Overview of Practical Approaches for Handling Missing Data in Clinical Trials

Global Two-Group Multiple Endpoint Adjustment Methods Applied to Clinical Trials

Interim Analyses: An FDA Reviewer's Experience and Perspective

A note on the conservativeness of the confidence interval approach for the selection of non-inferiority margin in the two-arm active-control trial

A reviewer's perspective on multiple endpoint issues in clinical trials

Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues

ON THE UTILITY OF THE DIRICHLET DISTRIBUTION FOR META-ANALYSIS OF CLINICAL STUDIES

Prognostic Variables in Clinical Trials

A Note on O'Brien's OLS and GLS Tests

Small-sample properties of finite population ratios

Bayesian optimal stratified sampling design

The utility of mixed-effects covariate analysis in rapid selection of doses in pediatric subjects: A case study with fexofenadine hydrochloride

Some comments on: Frequently used multiple endpoint adjustment methods in clinical trials by Bauer, P. et al

Reflections on the global burden of disease 2010 estimates

Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis

Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

Trial of SAGE-217 in Patients with Major Depressive Disorder

Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials

Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial

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