Lista de obras - E Claire Dees - Dominio Público Uruguay

A Multidisciplinary Breast Cancer Brain Metastases Clinic: The University of North Carolina Experience

artículo científico publicado en 2015

A Phase I Trial of the PI3K Inhibitor Buparlisib Combined With Capecitabine in Patients With Metastatic Breast Cancer

artículo científico publicado en 2017

A Phase I study of bortezomib plus irinotecan in patients with advanced solid tumors

artículo científico publicado en 2006

A Phase I study of the oral antimetabolite, CS-682, administered once daily 5 days per week in patients with refractory solid tumor malignancies

artículo científico publicado en 2006

A first in man phase I trial of the oral immunomodulator, indoximod, combined with docetaxel in patients with metastatic solid tumors

artículo científico publicado en 2014

A phase I and pharmacokinetic study of short infusions of UCN-01 in patients with refractory solid tumors

artículo científico publicado en 2005

A phase I and pharmacologic evaluation of the DNA intercalator CI-958 in patients with advanced solid tumors

scientific article published on 01 October 2000

A phase I and pharmacologic study of pyrazoloacridine and cisplatin in patients with advanced cancer

artículo científico publicado en 2003

A phase I and pharmacologic study of the combination of bortezomib and pegylated liposomal doxorubicin in patients with refractory solid tumors

artículo científico publicado en 2008

A phase I evaluation of the combination of vinflunine and erlotinib in patients with refractory solid tumors

artículo científico publicado en 2010

A phase I trial of everolimus in combination with 5-FU/LV, mFOLFOX6 and mFOLFOX6 plus panitumumab in patients with refractory solid tumors

artículo científico publicado en 2014

A phase I trial of sorafenib combined with cisplatin/etoposide or carboplatin/pemetrexed in refractory solid tumor patients

artículo científico publicado en 2010

A prospective pharmacologic evaluation of age-related toxicity of adjuvant chemotherapy in women with breast cancer

artículo científico publicado en 2000

Abstract PD07-10: Breast Cancer Patients Carrying the CYP2C8*3 Variant Are More Likely To Achieve Clinical Complete Response from Neoadjuvant Paclitaxel Treatment

Abstract PD10-07: Patients carrying CYP2C8*3 are at increased risk of paclitaxel-induced neuropathy

Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

article

American Joint Committee on Cancer tumor-node-metastasis stage after neoadjuvant chemotherapy and breast cancer outcome

artículo científico publicado en 2005

Aurora A Functional Single Nucleotide Polymorphism (SNP) Correlates With Clinical Outcome in Patients With Advanced Solid Tumors Treated With Alisertib, an Investigational Aurora A Kinase Inhibitor

artículo científico publicado en 2017

Axillary lymph node count is lower after neoadjuvant chemotherapy

artículo científico publicado en 2006

CYP2C8*3 increases risk of neuropathy in breast cancer patients treated with paclitaxel

artículo científico publicado en 2013

CYP2C8*3 predicts benefit/risk profile in breast cancer patients receiving neoadjuvant paclitaxel

artículo científico publicado en 2012

Central nervous system metastases in women after multimodality therapy for high risk breast cancer

scientific article published on 01 December 2004

Changing Natural History of HER2-Positive Breast Cancer Metastatic to the Brain in the Era of New Targeted Therapies

artículo científico publicado en 2017

Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial

scientific article published on 30 September 2019

Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer

scientific article published on 03 June 2019

Clinical evaluation of germline polymorphisms associated with capecitabine toxicity in breast cancer: TBCRC-015

scientific article published on 06 May 2020

Concomitant pregnancy and breast cancer: options for systemic therapy.

artículo científico publicado en 2005

Congruence of patient- and clinician-reported toxicity in women receiving chemotherapy for early breast cancer

artículo científico publicado en 2020

Correction to: Measuring and understanding adherence in a home-based exercise intervention during chemotherapy for early breast cancer

artículo científico publicado en 2019

Delivery of a healthy baby after first-trimester maternal exposure to lapatinib

scientific article published on 01 October 2006

Dendritic cells can be rapidly expanded ex vivo and safely administered in patients with metastatic breast cancer

artículo científico publicado en 2004

Does information from axillary dissection change treatment in clinically node-negative patients with breast cancer? An algorithm for assessment of impact of axillary dissection

artículo científico publicado en 1997

Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer

artículo científico publicado en 2012

Effects of Breast Cancer Adjuvant Chemotherapy Regimens on Expression of the Aging Biomarker, <i>p16<sup>INK4a</sup></i>

scientific article published on 18 December 2020

Extended follow-up of outcome measures in multiple myeloma patients treated on a phase I study with bortezomib and pegylated liposomal doxorubicin

scientific article published on 05 December 2006

First-in-Human Phase I Study of GSK2126458, an Oral Pan-Class I Phosphatidylinositol-3-Kinase Inhibitor, in Patients with Advanced Solid Tumor Malignancies

artículo científico publicado en 2015

Genetic heterogeneity beyond CYP2C8*3 does not explain differential sensitivity to paclitaxel-induced neuropathy

artículo científico publicado en 2014

Genotype-guided tamoxifen dosing increases active metabolite exposure in women with reduced CYP2D6 metabolism: a multicenter study

artículo científico publicado en 2011

High-resolution axillary ultrasound is a poor prognostic test for determining pathologic lymph node status in patients undergoing neoadjuvant chemotherapy for locally advanced breast cancer

artículo científico publicado en 2004

INNV-35. ROUTINE SEQUENCING OF BRAIN TUMORS UNCOVERS HIGH RATES OF ACTIONABLE OPPORTUNITIES: THE UNC EXPERIENCE

artículo científico publicado en 2018

Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans.

artículo científico publicado en 2008

Impact of Breast Cancer Molecular Subtypes on Locoregional Recurrence in Patients Treated with Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer ⬇️

artículo científico publicado el 26 de marzo de 2011

Improving Endocrine Therapy for Breast Cancer: It's Not That Simple ⬇️

artículo científico publicado el 10 de diciembre de 2012

Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials.

artículo científico publicado en 2017

LCCC 1025: a phase II study of everolimus, trastuzumab, and vinorelbine to treat progressive HER2-positive breast cancer brain metastases

scientific article published on 25 June 2018

Measuring and understanding adherence in a home-based exercise intervention during chemotherapy for early breast cancer

artículo científico publicado en 2017

Nanoparticle-Delivered Chemotherapy: Old Drugs in New Packages

artículo científico publicado en 2017

Ovarian ablation as adjuvant therapy for breast cancer

artículo científico publicado en 2001

Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx

scientific article published on 09 April 2020

Patient-Reported Toxicities During Chemotherapy Regimens in Current Clinical Practice for Early Breast Cancer

scientific article published on 14 December 2018

Patient-reported and clinician-reported chemotherapy-induced peripheral neuropathy in patients with early breast cancer: Current clinical practice

scientific article published on 15 May 2019

Patient-reported symptom severity, interference with daily activities, and adverse events in older and younger women receiving chemotherapy for early breast cancer

artículo científico publicado en 2020

Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study.

artículo científico

Perceptions and management approaches of physicians who care for women with ductal carcinoma in situ

scientific article published on 01 June 2008

Pharmacogenomics, Pharmacokinetics, and Pharmacodynamics in the Era of Targeted Therapies

artículo científico publicado en 2016

Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors

artículo científico publicado en 2010

Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies

artículo científico publicado en 2004

Phase I Clinical Trials in Acute Myeloid Leukemia: 23-Year Experience From Cancer Therapy Evaluation Program of the National Cancer Institute

artículo científico publicado en 2015

Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations ⬇️

artículo científico publicado el 5 de julio de 2012

Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301

artículo científico publicado en 2009

Phase I and pharmacokinetic trial of carboplatin and albumin-bound paclitaxel, ABI-007 (Abraxane®) on three treatment schedules in patients with solid tumors

artículo científico publicado en 2007

Phase I assessment of new mechanism-based pharmacodynamic biomarkers for MLN8054, a small-molecule inhibitor of Aurora A kinase

artículo científico publicado en 2010

Phase I dose-escalation study of LCL161, an oral inhibitor of apoptosis proteins inhibitor, in patients with advanced solid tumors

artículo científico publicado en 2014

Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas

artículo científico publicado en 2005

Phase I study and biomarker analysis of lapatinib and concurrent radiation for locally advanced breast cancer.

artículo científico publicado en 2012

Phase I study of the gamma secretase inhibitor PF-03084014 in combination with docetaxel in patients with advanced triple-negative breast cancer

artículo científico publicado en 2016

Phase I trial of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with thoracic malignancies

artículo científico publicado en 2008

Phase I trial of vinflunine and pemetrexed in refractory solid tumors

artículo científico publicado en 2009

Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomogr

artículo científico publicado en 2015

Phase II open-label study of sunitinib in patients with advanced breast cancer ⬇️

artículo científico publicado el 17 de octubre de 2012

Phase II study of bortezomib and pegylated liposomal doxorubicin in the treatment of metastatic breast cancer

artículo científico publicado en 2010

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer

scientific article published on 22 August 2006

Phase II trial of capecitabine and weekly paclitaxel in patients with metastatic breast cancer previously treated with every-3-week taxane therapy

artículo científico publicado en 2007

Phase III randomized trial of bisphosphonates as adjuvant therapy in breast cancer: S0307

scientific article published on 31 October 2019

Pilot study of rosiglitazone as an in vivo probe of paclitaxel exposure ⬇️

artículo científico publicado el 1 de julio de 2012

Prospective Validation of a 21-Gene Expression Assay in Breast Cancer

artículo científico publicado en 2015

Quantifying the recruitment challenges with couple-based interventions for cancer: applications to early-stage breast cancer.

artículo científico publicado en 2009

Race, ethnicity and clinical outcomes in hormone receptor-positive, HER2-negative, node-negative breast cancer in the randomized TAILORx trial

artículo científico publicado en 2020

Ramucirumab With Eribulin Versus Eribulin in Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy: A Multicenter, Randomized, Phase II Study.

artículo científico publicado en 2016

Recent advances in systemic therapy for breast cancer

scientific article published on 01 November 1998

Response and cardiac toxicity of trastuzumab given in conjunction with weekly paclitaxel after doxorubicin/cyclophosphamide

artículo científico publicado en 2006

Retention and use of breast cancer recurrence risk information from genomic tests: the role of health literacy.

artículo científico publicado en 2007

Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307)

scientific article published on 15 September 2020

Risk perceptions and psychosocial outcomes of women with ductal carcinoma in situ: longitudinal results from a cohort study

artículo científico publicado en 2008

Role of cytochrome P450 phenotyping in cancer treatment

artículo científico publicado en 2005

Safety and activity of alisertib, an investigational aurora kinase A inhibitor, in patients with breast cancer, small-cell lung cancer, non-small-cell lung cancer, head and neck squamous-cell carcinoma, and gastro-oesophageal adenocarcinoma: a five-

artículo científico publicado en 2015

Size of residual lymph node metastasis after neoadjuvant chemotherapy in locally advanced breast cancer patients is prognostic

artículo científico publicado en 2006

Study of the biologic effects of lapatinib, a reversible inhibitor of ErbB1 and ErbB2 tyrosine kinases, on tumor growth and survival pathways in patients with advanced malignancies

artículo científico publicado en 2005

Targeting the ubiquitin-proteasome pathway in breast cancer therapy

artículo científico publicado en 2006

Taxane Doublets for Metastatic Breast Cancer: Do We Need Another Cytotoxic Pair or Another Approach? ⬇️

artículo científico publicado el 14 de noviembre de 2011

The effect of aprepitant and race on the pharmacokinetics of cyclophosphamide in breast cancer patients ⬇️

artículo científico publicado el 15 de enero de 2012

The effects of lapatinib on CYP3A metabolism of midazolam in patients with advanced cancer

artículo científico publicado en 2017

The incidence and predictive factors for leptomeningeal spread after stereotactic radiation for breast cancer brain metastases

artículo científico publicado en 2017

The influence of CYP3A5 expression on the extent of hepatic CYP3A inhibition is substrate-dependent: an in vitro-in vivo evaluation

artículo científico publicado en 2007

The interaction of post-traumatic growth and post-traumatic stress symptoms in predicting depressive symptoms and quality of life

artículo científico publicado en 2008

The product of the H19 gene may function as an RNA ⬇️

artículo científico publicado el 1 de enero de 1990

The proteasome as a target for cancer therapy.

artículo científico publicado en 2003

The role of the ubiquitination-proteasome pathway in breast cancer: applying drugs that affect the ubiquitin-proteasome pathway to the therapy of breast cancer

artículo científico publicado en 2003

The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes

artículo científico publicado en 2007

The warfarin-cranberry juice interaction revisited: A systematic in vitro-in vivo evaluation

artículo científico publicado en 2010

Women's interest in gene expression analysis for breast cancer recurrence risk.

artículo científico publicado en 2007

Lista de obras de E Claire Dees

A Multidisciplinary Breast Cancer Brain Metastases Clinic: The University of North Carolina Experience

A Phase I Trial of the PI3K Inhibitor Buparlisib Combined With Capecitabine in Patients With Metastatic Breast Cancer

A Phase I study of bortezomib plus irinotecan in patients with advanced solid tumors

A Phase I study of the oral antimetabolite, CS-682, administered once daily 5 days per week in patients with refractory solid tumor malignancies

A first in man phase I trial of the oral immunomodulator, indoximod, combined with docetaxel in patients with metastatic solid tumors

A phase I and pharmacokinetic study of short infusions of UCN-01 in patients with refractory solid tumors

A phase I and pharmacologic evaluation of the DNA intercalator CI-958 in patients with advanced solid tumors

A phase I and pharmacologic study of pyrazoloacridine and cisplatin in patients with advanced cancer

A phase I and pharmacologic study of the combination of bortezomib and pegylated liposomal doxorubicin in patients with refractory solid tumors

A phase I evaluation of the combination of vinflunine and erlotinib in patients with refractory solid tumors

A phase I trial of everolimus in combination with 5-FU/LV, mFOLFOX6 and mFOLFOX6 plus panitumumab in patients with refractory solid tumors

A phase I trial of sorafenib combined with cisplatin/etoposide or carboplatin/pemetrexed in refractory solid tumor patients

A prospective pharmacologic evaluation of age-related toxicity of adjuvant chemotherapy in women with breast cancer

Abstract PD07-10: Breast Cancer Patients Carrying the CYP2C8*3 Variant Are More Likely To Achieve Clinical Complete Response from Neoadjuvant Paclitaxel Treatment

Abstract PD10-07: Patients carrying CYP2C8*3 are at increased risk of paclitaxel-induced neuropathy

Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

American Joint Committee on Cancer tumor-node-metastasis stage after neoadjuvant chemotherapy and breast cancer outcome

Aurora A Functional Single Nucleotide Polymorphism (SNP) Correlates With Clinical Outcome in Patients With Advanced Solid Tumors Treated With Alisertib, an Investigational Aurora A Kinase Inhibitor

Axillary lymph node count is lower after neoadjuvant chemotherapy

CYP2C8*3 increases risk of neuropathy in breast cancer patients treated with paclitaxel

CYP2C8*3 predicts benefit/risk profile in breast cancer patients receiving neoadjuvant paclitaxel

Central nervous system metastases in women after multimodality therapy for high risk breast cancer

Changing Natural History of HER2-Positive Breast Cancer Metastatic to the Brain in the Era of New Targeted Therapies

Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial

Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer

Clinical evaluation of germline polymorphisms associated with capecitabine toxicity in breast cancer: TBCRC-015

Concomitant pregnancy and breast cancer: options for systemic therapy.

Congruence of patient- and clinician-reported toxicity in women receiving chemotherapy for early breast cancer

Correction to: Measuring and understanding adherence in a home-based exercise intervention during chemotherapy for early breast cancer

Delivery of a healthy baby after first-trimester maternal exposure to lapatinib

Dendritic cells can be rapidly expanded ex vivo and safely administered in patients with metastatic breast cancer

Does information from axillary dissection change treatment in clinically node-negative patients with breast cancer? An algorithm for assessment of impact of axillary dissection

Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer

Effects of Breast Cancer Adjuvant Chemotherapy Regimens on Expression of the Aging Biomarker, <i>p16<sup>INK4a</sup></i>

Extended follow-up of outcome measures in multiple myeloma patients treated on a phase I study with bortezomib and pegylated liposomal doxorubicin

First-in-Human Phase I Study of GSK2126458, an Oral Pan-Class I Phosphatidylinositol-3-Kinase Inhibitor, in Patients with Advanced Solid Tumor Malignancies

Genetic heterogeneity beyond CYP2C8*3 does not explain differential sensitivity to paclitaxel-induced neuropathy

Genotype-guided tamoxifen dosing increases active metabolite exposure in women with reduced CYP2D6 metabolism: a multicenter study

High-resolution axillary ultrasound is a poor prognostic test for determining pathologic lymph node status in patients undergoing neoadjuvant chemotherapy for locally advanced breast cancer

INNV-35. ROUTINE SEQUENCING OF BRAIN TUMORS UNCOVERS HIGH RATES OF ACTIONABLE OPPORTUNITIES: THE UNC EXPERIENCE

Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans.

Impact of Breast Cancer Molecular Subtypes on Locoregional Recurrence in Patients Treated with Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer ⬇️

Improving Endocrine Therapy for Breast Cancer: It's Not That Simple ⬇️

Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials.

LCCC 1025: a phase II study of everolimus, trastuzumab, and vinorelbine to treat progressive HER2-positive breast cancer brain metastases

Measuring and understanding adherence in a home-based exercise intervention during chemotherapy for early breast cancer

Nanoparticle-Delivered Chemotherapy: Old Drugs in New Packages

Ovarian ablation as adjuvant therapy for breast cancer

Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx

Patient-Reported Toxicities During Chemotherapy Regimens in Current Clinical Practice for Early Breast Cancer

Patient-reported and clinician-reported chemotherapy-induced peripheral neuropathy in patients with early breast cancer: Current clinical practice

Patient-reported symptom severity, interference with daily activities, and adverse events in older and younger women receiving chemotherapy for early breast cancer

Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study.

Perceptions and management approaches of physicians who care for women with ductal carcinoma in situ

Pharmacogenomics, Pharmacokinetics, and Pharmacodynamics in the Era of Targeted Therapies

Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors

Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies

Phase I Clinical Trials in Acute Myeloid Leukemia: 23-Year Experience From Cancer Therapy Evaluation Program of the National Cancer Institute

Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations ⬇️

Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301

Phase I and pharmacokinetic trial of carboplatin and albumin-bound paclitaxel, ABI-007 (Abraxane®) on three treatment schedules in patients with solid tumors

Phase I assessment of new mechanism-based pharmacodynamic biomarkers for MLN8054, a small-molecule inhibitor of Aurora A kinase

Phase I dose-escalation study of LCL161, an oral inhibitor of apoptosis proteins inhibitor, in patients with advanced solid tumors

Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas

Phase I study and biomarker analysis of lapatinib and concurrent radiation for locally advanced breast cancer.

Phase I study of the gamma secretase inhibitor PF-03084014 in combination with docetaxel in patients with advanced triple-negative breast cancer

Phase I trial of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with thoracic malignancies

Phase I trial of vinflunine and pemetrexed in refractory solid tumors

Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomogr

Phase II open-label study of sunitinib in patients with advanced breast cancer ⬇️

Phase II study of bortezomib and pegylated liposomal doxorubicin in the treatment of metastatic breast cancer

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer

Phase II trial of capecitabine and weekly paclitaxel in patients with metastatic breast cancer previously treated with every-3-week taxane therapy

Phase III randomized trial of bisphosphonates as adjuvant therapy in breast cancer: S0307

Pilot study of rosiglitazone as an in vivo probe of paclitaxel exposure ⬇️

Prospective Validation of a 21-Gene Expression Assay in Breast Cancer

Quantifying the recruitment challenges with couple-based interventions for cancer: applications to early-stage breast cancer.

Race, ethnicity and clinical outcomes in hormone receptor-positive, HER2-negative, node-negative breast cancer in the randomized TAILORx trial

Ramucirumab With Eribulin Versus Eribulin in Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy: A Multicenter, Randomized, Phase II Study.