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Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo (for Alirocumab)

Alirocumab

Lipid-Modifying Therapy (LMT)

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3).

Exclusion criteria:

Aged <18 years or legal age of adulthood, whichever was greater.
Participants without established CHD or CHD risk equivalent.
LDL-C <70 mg/dL (<1.81 mmol/L) in participants with a history of documented cardiovascular disease.
LDL-C <100 mg/dL (<2.59 mmol/L) in participants without a history of documented cardiovascular disease.
Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits.
Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin.
Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose.
Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg.
Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening period.

The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Placebo Q2W

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Arm Description

Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.

Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

Secondary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apo B at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Total-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis

Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.

Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis

Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis

Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Full Information

NCT ID

NCT02289963

First Posted

November 10, 2014

Last Updated

June 22, 2017

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02289963

Brief Title

Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy in South Korea and Taiwan

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan. Secondary Objectives: To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1). To evaluate the safety and tolerability of alirocumab. To evaluate the development of anti-alirocumab antibodies (ADA).

Detailed Description

The maximum study duration was approximately 35 weeks per participant, including up to 3 weeks screening period, 24 weeks double-blind treatment period, and 8 weeks follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

199 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Q2W

Arm Type

Placebo Comparator

Arm Description

Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.

Arm Title

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Arm Type

Placebo Comparator

Arm Description

Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Intervention Type

Drug

Intervention Name(s)

Placebo (for Alirocumab)

Intervention Description

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Intervention Type

Drug

Intervention Name(s)

Alirocumab

Other Intervention Name(s)

SAR236553, REGN727, Praluent®

Intervention Description

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Intervention Type

Drug

Intervention Name(s)

Lipid-Modifying Therapy (LMT)

Intervention Description

Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

Description

Time Frame

From Baseline to Week 24

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apo B at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Total-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis

Description

Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3). Exclusion criteria: Aged <18 years or legal age of adulthood, whichever was greater. Participants without established CHD or CHD risk equivalent. LDL-C <70 mg/dL (<1.81 mmol/L) in participants with a history of documented cardiovascular disease. LDL-C <100 mg/dL (<2.59 mmol/L) in participants without a history of documented cardiovascular disease. Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits. Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin. Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose. Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg. Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening period. The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 410009

City

Anyang-Si

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Investigational Site Number 410001

City

Anyang

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Investigational Site Number 410017

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

Investigational Site Number 410007

City

Busan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

Investigational Site Number 410002

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

Facility Name

Investigational Site Number 410011

City

Goyang-Si

ZIP/Postal Code

410-773

Country

Korea, Republic of

Facility Name

Investigational Site Number 410003

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

Investigational Site Number 410012

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Investigational Site Number 410018

City

Jeonju-Si

ZIP/Postal Code

561-712

Country

Korea, Republic of

Facility Name

Investigational Site Number 410006

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Investigational Site Number 410004

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

Investigational Site Number 410015

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Investigational Site Number 410008

City

Seoul

ZIP/Postal Code

110-746

Country

Korea, Republic of

Facility Name

Investigational Site Number 410005

City

Seoul

ZIP/Postal Code

134-727

Country

Korea, Republic of

Facility Name

Investigational Site Number 410010

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Investigational Site Number 410013

City

Ulsan

Country

Korea, Republic of

Facility Name

Investigational Site Number 158007

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Investigational Site Number 158005

City

Hsinchu

ZIP/Postal Code

30071

Country

Taiwan

Facility Name

Investigational Site Number 158011

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Investigational Site Number 158010

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Investigational Site Number 158006

City

Taichung

Country

Taiwan

Facility Name

Investigational Site Number 158009

City

Tainan Hsien

ZIP/Postal Code

710

Country

Taiwan

Facility Name

Investigational Site Number 158008

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Investigational Site Number 158001

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Investigational Site Number 158003

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Facility Name

Investigational Site Number 158002

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Investigational Site Number 158004

City

Taoyuan Hsien

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

33078867

Citation

Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

Results Reference

derived

PubMed Identifier

30946207

Citation

Chao TH, Hsiao PJ, Liu ME, Wu CJ, Chiang FT, Chen ZC, Chen CP, Yeh HI, Lee TH, Chiang CE. A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab. J Chin Med Assoc. 2019 Apr;82(4):265-271. doi: 10.1097/JCMA.0000000000000062.

Results Reference

derived

PubMed Identifier

29153823

Citation

Koh KK, Nam CW, Chao TH, Liu ME, Wu CJ, Kim DS, Kim CJ, Li I, Li J, Baccara-Dinet MT, Hsiao PJ, Chiang CE. A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT). J Clin Lipidol. 2018 Jan-Feb;12(1):162-172.e6. doi: 10.1016/j.jacl.2017.09.007. Epub 2017 Oct 19.

Results Reference

derived

Learn more about this trial

Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

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Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial