(mo)BETTA Trial in Transwomen for Optimization of ART ((mo)BETTA)

September 1, 2022 updated by: Jordan Elizabeth Lake, The University of Texas Health Science Center, Houston

Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial

The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77009
        • Thomas Street Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Self-identified transgender woman (TW)
  • HIV infection
  • Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks prior to entry.
  • Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.
  • No changes in ART in the 12 weeks prior to screening.
  • Current female hormone therapy use.
  • Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

  • Current or planned use of prohibited medications (Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea, Dofetilide, Cisapride, Atazanavir)
  • Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period.
  • Current use of androgen therapy.
  • Intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period.
  • Anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period.
  • Screening laboratory values as follows: (ANC <500 cells/mm^3; Hemoglobin <10 gm/dL; Cr Cl <30 mL/min (estimated by CKD-Epi equation); AST or ALT >3x ULN)
  • Evidence of resistance to any component of the current ART regimen (genotypic or phenotypic)
  • Current use of bictegravir in another investigational setting
  • Current use of other investigational agents that the participant could not receive unchanged, if needed, throughout the study period (unless approved by the study team)
  • Any condition that the study investigator believes would make the candidate unsuitable for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Switch ART
Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks
Drug: B/FTC/TAF
B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
Active Comparator: Continue Current ART
Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks.
Drug: Current ART
Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of Maintaining Undetectable HIV-1 RNA
Time Frame: 48 weeks
Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks
48 weeks
Frequency of Adverse Events
Time Frame: 48 weeks
Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events)
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fat Mass, Total
Time Frame: Baseline
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Fat Mass, Total
Time Frame: 48 weeks
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Fat Mass, Trunk
Time Frame: Baseline
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Fat Mass, Trunk
Time Frame: 48 weeks
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Fat Mass, Limbs
Time Frame: baseline
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
baseline
Fat Mass, Limbs
Time Frame: 48 weeks
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Percentage of Fat Mass (Total)
Time Frame: Baseline
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Percentage of Fat Mass (Total)
Time Frame: 48 weeks
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Percentage of Fat Mass (Trunk)
Time Frame: Baseline
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Percentage of Fat Mass (Trunk)
Time Frame: 48 weeks
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Percentage of Fat Mass (Limbs)
Time Frame: Baseline
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Percentage of Fat Mass (Limbs)
Time Frame: 48 weeks
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Lean Mass (Total)
Time Frame: Baseline
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Lean Mass (Limb)
Time Frame: Baseline
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Baseline
Lean Mass (Total)
Time Frame: 48 weeks
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Lean Mass (Limb)
Time Frame: 48 weeks
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
48 weeks
Hepatic Fat Content
Time Frame: Baseline
The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.
Baseline
Hepatic Fat Content
Time Frame: 48 weeks
The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.
48 weeks
Total Cholesterol
Time Frame: Baseline
Total cholesterol level
Baseline
Total Cholesterol
Time Frame: 48 weeks
Total cholesterol level
48 weeks
High-density Lipoprotein (HDL) Cholesterol Level
Time Frame: Baseline
Baseline
High-density Lipoprotein (HDL) Cholesterol Level
Time Frame: 48 weeks
48 weeks
Triglycerides
Time Frame: Baseline
Triglyceride level
Baseline
Triglycerides
Time Frame: 48 weeks
Triglyceride level
48 weeks
Low-density Lipoprotein (LDL) Cholesterol Level
Time Frame: Baseline
Baseline
Low-density Lipoprotein (LDL) Cholesterol Level
Time Frame: 48 weeks
48 weeks
Fasting Glucose Level
Time Frame: Baseline
Fasting Glucose level
Baseline
Fasting Glucose Level
Time Frame: 48 weeks
Fasting Glucose level
48 weeks
Insulin Resistance
Time Frame: Baseline
The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).
Baseline
Insulin Resistance
Time Frame: 48 weeks
The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).
48 weeks
Oxidized Low-density Lipoprotein (LDL) Level
Time Frame: Baseline
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Baseline
Oxidized Low-density Lipoprotein (LDL) Level
Time Frame: 48 weeks
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
48 weeks
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Time Frame: Baseline
Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness
Baseline
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Time Frame: 48 weeks
Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness
48 weeks
Aspartate Aminotransferase (AST) Level
Time Frame: Baseline
Baseline
Aspartate Aminotransferase (AST) Level
Time Frame: 48 weeks
48 weeks
Alanine Transaminase (ALT) Level
Time Frame: Baseline
Baseline
Alanine Transaminase (ALT) Level
Time Frame: 48 weeks
48 weeks
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
Time Frame: Baseline
glomerular filtration rate (GFR) level
Baseline
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
Time Frame: 48 weeks
glomerular filtration rate (GFR) level
48 weeks
Level of Adiponectin
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Adiponectin
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Endothelin-1
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Endothelin-1
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Insulin
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Insulin
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of D-dimer
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of D-dimer
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Tissue Factor
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Tissue Factor
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Soluble CD14 (sCD14)
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Soluble CD14 (sCD14)
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Level of Plasminogen Activator Inhibitor (PAI-1)
Time Frame: Baseline
Inflammatory and metabolic biomarkers level
Baseline
Level of Plasminogen Activator Inhibitor (PAI-1)
Time Frame: 48 weeks
Inflammatory and metabolic biomarkers level
48 weeks
Bone Mineral Density (BMD), Femur Total Mean
Time Frame: Baseline
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Baseline
Bone Mineral Density (BMD), Femur Total Mean
Time Frame: 48 weeks
BMD as measured by dual-energy x-ray absorptiometry (DXA)
48 weeks
Bone Mineral Density (BMD), AP-spine L1-L4
Time Frame: Baseline
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Baseline
Bone Mineral Density (BMD), AP-spine L1-L4
Time Frame: 48 weeks
BMD as measured by dual-energy x-ray absorptiometry (DXA)
48 weeks
T-Score AP-spine L1-L4
Time Frame: Baseline

Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Baseline
T-Score AP-spine L1-L4
Time Frame: 48 weeks

Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
48 weeks
T-Score Total Body
Time Frame: Baseline

Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Baseline
T-Score Total Body
Time Frame: 48 weeks

Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
48 weeks
Bone Mineral Density (BMD), Total Body
Time Frame: Baseline
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Baseline
T-Score Femur Total Mean
Time Frame: Baseline

Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Baseline
T-Score Femur Total Mean
Time Frame: 48 weeks

Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
48 weeks
T-Score Femur Neck Mean
Time Frame: Baseline

Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Baseline
T-Score Femur Neck Mean
Time Frame: 48 weeks

Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)

A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
48 weeks
Bone Mineral Density (BMD), Femur Neck Mean
Time Frame: 48 weeks
BMD as measured by dual-energy x-ray absorptiometry (DXA)
48 weeks
Bone Mineral Density (BMD), Femur Neck Mean
Time Frame: Baseline
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Baseline
Bone Mineral Density (BMD), Total Body
Time Frame: 48 weeks
BMD as measured by dual-energy x-ray absorptiometry (DXA)
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordan E Lake, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-17-0480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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