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Completed

NCT Number: NCT01729754

A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)

This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of participants achieving >= Psoriasis Area Sensitivity Index of 75% (PASI-75) response and the proportion of participants with a Physician's Global Assessment (PGA) score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 12.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 52 weeks, and a 20-week follow-up period. The base study treatment period is divided into 3 sequential parts.

In Part 1 of the base study (Week 0 to Week 12), participants will be randomized to one of 4 study arms (Arm A: tildrakizumab 200 mg + matching placebo to etanercept; Arm B: tildrakizumab 100 mg + matching placebo to etanercept; Arm C: matching placebo to tildrakizumab + matching placebo to etanercept; Arm D: matching placebo to tildrakizumab + etanercept 50 mg).

In Part 2 of the base study (Week 12 to Week 28), participants in Arm A and Arm B will receive matching placebo to tildrakizumab to maintain blinding at Week 12 and will receive either tildrakizumab 200 mg (Arm A) or tildrakizumab 100 mg (Arm B) at Weeks 12 and 16. Participants in Arm A and Arm B will also receive matching placebo to etanercept once weekly through study Week 28. At study Week 12, Arm C participants will be re-randomized to receive their first dose of tildrakizumab 200 mg or tildrakizumab 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16. Participants in Arm C will also receive matching placebo to etanercept through treatment Week 28. Participants in Arm D will continue with once weekly doses of etanercept through study Week 28 in combination with matching placebo to tildrakizumab.

In Part 3 of the base study (Week 28 to Week 52), participants in Arm A with >= PASI-75 response at Week 28 will be re-randomized to either continue tildrakizumab 200 mg or receive tildrakizumab 100 mg at study Weeks 28, 40, and 52. Participants with >= PASI-50 response but < PASI-75 response will continue to receive tildrakizumab 200 mg every 12 weeks and those participants with < PASI-50 response will be discontinued from the study. Participants in Arm B with >= PASI-75 response at Week 28 will continue to receive tildrakizumab 100 mg every 12 weeks. Those with >= PASI-50 response but < PASI-75 response will be re-randomized to receive continued tildrakizumab 100 mg or tildrakizumab 200 mg every 12 weeks. Participants in Arm B with < PASI-50 response will be discontinued from the study. Participants in Arm C will continue to receive treatment every 12 weeks according to their re-randomized treatment assignment. Participants in Arm D that achieve >= PASI-75 response at Week 28 will be discontinued from the study. Those participants with < PASI-75 response at Week 28 will be crossed over to tildrakizumab 200 mg to receive doses at Weeks 32, 36 and 48.

Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be monitored for an additional 20 weeks in the follow-up period. Each participant will receive tildrakizumab 200 mg or tildrakizumab 100 mg every 12 weeks up to study Week 244 according to their treatment assignment at the conclusion of Part 3 of the base study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to enrollment;
  • Candidate for phototherapy or systemic therapy;
  • Premenopausal female participants must agree to abstain from heterosexual activity or use a medically approved method of contraception or use appropriate effective contraception as per local regulations or guidelines
  • For the extension study: must have completed Part 3 of the base study
  • For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study

Exclusion criteria

  • Non-plaque forms of psoriasis
  • Presence or history of severe psoriatic arthritis and is well-controlled on current treatment regimen
  • Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
  • Participant is expected to require topical therapy, phototherapy, or systemic therapy during the trial
  • Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
  • Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17 antagonists
  • Latex allergy or sensitivity
  • Active or untreated latent tuberculosis (TB)
  • For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or are breast feeding
  • For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
  • For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study

Treatment and study plan

Tildrakizumab 200 mg

Drug

Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.

Other names: SCH 900222, MK-3222

Tildrakizumab 100 mg

Drug

Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.

Other names: SCH 900222, MK-3222

Tildrakizumab Placebo

Drug

Matching placebo to tildrakizumab administered SC

Etanercept Placebo

Drug

Matching placebo to etanercept administered SC

Etanercept 50 mg

Drug

Etanercept 50 mg administered SC

Other names: Embrel

Primary outcomes

  1. Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)

    Time frame: Week 12

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.

  2. Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)

    Time frame: Week 12

    The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.

  3. Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)

    Time frame: Up to Week 12

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  4. Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)

    Time frame: Up to Week 12

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)

    Time frame: Week 28

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.

  2. Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)

    Time frame: Week 40

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  3. Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)

    Time frame: Week 52

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  4. Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)

    Time frame: Week 28

    The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.

  5. Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)

    Time frame: Week 40

    The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  6. Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)

    Time frame: Week 52

    The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  7. Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)

    Time frame: Week 12

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.

  8. Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)

    Time frame: Week 28

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.

  9. Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)

    Time frame: Week 40

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  10. Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)

    Time frame: Week 52

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  11. Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)

    Time frame: Week 12

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.

  12. Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)

    Time frame: Week 28

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.

  13. Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)

    Time frame: Week 40

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  14. Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)

    Time frame: Week 52

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  15. Baseline Dermatology Life Quality Index (DLQI)

    Time frame: Baseline

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

  16. Change From Baseline in the DLQI at Week 12 (Part 1)

    Time frame: Baseline and Week 12

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

  17. Change From Baseline in the DLQI at Week 28 (Part 2)

    Time frame: Baseline and Week 28

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

  18. Change From Baseline in the DLQI at Week 40 (Part 3)

    Time frame: Baseline and Week 40

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  19. Change From Baseline in the DLQI at Week 52 (Part 3)

    Time frame: Baseline and Week 52

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  20. Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)

    Time frame: Week 12

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

  21. Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)

    Time frame: Week 28

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

  22. Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)

    Time frame: Week 40

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  23. Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)

    Time frame: Week 52

    The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  24. Mean Change From Baseline in PASI Score Over Time (Part 1)

    Time frame: Baseline and Week 4, Week 8 or Week 12

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.

  25. Mean Change From Baseline in PASI Score Over Time (Part 2)

    Time frame: Baseline and Week 16, Week 22 or Week 28

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.

  26. Mean Change From Baseline in PASI Score Over Time (Part 3)

    Time frame: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

  27. Mean Percent Change From Baseline in PASI Score Over Time (Part 1)

    Time frame: Baseline and Week 4, Week 8 or Week 12

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.

  28. Mean Percent Change From Baseline in PASI Score Over Time (Part 2)

    Time frame: Baseline and Week 16, Week 22 or Week 28

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.

  29. Mean Percent Change From Baseline in PASI Score Over Time (Part 3)

    Time frame: Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52

    The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)

Acronym: reSURFACE 2

Important dates

Study start
2013
Primary completion
2015
Study completion
2021
First posted
Nov 20, 2012
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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