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CompletedNCT06362759TRANQUILITYUpdated Aug 11, 2026Results posted

A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP

A Phase 2 interventional study of TOUR006 - 50 MG and TOUR006 - 25 MG in Chronic Kidney Diseases, Chronic Kidney Insufficiency and Chronic Renal Diseases, sponsored by Tourmaline Bio, Inc., a Novartis Company. Completed at 38 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Tourmaline Bio, Inc., a Novartis Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 (also known as pacibekitug) in participants with chronic kidney disease and elevated hs-CRP.

Read the detailed description

Previous clinical studies have suggested that IL-6-driven inflammation plays a key role in the pathogenesis of cardiovascular diseases including atherosclerotic cardiovascular disease (ASCVD) and heart failure. This Phase 2 study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006, a fully human monoclonal antibody against IL-6. TOUR006 binds the IL-6 cytokine and inhibits downstream IL-6 signaling, thereby reducing the pharmacodynamic marker, hs-CRP.

02

Conditions studied

  • Chronic Kidney Diseases
  • Chronic Kidney Insufficiency
  • Chronic Renal Diseases
  • Chronic Renal Insufficiency
  • Kidney Insufficiency, Chronic
  • C-Reactive Protein
  • High Sensitivity C-Reactive Protein
  • Hs-CRP
  • hsCRP

Keywords

  • Interleukin-6
  • IL-6
  • IL6
  • Interleukin-6 Inhibitors
  • Anti-interleukin-6 Agents
  • Anti-inflammatory Agents
  • Antiinflammatory Agent
  • Antiinflammatory Agents
  • Agents, Antiinflammatory
  • Anti-inflammatory Agent
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 143 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Tourmaline Bio, Inc., a Novartis Company is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥18 years at time of ICF signature.
  • Serum hs-CRP level ≥2.0 mg/L and \<15 mg/L
  • Diagnosis of chronic kidney disease, eGFR ≥15 and \<60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR>200 mg/g
  • Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.
  • Agreement to comply with contraception and reproduction restrictions

Exclusion criteria

Exclusion Criteria:

  • Clinical evidence or suspicion of active infection
  • Current or recent COVID-19 infection within 30 days
  • Serious infection within 6 months or more than 1 such episode within 18 months
  • Any history of a serious opportunistic infection within 18 months
  • Known history of immunodeficiency
  • History of gastrointestinal ulceration or perforation within 12 months
  • History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
  • History of GI bleeding requiring hospitalization and/or transfusion within 6 months
  • New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months
  • Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
143 participants (actual)

Study arms

  • Experimental
    TOUR006 - 50 MG

    50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

    Drug: TOUR006 - 50 MG

  • Experimental
    TOUR006 - 25 MG

    25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

    Drug: TOUR006 - 25 MG

  • Experimental
    TOUR006 - 15 MG

    15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150

    Drug: TOUR006 - 15 MG

  • Placebo comparator
    Placebo

    Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150

    Other: Placebo

Interventions

  • DrugTOUR006 - 50 MG

    TOUR006 50 MG

    Also known as: Pacibekitug 50 MG

  • DrugTOUR006 - 25 MG

    TOUR006 25 MG

    Also known as: Pacibekitug 25 MG

  • DrugTOUR006 - 15 MG

    TOUR006 15 MG

    Also known as: Pacibekitug 15 MG

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90

    Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.

    Time frame: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

Secondary outcomes

  1. Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)

    Proportion of participants with time-averaged hs-CRP \< 2 mg/L (90 Days)

    Time frame: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

  2. Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180

    Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 180. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 180 visits (approximately 150 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.

    Time frame: Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

  3. Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006

    Mean trough serum concentrations (ng/mL) of TOUR006 at Days 30, 60, 90,120, 150, 180, 240, 300, and 365. On dosing visits (BL and Day 30, 60, 90, 120, and 150 visits), PK samples were collected pre-dose. PK blood samples were collected on Study Days 180, 240, 300, and 365 at approximately the same time as the pre-dose samples were collected on previous dosing visits.

    Time frame: Baseline through Day 365

  4. Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD

    Evaluates the percentage of participants with treatment emergent adverse events (AE), which includes serious and nonserious AEs. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.

    Time frame: Baseline through Day 365.

  5. Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD

    Evaluates the percentage of participants with serious treatment emergent adverse events. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.

    Time frame: Baseline through Day 365.

07

Results

Posted Aug 11, 2026

Participant flow

Participants were recruited from 49 study centers in the United States between May 2024 and December 2024. Of 49 sites, 38 sites enrolled participants. The first participant was enrolled on May 15, 2024 and the last participant was enrolled on December 3, 2024.

Participant flow — Overall Study
MilestonePlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Started36353636
Dosed36353535
Completed33332932
Not completed3274
Withdrew: Withdrawal by subject2044
Withdrew: Death0110
Withdrew: Adverse event0010
Withdrew: Non-compliance1000
Withdrew: Lost to follow-up0100
Withdrew: Eligibility violation0010

Outcome measures

PrimaryTime-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90

Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.

Time frame:
Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Reported as:
Median · Time-Averaged Percent Change in hsCRP
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90
Time-Averaged Percent Change in hsCRPPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90-14.8 (-35.8 to 17.4)-75.2 (-82.3 to -69.7)-85.7 (-92.3 to -78.0)-84.7 (-92.3 to -70.3)
Statistical analysis
  • Placebo vs TOUR006 - 25 MG · Quantile Regression · p = <0.0001 · Median difference (net): -59.817 · 95% CI -79.690 to -39.943
  • Placebo vs TOUR006 - 50 MG · Quantile Regression · p = <0.0001 · Median difference (net): -70.155 · 95% CI -90.188 to -50.122
  • Placebo vs TOUR006 - 15 MG · Quantile Regression · p = <0.0001 · Mean difference (net): -68.627 · 95% CI -88.765 to -48.489
SecondaryProportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)

Proportion of participants with time-averaged hs-CRP \< 2 mg/L (90 Days)

Time frame:
Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Reported as:
Count of participants · Participants
Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)
ParticipantsPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)8252430
Statistical analysis
  • Placebo vs TOUR006 - 25 MG · Cochran-Mantel-Haenszel · p = <0.0001
  • Placebo vs TOUR006 - 50 MG · Cochran-Mantel-Haenszel · p = <0.0001
  • Placebo vs TOUR006 - 15 MG · Cochran-Mantel-Haenszel · p = <0.0001
SecondaryTime-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180

Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 180. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 180 visits (approximately 150 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.

Time frame:
Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Reported as:
Median · Time-averaged percent change in hsCRP
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180
Time-averaged percent change in hsCRPPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 1806.8 (-27.2 to 51.9)-76.4 (-82.1 to -65.9)-85.3 (-93.1 to -72.2)-88.8 (-91.9 to -72.8)
Statistical analysis
  • Placebo vs TOUR006 - 25 MG · Quantile Regression · p = <0.0001 · Median difference (net): -82.985 · 95% CI -105.789 to -60.180
  • Placebo vs TOUR006 - 50 MG · Quantile Regression · p = <0.0001 · Median difference (net): -92.503 · 95% CI -115.589 to -69.418
  • Placebo vs TOUR006 - 15 MG · Quantile Regression · p = <0.0001 · Median difference (net): -94.246 · 95% CI -117.344 to -71.148
SecondaryEvaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006

Mean trough serum concentrations (ng/mL) of TOUR006 at Days 30, 60, 90,120, 150, 180, 240, 300, and 365. On dosing visits (BL and Day 30, 60, 90, 120, and 150 visits), PK samples were collected pre-dose. PK blood samples were collected on Study Days 180, 240, 300, and 365 at approximately the same time as the pre-dose samples were collected on previous dosing visits.

Time frame:
Baseline through Day 365
Reported as:
Mean · ng/mL
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
ng/mLTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Day 301347.86 ± 544.502753.95 ± 718.79857.00 ± 335.31
Day 60964.92 ± 345.991735.04 ± 597.821473.06 ± 559.41
Day 90668.35 ± 257.771117.06 ± 416.791830.07 ± 742.07
Day 1201999.28 ± 692.933502.15 ± 1129.171963.65 ± 799.95
Day 1501361.08 ± 507.402098.06 ± 680.552031.46 ± 986.05
Day 180872.10 ± 322.201383.64 ± 609.802067.92 ± 909.09
Day 240395.98 ± 197.27566.17 ± 371.681025.93 ± 610.17
Day 300180.37 ± 131.07241.66 ± 200.18419.44 ± 333.82
Day 36562.53 ± 89.7787.27 ± 106.79164.45 ± 171.32
SecondaryEvaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD

Evaluates the percentage of participants with treatment emergent adverse events (AE), which includes serious and nonserious AEs. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.

Time frame:
Baseline through Day 365.
Reported as:
Count of participants · Participants
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
ParticipantsPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD23222121
SecondaryEvaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD

Evaluates the percentage of participants with serious treatment emergent adverse events. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.

Time frame:
Baseline through Day 365.
Reported as:
Count of participants · Participants
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
ParticipantsPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD6763

Adverse events

Collected over Baseline through Day 365.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/36 (0%)6/36 (16.7%)22/36 (61.1%)
TOUR006 - 25 MG1/35 (2.9%)7/35 (20%)21/35 (60%)
TOUR006 - 50 MG1/35 (2.9%)6/35 (17.1%)21/35 (60%)
TOUR006 - 15 MG0/35 (0%)3/35 (8.6%)21/35 (60%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Acute Kidney InjuryRenal and urinary disorders0/360/351/352/35
PneumoniaInfections and infestations2/361/351/350/35
Cardiac Failure CongestiveCardiac disorders2/360/351/350/35
Appendicitis PerforatedInfections and infestations0/360/351/350/35
BacteraemiaInfections and infestations0/361/350/350/35
COVID-19Infections and infestations0/361/350/350/35
Gastroenteritis RotavirusInfections and infestations0/361/350/350/35
Necrotising Fasciitis StreptococcalInfections and infestations0/361/350/350/35
SepsisInfections and infestations0/361/350/350/35
Wound CellulitisInfections and infestations0/361/350/350/35
Most frequent other events
Showing 10 of 163
Most frequent other events
EventPlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MG
Urinary Tract InfectionInfections and infestations4/361/352/354/35
Back PainMusculoskeletal and connective tissue disorders1/363/350/351/35
HypertensionVascular disorders2/360/353/350/35
COVID-19Infections and infestations1/360/351/352/35
PneumoniaInfections and infestations2/360/352/351/35
Upper Respiratory Tract InfectionInfections and infestations2/361/352/350/35
Ear InfectionInfections and infestations1/360/352/350/35
Otitis MediaInfections and infestations0/360/352/350/35
HypokalaemiaMetabolism and nutrition disorders0/360/351/352/35
HypercalcaemiaMetabolism and nutrition disorders0/362/350/350/35

Baseline characteristics

Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (Modified-ITT)

Age, Continuous
Age, Continuous(years)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
Median72 (62 to 77)73 (66 to 76)70 (61 to 78)65 (60 to 73)71 (62 to 77)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
Female2117192178
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
Hispanic or Latino8107732
Not Hispanic or Latino2321232794
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American78111238
White2423192187
More than one race00000
Unknown or Not Reported00011
Region of Enrollment
Region of Enrollment(participants)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
United States31313034126
CKD Stage (IWRS)
CKD Stage (IWRS)(Participants)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
CKD Stage 3 or UPCR ≥ 200 mg/g and eGFR ≥ 60 mL/min/1.73m226272530108
CKD Stage 4545418
hs-CRP, mg/L
hs-CRP, mg/L(mg/L)PlaceboTOUR006 - 25 MGTOUR006 - 50 MGTOUR006 - 15 MGTotal
Median3.60 (2.70 to 5.10)3.90 (2.35 to 5.55)5.18 (3.60 to 7.35)4.73 (3.80 to 7.40)4.45 (3.00 to 6.15)
08

Study locations

38 sites
  • Site - 0101
    Birmingham, Alabama 35209, United States
  • Site - 0135
    Huntsville, Alabama 35763, United States
  • Site - 0145
    Huntsville, Alabama 35805, United States
  • Site - 0104
    Phoenix, Arizona 85018, United States
  • Site - 0125
    San Dimas, California 91773, United States
  • Site - 0112
    Valencia, California 91355, United States
  • Site - 0128
    Valencia, California 91355, United States
  • Site - 0136
    Stamford, Connecticut 06905, United States
  • Site - 0113
    Greenacres City, Florida 334667, United States
  • Site - 0149
    Pembroke Pines, Florida 33024, United States
  • Site - 0144
    Plantation, Florida 33317, United States
  • Site - 0119
    Port Orange, Florida 32127, United States
  • Site - 0151
    Tampa, Florida 33634, United States
  • Site - 0122
    Savannah, Georgia 31406, United States
  • Site - 0106
    Chicago, Illinois 60655, United States
  • Site - 0115
    Morton, Illinois 61550, United States
  • Site - 0114
    Council Bluffs, Iowa 51501, United States
  • Site - 0129
    Metairie, Louisiana 70006, United States
  • Site - 0123
    Las Vegas, Nevada 89121, United States
  • Site - 0130
    Middletown, New York 10940, United States
  • Site - 0110
    Charlotte, North Carolina 28208, United States
  • Site - 0117
    Fargo, North Dakota 58104, United States
  • Site - 0120
    Cincinnati, Ohio 45219, United States
  • Site - 0127
    Marion, Ohio 43302, United States
  • Site - 0132
    Bethlehem, Pennsylvania 18017, United States
  • Site - 0126
    Providence, Rhode Island 02818, United States
  • Site - 0102
    Fort Mill, South Carolina 29707, United States
  • Site - 0103
    Greenville, South Carolina 29607, United States
  • Site - 0108
    Knoxville, Tennessee 37923, United States
  • Site - 0148
    Greenville, Texas 75402, United States
  • Site - 0105
    Houston, Texas 77043, United States
  • Site - 0111
    Lampasas, Texas 76550, United States
  • Site - 0150
    McKinney, Texas 75069, United States
  • Site - 0107
    San Antonio, Texas 78212, United States
  • Site - 0141
    San Antonio, Texas 78255, United States
  • Site - 0109
    Manassas, Virginia 20110, United States
  • Site - 0147
    Morgantown, West Virginia 26505, United States
  • Site - 0134
    Kenosha, Wisconsin 53144, United States
09

References and documents

Study documents

  • Study protocol · Apr 7, 2025
  • Statistical analysis plan · Feb 12, 2026

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06362759
Lead sponsor
Tourmaline Bio, Inc., a Novartis Company
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
May 15, 2024
Primary completion
Mar 6, 2025
Completion
Dec 4, 2025
Results posted
Aug 11, 2026
Last update
Aug 11, 2026

Study contacts

Clinical Trials
study director · Tourmaline Bio

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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