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NCT04279574

Clinical Performance of Chairside CAD/CAM Restorations

Completed NA Results posted Last updated 24 March 2025
What this trial tests

NA trial testing Lithium disilicate onlays (IPS emaxCAD/Ivoclar) in Dental Cements in 58 participants. Completed in 22 May 2024.

Timeline
26 August 2020
Primary endpoint
22 May 2024
22 May 2024

Quick facts

Lead sponsorSolventum US LLC
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment58
Start date26 August 2020
Primary completion22 May 2024
Estimated completion22 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Solventum US LLC — full company profile →

Who can join

Adults 18 to 89, any sex, with Dental Cements or Caries,Dental. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores] Primary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Retention. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[5b.1 Restoration in place; 5b.5 Complete loss of restoration\] Functional property (retention) assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays37
CAD/CAM Crowns39
CAD/CAM Onlays2
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays36
CAD/CAM Crowns38
CAD/CAM Onlays2
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Material Fracture. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional properties assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays38
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Approximal anatomical contact form - mesial. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays38
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays2
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays36
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays4
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays34
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays5
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays34
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays5
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays33
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays5
CAD/CAM Crowns0
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Approximal anatomical contact point - mesial. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays38
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays35
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays33
CAD/CAM Crowns37
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns2
CAD/CAM Onlays1
CAD/CAM Crowns1
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays34
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays33
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Approximal Anatomical Contact Form - Distal. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays29
CAD/CAM Crowns25
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays27
CAD/CAM Crowns24
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays27
CAD/CAM Crowns22
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays26
CAD/CAM Crowns24
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays24
CAD/CAM Crowns22
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Approximal Anatomical Contact Point - Distal. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays29
CAD/CAM Crowns25
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays27
CAD/CAM Crowns24
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays27
CAD/CAM Crowns22
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays26
CAD/CAM Crowns23
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays24
CAD/CAM Crowns21
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns1
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Occlusal contour and wear. Evaluations according to FDI World Dental Federation critera (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays38
CAD/CAM Crowns37
CAD/CAM Onlays0
CAD/CAM Crowns2
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0
Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores] Secondary · 3 years with assessments at 6 months, 1 year, 2 years, and 3 years

Recurrence of caries, erosion, abfraction. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Biological properties assessed by visual and/or tactile assessment by two independent examiners.\]

6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays37
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Marginal Adaptation. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Functional property assessed by visual and/or tactile assessment by two independent examiners.\]

Baseline
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays31
CAD/CAM Crowns31
CAD/CAM Onlays9
CAD/CAM Crowns9
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays20
CAD/CAM Crowns14
CAD/CAM Onlays19
CAD/CAM Crowns25
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays12
CAD/CAM Crowns9
CAD/CAM Onlays27
CAD/CAM Crowns31
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays1
CAD/CAM Crowns11
CAD/CAM Onlays37
CAD/CAM Crowns28
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0
Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores] Secondary · 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years

Surface Luster: Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\]

Baseline
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
6 months post-restoration
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays38
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0
Short-term Post-operative Sensitivity (Onlays and Crowns) Secondary · up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic

Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[Rating Scale 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor\] Biological properties assessed by patient interview.

1 week post-restoration
GroupValue95% CI
CAD/CAM Onlays37
CAD/CAM Crowns34
CAD/CAM Onlays3
CAD/CAM Crowns4
CAD/CAM Onlays0
CAD/CAM Crowns2
CAD/CAM Onlays0
CAD/CAM Crowns0
2 weeks post-restoration
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns37
CAD/CAM Onlays0
CAD/CAM Crowns2
CAD/CAM Onlays0
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
3 weeks post-restoration
GroupValue95% CI
CAD/CAM Onlays0
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays40
CAD/CAM Crowns0
Gingival Index (Onlays and Crowns) Secondary · 3 years with assessments at 6 months, 1 year, 2 years, and 3 years

Loe \& Silness Index, 1963 \[0: normal gingiva, 1: mild inflammation and no bleeding, 2: moderate inflammation and bleeding, 3: severe inflammation\]

6 months post-restporation
GroupValue95% CI
CAD/CAM Onlays40
CAD/CAM Crowns40
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays0
CAD/CAM Crowns0
1 year post-restoration
GroupValue95% CI
CAD/CAM Onlays38
CAD/CAM Crowns38
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
2 years post-restoration
GroupValue95% CI
CAD/CAM Onlays39
CAD/CAM Crowns39
CAD/CAM Onlays0
CAD/CAM Crowns1
CAD/CAM Onlays0
CAD/CAM Crowns0
CAD/CAM Onlays1
CAD/CAM Crowns0
3 years post-restoration
GroupValue95% CI
CAD/CAM Onlays37
CAD/CAM Crowns37
CAD/CAM Onlays1
CAD/CAM Crowns2
CAD/CAM Onlays1
CAD/CAM Crowns1
CAD/CAM Onlays1
CAD/CAM Crowns0

Adverse events — posted to ClinicalTrials.gov

Time frame: From participant's first treatment restoration to subject's completion of the study, an average of 3 years... Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CAD/CAM Onlays
Serious: 1/35 (3%)
Deaths: 1/35
CAD/CAM Crowns
Serious: 0/33 (0%)
Deaths: 0/33

Serious adverse events (1 terms)

ReactionSystemCAD/CAM OnlaysCAD/CAM Crowns
DeathGeneral disorders

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT04279574 adverse events section.

Sponsor's own description

This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive. Full contour zirconia crowns will be cemented using a self-adhesive resin cement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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