For Patients & Caregivers

Physical Activity & Joint Health in HEMLIBRA

Before you read our physical activity data, be sure to check out our pivotal HAVEN 1-HAVEN 4 trials. HEMLIBRA was analyzed in 3 additional studies that examined joint health and physical activity. Explore all 3 studies below.35-37

BEYOND ABR TSUBASA AOZORA
BEYOND ABR

Beyond ABR: Exploring Joint Health and Physical Activity in People With Hemophilia A Switching From FVIII to HEMLIBRA36

Study Design

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Beyond ABR is an ongoing 3-year, Phase 4, multicenter, open-label study conducted in 12 countries.36

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The study includes 136 patients with severe or moderate hemophilia A aged 13-69 years without FVIII inhibitors receiving HEMLIBRA who were treated with factor VIII prophylaxis for ≥24 weeks.*36

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This is an interim analysis. At data cut-off (Nov 29, 2024), 130 patients were still being treated with HEMLIBRA. HEMLIBRA was dosed according to label. The median (range) duration was 76 (13-122) weeks.36

These data are a descriptive analysis and therefore should be interpreted with caution.

Key assessments:

  • Joint health evaluation using HJHS 2.1,† numerical changes in problem joint counts,‡ target joint resolution§36
  • Physical activity data using IPAQ-SF36
  • Zero treated bleeds36
  • Safety through incidence and seriousness of AEs36

Patient Characteristics

  • The median age (range) was 26.5 years old (13-63)36
  • 100% of the patients were male36
  • 25 patients (18.4%) had moderate hemophilia A and 111 (81.6%) had severe hemophilia A36
  • 33 patients (24.3%) had ≥1 joint with a previous surgery/procedure36

Study Results: Joint Health

Mean HJHS (Hemophilia Joint Health Scores) Scores at Months 6 and 12||36
  • At Months 6 and 12, mean HJHS scores decreased at the patient level from 10.1 at baseline to 8.7 and 7.9 at Months 6 and 12, respectively36

The mean (SD) HJHS sum of joints (excluding Global Gait Score) had improved by 2.0 (6.4) at Month 6 (N=93) and 2.8 (7.9) at Month 12 (N=88)†36

Proportion of patients with improved, stable, or worsening HJHS sum of joints scores#36
  • At 6 months, 23.7% of patients improved their HJHS joint score by at least 4 points, 69.9% had little or no change (less than 4 points), and 6.5% worsened by at least 4 points36
  • At 12 months, 26.1% of patients improved their HJHS joint score by at least 4 points, 68.2% had little or no change (less than 4 points), and 5.7% worsened by at least 4 points36

These data are a descriptive analysis and therefore should be interpreted with caution.

Changes in Reported Problem Joint Counts From Baseline‡36
  • 30% (35/117) of patients had decreased the number of problem joints from baseline at Month 1236
  • 14% (16/117) of patients had increased the number of problem joints from baseline at Month 1236
HEMLIBRA® (emicizumab-kxwh) Joints Icon

27/27 target joint resolution at Month 12 in 15 patients who remained in the study for at least 1 year§36

A majority of patients reported zero treated bleeds36

  • 81% of patients (110/136) reported zero treated bleeds in Weeks 1-24
  • 78% of patients (105/134) reported zero treated bleeds in Weeks 25-48
EmiPref Survey Outcomes
  • 96% of patients (125/130) at Month 6 preferred emicizumab to their previous FVIII prophylaxis in the EmiPref survey, while 1/130 (0.8%) preferred their previous treatment; 4/130 (3.1%) had no preference36

These data are a descriptive analysis and therefore should be interpreted with caution.

Study Results: Physical Activity

Physical activity data were obtained using IPAQ-SF.36

% of Patients Reporting Physical Activity at Months 3 and 12 vs Baseline

IPAQ scores between baseline and Month 12**36
  • From baseline to Month 3, patients engaging in high physical activity increased by 8.6 percentage points, moderate physical activity was unchanged, and low physical activity decreased by 8.6 percentage points (data not shown)36
  • From baseline to Month 12, patients engaging in high physical activity increased by 6 percentage points, moderate physical activity increased by 3.6 percentage points, and low physical activity decreased by 9.6 percentage points36

These data are a descriptive analysis and therefore should be interpreted with caution.

Safety profile

No new safety signals were identified36

  • 113/136 (83.1%) of patients reported ≥1 AE36
  • No AEs leading to treatment discontinuation36
  • No HEMLIBRA-related serious AEs36
  • There were no thromboembolic events or TMAs36
  HEMLIBRA36
(N=136)
Total number of AEs, n 372
Total number of patients with ≥1 AE n (%) 113 (83.1)
AE with fatal outcome 0
Serious AE†† 9 (6.6)
AE leading to withdrawal from treatment 0
AE leading to dose modification/interruption 2 (1.5)
Grades 3-5 AE 14 (10.3)
Related AE 18 (13.2)
AEs of special interest, n (%)‡‡ 0 (0)

These data are a descriptive analysis and therefore should be interpreted with caution.

*Patients who had joint replacement, joint procedure, synovectomy, or synoviorthesis less than 2 years before recruitment were excluded.36

†Patients or single joints with a medical history of joint surgery/procedure were not included in the HJHS analysis. Meaningful changes in HJHS were ≥2 points at the single joint level and ≥4 points at the patient level.36

‡Defined as chronic joint (neck, shoulders, elbows, wrists, knees, hips, ankles, spine) pain and/or limited range of movement due to compromised joint integrity with or without persistent bleeding.36

§A baseline target joint with <3 spontaneous or traumatic bleeds in a 52-week period was considered resolved.36

||Mean scores are calculated from all patients with data at that timepoint; change from baseline is calculated in patients with data at both baseline and Month 6 or Month 12.36

Max score: 120 = 6 joints × 20 points each.36

#Total percentage may not equal 100% due to rounding.36

**Scores are reported in all patients with data at both timepoints.36

††Included influenza, hematemesis, hematochezia, ligament rupture, hemarthrosis, unstable angina, seizures, upper respiratory tract infection, multiple trauma; none were deemed related to treatment.36

‡‡Included anaphylactic reactions, thromboembolic events, TMAs, drug-induced liver injuries.36

AEs=adverse events; CI=confidence interval; FVIII=factor VIII; HJHS=Hemophilia Joint Health Score; EmiPref=Emicizumab Preference; IPAQ-SF=International Physical Activity Questionnaire-Short Form; SD=standard deviation.

NEXT: TSUBASA: Physical activity data
TSUBASA

TSUBASA: An observational study evaluating association between physical activity and bleeding events on HEMLIBRA35

Study Design

Physical activity was measured in 5 specific 8-day monitoring periods.†35

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The type of physical activity and bleeding events were manually recorded using the electronic-patient reported outcomes (ePRO application)1,35

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129 Japanese patients with hemophilia A without FVIII inhibitors enrolled1,35

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Patients took a loading dose of HEMLIBRA at 3 mg/kg weekly for 4 weeks, followed by maintenance doses of either 1.5 mg/kg QW, 3 mg/kg Q2W, or 6 mg/kg Q4W35

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Treatment was continued until 97 weeks or until discontinuation based on HCP judgment or patient request‡1,35

†All patients ≥6 years of age wore a CentrePoint® Insight watch activity tracker for 5 specified 8-day monitoring periods at Weeks 5, 25, 49, 73, and 97. Patients reported data related to exercise at Week 5 and at 24-week intervals (Weeks 25, 49, 73, and 97). Activity intensity was calculated using the tracker.48
‡Patients reported data related to exercise at Week 5 and at 24-week intervals (Weeks 25, 49, 73, and 97).35

Limitations

  • TSUBASA was an exploratory study with no comparator arm35
  • Patients could report bleeds any time, but only those within 5 specific 8-day periods were evaluated for their relation to exercise. Bleeds occurring within 7 days of an activity were considered associated with the activity event35
    • In this study, there was the potential to underestimate activity-related bleeds due to any additional physical activity performed beyond these time periods35
  • Patient-reported outcomes are subject to participation rates and interpretation35
  • Reasons for FVIII coagulation product administration, apart from maintaining hemostasis, was not reported49
  • Generalizability was limited to patients with hemophilia A without other inherited/acquired bleeding disorders or undergoing immune tolerance induction treatment49
HEMLIBRA® (emicizumab-kxwh) Activity Icon

RESULTS – 2 out of 968 instances of physical activity were associated with bleeds35

  • 968 instances of physical activity were documented in the study§35
    • Of the 129 patients, 104 were ≥6 years of age and eligible to record data on physical activity35
  • 73 patients recorded ≥1 physical activity event
    • Median (range) age was 39 (6-73) years35
    • 82.2% had severe hemophilia A35
    • 13 had target joints at baseline35
    • All patients had prior exposure to coagulation factor products||35
  • 9 prophylactic uses of hemostatic agents occurred within 24 hours prior to exercise (6/73 patients)35
  • 2 (0.2%) documented activities were associated with bleeding35
    • Basketball (moderate risk) and fishing (low risk)35
    • Both patients had severe hemophilia A35
    • The mean (SD) calculated ABR for treated bleeds was 1.9 (4.3) in the overall population35

These data are a descriptive analysis and therefore should be interpreted with caution.

§172 instances of exercises that were not on the risk categorization list.35
||58 (79.5%) patients had received FVIII prophylaxis.35
100 patients (77.5%) received 1403 doses of non-HEMLIBRA hemostatic agents; during exercise assessments, 30 (23.3%) received 77 doses.35

Physical activity reported in patients ≥6 years of age35#

Risk Categorization
n=number of patients		 Number of physical activity events
Low (n=58) 556
Walking 374
Radio calisthenics 84
Weight training 34
Fishing 27
Golf 18
Swimming 7
Darts 5
Aqua dance 3
Trekking (climbing) 3
Hiking 1
Moderate (n=27) 182
Cycling/biking 112
Jogging/running 20
Tennis 16
Basketball 10
Dodgeball 7
Rubber-ball baseball 4
Table tennis 4
Jumping rope 3
Softball 3
Bowling 2
Soft tennis 1
High (n=14) 58
Soccer 13
Athletics/marathon 9
Trampoline 8
Weight lifting 6
Badminton 5
Karate 4
Volleyball 4
Motorcycle sports 3
Handball 2
Kendo 2
Football 1
Judo 1

Every patients' experience on HEMLIBRA is different. Please discuss treatment goals individually with your patients.

These data are a descriptive analysis and therefore should be interpreted with caution.

#Risk categorization according to the National Bleeding Disorder Foundation risk classification.

TSUBASA Safety Profile

No new safety concerns were identified35

  • 62/129 (48.1%) of patients reported ≥1 AE35
  • No AEs leading to treatment discontinuation35
  • No HEMLIBRA-related serious AEs35
  • There were no intracranial hemorrhages or thromboembolic events48
  • No patients developed FVIII inhibitors on study48
  HEMLIBRA
(N=129)35,48
Total number of AEs, n 137
Patients with ≥1 AE, n (%) 62 (48.1)
AE leading to withdrawal from treatment 0 (0)
AE related to treatment 7 (5.4)**
Patients with ≥1 SAE, n (%) 13 (10.1)
AEs of special interest, n (%)
Thromboembolic events		 0 (0%)

These data are a descriptive analysis and therefore should be interpreted with caution.

**7 patients reported 10 AEs related to HEMLIBRA; 2 injection-site erythema and 5 injection-site reactions in 6 patients. Headache, vertigo, and alopecia all occurred in 1 patient.35

NEXT: AOZORA: Long-Term Safety and Joint Health
AOZORA

AOZORA: Long-Term Safety and Joint Health in Pediatric Patients With Hemophilia A Without FVIII Inhibitors37

Study Design

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AOZORA is an ongoing Phase 4 open-label study in Japanese patients and has no comparator arm.37

HEMLIBRA® (emicizumab-kxwh) CEM Icon

The study includes 30 patients with severe hemophilia A aged <12 years without FVIII inhibitors receiving HEMLIBRA, 10 of whom were previously enrolled in the HOHOEMI study.37

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This is an interim 3-year analysis. These results were collected through 145 weeks.37

These data are a descriptive analysis and therefore should be interpreted with caution.

Endpoints

The primary endpoints were long-term safety and joint health and function. An additional exploratory endpoint was ABR for treated bleeds.37

Limitations

  • Broad pediatric age range (<12 yrs) with differing activity levels and joint stress37
  • Majority of patients were on prior prophylaxis, with variable treatment duration37
  • Potential inter-rater variability in assessments37
  • MRI scoring cannot distinguish effusion from hemarthrosis37
  • MRI assessments every 3 years may miss interim changes37

Methods

Joint health was evaluated in 2 ways in AOZORA:

  • The IPSG MRI scale†: Additive tool used to quantify hemophilic arthropathy in both knees and ankles37
    • Assesses soft-tissue changes (effusion/hemarthrosis, synovial hypertrophy, and hemosiderin deposition) and osteochondral changes (surface erosions, subchondral cysts, and cartilage degradation)37
    • Score range from 0 (normal) to 17 (severe damage) for each joint37
  • HJHS Version 2.1: Validated tool that consists of an 8-item scoring for each joint and a global gait score37,50
    • A higher score indicates worse joint health37,50

Study Results: Joint Health

  • IPSG MRI scores remained at 0 from Week 1 (n=29) to Week 145 (n=26) in 11 (42.3%) patients37
    • 9 patients showed score improvements, 2 patients maintained the same score, and 4 patients experienced an increase in score37
  • Changes in soft tissue were observed in 15 patients37
    • Synovial hypertrophy and hemosiderin were observed in 7 patients at Week 1, and all patients had improved scores by Week 14537
    • Effusion/hemarthrosis was observed in 8 patients at Week 1 and in 11 patients at Week 14537
      • In 2 patients, effusion/hemarthrosis was present at baseline, but no longer observed at Week 14537
      • Scores increased in 7 patients, decreased in 3, and showed no change in 1 patient37
    • At the joint level, the number of joints with effusion/hemarthrosis increased from Week 1 to Week 145 (in patients who were ≥2 years)‡37
  • Two patients exhibited osteochondral changes37

These data are a descriptive analysis and therefore should be interpreted with caution.

HJHS Total Score and Model-based ABR37

  • 18 (66.7%) patients maintained a score of 0 from Week 1 to Week 14537
  • Between Week 1 and Week 145, 5 had a decrease in total score, 3 had an increase, and 1 had no change37
  • The mean model-based ABR for treated bleeds was 3.6 prior to HEMLIBRA and 0.8 while receiving HEMLIBRA.37
  • The model-based ABR for treated joint bleeds was 0.5 prior to HEMLIBRA and 0.2 while receiving HEMLIBRA.37

These data are a descriptive analysis and therefore should be interpreted with caution.

AOZORA Safety Profile

  All patients37
(N=30)
Total number of AEs, n 404
Patients with ≥1 AE, n (%) 29 (96.7)
AE leading to withdrawal from treatment 0 (0)
AE leading to dose modification/interruption 0 (0)
Grade 3-5 AE|| 5 (16.7)
Any SAEs 5 (16.7)
HEMLIBRA-related AEs, n (%) 5 (16.7)
Injection-site reaction 5 (16.7)
Anemia** 1 (3.3)
  • There were 7 HEMLIBRA-related AEs in 5 patients in AOZORA: 6 injection-site reactions and 1 case of anemia37
  • There were no thrombotic events including thrombotic microangiopathies, no fatal AEs, and no AEs resulted in withdrawal from treatment or dose modification/interruption37
  • One patient developed FVIII inhibitors37

These data are a descriptive analysis and therefore should be interpreted with caution.

†IPSG MRI scoring does not distinguish between effusion and hemarthrosis.37

‡In 5 patients between the age 2-6, no bleeding was observed in the joints with increased effusion/hemarthrosis scores, and the authors believe the increased findings are associated with effusion/hemarthrosis due to increased physical activity in growing children. At the patient level, no clear trend toward increase effusion/hemarthrosis was observed.37

§These results are limited by retrospective data collection; prior to treatment was defined as 24 weeks prior to enrollment.37

||Five patients experienced 7 events: Grade 3 AEs including posttraumatic pain (n=1); soft tissue hemorrhage (n=1); hemophilic arthropathy (n=1) and hemarthrosis (n=2); Grade 4 AEs including skull fracture (n=1) and subdural hematoma (n=1).37

No SAEs were considered related to emicizumab.37

**Reported as a decreased hemoglobin level of 13.1 g/dL with no clinical symptoms.37

ABR=annualized bleed rate; AE=adverse event; CI=confidence interval; FVIII=factor VIII; HJHS=hemophilia joint health score; IPSG=International Prophylaxis Study Group; MRI=magnetic resonance imaging; SAE=serious adverse event; SD=standard deviation.

HEMLIBRA was also studied in infants and children

Explore HEMLIBRA clinical trial results across various patient populations

See the Results
HEMLIBRA was also studied across a broad range of patients1,6

Explore the clinical trial results

See the results

Indication & Important Safety Information

Indication
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur. 

Warnings and Precautions
Thrombotic Microangiopathy (TMA) and Thromboembolism Associated With HEMLIBRA and aPCC
In clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic events were reported in 0.5% of patients (2/391). In patients who received at least one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic events were reported in 5.4% of patients (2/37). Patients with TMA presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13.

Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Due to the long half-life of HEMLIBRA, the potential for an interaction with aPCC may persist for up to 6 months after the last dose. Monitor for the development of TMA and/or thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA and/or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of TMA and/or thrombotic events on a case-by-case basis.

Immunogenicity
Treatment with HEMLIBRA may induce anti-drug antibodies. Anti-emicizumab-kxwh antibodies were reported in 5.1% of patients (34/668) treated with HEMLIBRA in clinical trials. Most patients with anti-emicizumab-kxwh antibodies did not experience a change in HEMLIBRA plasma concentrations or an increase in bleeding events; however, in uncommon cases (incidence <1%), the presence of neutralizing antibodies with decreasing plasma concentration may be associated with loss of efficacy.

Monitor for clinical signs of loss of efficacy (eg, increase in breakthrough bleeding events) and if observed, promptly assess the etiology and consider a change in treatment if neutralizing anti-emicizumab-kxwh antibodies are suspected.

Laboratory Coagulation Test Interference
HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based on aPTT, such as one-stage, factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based coagulation laboratory test results in patients who have been treated with HEMLIBRA prophylaxis should not be used to monitor HEMLIBRA activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers.

Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.

Results unaffected by HEMLIBRA: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrombin time (PT)-based single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation factors (eg, Factor V Leiden, Prothrombin 20210).

Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.

Adverse Reactions
Characterization of aPCC Treatment in Pooled Clinical Trials
There were 130 instances of aPCC treatment in 37 patients, of which 13 instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; 2 of the 13 were associated with thrombotic events and 3 of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.

Injection Site Reactions
In total, 85 patients (22%) reported injection site reactions (ISRs). All ISRs observed in HEMLIBRA clinical trials were reported as mild to moderate intensity and 93% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (11%), injection site pruritus (4%), and injection site pain (4%).

Other Less Common (<1%) Reactions
Rhabdomyolysis was reported in 2 adult patients with asymptomatic elevations in serum creatine kinase without associated renal or musculoskeletal symptoms. In both instances, the event occurred following an increase in physical activity.

Drug Interactions
Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC.

Pregnancy, Lactation, Females and Males of Reproductive Potential
Women of childbearing potential should use contraception while receiving HEMLIBRA. It is not known whether HEMLIBRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMLIBRA should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HEMLIBRA and any potential adverse effects on the breastfed child from HEMLIBRA or from the underlying maternal condition.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING.

    • HEMLIBRA package insert. South San Francisco, CA: Genentech, Inc.; 2025.

      HEMLIBRA package insert. South San Francisco, CA: Genentech, Inc.; 2025.

    • FDA Approves Genentech’s HEMLIBRA (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors. Genentech Press Release. South San Francisco, CA: Genentech; October 4, 2018.

      FDA Approves Genentech’s HEMLIBRA (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors. Genentech Press Release. South San Francisco, CA: Genentech; October 4, 2018.

    • Data on File. Genentech, Inc.

      Data on File. Genentech, Inc.

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      Young G, Liesner R, Chang T, et al. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019;134(24):2127​​-2138. doi:10.1182/blood.2019001869

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      Young G, Sidonio R, Oldenburg J, et al. Efficacy/safety in children on 2/4-weekly emicizumab prophylaxis: 52-week outcomes in HAVEN 2. Presented at the American Society of Pediatric Hematology/Oncology (ASPHO) Conference; May 4​-7, 2022; Pittsburgh, Pennsylvania.

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      Shima M, Nagao A, Taki M, et al. Long-term safety and efficacy of emicizumab for up to 5.8 years and patients’ perceptions of symptoms and daily life: a phase 1/2 study in patients with severe haemophilia A. Haemophilia. 2021;27(1):81​-89. doi:10.1111/hae.14205

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      Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979​-987. doi:10.1111/hae.13848

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      Négrier C, Mahlangu J, Lehle M, et al. Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study. Lancet Haematol. 2023;10(3):e168-e177. doi:10.1016/S2352-3026(22)00377-5

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      Efficacy, safety, and pharmacokinetic study of prophylactic emicizumab versus no prophylaxis in hemophilia A participants (HAVEN 5). Clinicaltrials.gov identifier: NCT03315455. Updated September 25, 2024. Accessed July 7, 2026. https://clinicaltrials.gov/ct2/show/NCT03315455.

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