Clinically Meaningful Reduction in Drop Seizures in Patients with Lennox–Gastaut Syndrome Treated with Cannabidiol: Post Hoc Analysis of Phase 3 Clinical Trials
Neurology, Epilepsy and Movement Disorders Unit, Bambino Gesù Children’s Hospital, IRCCS, Full Member of European Reference Network EpiCARE, Rome, Italy
University Hospitals KU Leuven, Leuven, Belgium
APHP, Robert Debré University Hospital, Pediatric Neurology Department, CRMR epilepsies rares, EpiCare Member, Paris, France
Université Paris Cité, INSERM NeuroDiderot, Paris, France
Institut Universitaire de France (IUF), Paris, France
Jazz Pharmaceuticals, Inc., Gentium Srl, Villa Guardia, Italy
University Hospitals of Leuven, Leuven, Belgium
Jazz Pharmaceuticals, Switzerland GmbH, Zug, Switzerland
Royal Hospital for Children and University of Glasgow, Glasgow, UK
Abstract
Background and Objective
In clinical trials of patients with Lennox–Gastaut syndrome (LGS), a ≥ 50% reduction in drop seizure frequency is generally accepted as a key endpoint. However, smaller reductions (< 50%) may yet be impactful for patients in real-world settings. This exploratory analysis evaluated the threshold for a clinically important response in drop seizures that is associated with the Caregiver Global Impression of Change (CGIC) scale score in patients with LGS treated with cannabidiol (CBD) oral solution and assessed the suitability of CGIC as an anchor for meaningful change.
Methods
This exploratory post hoc analysis included patients with LGS (N = 215, age 2–55 years) receiving CBD (Epidiolex® [USA]/Epidyolex® [EU]; 100 mg/mL oral solution) in two phase 3 randomized placebo-controlled trials (NCT02224690, April–October 2015, and NCT02224560, June– December 2015). Reduction in drop seizures (involving sudden loss of muscle tone) was anchored to CGIC scores of “slightly improved” or better or “much improved” or better, to determine the threshold at which seizure reduction can be considered clinically meaningful to patients. Spearman’s correlation indicated suitability of anchors (absolute value ≥ 0.30 deemed appropriate).
Results
In the 215 patients receiving CBD with a CGIC score recorded, CGIC was “slightly improved” or better in 60% of patients, and “much improved” or better in 31% after 14 weeks of treatment. With a CGIC rating of “slightly improved” or better, the best threshold for a clinically important response in drop seizure reduction was − 30.6% (57.7% of patients). Mean and median percentage reductions in drop seizures were − 46.9% and − 58.6%, respectively. Using “much improved” or better, the best threshold was − 49.6% (40.5% of patients). Mean and median percentage reductions in drop seizures were − 57.6% and − 66.0%, respectively. Spearman’s correlation was 0.47.
Conclusion
Anchoring to CGIC of “slightly improved” or better, the threshold for a clinically meaningful reduction in drop seizure frequency was 31%, suggesting that a 50% cutoff may overlook patients with meaningful improvements in their overall condition, as perceived by their caregivers. CGIC scores, although potentially less nuanced than other standardized clinical assessments, were appropriate anchors to determine thresholds. This exploratory analysis may help contextualize clinical trial data to better understand potential patient benefit attained by reductions in drop seizure frequency observed in real-world settings that are < 50%.
Clinical Trials Registration Numbers
NCT02224560 and NCT02224690.
Graphical Abstract
Article notes
Untitled section
Accepted 2025 Jun 8; Issue date 2025.
Key Points
| While reducing seizure frequency is the main treatment goal in Lennox–Gastaut syndrome (LGS), it is important to understand what extent of seizure reduction is clinically impactful for patients. |
| This post hoc analysis investigated correlations between the reduction in drop seizures and Caregiver Global Impression of Change (CGIC) scores in patients with LGS from the cannabidiol (CBD) phase 3 clinical trials. |
| CGIC scores of either “slightly improved” or better or “much improved” or better were reported in 60% and 31%, respectively, of patients with LGS after receiving adjunctive CBD. |
| The thresholds for clinically meaningful reductions in drop seizures associated with a CGIC of “slightly improved” or better or “much improved” or better were − 30.6% and − 49.6%, respectively. |
| These findings may help physicians contextualize clinical trial data to better understand potential patient benefit attained by reduced seizure frequency. |
Introduction
Lennox–Gastaut syndrome (LGS) is a rare developmental and epileptic encephalopathy (DEE), estimated in population-based studies to affect 2.9–28 per 100,000 people [1–3]. LGS is thought to account for 1–2% of all epilepsy cases and 1–10% of childhood epilepsies [1, 4, 5], with a cumulative incidence of 13.2 (95% confidence interval [CI]: 4.1, 41.9) per 100,000 children [6]. According to a 2022 position paper from the International League Against Epilepsy (ILAE), LGS is characterized by (1) multiple types of drug-resistant seizures, with onset before 18 years, one of which must include tonic seizures; (2) cognitive and often behavioral impairments, which may not be present at the onset of seizures; and (3) diffuse slow spike-and-wave and generalized paroxysmal fast activity observed on electroencephalogram [7]. Drop seizures, occurring in > 50% of patients with LGS [8, 9], are one of the more disabling types of seizure and can result in traumatic brain injury [4, 10, 11]. These drop seizures are often preceded by a generalized myoclonic jerk, followed by either a tonic contraction of axial muscles or axial atony or a combination, leading to a sudden fall [8].
Despite the availability of various antiseizure medications (ASMs), treatment resistance means patients with LGS continue to experience a high burden of disease in terms of both seizure and non-seizure symptoms [8, 9, 12]. Plant-derived, highly purified cannabidiol (CBD; Epidiolex® [USA]/Epidyolex® [EU]; 100 mg/mL oral solution) is approved in several countries for the treatment of seizures associated with LGS [13–17]. Two phase 3 double-blind, randomized, placebo-controlled trials (NCT02224560 and NCT02224690) investigated the efficacy of CBD (10 or 20 mg/kg/day for 14 weeks) as an adjunctive therapy to conventional ASMs in patients with LGS [9, 18]. Median percent reduction from baseline in drop seizure frequency was 37.2–43.9% with CBD versus 17.2–21.8% with placebo [9, 18].
Randomized controlled trials (RCTs) assess the efficacy and safety of an ASM on the basis of change in drop seizure frequency from baseline and responder analyses [18, 19]. Though seizure freedom would be the ultimate goal for all patients with epilepsy, in reality this target is usually not achieved [20, 21]. Clinical trials frequently require ≥ 50% reduction in seizure frequency as a key endpoint [18, 22]. However, this threshold does not account for other non-seizure outcomes that may be clinically meaningful for a patient [23, 24]. Indeed, smaller reductions in seizure frequency may yet be clinically impactful for patients with LGS, and treatment should consider the optimization of seizure control while balancing all factors that impact quality of life [25]. This post hoc analysis aimed to evaluate the threshold at which we observe a clinically meaningful reduction in drop seizures that is associated with Caregiver Global Impression of Change (CGIC) scale score in patients with LGS treated with CBD oral solution in the two pivotal phase 3 RCTs [9, 18].
Methods
Analysis Design and Participants
This post hoc analysis included children and adults with LGS (aged 2–55 years) from either of the two phase 3 RCTs, in which participants received CBD (10 or 20 mg/kg/day) or placebo for 14 weeks [9, 18]. Full details of the study designs and patient eligibility criteria have been published previously [9, 18]. The full analysis set included in the current study comprised all patients with LGS from the pooled intention-to-treat analysis set of the RCTs who received CBD (10 or 20 mg/kg/day) and had a CGIC score recorded. Subgroup analyses were conducted in pediatric patients (those aged < 18 years), adults (patients aged ≥ 18 years), and participants taking clobazam at the time of the trials (the “on-clobazam” subgroup). The phase 3 trials were conducted using Epidiolex®/Epidyolex® (100 mg/mL oral solution) and the results of this post hoc analysis do not apply to other CBD-containing products.
Endpoints
The primary endpoints were thresholds for a clinically important response determined as the percentage reductions in drop seizures, which were defined as paroxysmal events (atonic, tonic, or tonic–clonic), involving the entire body, trunk, or head [26]. Seizure frequency was assessed as change from baseline in 28-day average drop seizure count. CGIC was recorded at each visit, and for the purposes of anchoring herein, CGIC recorded at end of study was used (Fig. 1). The reductions were best associated (anchored) with the CGIC categories “slightly improved” or better or “much improved” or better, and thresholds for a minimal clinically important difference in drop seizure reduction with CGIC anchoring.
A secondary endpoint was correlations between the ordinal version of the anchor variable (CGIC scored on a 7-point scale: 1 = “very much improved,” 2 = “much improved,” 3 = “slightly improved,” 4 = “no change,” 5 = “slightly worse,” 6 = “much worse,” or 7 = “very much worse”) and study outcome (percentage reduction from baseline to end of RCT treatment period, in 28-day average drop seizure count). Another secondary endpoint was the distribution of percentage reduction in drop seizure count in those with CGIC scores with the anchors of “very much improved,” “much improved,” and “slightly improved” versus “much worse” and “very much worse” and of “very much improved” and “much improved” versus “slightly improved,” “much worse,” and “very much worse.” The final secondary endpoint was seizure response based on clinically important response thresholds.
Statistical Analysis
The thresholds for a clinically meaningful reduction in drop seizures were defined as a “relevant treatment benefit” for clinically important response and “the smallest change detected beyond random error (statistically relevant)” for minimal clinically important difference. Anchor-based methods, i.e., area under the receiver operating characteristic curves (ROC AUCs) derived using logistic regression and mean/median central tendency methods, were applied to determine the thresholds for a clinically important response [27]. Thresholds for minimal clinically important difference were determined using distribution-based methods with half standard deviation (SD) and standard error of the mean (SEM) [28–31]. Thresholds for a clinically important response and a minimal clinically important difference were anchored to CGIC scores of “slightly improved” or better (scores from 1–3 versus scores 4–7) or “much improved” or better (scores of 1–2 versus scores 3–7). Spearman’s correlations were calculated between the ordinal version of the anchor variable (CGIC scored) and the percentage reduction in drop seizure count at end of the RCT treatment, with correlations ≥ 0.30 in absolute value deemed as demonstrating suitable anchors in line with the literature recommendations [32]. Continuous data were summarized using descriptive statistics comprising the number of patients with data to be summarized (n), mean, SD, median, first and third quartiles (Q1 and Q3), minimum (min), and maximum (max). Categorical variables are presented using counts and percentages. Analyses and summary outputs were generated using SAS® version 9.4 (or newer).
Results
Patient Characteristics
This post hoc analysis included 215 participants from the two RCTs, with a mean age of 16 years (SD: 9.8). At baseline, the mean number of drop seizures per 28 days was 191.2 (SD: 548.2), and the median (Q1, Q3) was 83.1 (36.4, 180.3). Patients were already receiving treatment with clobazam (47.9%), valproate (38.1%), lamotrigine (33.0%), levetiracetam (28.4%), and rufinamide (30.7%). See Table 1 for demographics and baseline characteristics.
| RCT total (n = 215) | |
|---|---|
| Age (years) | |
| Mean (SD) | 16.0 (9.8) |
| Median | 13.6 |
| Q1, Q3 | 8.7, 20.6 |
| Min, max | 3, 48 |
| Sex, n (%) | |
| Female | 98 (45.6) |
| Male | 117 (54.4) |
| Race | |
| Asian | 4 (1.9) |
| Black/African-American | 10 (4.6) |
| N/A | 1 (0.5) |
| Other | 15 (7.0) |
| White | 185 (86.0) |
| Drop seizures per 28 days (n = 214) | |
| Mean (SD) | 191.2 (548.2) |
| Median | 83.1 |
| Q1, Q3 | 36.4, 180.3 |
| Min, Max | 10, 7494 |
| Current ASM, n (%) | |
| Clobazam | 103 (47.9) |
| Valproate | 82 (38.1) |
| Lamotrigine | 71 (33.0) |
| Levetiracetam | 61 (28.4) |
| Rufinamide | 66 (30.7) |
Improvements in Condition
CGIC scores were available from caregivers of 215 patients with LGS treated with CBD. Of these, caregivers reported that the patient’s overall condition was “slightly improved” or better in 129 (60.0%) patients and “much improved” or better in 67 (31.2%) patients; caregivers reported a CGIC score 4–7 for the remaining patients. Using a CGIC rating of “slightly improved” or better as the anchor, the best threshold for a clinically important response in drop seizure reduction was − 30.6%, with corresponding accuracy of 71.6% (Fig. 2). Applying this cutoff identified 57.7% of patients as having a clinically important response. Among the 57.7% of patients with a clinically important response by this definition, the mean percentage reduction in drop seizures was − 46.9% and median was − 58.6% (Table 2). Using a CGIC rating of “much improved” or better as the anchor, the best threshold for a clinically important response in drop seizure reduction in the pooled RCTs was − 49.6%, with corresponding accuracy of 69.3% (Fig. 3). Applying this cutoff, 40.5% of patients were identified as having a clinically important response. Among the patients with a clinically important response by this definition, the mean percentage reduction in drop seizures was −57.6%, and median was − 66.0% (Table 3).
| Pooled RCTs (n = 215) | |
|---|---|
| Clinically important response, percentage (%) drop seizure reduction | |
| Best cutoff from ROC curve | −30.6 |
| Patients with clinically important response, n (%) | 124 (57.7) |
| Mean percentage (%) drop seizure reduction in patients with clinically important response | −46.9 |
| Median percentage (%) drop seizure reduction in patients with clinically important response | −58.6 |
| Minimal clinically important difference, percentage (%) drop seizure reduction | |
| Half SD | −21.0 |
| SEM | −23.0 |
| Pooled RCTs (n = 215) | |
|---|---|
| Clinically important response, percentage (%) drop seizure reduction | |
| Best cutoff from ROC curve | − 49.6 |
| Patients with clinically important response, n (%) | 87 (40.5) |
| Mean percentage (%) drop seizure reduction in patients with clinically important response | − 57.6 |
| Median percentage (%) drop seizure reduction in patients with clinically important response | − 66.0 |
| Minimal clinically important difference, percentage (%) drop seizure reduction | |
| Half SD | − 18.4 |
| SEM | − 20.1 |
With a CGIC rating of “slightly improved” or better as the anchor, the best minimal clinically important difference threshold, as determined by half SD (and SEM), for drop seizure reduction in the pooled RCTs was − 20.9% (− 23.0%). With a CGIC rating of “much improved” or better as the anchor, the best minimal clinically important difference threshold, as determined by half SD (and SEM), for drop seizure reduction in the pooled RCTs was −18.4% (−20.1%).
CGIC seems an appropriate anchor to assess the thresholds for clinically meaningful reductions in drop seizure rate as determined by Spearman’s correlation between CGIC scores and monthly drop seizure reduction of 0.47.
Improvements in Condition: Subgroups
In the subgroup of pediatric patients (< 18 years, n = 146), the best clinically important response threshold for drop seizure reduction with a CGIC rating of “slightly improved” or better as the anchor was − 28.2%. In adult patients (≥ 18 years, n = 69), the equivalent best clinically important response threshold was − 37.8%. In the subgroup of patients receiving concomitant clobazam (n = 103), the best clinically important response threshold for drop seizure reduction with a CGIC rating of “slightly improved” or better as the anchor was −37.8% (Fig. 4). Thresholds with “much improved” or better as the anchor and minimal clinically important difference values are reported in Table 4.
| Pooled RCTs | ||
|---|---|---|
| Anchor: CGIC score of “slightly improved” or better | Anchor: CGIC score of “much improved” or better | |
| Pediatric patients (n = 146) | − 19.3 | − 14.9 |
| Adult patients (n = 69) | − 23.1 | − 22.7 |
| Patients on clobazam (n = 103) | − 22.6 | − 16.7 |
Discussion
The findings of this post hoc analysis of patients with LGS taking adjunctive CBD during the RCTs indicate that the threshold for a clinically meaningful reduction in drop seizure frequency was 31% when anchored to CGIC “slightly improved” or better. Anchoring more stringently to “much improved” or better, the threshold for a clinically important reduction was 47%. CGIC score was determined to be an appropriate anchor for defining what could be considered a clinically meaningful reduction in drop seizure rate, as indicated by a Spearman’s correlation of ≥ 0.30. Spearman’s correlation with an absolute value of ≥ 0.30 has previously been recommended to indicate the suitability of anchors and prevent the interpretation thresholds from being affected by random variation in a study in patients with narcolepsy and sleep apnea [32]. While the present study analyses a different disease state, the principle of this statistical approach in indicating the suitability of the anchors used still applies. Anchoring CGIC scores to the reduction in drop seizures by using both anchor-based methods (i.e., ROC curves) and distribution-based methods to determine the thresholds ensures the robustness of the findings from this post hoc analysis [32]. Most caregivers (60%) reported patients’ overall condition to be at least slightly improved during the 14-week treatment period with CBD. Caregiver ratings of “slightly improved” or better according to the CGIC were associated with a 31% reduction in drop seizure frequency. Anchoring more stringently to “much improved” or better, the threshold for a clinically important reduction was 47%.
The main treatment goal for patients with LGS is seizure reduction [33, 34]. The 50% cutoff for seizure reduction is used as an arbitrary threshold by regulatory authorities to ensure there is a consistent benchmark against which to assess new treatments in the clinical trial setting [23]. Other studies investigating the concept of clinically meaningful changes in seizure reduction in patients with LGS or DS align with this threshold of ≥ 50% but have not correlated changes with CGIC or otherwise examined the perspectives of caregivers and patients in determining what degree of a reduction is impactful for the patient [35, 36]. However, in the real-world setting, this arbitrary threshold does not account for factors beyond seizure reduction that may be impactful for patients when considering all outcomes [34]. For instance, if the adverse events are not serious or if there is a lack of availability of other interventions, lower thresholds should perhaps be considered in clinical practice [37].
LGS has a significant impact on the health-related quality of life and daily activities of patients and their caregivers and families [2, 3, 38]. There is a need to balance seizure reduction in the face of treatment resistance due to the drug-resistant nature of the seizures with non-seizure outcomes and the potential impact on quality of life of polypharmacy and treatment-related adverse events [34, 39]. Other challenges in the management of epilepsy beyond seizure control include neuropsychiatric comorbidity, behavioral difficulties, and increased risks of detrimental effects of antiseizure treatment, which are difficult to quantify due to patient-to-patient variability [40]. By correlating the extent of drop seizure reduction with the overall improvement in a patient’s condition, clinicians can adopt a more comprehensive perspective of treatment benefit. This approach fosters a more complete view of therapeutic outcomes [41].
In the present analysis, the minimal clinically important difference thresholds for drop seizure reduction were around 20%, depending on the anchor. These values, and those for a clinically important response anchored to at least a slight improvement in CGIC, suggest that a 50% cutoff for a meaningful reduction in drop seizure frequency would overlook valuable improvements in a patient’s overall condition as perceived by their caregivers. These thresholds apply to the analysis of treatment benefit across RCT populations in a controlled setting. In real-world practice, evaluating meaningful change and making treatment decisions for individual patients is more nuanced. Nevertheless, definitions of meaningful change may assist physicians in understanding what to expect from a treatment, and in considering how their patient’s experience compares with that of patients involved in the pivotal trials.
Clinically important response thresholds similar to the main analyses were observed in the pediatric (2–17 years), adult (≥ 18 years), and on-clobazam subgroup analyses. Even so, using a CGIC score of “slightly improved” or better as an anchor, the threshold for clinically important response in drop seizure reduction was higher in adult patients compared with pediatric patients, albeit there was no statistical comparison between these groups; however, using “much improved” or better identified a lower threshold for clinically important response in adult patients compared with pediatric patients. It is interesting to note that the thresholds for adult patients were the same (37.8%) for CGIC scores of “slightly improved” and “much improved,” while in children, there appeared to be a difference (− 28.2% for “slightly improved” or better and − 59.4% for “much improved” or better). The reason for this contrast is not clear, but it may indicate that caregivers of younger patients are more alert to or more able to notice a minor improvement, or that they have a higher expectation for “much improved.”
The study has several limitations that should not be overlooked, including the fact that the results of this post hoc analysis are exploratory rather than confirmatory; the relationship between seizure reduction and CGIC improvement is not definitively proven [42]. Measures such as CGIC scores are subjective, do not fully capture the entire spectrum of possible clinical improvements, and may introduce bias, thereby impacting the thresholds of clinically meaningful improvement [43]. Incorporating more standardized and objective measures, such as Vineland Adaptive Behavior Scales (VABS) and Child Behavior Checklist (CBCL) assessments would likely provide a more nuanced and complete picture of the clinical changes observed. Moreover, this issue highlights the need for improved tools to assess non-seizure outcomes in patients with LGS. Recent efforts have been made to develop such tools, which, if consistently used in clinical trial settings, could help give a more comprehensive view of non-seizure-related outcomes [44]. The inclusion of such measures should be considered for future evaluations in real-world settings. Adverse events are reported in full for each of the RCTs [9, 18] and were not included as part of this analysis. However, the tolerability of CBD can be considered to be reflected by the CGIC. As such, patients with high seizure reduction may not necessarily report an improvement in CGIC due to adverse events. The suitable number of participants in each anchor category was not determined with analytical tests. While we consider the sample size to be sufficient to provide reliable results, it is acknowledged that, when considering the exploratory subgroup analyses, the sample size of adult patients (n = 69) compared with pediatric patients (n = 146) further limits any speculative between-group comparisons. Furthermore, while adult patients are more likely to have used a greater number of previous ASMs compared with children, some pediatric and adolescent patients, particularly those with early-onset or treatment-resistant epilepsy, may also have extensive treatment histories, which may impact medication effectiveness [45]. Regarding the statistical analyses, the applied anchor-based and distribution-based methods may depend on data distribution. Thus, unbalancing or skewness on the underlying data structure may impact the performance metrics derived from the ROC curve or distribution statistics. As such, more than one approach to identify the clinically meaningful thresholds and consolidate interpretation of the results was used in the present analysis [46]. It is important to note that threshold identification using anchoring methods may oversimplify complex clinical relationships, particularly those influenced by hidden interactions or confounding variables. Finally, while ROC can be useful, treating physicians and patients are not likely to be familiar with the concepts of ROC AUC, and clinicians tend to focus on clinically relevant thresholds that are meaningful to patients [47]. As such, the contextualization of these statistical analyses provided herein is important to fully support clinical interpretation.
Conclusions
In this post hoc analysis of two pivotal RCTs, anchoring to a CGIC score of “slightly improved” or better, the threshold for a clinically meaningful reduction in drop seizure frequency was 31%, suggesting that a 50% cutoff may overlook patients with meaningful improvements in their overall condition, as perceived by their caregivers. CGIC was confirmed as an appropriate anchor to determine thresholds for clinically meaningful reductions in drop seizure rates in patients with LGS treated with CBD. By indicating the point at which a reduction in seizures is considered clinically impactful for a patient in terms of its correlation with an improvement in their symptom severity and treatment response (as measured by CGIC), these analyses may help physicians to contextualize the clinical trial data and better understand the potential patient benefit attained by reductions in seizure frequency that are < 50%. Further research into the use of CGIC and other standardized, more objective measures of clinical improvement as anchors for defining clinically meaningful responses in seizure reduction both in clinical and real-world settings is warranted.
Acknowledgements
Under the direction of the authors, medical writing support for the development of the outline and subsequent drafts of this manuscript was provided by Anna Boake, BSc; medical writing support for implementing revisions after peer review was provided by Lahoor Basha, PharmD, and editorial support (proofreading, formatting, and copyediting) was provided by Chiara Lee, Ph.D., all of Syneos Health, UK, and was funded by Jazz Pharmaceuticals, Inc. in accordance with Good Publication Practice (GPP 2022) guidelines (GPP 2022 (ismpp.org). Jazz Pharmaceuticals also reviewed and edited the manuscript for scientific accuracy. The authors would like to thank all of the study investigators, study staff, nursing team, and patients for their participation in the original clinical trials from which this post hoc analysis was derived.
Declarations
Funding
This post hoc analysis and open access fees for this publication were funded by Jazz Pharmaceuticals, Inc.
Conflicts of interest
N.S., S.A., L.L., and S.M.Z. have received consulting fees, conducted studies funded by, or received honoraria for services provided to Jazz Pharmaceuticals, Inc.; N.S. was also supported by Italian Ministry of Health with Current Research Funds; C.N. is an employee of Jazz Pharmaceuticals, Switzerland GmbH, with stock and/or stock options in the company, and T.G. is an employee of Jazz Pharmaceuticals, Inc, with stock and/or stock options in the company.
Ethics approval
Not applicable.
Consent to participate
Not applicable.
Consent for publication
Not applicable.
Availability of data and material
All relevant data are provided with the manuscript and supporting files. Jazz has established a process to review requests from qualified external researchers for data from Jazz-sponsored clinical trials in a responsible manner that includes protecting patient privacy, assurance of data security and integrity, and furthering scientific and medical innovation. Additional details on Jazz Pharmaceuticals data sharing criteria and process for requesting access can be found at: https://www.jazzpharma.com/science/clinical-trial-data-sharing/.
Code availability
Not applicable.
References
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