Does Presymptomatic Treatment of Spinal Muscular Atrophy Improve Outcomes?
BACKGROUND AND PURPOSE:
Biallelic SMN1 deletions and three SMN2 copies usually leads to the development of spinal muscular atrophy (SMA) type 2 in childhood
Onasemnogene abeparvovec is gene replacement therapy
Delivers SMN cDNA using an adeno-associated virus-9 (AAV9) vector
Single IV infusion
Strauss et al. (Nature Medicine, 2022) investigated the efficacy and safety of onasemnogene abeparvovec treatment for pre-symptomatic children with SMA type 2
METHODS:
Open-label, single-arm, Phase III study
16 sites in 6 countries
Participants
Infants identified with SMA through newborn screening
Normal neuromuscular function who were able to swallow and breathe normally
Intervention
Onasemnogene abeparvovec
Study design
Single infusion over 60 minutes
Multiple outpatient assessment visits through 24 months of age
Primary outcome
Independent standing, for at least 3 seconds at any visit up to 24 months of age
Secondary outcome
Walking independently, for at least five steps at any visit up to 24 months of age
RESULTS:
15 children | 9 female
Median gestational age at birth: 39 weeks
Median weight: 3.4 kg
Median age at time of molecular confirmation: 8 days
At screening, all children had normal neuromuscular function
Standing independently at 24 months (P<0.0001)
Treatment group: 100% (14 occurred within normal developmental window)
Natural history population: 24%
Walking independently at 24 months (P<0.0001)
Treatment group: 93%
Natural history population: 21%
All children survived without permanent ventilation at 14 months
Maintained body weight (≥3rd WHO percentile) without feeding support through 24 months: 67%
No children required nutritional or respiratory support
There were no serious adverse events that were treatment-related
CONCLUSION:
For asymptomatic infants with SMA type 2, onasemnogene abeparvovec was effective and safe
Most treated children were able to sit and walk independently at 24 months of age
The authors state
Given the durability of benefit observed in the follow-up study of the Phase I START trial, and the fact that motor neurons are non-dividing cells, we are optimistic that one-time treatment with onasemnogene abeparvovec will add years of independent mobility, intact bulbar function, and good health-related quality of life for children in the three-copy cohort
Meta-Analysis: Idiopathic Polyhydramnios and Adverse Pregnancy Outcomes
BACKGROUND AND PURPOSE:
Pagan et al. (Ultrasound in Obstetrics & Gynecology, 2022) analyzed pregnancy outcomes in singleton pregnancies with idiopathic polyhydramnios
METHODS:
Systematic review and meta-analysis
Study Inclusion criteria
Prospective and retrospective studies
Presence of a control group (normal amniotic fluid volume)
Singleton pregnancies
Idiopathic polyhydramnios: Identified using sonographic amniotic fluid volume assessment
Study design
Polyhydramnios definition: Four-quadrant AFI with polyhydramnios ≥24 cm or single deepest pocket (SDP) ≥8 cm | AFI >25 cm also included (commonly used definition)
Idiopathic polyhydramnios: No etiology identified on ultrasound
Effect estimates expressed as odds ratio (OR) and its corresponding 95% CI
Pregnancies complicated by idiopathic polyhydramnios had higher odds of
Neonatal death: OR 8.68 (95% CI, 2.91 to 25.87)
Intrauterine fetal demise: OR 7.64 (95% CI, 2.50 to 23.38)
NICU admission: OR 1.94 (95% CI, 1.45 to 2.59)
5-minute APGAR score <7: OR 2.21 (95% CI, 1.34 to 3.62)
Macrosomia: OR 2.93 (95% CI, 2.39 to 3.59)
Malpresentation: OR 2.73 (95% CI, 2.06 to 3.61)
Cesarean delivery: OR 2.31 (95% CI, 1.79 to 2.99)
CONCLUSION:
Pregnancies with idiopathic polyhydramnios are associated with increased odds of adverse pregnancy outcomes, particularly neonatal death and intrauterine fetal demise
Antenatal fetal surveillance may be a consideration for pregnancies with idiopathic polyhydramnios
The authors state
Currently, there is insufficient data on the threshold of the AFV (mild, moderate or severe) at which antenatal testing should be initiated
Future investigations are needed to determine an AFV threshold above which antenatal testing would be helpful
RCT Results: Does Relugolix Combined with Estradiol and Progestin Improve Endometriosis Pain While Preserving Bone Mineral Density?
BACKGROUND AND PURPOSE:
Relugolix is an oral gonadotropin-releasing hormone receptor antagonist
Combined with estradiol and a progestin to limit hot flashes and maintain bone mineral density
Giudice et al. (The Lancet, 2022) evaluated the efficacy and safety of relugolix combined with estradiol and a progestin for the treatment of endometriosis-related pain
METHODS:
Two phase 3, multicenter, randomized, double-blind, placebo-controlled trials
Participants
Women 18 to 50 years
Multicenter: Africa | Australasia | Europe | North America | South America
Women had either
Surgically or directly visualized endometriosis with or without histological confirmation
Endometriosis with histological diagnosis alone
Eligible women had
Moderate to severe endometriosis-associated pain during the 35-day run-in period
Dysmenorrhea Numerical Rating Scale (NRS) score of ≥4.0 on two or more days
Mean non-menstrual pelvic pain NRS score of ≥2.5 or a mean score of ≥1.25 that included a score of ≥5 on ≥4 days
Delayed relugolix combination therapy (relugolix 40 mg monotherapy followed by relugolix combination therapy, each for 12 weeks)
Placebo
Study design
Randomization 1:1:1
Efficacy and safety were analyzed in the modified intent-to-treat population
Post-treatment follow-up for safety, specifically for bone mineral density and menses recovery, is ongoing at the time of publication
Primary outcomes
Responder rates at week 24 for dysmenorrhea and non-menstrual pelvic pain
RESULTS:
SPIRIT 1: 638 patients | SPIRIT 2: 623 patients
Dysmenorrhea responder criteria was significantly improved with combination therapy
SPIRIT 1
Relugolix combination therapy: 75%
Placebo: 27%
Treatment difference 47.6% (95% CI, 39.3 to 56.0); p<0.0001
SPIRIT 2
Relugolix combination therapy: 75%
Placebo: 30%
Treatment difference 44.9% (95% CI, 36.2 to 53.5); p<0.0001
Non-menstrual pain was significantly improved with combination therapy
SPIRIT 1
Relugolix combination therapy: 58%
Placebo: 40%
Treatment difference 18.9% (95% CI, 9.5 to 28.2); p<0.0001
SPIRIT 2
Relugolix combination therapy: 66%
Placebo: 43%
Treatment difference 23.4% (95% CI, 13.9 to 32.8); p<0.0001
Delayed relugolix combination was also associated with pain improvement (p<0.0001 for treatment difference vs placebo)
Dysmenorrhea
SPIRIT 1: 72%
SPIRIT 3: 73%
Non-menstrual pelvic pain
SPIRIT 1: 58%
SPIRIT 2: 53%
Most common adverse events
Headache
Nasopharyngitis
Hot flushes
There were nine reports of suicidal ideation across both studies
Placebo run-in: 2 reports
Placebo: 2
Relugolix combination therapy: 2
Delayed relugolix combination therapy: 3
There were no deaths
Bone mineral density loss in the relugolix combination therapy groups was higher than in placebo, but was less than 1% in both studies
SPIRIT 1
Relugolix combination therapy: –0.70%
Delayed relugolix combination: –2.0%
Placebo: 0.21%
SPIRIT 2
Relugolix combination therapy: –0.78%
Delayed relugolix combination: –1.9%
Placebo: 0.02%
Decreases in opioid use were seen in treated patients as compared with placebo
CONCLUSION:
Endometriosis-associated pain was significantly improved with relugolix combination therapy
The combination therapy was well tolerated, with minimal bone mineral density losses, and mostly minor adverse side effects
Combination therapy may allow for long-term treatment that does not rely on opioid use or repeat surgical intervention
The authors state
The combination of relugolix, estradiol, and norethisterone acetate might provide the therapeutic benefits of GnRH receptor antagonism to suppress endogenous oestradiol concentrations and improve symptoms of endometriosis while minimising the risk of hypoestrogenic-related bone loss and vasomotor symptoms, potentially enabling long-term use
Does Genetic Testing for Familial Hypercholesterolemia Improve Disease Detection vs Clinical Features Alone?
BACKGROUND AND PURPOSE:
Heterozygous familial hypercholesterolemia (FH) is a common, heritable disorder that causes premature cardiovascular disease
Despite the genetic basis of FH, there is no national screening program in the US to identify individuals with pathogenic or likely pathogenic variants
Bellows et al. (Journal of the American Heart Association) sought to determine if using genetic testing would enhance screening methods based on clinical factors only
METHODS:
Population
UK Biobank participants
Exposures
Clinical characteristics
FH variant status
Study design
A regression model to predict the probability of having any FH variants was developed using participant exposure statuses
The regression model and modified Dutch Lipid Clinic Network criteria were applied to adult participants in the National Health and Nutrition Examination Survey (NHANES) to estimate the yield of FH screening programs using
49,738 UK Biobank participants used for regression model generation | 39,790 participants in NHANES used to estimate yield of screening
The regression model accurately predicted FH variant status in UK Biobank participants
Observed prevalence: 0.27%
Predicted prevalence: 0.26%
Area under the receiver-operator characteristic (ROC) curve: 0.88
In NHANES, estimated yield per 1000 individuals screened
With Dutch Lipid Clinic Network clinical criteria alone
3.7 cases (95% CI, 3.0 to 4.6)
With genetic testing alone
3.8 cases (95% CI, 2.7 to 5.1)
With combination of clinical criteria with genetic testing
6.6 cases (95% CI, 5.3 to 8.0)
In young adults 20 to 39 years
Clinical criteria alone: Estimated to yield 1.3 FH cases per 1000 people screened (95% CI, 0.6 to 2.5)
Addition of genetic testing: Estimated to increase to 4.2 FH cases (95% CI, 2.6 to 6.4)
CONCLUSION:
Combining genetic screening with clinical criteria may improve detection of FH, increasing opportunities for early treatment
The authors state
Targeted screening strategies, such as offering genetic testing to adults with an LDL‐C ≥160 mg/dL or adults aged 20 to 39 years, may increase screening yield, and could allow for earlier identification and treatment of FH
RCT Results: Is the Mediterranean Diet or a Low-Fat Diet Better for Secondary Prevention of Cardiovascular Disease?
BACKGROUND AND PURPOSE:
Mediterranean and low-fat diets are both protective against cardiovascular disease (CVD)
Whether these diets are also effective at secondary prevention of CVD, and whether one diet is better than the other, is understudied
Delgado-Lista et al. (The Lancet, 2022) performed a long-term randomized trial to compare the effects of these two diets in secondary prevention of CVD
METHODS:
Single-center, randomized clinical trial
The CORDIOPREV study
Participants
Patients with established coronary heart disease
20 to 75 years
Interventions
Mediterranean diet
Low-fat diet
Study design
Follow-up: 7 years
Clinical investigators were masked to treatment assignment, but participants were not
There was a higher incidence of the primary outcome in the participants assigned to the low-fat diet
Mediterranean: 28.1 per 1000 person-years (95% CI, 27.9 to 28.3)
Low-fat: 37.7 per 1000 person-years (95% CI, 37.5 to 37.9)
Log-rank p=0.039
Adjusted hazard ratios (HRs) of the different models favored the Mediterranean diet
Range: 0.719 (95% CI, 0.541 to 0.957) to 0.753 (95% CI, 0.568 to 0.998)
These effects were more pronounced in men
Mediterranean: 16.2% experienced primary outcome
Low-fat: 22.8% experienced primary outcome
Multi-adjusted HR 0.669 (95% CI, 0.489 to 0.915); log-rank p=0.013
In women, no difference was found between groups
CONCLUSION:
For the secondary prevention of CVD, a Mediterranean diet was more effective than a low-fat diet
Inability to find a difference among women may be due to study being underpowered in the female group or there is a sex factor difference in dietary response
The authors state
In summary, the CORDIOPREV study reports that a Mediterranean diet is superior to a low-fat diet in preventing major cardiovascular events in secondary prevention of cardiovascular disease
BMI ≥27 and at least one weight-related complication, excluding diabetes
Interventions
Once-weekly, subcutaneous tirzepatide for 72 weeks at
5 mg
10 mg
15 mg
Placebo
Study design
Randomization: 1:1:1:1
There was a 20-week dose-escalation period
Intention-to-treat population: Effects assessed regardless of treatment discontinuation
Primary outcomes
Percentage change in weight from baseline
Weight reduction ≥5%
RESULTS:
2539 participants
Mean body weight at baseline: 104.8 kg
Mean BMI at baseline: 38.0
BMI ≥30: 94.5%
Compared to placebo, the mean percentage change in weight at week 72 was greater with all dosages (P<0.001)
5-mg doses: −15.0% (95% CI, −15.9 to −14.2)
10-mg doses: −19.5% (95% CI, −20.4 to −18.5)
15-mg doses: –20.9% (95% CI, −21.8 to −19.9)
Placebo: −3.1% (95% CI, −4.3 to −1.9)
Percentage of participants who had weight reduction of ≥5% (P<0.001 for all comparisons with placebo)
5-mg doses: 85% (95% CI, 82 to 89)
10-mg doses: 89% (95% CI, 86 to 92)
15-mg doses: 91% (95% CI, 88 to 94)
Placebo: 35% (95% CI, 30 to 39)
Percentage of participants with a reduction in body weight of ≥20% (P<0.001 for all comparisons with placebo)
10-mg doses: 50% (95% CI, 46 to 54)
15-mg doses: 57% (95% CI, 53 to 61)
Placebo: 3% (95% CI, 1 to 5)
Tirzepatide led to improvements in all prespecified cardiometabolic measures
Most common adverse events were gastrointestinal
Most were mild to moderate in severity
Adverse events causing treatment discontinuation
5-mg doses: 4.3%
10-mg doses: 7.1%
15-mg doses: 6.2%
Placebo: 2.6%
CONCLUSION:
For patients with obesity, tirzepatide, at doses of 5-mg, 10-mg and 15-mg, improved body weight reduction vs placebo
The authors state
This is an unusually substantial degree of weight reduction in response to an antiobesity medication as compared with findings reported in other phase 3 clinical trials
Given that tirzepatide is both a GIP receptor and GLP-1 receptor agonist, we speculate that there may be additive benefit in targeting multiple endogenous nutrient-stimulated hormone pathways that have been implicated in energy homeostasis
RCT Results: Would Double Dosing Emergency Oral Contraceptives Improve Outcomes in Those with Obesity?
BACKGROUND AND PURPOSE:
Obesity is a risk factor for emergency contraception failure
Edelman et al. (Obstetrics & Gynecology, 2022) assessed whether doubling the dose of emergency levonorgestrel (LNG)-containing oral contraception improves pharmacodynamic outcomes in individuals with obesity
METHODS:
Randomized controlled trial
Participants
18 to 35 years
Regular menstrual cycles (21 to 35 days)
BMI >30
Weight ≥176 lbs
Interventions
Single dose: 1.5 mg LNG
Double dose: 3 mg LNG
Study design
Ovulation was confirmed in all participants (luteal progesterone level >3 ng/mL)
Participants were monitored with transvaginal ultrasonography and blood sampling for progesterone, LH, and estradiol every other day
Intervention provided at the point when a dominant follicle ≥15 mm was identified
Daily monitoring for up to 7 days
Power analysis
80% power to detect a 30% difference in the proportion of cycles with at least a 5 day delay in follicle rupture (50% decrease)
5% significance level
Sample size calculation: 70 participants (taking into account potential drop out)
Primary outcome
Difference in the proportion of participants with no follicle rupture 5 days postdosing between groups
RESULTS:
70 total participants
Mean age 28 years | Mean BMI 38
No difference seen in the proportion of participants without follicle rupture more than 5 days post–LNG dosing between the groups
LNG 1.5 mg: 51.4%
LNG 3.0 mg: 68.6%
P=0.14
Among participants with follicle rupture before 5 days, the time to rupture did not differ between groups
The day at which there was a 75% probability of no rupture is day 2 for both groups
CONCLUSION:
Doubling the dose of LNG-based emergency oral contraceptive did not improve rate of ovulation inhibition in participants with obesity, suggesting that double dosing would not improve outcomes in this population
Limitations of this study include ovulation inhibition being used as a proxy for ovulation | Actual outcome of interest would be pregnancy rate
The authors state
Our results do not support a recommendation of double dosing of LNG for emergency contraception in individuals with obesity
Clinical studies suggest that emergency contraception with LNG does not work in women who weigh more than 70 kg, but that ulipristal acetate appears effective
Meta-Analysis: Azithromycin vs Erythromycin for PPROM
BACKGROUND AND PURPOSE:
Seaman et al. (AJOG, 2022) estimated the effect of erythromycin vs azithromycin on the latency and the rate of clinical chorioamnionitis in women with PPROM
METHODS:
Systematic review and meta-analysis
Study inclusion criteria
Studies comparing duration of latency and the rate of clinical chorioamnionitis in the setting of PPROM
Patients treated with erythromycin and azithromycin
Study design
Mean differences and odds ratios (OR) with 95% confidence intervals were estimated for outcomes
Results pooled using random effects model
Chorioamnionitis diagnosis: ≥2 of the following signs and symptoms
Mean length of latency in women with PPROM was similar between individuals treated with erythromycin and azithromycin
Erythromycin: 6.6 days
Azithromycin: 6.7 days
Mean difference 0.07 days (95% CI, −0.45 to 0.60)
Median point prevalence rates of clinical chorioamnionitis
Erythromycin: 25% (95% CI, 12 to 32)
Azithromycin: 14% (95% CI, 9 to 24)
The overall clinical chorioamnionitis rate in women treated with azithromycin was lower than women treated with erythromycin
Pooled OR: 0.53 (95% CI, 0.39 to 0.71)
Neonatal outcomes were similar between groups for the following
Neonatal sepsis | RDS | Perinatal death
CONCLUSION:
Treating PPROM with azithromycin and erythromycin results in similar latency period
There was a lower rate of chorioamnionitis with azithromycin treatment
Limitations of the study include lack of any trials that randomized patients to one macrolide antibiotic vs the other
The authors state
Organizations involved in national guideline development weighing the harms and benefits in the context of the current strength of evidence available may consider revising the existing recommendation for the use of the macrolide erythromycin with PPROM to allow alternative macrolide regimens
However, until the result of prospective RCTs currently ongoing are available, contemporary guidelines recommend using erythromycin concurrently with a beta-lactam antibiotic unless erythromycin is unavailable, or the patient does not tolerate its administration
More Evidence: Is Prenatal Antiseizure Medication Exposure Linked to Childhood Neurodevelopmental Impairment?
BACKGROUND AND PURPOSE:
Bjørk et al. (JAMA Neurol, 2022) assessed whether prenatal antiseizure medication (ASM) is associated with increased risk for neurodevelopmental disorders
METHODS:
Population-based cohort study
Nordic register-based study of antiepileptic drugs in pregnancy (SCAN-AED)
Population
Mother-child pairs in Denmark, Finland, Iceland, Norway, and Sweden
From 1996 to 2017
Exposure
Prenatal exposure to ASM: Derived from maternal prescription fills
Study design
Cox proportional hazards regression was used to generate hazard ratios (HR), with adjustment for potential confounders
Primary outcome
Cumulative incidence of neurodevelopmental disorders at age 8 years in exposed and unexposed children
Autism spectrum disorder (ASD)
Intellectual disability (ID)
Any neurodevelopmental disorder (ASD and/or ID)
RESULTS:
4,494,926 mother-child pairs
50.3% male, median (IQR) age at end of follow-up: 8 (4.0 to 12.1) years
Neurodevelopmental disorders were more likely in children whose mothers had epilepsy and were taking ASM, compared to children whose mothers had epilepsy but were not taking ASM
No exposure
ASD diagnosis: 1.5%
ID diagnosis: 0.8%
Topiramate monotherapy
ASD: 4.3%
aHR 2.8 (95% CI, 1.4 to 5.7)
ID: 3.1%
aHR 3.5 (95% CI, 1.4 to 8.6)
Valproate monotherapy
ASD: 2.7%
aHR 2.4 (95% CI, 1.7 to 3.3)
ID: 2.4%
aHR 2.5 (95% CI, 1.7 to 3.7)
Some duotherapies were also associated with increased risks of neurodevelopmental disorders in children of women with epilepsy
Levetiracetam with carbamazepine
8-year cumulative incidence: 5.7%
aHR 3.5 (95% CI, 1.5 to 8.2)
Lamotrigine with topiramate
8-year cumulative incidence: 7.5%
aHR 2.4 (95% CI, 1.1 to 4.9)
Evetiracetam with lamotrigine was not associated with an increased risk of neurodevelopmental disorders
8-year cumulative incidence: 1.6%
aHR 0.9 (95% CI, 0.3 to 2.5)
CONCLUSION:
This study demonstrates significant associations between certain prenatal antiseizure medications and neurodevelopmental disorders in offspring
Associations persisted after adjusting for confounding factors
The authors state
…prenatal exposure to topiramate and valproate was associated with a risk of ASD and ID, which increased with higher doses
ASM duotherapies, except lamotrigine with levetiracetam, were similarly associated with neurodevelopmental disorders
Meta-analysis: Estrogen-Containing Contraceptives and VTE Recurrence
BACKGROUND AND PURPOSE:
Wiegers et al. (Journal of Thrombosis and Haemostasis, 2022) determined the rate of recurrent VTE after discontinuation of anticoagulant treatment in women with a first episode of VTE related to estrogen-containing contraceptives
METHODS:
Systematic review and meta-analysis
Study inclusion criteria
Prospective and retrospective studies
Studies that reported on recurrence after a first VTE (DVT or PE) related to estrogen-containing contraceptives | Mean age <50 years
Focus on combined oral estrogen-containing contraceptives and estrogen-containing vaginal patches or rings
Patients completed ≥3 months of anticoagulant treatment
Study design
Recurrence rates per 100 patient-years
Data pooled using random-effects model
Incidence rates were reported separately based on
Study follow-up duration (≤1 year, 1 to 5 years, and >5 years)
Subgroup analyses
Primary Outcome
VTE Recurrence rates
RESULTS:
14 studies
Pooled recurrence rate
1.57 per 100 patient-years (95% CI, 1.10 to 2.23)
Recurrence rate by follow-up duration
≤1 year follow-up
2.73 per 100 patient-years (95% CI, 0.00 to 3643)
1 to 5 years of follow-up
1.35 per 100 patient-years (95% CI, 0.68 to 2.68)
>5 years of follow-up
1.42 per 100 patient-years (95% CI, 0.84 to 2.42)
CONCLUSION:
Risk of VTE recurrence after a primary VTE incident related to estrogen-containing contraception appears to be low
The authors suggest that short-term anticoagulation is the favorable treatment option
Limitations of this study include insufficient data to determine the impact of different formulations and types of estrogen-containing contraceptives | Large prospective studies are needed
The authors state
The risk of VTE recurrence in women with estrogen-containing contraceptives appears to be low, which supports short-term anticoagulation for 3–6 months after VTE related to estrogen-containing contraceptives
However, data and contributing risk factors for this specific patient population are limited and strong recommendations about duration of anticoagulants cannot be made
What is the Live Birth Rate After Oocyte Cryopreservation?
BACKGROUND AND PURPOSE:
Data are limited regarding live birth rate following oocyte cryopreservation
Cascante et al. (Fertility and Sterility, 2022) reviewed outcomes of patients who underwent autologous oocyte thaw after planned oocyte cryopreservation
METHODS:
Retrospective cohort study
Population
All patients who underwent ≥1 autologous oocyte thaw before December 2020
Primary outcome
Final live birth rate (FLBR) per patient
Inclusion: Patients who had a live birth or consumed all remaining oocytes or embryos
Median time between first cryopreservation and thaw: 4.2 years
The median numbers of thawed
Oocytes: 14 per patient
Metaphase II oocytes (M2s): 12 per patient
Overall survival of all thawed oocytes: 79%
Patients who underwent ≥1 transfer: 61%
Usable embryos derived from
Thawed M2s: 25%
Live birth rates
For euploid transfers (n=262): 55%
For nonbiopsied transfers (n=158): 31%
FLBR per patient: 39%
Age at cryopreservation and the number of M2s thawed were predictive of live birth
The FLBR per patient was >50% for patients aged <38 years at cryopreservation or who thawed ≥20 M2s
CONCLUSION:
For patients who underwent transfer of autologous thawed oocytes, the final live birth rate was 39%
Comparable to the final live birth rate with age-matched IVF
Limitation of this study includes small sample size | Analyses in larger cohorts are necessary
The authors state
This study is the largest US report of thaw outcomes from OC performed for age-related fertility decline and provides important insight into OC outcomes
Our results provide realistic expectations for those considering OC and demonstrate that OC empowers women with reproductive autonomy
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