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Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events
TREXIMET should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD) or to patients with a history of CABG surgery (see CONTRAINDICATIONS). It is strongly recommended that sumatriptan-containing products not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of CAD and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history or electrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, TREXIMET should not be administered (see CONTRAINDICATIONS).
For patients with risk factors predictive of CAD who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of TREXIMET take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received sumatriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining an electrocardiogram (ECG) immediately following first-time use of TREXIMET in patients with risk factors.
It is recommended that patients who are intermittent long-term users of TREXIMET and who have or acquire risk factors predictive of CAD as described above undergo periodic cardiovascular evaluation as they continue to use TREXIMET.
The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to sumatriptan-containing products.
Cardiac Events and Fatalities Associated With 5-HT1 Agonists
Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of sumatriptan. Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low.
The fact that sumatriptan can cause coronary vasospasm, that some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD, and the close proximity of the events to sumatriptan use support the conclusion that some of these cases were caused by the drug. In cases, however, where there has been known underlying coronary artery disease, the relationship is uncertain.
Cardiovascular Thrombotic Events and Fatalities Associated With Nonsteroidal Anti-inflammatory Drugs
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years' an increased risk of serious cardiovascular duration have shown thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. To minimize the potential risk for an adverse cardiovascular event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the signs and/or symptoms of serious cardiovascular events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious gastrointestinal events (see WARNINGS: Risk of Gastrointestinal Ulceration, Bleeding, and Perforation With Nonsteroidal Anti-inflammatory Drug Therapy).
Premarketing Experience With TREXIMET
Among 3,302 patients with migraine who received TREXIMET in premarketing controlled and uncontrolled clinical trials, a 47-year-old female with cardiac risk factors in an open-label 12-month safety study experienced signs and symptoms of acute coronary syndrome approximately 2 hours after receiving TREXIMET.
Drug-Associated Cerebrovascular Events and Fatalities
Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral or subcutaneous sumatriptan, and some have resulted in fatalities. The relationship of sumatriptan to these events is uncertain. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should also be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., cerebrovascular accident, transient ischemic attack).
Other Vasospasm-Related Events
Sumatriptan may cause vasospastic reactions other than coronary artery vasospasm. Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported. Transient and permanent blindness and significant partial vision loss have been reported with the use of sumatriptan. Visual disorders may also be part of a migraine attack.
Increase in Blood Pressure
TREXIMET is contraindicated in patients with uncontrolled hypertension (see CONTRAINDICATIONS). TREXIMET should be used with caution in patients with controlled hypertension.
Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension receiving sumatriptan. Sumatriptancontaining products should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed.
NSAID-containing products can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. The potential effect on blood pressure associated with long-term use of TREXIMET has not been studied. Blood pressure should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
TREXIMET should be used with caution in patients with fluid retention or heart failure. Fluid retention and edema have been observed in some patients taking NSAIDs. Since each TREXIMET tablet contains 61.2 mg of sodium (about 2.7 mEq/500 mg of naproxen sodium), this should be considered in patients whose overall intake of sodium must be severely restricted.
The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with TREXIMET, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with TREXIMET and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see PRECAUTIONS: DRUG INTERACTIONS).
Risk of Gastrointestinal Ulceration, Bleeding, and Perforation With Nonsteroidal Anti-inflammatory Drug Therapy
TREXIMET contains an NSAID. NSAID-containing products can cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only 1 in 5 patients who develop a serious upper gastrointestinal adverse event on NSAID therapy is symptomatic. Upper gastrointestinal ulcers, gross bleeding, or perforation caused by NSAIDs appear to occur in approximately 1% of patients treated daily for 3 to 6 months and in about 2% to 4% of patients treated for 1 year. These trends continue with longer duration of use, increasing the likelihood of developing a serious gastrointestinal event at some time during the course of therapy. However, even short-term therapy is not without risk. Among 3,302 patients with migraine who received TREXIMET in premarketing controlled and uncontrolled clinical trials, 1 patient experienced a recurrence of gastric ulcer after taking 8 doses over 3 weeks, and 1 patient developed a gastric ulcer after treating an average of 8 attacks per month over 7 months.
NSAID-containing products, including TREXIMET, should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing gastrointestinal bleeding compared to patients with neither of these risk factors. Other factors that increase the risk for gastrointestinal bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal gastrointestinal events are in elderly or debilitated patients, and therefore special care should be taken in treating this population.
To minimize the potential risk for an adverse gastrointestinal event in patients treated with an NSAID-containing product, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of gastrointestinal ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse event is suspected. This should include discontinuation of the NSAID until a serious gastrointestinal adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and angiotensin-converting enzyme (ACE) inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease
Treatment with TREXIMET is not recommended in patients with advanced renal disease. If therapy with TREXIMET must be initiated, close monitoring of the patient's ee CLINICAL PHARMACOLOGY: Pharmacokineticsrenal function is advisable (s and PRECAUTIONS: Renal Effects). No information is available from controlled clinical studies regarding the use of TREXIMET in patients with advanced renal disease.
As with other NSAID-containing products, anaphylactic/anaphylactoid reactions may occur in patients without known prior exposure to naproxen. TREXIMET should not be given to patients with the aspirin triad. This symptom complex typically occurs in patients with asthma who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS, PRECAUTIONS: Preexisting Asthma, and PRECAUTIONS: DRUG INTERACTIONS).
Anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens (see CONTRAINDICATIONS). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
NSAID-containing products, including TREXIMET, can cause serious adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
TREXIMET should not be used in late pregnancy because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus. TREXIMET should not be used during early pregnancy unless the potential benefit justifies the potential risk to the fetus (see PRECAUTIONS: Pregnancy).
Chest discomfort and jaw or neck tightness have been reported following use of sumatriptan. Only rarely have these symptoms been associated with ischemic ECG changes. However, because sumatriptan may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following TREXIMET should be evaluated for the presence of CAD or a predisposition to Prinzmetal variant angina before receiving additional doses of TREXIMET and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur. Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome, following TREXIMET should be evaluated for atherosclerosis or predisposition to vasospasm (see WARNINGS: Cardiovascular Effects).
Diseases That May Alter the Absorption, Metabolism, or Excretion of Drugs
TREXIMET should also be administered with caution to patients with diseases that may alter the absorption, metabolism, or excretion of drugs, such as impaired renal function.
TREXIMET should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold. There have been reports of seizure following administration of sumatriptan.
Other Potentially Serious Neurologic Conditions
Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine headache or who experience a headache that is atypical for them. There have been reports where patients received sumatriptan for severe headaches that were subsequently shown to have been secondary to an evolving neurologic lesion (see WARNINGS: Drug-Associated Cerebrovascular Events and Fatalities). For a given attack, if a patient does not respond to the first dose of TREXIMET, the diagnosis of migraine should be reconsidered before administration of a second dose.
TREXIMET is contraindicated in patients with hepatic impairment (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY). A patient with symptoms and/or signs suggesting liver dysfunction or in whom an abnormal liver test has occurred should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with TREXIMET. Borderline elevations of 1 or more liver tests may occur in up to 15% of patients who take NSAID-containing products. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Notable (3 times the upper limit of normal) elevations of SGPT (ALT) or SGOT (AST) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported with NSAIDs. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with TREXIMET. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash), TREXIMET should be discontinued.
Overuse of acute migraine drugs (e.g. ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. Migraine patients should be informed about the risks of medication overuse, and encouraged to record headache frequency and drug use.
Binding to Melanin-Containing Tissues
In rats treated with a single subcutaneous dose (0.5 mg/kg) or oral dose (2 mg/kg) of radiolabeled sumatriptan, the elimination half-life of radioactivity from the eye was 15 and 23 days, respectively, suggesting that sumatriptan and/or its metabolites bind to the melanin of the eye. Because there could be an accumulation in melanin-rich tissues over time, sumatriptan could possibly cause toxicity in these tissues after extended use. However, no effects on the retina related to treatment with sumatriptan were noted in any of the oral or subcutaneous toxicity studies. Although no systematic monitoring of ophthalmologic function was undertaken in clinical trials and no specific recommendations for ophthalmologic monitoring are offered, prescribers should be aware of the possibility of long term ophthalmologic effects.
Sumatriptan causes corneal opacities and defects in the corneal epithelium in dogs (see Animal Toxicology). Adverse eye findings have also been observed in animal studies with some NSAIDs. Patients were not systematically evaluated for these changes in clinical trials. However, since the animal findings raise the possibility that adverse effects on the eye may occur in humans, it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs.
Caution is recommended in patients with preexisting kidney disease or dehydration (see WARNINGS: Renal Effects). Naproxen and its metabolites are eliminated primarily by the kidneys; therefore, TREXIMET should be used with caution in patients with significantly impaired renal function, and monitoring of serum creatinine and/or creatinine clearance is advised in these patients. TREXIMET is not recommended for use in patients with creatinine clearance less than 30 mL/min (see CLINICAL PHARMACOLOGY: Special Populations).
Patients on long-term treatment with NSAIDs, including TREXIMET, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, occult or gross gastrointestinal blood loss, or an incompletely described effect upon erythropoiesis. Patients receiving TREXIMET who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored. NSAID-containing products inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm that can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, TREXIMET should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Because serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of gastrointestinal bleeding. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash), or abnormal liver tests persist or worsen, TREXIMET should be discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of TREXIMET has not been studied.
The carcinogenic potential of sumatriptan was evaluated in oral carcinogenicity studies in mice (78 weeks) and rats (104 weeks). The highest dose administered to mice and rats (160 mg/kg/day) is approximately 9 and 18 times, respectively, the recommended human oral daily dose of 85 mg sumatriptan on a mg/m² basis. There was no evidence of an increase in tumors in either species related to sumatriptan administration.
The carcinogenic potential of naproxen sodium was evaluated in a 2-year oral carcinogenicity study in rats at doses of 8, 16, and 24 mg/kg/day and in another 2-year oral carcinogenicity study in rats at a dose of 8 mg/kg/day. No evidence of tumorigenicity was found in either study, at doses up to approximately 0.5 times the recommended human oral daily dose of 500 mg/day naproxen sodium on a mg/m² basis.
The combination of sumatriptan and naproxen sodium was negative in an in vitro mouse lymphoma tk assay in the presence and absence of metabolic activation. However, in separate in vitro mouse lymphoma tk assays, naproxen sodium alone was reproducibly positive in the presence of metabolic activation.
Naproxen sodium alone and in combination with sumatriptan was positive in an in vitro clastogenicity assay in mammalian cells in the presence and absence of metabolic activation. The clastogenic effect for the combination was reproducible within this assay and was greater than observed with naproxen sodium alone. Sumatriptan alone was negative in these assays.
Chromosomal aberrations were not induced in peripheral blood lymphocytes following 7 days of twice-daily dosing with TREXIMET in human volunteers.
In previous studies, sumatriptan alone was not mutagenic in 2 gene mutation assays (the Ames test and the in vitro Chinese Hamster V79/HGPRT assay) and was not clastogenic in 2 cytogenetics assays (the in vitro human lymphocyte assay and the in vivo rat micronucleus assay).
Impairment of Fertility
The effect of TREXIMET on fertility in animals has not been studied.
In a study in which male and female rats were dosed daily with oral sumatriptan prior to and throughout the mating period, there was a treatment-related decrease in fertility secondary to a decrease in mating in animals treated with 50 and 500 mg/kg/day. The highest no-effect dose for this finding was 5 mg/kg/day, or approximately 0.5 times the recommended human oral daily dose of 85 mg sumatriptan on a mg/m² basis. It is not clear whether the problem is associated with treatment of the males or females or both combined. In a similar study of sumatriptan by the subcutaneous route there was no evidence of impaired fertility at doses up to 60 mg/kg/day.
Pregnancy Category C
In developmental toxicity studies in rabbits, oral treatment with sumatriptan combined with naproxen sodium (5/9, 25/45, or 50/90 mg/kg/day sumatriptan/naproxen sodium) or each drug alone (50/0 or 0/90 mg/kg/day sumatriptan/naproxen sodium) resulted in decreased fetal body weight in all treated groups and in increased embryofetal death at the highest dose of naproxen, alone and in combination with sumatriptan. Naproxen sodium, alone and in combination with sumatriptan, increased the total incidences of fetal abnormalities at all doses and increased the incidences of specific malformations (cardiac interventricular septal defect in the 50/90-mg/kg/day group, fused caudal vertebrae in the 50/0- and 0/90-mg/kg/day groups) and variations (absent intermediate lobe of the lung, irregular ossification of the skull, incompletely ossified sternal centra) in the 50/0- and 0/90-mg/kg/day groups. A no-effect dose for development toxicity in rabbits was not established. The lowest effect dose was 5/9 mg/kg/day sumatriptan/naproxen sodium, which was associated with plasma exposures (AUC) to sumatriptan and naproxen that were 1.4 and 0.14 times, respectively, those attained at the maximum recommended human oral daily dose of 85 mg sumatriptan and 500 mg naproxen sodium.
In previous developmental toxicity studies in rats and rabbits, oral treatment with sumatriptan was associated with embryolethality, fetal abnormalities, and pup mortality. Oral treatment of pregnant rats with sumatriptan during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities and decreased pup survival at doses of 250 mg/kg/day or higher. The highest no-effect dose was approximately 60 mg/kg/day, which is approximately 7 times the recommended human oral daily dose of 85 mg sumatriptan on a mg/m² basis. Oral treatment of pregnant rabbits with sumatriptan during the period of organogenesis resulted in an increased incidence of cervicothoracic vascular and skeletal abnormalities at a dose of 50 mg/kg/day and embryolethality at 100 mg/kg/day. The highest no-effect dose for embryotoxicity in rabbits was 15 mg/kg/day, or approximately 3 times the recommended human oral daily dose of 85 mg sumatriptan on a mg/m² basis.
Inhibitors of prostaglandin synthesis (including naproxen) are known to delay parturition. Because of this and the known effects of drugs of this class on the human fetal cardiovascular system (closure of the ductus arteriosus), use during third trimester should be avoided.
There are no adequate and well-controlled studies in pregnant women.
TREXIMET should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
To monitor fetal outcomes of pregnant women exposed to TREXIMET, GlaxoSmithKline maintains a TREXIMET Pregnancy Registry. Physicians are encouraged to register patients as soon as possible after they become pregnant and (if possible) before the outcome of the pregnancy is known by calling (800) 336-2176.
Labor and Delivery
In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. Naproxen-containing products are not recommended in labor and delivery because, through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
Both active components of TREXIMET, sumatriptan and naproxen sodium, have been reported to be excreted in human breast milk. Because of the possible adverse effects of these drugs on neonates, use of TREXIMET in nursing mothers should be avoided.
Safety and effectiveness of TREXIMET in pediatric patients have not been established.
TREXIMET is contraindicated for use in elderly patients who have abnormal hepatic function, and is not recommended for use in elderly patients who have decreased renal function, higher risk for unrecognized CAD, and increases in blood pressure that may be more pronounced in the elderly (see CONTRAINDICATIONS: Hepatic Impairment, WARNINGS: Cardiovascular Effects, and CLINICAL PHARMACOLOGY: Pharmacokinetics).
Last reviewed on RxList: 12/2/2011
This monograph has been modified to include the generic and brand name in many instances.
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