US Pharm. 2024;49(10):17-23.

New molecular entities (NMEs), as defined by the FDA, are new drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in 2023–2024 (TABLE 1) highlight the basic clinical and pharmacologic profiles for each new drug, as well as key precautions and warnings. Also included are brief summaries of selected dosing, pharmacokinetic, adverse-reaction (AR), and drug-interaction information submitted to the FDA in support of the manufacturer’s New Drug Application. This review is intended to be objective rather than evaluative in content. The information for each NME was obtained primarily from sources published prior to FDA approval. Experience clearly demonstrates that some aspects of an NME’s therapeutic profile are not detected in premarketing clinical studies and emerge after the drug is used in the broader population. For example, previously unreported ARs become apparent for some NMEs within several years of their marketing. Some NMEs may even acquire at least one black box warning for serious ARs or be withdrawn from the market for safety reasons not recognized at the time of approval. Therefore, while this review offers an introduction to certain new drugs, it is essential that practitioners be aware of changes in their therapeutic profiles as reported in the pharmaceutical and medical literature and by patients.


LetibotulinumtoxinA-wlbg (Letybo, Hugel)

Indication and Clinical Profile1,2: LetibotulinumtoxinA-wlbg is approved for treatment of moderate-to-severe frown (glabellar) lines in adults. Glabellar lines appear in the skin over the forehead, between and above the eyebrows and the nose. Over time, as a result of skin tightness, muscle activity, face shape, genetics, and various intrinsic and extrinsic causes, the glabellar lines may remain permanently, evolving into wavy furrows in the forehead.

The efficacy and safety of letibotulinumtoxinA-wlbg were demonstrated in three clinical trials (BLESS I, BLESS II, and BLESS III) involving >1,000 participants aged 18 to 75 years with moderate-to-severe glabellar lines. These trials were conducted at 31 sites in the United States and the European Union. Patients received a single IM injection of letibotulinumtoxinA-wlbg or placebo at five sites within the muscles between the eyebrows. Improvement of wrinkles from baseline to week 4 was assessed independently by both the investigator and the patient using the Glabellar Line Scale, a 4-point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). In all three trials, patients with moderate-to-severe (i.e., grade 2 or 3) wrinkles between the eyebrows had improvement of frown lines 4 weeks after treatment with letibotulinumtoxinA-wlbg. In BLESS I, 47% of patients treated with letibotulinumtoxinA-wlbg had temporary improvement of wrinkles between the eyebrows compared with 0% of patients in the placebo group. In BLESS II, 49% of patients treated with letibotulinumtoxinA-wlbg had temporary improvement of wrinkles between the eyebrows compared with 2% of placebo patients. In BLESS III, 65% of patients treated with letibotulinumtoxinA-wlbg had temporary improvement of wrinkles between the eyebrows compared with 0% of placebo patients.

Pharmacology and Pharmacokinetics1,2: LetibotulinumtoxinA-wlbg is a 900 kDa botulinum toxin type A produced from fermentation of Clostridium botulinum. It acts as an acetylcholine release inhibitor. Specifically, botulinum toxin cleaves key proteins required for nerve activation. First, the toxin binds specifically to the presynaptic surface of cholinergic neurons. Once bound, it is taken up into the nerve by vesicle by receptor-mediated endocytosis. When inside the nerve, the toxin is released to the cytoplasm, where it cleaves SNARE proteins. These proteins are required for acetylcholine vesicles to bind to the intracellular cell membrane. Inhibition of SNARE proteins prevents the nerve cell from releasing vesicles of neurotransmitters, stopping nerve signaling and leading to flaccid paralysis.

Adverse Reactions and Drug Interactions1,2: The most common side effects of letibotulinumtoxinA-wlbg in trials included headache, drooping of eyelid and brow, eyelid twitching, and headache. The product contains a black box warning stating that the effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. The product is contraindicated in cases of known hypersensitivity to any botulinum toxin preparation or to any of the components in the letibotulinumtoxinA-wlbg formulation and when there is infection at the injection site. Additional warnings include potential spread of toxin effects that may compromise swallowing and breathing and possible hypersensitivity reactions. Also, caution should be exercised when using this drug in patients with preexisting cardiovascular disease, compromised respiratory function, dysphagia, or a concomitant neuromuscular disorder.

Dosage and Administration1,2: LetibotulinumtoxinA-wlbg is supplied as a single-dose vial containing 50 Units or 100 Units of freeze-dried powder. The recommended dose of this medication is 0.1 mL (4 Units) by IM injection into each of five sites, for a total dose of 20 Units.

Bimekizumab-bkzx (Bimzelx, UCB)

Indication and Clinical Profile3,4: Bimekizumab-bkzx is indicated for treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Plaque psoriasis is the most common type of psoriasis, causing dry, itchy, raised skin patches covered with scales (plaques), usually on the elbows, knees, lower back, and scalp. The affected skin might heal with temporary changes in color (hyperpigmentation). Psoriasis is thought to result from dysregulation of the immune system and is facilitated by a variety of cytokines released by dendritic cells and T-helper cells.

Bimekizumab-bkzx was approved for use in the European Union in August 2021. In the United States, FDA approval was based on results from three phase III, multicenter, randomized, placebo-controlled trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of bimekizumab-bkzx in 1,480 adults with moderate-to-severe plaque psoriasis. More than 80% of patients receiving bimekizumab-bkzx (320 mg every 4 weeks) achieved at least 90% improvement in Psoriasis Area and Severity Index score (PASI 90) and an Investigator Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1) at week 16. Approximately 60% of patients achieved PASI 100 at week 16. Clinical responses were rapid, with >70% of patients achieving PASI 75 at week 4 following one dose (320 mg). Patients treated with bimekizumab-bkzx achieved superior levels of skin clearance at week 16 compared with those who received placebo (BE READY and BE VIVID), ustekinumab (BE VIVID), or adalimumab (BE SURE). Clinical responses achieved with bimekizumab-bkzx at week 16 (PASI 90 and PASI 100) were maintained for up to 1 year. Long-term data showed that clinical responses were maintained in the vast majority of patients to 3 years of bimekizumab-bkzx treatment.

Pharmacology and Pharmacokinetics3,4: The pathology of plaque psoriasis is driven primarily by tumor necrosis factor alpha (TNF-alpha) and interleukins 17 (IL-17) and 23 (IL-23), with the axis between these three cytokines integral to the maintenance phase of psoriasis. IL-17 acts through two separate mechanisms. The first, dependent on the cytoplasmic adaptor protein ACT1, involves the activation of nuclear factor-kappa B and the transcription of inflammatory genes. The second, independent of ACT1, involves the activation of the Janus kinase/STAT signaling cascade, which leads to further transcription of proinflammatory proteins and continued psoriasis pathogenicity. Bimekizumab-bkzx is a monoclonal antibody targeted against IL-17A, IL-17F, and a heterodimer of the two called IL-17AF. Bimekizumab-bkzx blocks the interaction of these ILs with their respective receptors, thus reducing psoriatic inflammation.

The absolute bioavailability of bimekizumab-bkzx is estimated to be 70%, and the median volume of distribution at steady state was 11.2 L. The median clearance is 0.337 L/day (32.7%), with a mean terminal elimination half-life of 23 days. Bimekizumab-bkzx is expected to be degraded into small peptides by catabolic pathways and excreted. No significant differences in the pharmacokinetics of bimekizumab-bkzx were observed based on age (≥18 years).

Adverse Reactions and Drug Interactions3,4: The common adverse reactions (≥1%) reported in clinical trials included upper respiratory tract infections, oral candidiasis (thrush), headache, injection-site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, and fatigue. In addition to the increased risk of infection, bimekizumab-bkzx may increase the risk of suicidal ideation and behavior. Therefore, patients and caregivers should monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. Also, as cases of inflammatory bowel disease (IBD) have been reported in clinical trials with other IL-17 inhibitors, this drug should be avoided in patients with active IBD. Finally, elevated serum transaminases were reported in clinical trials. Therefore, these enzymes should be monitored during drug therapy and bimekizumab-bkzx permanently discontinued in patients with drug-associated combined elevations of transaminases and bilirubin.

The production of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNF-alpha, interferon) during chronic inflammation. Treatment with bimekizumab-bkzx may modulate serum levels of some cytokines, which could alter CYP levels. Therefore, upon initiation or discontinuation in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, the clinician should consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

Dosage and Administration3,4: Bimekizumab-bkzx is supplied as an injection for SC administration. The recommended dosage is 320 mg (given as two SC injections of 160 mg each) at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing >120 kg, a dosage of 320 mg every 4 weeks after week 16 should be considered. Missed doses should be administered as soon as possible, with resumption of dosing at the regular scheduled time. All age-appropriate vaccinations should be completed prior to drug initiation, and patients should be evaluated for tuberculosis infection before treatment initiation. Liver enzymes, alkaline phosphatase, and bilirubin should be determined prior to initiating treatment with bimekizumab-bkzx and monitored during therapy.

Etrasimod (Velsipity, Pfizer)

Indication and Clinical Profile5,6: Etrasimod is indicated for treatment of moderately to severely active ulcerative colitis (UC) in adults. UC is a form of inflammatory bowel disease in which the lining of the large intestine and rectum becomes inflamed. The exact cause of UC is unknown, but it appears to result from a malfunction of the immune system that leads it to attack the cells of the digestive tract. Diet and stress were previously suspected as causes, but these factors appear to merely aggravate the disease. Heredity may also play a role, as UC is more common in people who have family members with the disease. However, most people with UC do not have this family history.

Approval of etrasimod was based on results from the ELEVATE UC Phase 3 Program (comprising two trials, ELEVATE UC 52 and ELEVATE UC 12), which evaluated the safety and efficacy of once-daily etrasimod 2 mg for clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biological, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in the two studies were naïve to biological or JAK inhibitor therapy, and the studies also included patients with isolated proctitis. In ELEVATE UC 52, 27% of patients receiving etrasimod compared with 7% of patients receiving placebo achieved remission at week 12, and 32% of etrasimod patients compared with 7% of placebo patients achieved remission at week 52. In ELEVATE UC 12, clinical remission was achieved in 26% of patients receiving etrasimod compared with 15% of patients receiving placebo. All key secondary efficacy endpoints, including endoscopic improvement and mucosal healing, were met at week 12.

Pharmacology and Pharmacokinetics5,6: Etrasimod (FIGURE 1) is a novel tetrahydrocyclopenta-indole compound that acts as a sphingosine-1-phosphate (S1P) receptor modulator, binding with high affinity to S1P receptor subtypes 1, 4, and 5 (S1P1,4,5). This drug has minimal activity on S1P3 (25-fold lower than maximum concentration of drug at the recommended dose) and no activity on S1P2. The mechanism by which etrasimod exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines. Etrasimod has been shown to partially and reversibly block the capacity of lymphocytes to egress from lymphoid organs, reducing the number of lymphocytes in peripheral blood.


Adverse Reactions and Drug Interactions5,6: In clinical trials, the most common adverse reactions (incidence >5%) were headache, dizziness, and elevated liver-function tests. Etrasimod is contraindicated in patients who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure (HF) requiring hospitalization, or Class III or IV HF in the past 6 months. It is also contraindicated in those with a history or presence of Mobitz type II second- or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless the patient has a functioning pacemaker. The prescribing information for etrasimod includes warnings and precautions concerning increased risk of infection, AV-conduction delays, increased blood pressure, macular edema, posterior reversible encephalopathy syndrome, decreased pulmonary function, liver injury, and fetal toxicity. These precautions require significant patient evaluation prior to initiating therapy and may preclude drug use or necessitate drug discontinuation.

A transient decrease in heart rate and AV-conduction delays may occur when initiating etrasimod. Therefore, the advice of a cardiologist should be sought before initiating antiarrhythmics or beta-blockers in patients receiving etrasimod. The concomitant administration of antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies should be avoided during and in the weeks following administration of etrasimod due to enhanced risk of immune-system suppression. Concomitant use of etrasimod with drugs that are moderate-to-strong inhibitors of CYP2C9 or CYP3A4 is not recommended, as this may result in increased drug exposure. Also, concurrent use of etrasimod is not recommended in patients who are CYP2C9 poor metabolizers and on moderate-to-strong CYP2C8 or CYP3A4 inhibitors. Finally, concomitant use of etrasimod with drugs that are combined CYP3A4 (strong), CYP2C8 (moderate), and CYP2C9 (moderate) inducers (i.e., rifampin) is not recommended because this may result in reduced etrasimod exposure and efficacy.

Dosage and Administration5,6: Etrasimod is supplied as 2-mg tablets for oral administration. The recommended dosage is 2 mg orally once daily. The tablets may be taken with or without food, but they should be swallowed whole. Based on the drug’s warnings, the following should be assessed prior to initiating therapy: CBC (within the past 6 months), ECG (to determine whether preexisting conduction abnormalities are present), liver-function tests (within the past 6 months), ophthalmic examination (fundus including the macula), skin examination, vaccination record (varicella zoster virus), and a list of current or prior medications, specifically those that could slow heart rate or AV conduction, and antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies.

Berdazimer (Zelsuvmi, Ligand)

Indication and Clinical Profile7,8: Berdazimer is indicated for topical treatment of molluscum contagiosum (MC) in adults and children aged >1 year, and it is the first novel drug approved for this infection. MC, which is caused by a poxvirus, affects approximately 6 million people—primarily children—annually in the United States, with up to 73% of children remaining untreated. MC is usually characterized by benign, mild skin lesions (mollusca) that may appear anywhere on the body. Mollusca are small, raised, and usually white, pink, or flesh-colored with a dimple or pit in the center. MC typically resolves without scarring within 6 to 12 months but may take as long as 4 years. Because MC is highly contagious, treatment is essential to reduce transmission to other areas of the body or to other people.

Approval of berdazimer was based on three clinical trials (B-SIMPLE1, B-SIMPLE2, and B-SIMPLE4) that enrolled a total of 1,598 patients aged ≥6 months with three to 70 MC lesions. The three trials were similar in design, with all patients randomized to treatment with either berdazimer topical gel or vehicle gel applied to all lesions once daily for 12 weeks and then a 12-week follow-up period. The primary endpoints included complete clearance of all lesions at week 12, with safety and tolerability measures including adverse-event frequency and severity, as well as assessment of local skin reaction and scarring. In B-SIMPLE4, 32.4% of the berdazimer group achieved complete clearance of lesions compared with 19.7% of the vehicle group at week 12. However, B-SIMPLE2 and B-SIMPLE1 did not demonstrate statistical significance for complete lesion clearance (30% vs. 20.3% and 26% vs. 22%, respectively). When all three studies were combined, the success rate was 30.0% versus 19.8% (P <.001).

Pharmacology and Pharmacokinetics7,8: Berdazimer (FIGURE 2), a polymer formed from sodium 1-hydroxy-3-methyl-3-(3-(trimethoxysilyl)propyl)-1-triazene-2-oxide and tetraethyl silicate, acts as a nitric oxide (NO)-releasing agent. Although the mechanism of action for the treatment of MC is unknown, NO has been shown to have antiviral properties. Measurement of hMAP3, the NO metabolite of berdazimer, demonstrated that once-daily application of the drug resulted in minimal systemic absorption in children aged 2 to 12 years, and therefore a complete pharmacokinetic profile has not been reported.


Adverse Reactions and Drug Interactions7,8: The most commonly reported adverse reactions (>1%) in clinical trials were application-site reactions, including pain such as burning or stinging sensations (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). Application-site reactions, including allergic contact dermatitis, have occurred in patients treated with berdazimer, and these are characterized by pain, pruritus, swelling, or erythema at the application site lasting >24 hours. If allergic dermatitis occurs, berdazimer should be discontinued. Since this drug is not significantly absorbed from the site of administration, there are no reported pharmacokinetic drug interactions.

Dosage and Administration7,8: Berdazimer, a topical gel, is supplied in a carton containing two tubes: Tube A, containing berdazimer gel, and Tube B, containing hydrogel. Equal amounts of gel from Tube A and Tube B should be mixed before application per the instructions for use in the drug label. The product should not be premixed or stored. The mixture should be applied immediately in an even, thin layer and allowed to dry for 10 minutes after application, and the hands should be washed unless they are being treated. Application of the product to uninvolved skin should be avoided. Swimming, bathing, or washing should be avoided for 1 hour after application. This medication is not for ophthalmic, oral, or intravaginal use. Berdazimer should be applied once daily to each MC lesion for up to 12 weeks.

Cefepime and enmetazobactam (Exblifep, Allecra)

Indication and Clinical Profile9,10: The combination of cefepime and enmetazobactam (cefepime/enmetazobactam) is indicated for treatment of patients aged ≥18 years with complicated urinary tract infections (UTIs), including pyelonephritis, caused by susceptible microorganisms. Most UTIs are caused by colonization of the urogenital tract with rectal and perineal flora, most commonly Escherichia coli, Enterococcus, Klebsiella, and Pseudomonas. Of these, E coli is the most common. Complicated UTIs tend to be caused by a much wider range of organisms, some of which may be multidrug-resistant, necessitating broader-spectrum antibiotics.

FDA approval of cefepime/enmetazobactam was based on clinical data documenting its effectiveness against gram-negative resistant bacteria, especially resistance mediated by extended-spectrum and AmpC beta-lactamases, as well as results of a randomized, double-blind, multicenter, phase III trial. This trial, designated as ALLIUM, enrolled 1,041 adults aged ≥18 years with a clinical diagnosis of complicated UTI or acute pyelonephritis caused by gram-negative urinary pathogens. Via randomization, patients received either cefepime 2 g/enmetazobactam 0.5 g or piperacillin 4 g/tazobactam 0.5 g via 2-hour infusion every 8 hours for 7 days. The results indicated that cefepime/enmetazobactam, compared with piperacillin/tazobactam, met criteria for noninferiority as well as superiority with respect to the primary outcome of clinical cure and microbiological eradication. The primary outcome was achieved in 79% (273/345) of patients receiving cefepime/enmetazobactam compared with 59% (196/333) of those receiving piperacillin/tazobactam. In the 21% (142/678) of patients with an extended-spectrum beta-lactamase (ESBL)-producing pathogen, 74% (56/76) of patients in the cefepime/enmetazobactam group achieved the composite outcome compared with only 52% (34/66) of those in the piperacillin/tazobactam group.

Pharmacology and Pharmacokinetics9,10: Cefepime/enmetazobactam (FIGURE 3) is a combination of the third-generation, broad-spectrum cephalosporin cefepime and the novel azabicyclo[3.2.0]heptane beta-lactamase (BL) inhibitor enmetazobactam. The bactericidal action of cefepime results from disruption of bacterial cell wall synthesis by inhibition of penicillin binding protein targets. Cefepime is not inactivated by some BLs, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria, but is inactivated by ESBLs, some oxacillinases, and carbapenem hydrolyzing BLs. The enmetazobactam component of cefepime/enmetazobactam is an inhibitor of ESBLs, thus enhancing this medication’s spectrum of activity.


At recommended doses, peak plasma levels of cefepime and enmetazobactam are 99.8 mcg/mL and 19.8 mcg/mL, respectively, with AUCs of 380 mcg . h/mL and 75.3 mcg . h/mL. Each component of the drug product has a relatively low volume of distribution (<25 L) and is minimally bound by plasma proteins. Neither component of the drug product is significantly metabolized, and both have a half-life of about 2.5 hours. Each component of the drug product is excreted primarily in the urine (85%-90%).

Adverse Reactions and Drug Interactions9,10: The most frequently reported adverse reactions occurring in >5% of patients treated with cefepime/enmetazobactam in clinical trials included phlebitis and infusion-site reactions, headache, and elevated transaminases and bilirubin levels. Cefepime/enmetazobactam is contraindicated in patients with a history of serious hypersensitivity reactions to its components or other beta-lactam antibacterial drugs. Neurotoxicity has been reported during treatment with the cefepime component of cefepime/enmetazobactam, observed most often in patients with renal impairment who did not receive appropriate dosage adjustment of cefepime. Clostridioides difficile–associated diarrhea has been reported with nearly all systemic antibacterial agents, including cefepime/enmetazobactam. The clinician should evaluate if neurotoxicity or diarrhea occurs and consider discontinuing the medication.

Few drug interactions have been reported with cefepime/enmetazobactam, due primarily to its metabolism and excretion profile. Renal function should be monitored if cefepime/enmetazobactam is used concurrently with aminoglycosides or diuretics. Administration of this drug may result in a false-positive reaction for glucose in the urine with certain methods.

Dosage and Administration9,10: Cefepime/enmetazobactam is supplied as a solution for IV administration. The recommended dosage is 2.5 g (cefepime 2 g and enmetazobactam 0.5 g) administered every 8 hours over a 2-hour period in patients with an estimated glomerular filtration rate between 60 mL/minute and 129 mL/minute. The prescribing information contains additional dosing information for patients with renal dysfunction. The duration of therapy is 7 days (duration up to 14 days in patients with concurrent bacteremia).

REFERENCES

1. Letybo (letibotulinumtoxinA-wlbg) product information. Newport Beach, CA: Hugel America, Inc; February 2024.
2. Mueller DS, Prinz V, Adelglass J, et al. Efficacy and safety of letibotulinumtoxin A in the treatment of glabellar lines: a randomized, double-blind, multicenter, placebo-controlled phase 3 study. Aesthet Surg J. 2022;42(6):677-688.
3. Bimzelx (bimekizumab-bkzx) product information. Smyrna, GA: UCB, Inc; October 2023.
4. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142-152.
5. Velsipity (etrasimod) product information. New York, NY: Pfizer Labs; October 2023.
6. Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod 2 mg once daily as treatment for moderately to severely active ulcerative colitis: results from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials [abstract 968a]. Gastroenterology. 2022;162(7):s-1395.
7. Zelsuvmi (berdazimer) product information. Wilmington, DE: EPIH SPV, LLC; January 2024.
8. Ligand Pharmaceuticals Inc. US Food and Drug Administration approves ZELSUVMI™ as a first-in-class medication for the treatment of molluscum contagiosum. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum/default.aspx. Accessed January 8, 2024.
9. Exblifep (cefepime and enmetazobactam) product information. Saint Louis, France: Allecra Therapeutics SAS; February 2024.
10. Hsu CK, Tsai WW, Lai CC. Cefepime/enmetazobactam vs piperacillin/tazobactam and complicated urinary tract infection or acute pyelonephritis. JAMA. 2023;329(8):684-685.

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