The main purpose of the study is to study the pharmacokinetics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg, produced by Shandong Lukang Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (trade name: Edabi®, specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/postprandial state.

Start Date21 Aug 2025

Sponsor / Collaborator

Shandong Lukang Pharmaceutical Co., Ltd.

CTR20252428

/ CompletedNot Applicable

美阿沙坦钾片空腹人体生物等效性研究

[Translation] Study on the bioequivalence of Asartan potassium tablets in fasting volunteers

以山东新时代药业有限公司的美阿沙坦钾片为受试制剂，Takeda Pharma A/S持证的美阿沙坦钾片（易达比®）为参比制剂，考察两制剂在空腹状态下单次给药吸收速度和程度的差异，评价两制剂是否生物等效。

[Translation]

The Asartan Potassium Tablets produced by Shandong Xinshidai Pharmaceutical Co., Ltd. were used as the test preparation, and the Asartan Potassium Tablets (Edabi®) certified by Takeda Pharma A/S were used as the reference preparation. The differences in the absorption rate and extent of a single dose of the two preparations under fasting conditions were investigated to evaluate whether the two preparations were bioequivalent.

Start Date18 Jul 2025

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

CTR20252168

/ RecruitingNot Applicable

美阿沙坦钾片在中国健康受试者中进行的单中心、随机、开放、单次(空腹/餐后)口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of Asartan Potassium Tablets in healthy Chinese subjects.

主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂美阿沙坦钾片(规格:按美阿沙坦(C30H24N4O8)计 80mg;生产企业:石家庄格瑞药业有限公司)和参比制剂美阿沙坦钾片(商品名:易达比(EDARBI);规格:按美阿沙坦(C30H24N4O8)计 80mg;持证商:Takeda Pharma A/S)后的药代动力学特征,评价空腹/餐后状态下两种制剂在健康受试者体内的生物等效性。次要目的:观察受试制剂美阿沙坦钾片和参比制剂美阿沙坦钾片(易达比(EDARBI))在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg based on Asartan (C30H24N4O8); Manufacturer: Shijiazhuang Grey Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (Trade name: EDARBI; Specification: 80 mg based on Asartan (C30H24N4O8); Licensee: Takeda Pharma A/S) in healthy Chinese subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in healthy subjects in the fasting/fed state. Secondary objective: To observe the safety of the test preparation, Asartan Potassium Tablets and the reference preparation, Asartan Potassium Tablets (EDARBI) in healthy Chinese subjects.

Start Date01 Jul 2025

Sponsor / Collaborator

Shi Jiazhuang Great Pharmaceutical Co.,Ltd

100 Clinical Results associated with Azilsartan Kamedoxomil

100 Translational Medicine associated with Azilsartan Kamedoxomil

100 Patents (Medical) associated with Azilsartan Kamedoxomil

833

Literatures (Medical) associated with Azilsartan Kamedoxomil

01 Sep 2025·PULMONARY PHARMACOLOGY & THERAPEUTICS

A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrier

Article

Author: Asbjarnarson, Arni ; Lehmann, Fredrik ; Gardarsson, Fridrik Runar ; Joelsson, Jon Petur ; Arason, Ari Jon ; Gudjonsson, Thorarinn ; Valdimarsdottir, Bryndis ; Teodorovic, Peter ; Kricker, Jennifer Ann ; Sigurdsson, Snaevar ; Ingthorsson, Saevar ; Page, Clive ; Parnham, Michael John

Epithelial barrier failure, a feature of several inflammatory lung diseases, contributes to exacerbations and disease progression. Acute exacerbations are often treated with macrolides, including azithromycin (AZM). In part, this is due to both primary antimicrobial and additional immunomodulatory actions, complemented by recently reported enhanced integrity of respiratory epithelial barriers. However, long-term "off label" use of macrolides is associated with increased bacterial resistance. We now introduce a new class of compounds, "Barriolides" that are analogues of AZM promoting airway epithelial barrier integrity in vitro, with negligible antibacterial activity. The lead compound is EP395 which does not affect cell viability up to 100 μM in VA10 bronchial epithelial cells. Treatment with EP395 for three weeks enhanced epithelial barrier integrity, measured by increased transepithelial electrical resistance, reduced paracellular flux in air-liquid interface culture and increased expression of tight junction proteins. EP395 also induced epidermal differentiation and formation of lamellar bodies, complemented by a relevant genetic footprint. In mice exposed to sulphur dioxide, pre-treatment with EP395 reduced extravasation of human serum albumin into the bronchoalveolar lavage fluid. These data demonstrate epithelial barrier-protecting effects of EP395, a promising candidate for treatment of chronic respiratory diseases without risk of bacterial resistance.

01 Aug 2025·EBioMedicine

Effect of long-term azithromycin treatment on gut microbial diversity in children and adolescents with HIV-associated chronic lung disease

Article

Author: Pettersen, Veronika Kuchařová ; Mwaikono, Kilaza Samson ; Flygel, Trym Thune ; Flaegstad, Trond ; Abotsi, Regina Esinam ; Ferrand, Rashida Abbas ; Bargheet, Ahmed ; Sovershaeva, Evgeniya ; Simms, Victoria ; Hameiri-Bowen, Dan ; Claassen-Weitz, Shantelle ; Nicol, Mark ; Mchugh, Grace ; Hjerde, Erik ; Cavanagh, Jorunn Pauline

BACKGROUND:

HIV-associated chronic lung disease (HCLD) is common in children and adolescents growing up with HIV. The use of azithromycin (AZM) reduces the rate of acute respiratory exacerbations in this population, however, impact of this treatment on the gut microbiota and associations with blood-derived inflammatory markers have not been studied.

METHODS:

Children and adolescents with HCLD in Harare, Zimbabwe and Blantyre, Malawi were recruited in a double-blind, placebo-controlled trial of once-weekly AZM or placebo for 48 weeks (BREATHE trial, NCT02426112). Rectal swabs were collected at inclusion (N = 346), 48 weeks (treatment end, N = 313), and 72 weeks (six months after treatment cessation, N = 244). The bacterial composition of fecal swabs was determined using 16S rRNA gene sequencing. Plasma biomarkers at inclusion and 48 weeks were measured using Luminex multiplex bead assay.

FINDINGS:

At 48 weeks, bacterial α-diversity was significantly lower in the AZM group, with 27 bacterial genera showing differential abundance between the study groups. The placebo group exhibited higher interconnectivity between bacterial genera at 48 weeks compared to the AZM group. Correlations between the top seven differentially abundant genera and biomarkers observed at inclusion were no longer significant at 48 weeks in both groups. Depletion of Campylobacter persisted for six months after cessation of AZM treatment.

INTERPRETATION:

Long-term AZM treatment in HCLD patients affects their gut bacterial composition at least 6 months after its cessation. The consequences of reduced bacterial diversity, such as altered interaction with the immune system and risk of resistance, need further investigation to understand how to optimise gut health during long-term antibiotic treatments.

FUNDING:

The study was funded by the Norwegian Research Council and Helse Nord (HNF 1387-17).

01 Aug 2025·JOURNAL OF INFECTION AND CHEMOTHERAPY

Examining the safety and efficacy of Azithromycin in Cystic fibrosis: A systematic review and Meta-analysis

Review

Author: Jacob, Gerrit ; Elmegeed, Aya Abd ; Aljebeai, Abdel-Karim ; Mahmoud, Rania M ; Marzuuk, Naglaa M ; Danpanichkul, Pojsakorn ; Attia, Abdelrahman M ; Sudan, Esraa S F ; Hassan, Muhammad M ; Rabbani, Syed Arman ; Abdullah, Ahmed R ; Lotfy, Mariam A

Cystic fibrosis (CF) patients experience chronic lung inflammation and decline. Azithromycin (AZM), a macrolide antibiotic, offers potential anti-inflammatory and antimicrobial benefits. We aim to evaluate the safety and efficacy of AZM therapy in patients with CF. A comprehensive search was conducted across PubMed, Scopus, Web of Science, and Cochrane on 22 December 2023. We included all relevant randomized controlled trials (RCTs) and cohort studies. Meta-analysis was conducted using R Studio software (version: 2023.12.1). Continuous outcomes were expressed as weighted mean differences with standard deviation (SD), and dichotomous variables were reported as relative risks with a 95 % confidence interval (CI). A total of 18 studies comprising 2877 patients were included, with 11 studies meeting the criteria for inclusion in the meta-analysis. AZM significantly reduced the need for new oral antibiotics (RR = 0.77; 95 % CI: [0.66, 0.89]). No significant increase in adverse events was observed. However, lung function (FEV1, FVC, FEF), inflammatory markers, and pulmonary exacerbations remained unchanged. Azithromycin holds promise for managing CF, but further research is needed to fully understand its long-term impact on lung health and resistance patterns.

News (Medical) associated with Azilsartan Kamedoxomil

06 Nov 2024

·pharma.economictimes.indiatimes.com

Paracetamol to PAN-D: CDSCO finds over 50 sub-standard drugs. Check full list of medicines

New Delhi: The Central Drugs Standard Control Organisation ( CDSCO ) has identified over 50 drugs which have failed in the drug test. In its latest report, the controller said 50 drugs including Paracetamol are "not of standard quality" (NSQ). The report has also flagged calcium and vitamin D3 supplements, anti-diabetes pills, and high blood pressure medicines. Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd were specifically mentioned for quality concerns. The report listed a total of 48 drugs in the NSQ category, including a Gauze Roll Non Sterile Roller Bandage. NSQ alerts come from monthly random sampling conducted by state drug officers. Some of the medicines were produced by companies like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare. Additionally, the CDSCO shared another list that features five more drugs that failed quality tests. The pharmaceutical companies denied responsibility for these drugs. They claim they are "spurious," and one response from a company stated, "The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subjected to outcome of investigation." CDSCO NSQ Test: Full list of drugs and their manufacturers Here is the list of drugs that failed the CDSCO test along with the manufacturers: Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) - M/s. Alkem Health Science Amoxicillin & Potassium Clavulanate Tablets (Mexclav 625) - M/s. Meg Lifesciences Calcium And Vitamin D3 Tablets IP (Shelcal 500) - M/s. Pure & Cure Healthcare Pvt. Ltd. Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) - M/s. Scott-Edil Pharmacia Ltd. Vitamin B Complex with Vitamin C Softgels - M/s. Asoj Soft Caps Pvt. Ltd. Rifmin 550 (Rifaximin Tablets 550 mg) - M/s. Legen Healthcare Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan - D) - M/s. Alkem Health Science Paracetamol Tablets IP 500 mg - M/s. Karnataka Antibiotics and Pharmaceuticals Ltd. Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) - M/s. Pure & Cure Healthcare Pvt. Ltd. Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) (RL 500 ml) - M/s. Vision Parenteral Pvt. Ltd. Fexofenadine Hydrochloride Tablets IP 120 mg - M/s. Maxtar Bio-Genics Laxnorm Solution (Lactulose Solution USP) - M/s. Athens Life Sciences Heparin Sodium Injection 5000 Units (Hostranil Injection) - M/s. Health Biotech Ltd. Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) - M/s. Ornate Pharma Pvt. Ltd. Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) - M/s. Hetero Labs Limited Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) - M/s. HSN International Rolled Gauze (Non-Sterilized) - M/s. Blazon India Ciprofloxacin Tablets IP 500 mg (Ocif-500) - M/s. Ornate Labs Pvt. Ltd. Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold) - M/s. Unispeed Pharmaceuticals Pvt. Ltd. Adrenaline Injection IP Sterile 1 ml - M/s. Alves Healthcare Pvt. Ltd. Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) RL 500ml - M/s. Vision Parentral Pvt. Ltd. Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate, and Menthol Gel) - M/s. Universal Twin Labs Atropine Sulphate Injection IP 2 ml - M/s. Nandani Medical Laboratories Pvt. Ltd. Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G) - M/s. Daxin Pharmaceuticals Pvt. Ltd. Heparin Sodium Injection IP 25000 IU / 5ml - M/s. Scott-Edil Pharmacia Ltd. Cefepime & Tazobactam for Injection (Crupime - TZ Kid Injection) - M/s. Cosmas Research Lab. Ltd. Atropine Sulphate Injection IP (Atropine Sulphate) - M/s. Priya Pharmaceuticals Salbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup (Acozil Expectorant) - M/s. Antila Lifesciences Pvt. Ltd. Diclofenac Sodium IP - M/s. Sara Exports Ltd. Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) - M/s. Digital Vision Phenytoin Sodium Injection USP - M/s. Health Biotech Ltd. Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) - M/s. Win Cure Pharma Calcium 500 mg with Vitamin D3 250 IU Tablets IP - M/s. Life Max Cancer Laboratories Amoxycillin and Potassium Clavulanate Tablets IP 625 mg (Renamega- CV 625) - M/s. Malik Lifesciences Pvt. Ltd. Olmesartan Medoxomil Tablets IP 40 mg - M/s. Life Max Cancer Laboratories INFUSION SET-NV - M/s. Medivision Healthcare Telmisartan Tablets IP 40 mg - M/s. Life Max Cancer Laboratories Alprazolam Tablets IP 0.25 mg (Erazol-0.25 Tablets) - M/s. Elikem Pharmaceuticals Pvt. Ltd. Glimepiride Tablets IP (2 mg) - M/s. Mascot Health Series Pvt. Ltd. Calcium and Vitamin D3 Tablets IP - M/s. Unicure India Ltd. Metronidazole Tablets IP 400mg - M/s. Hindustan Antibiotics Ltd. Paziva -40 - M/s. Gnosis Pharmaceuticals Pvt. Ltd. Pantomed -40 - Digital Vision 176 Cefixime Oral Suspension IP (Dry Syrup) - Nestor Pharmaceuticals Ltd. Moxymed CV - Alexa Pharmaceuticals Frusemide Injection IP 20 mg - Nestor Pharmaceuticals Ltd. Kudajarishtam - Bala Herbals Tab Nodosis - Steadfast Medishield Pvt. Ltd. Haridrakhanda - Bhaskara Vilasam Vaidyasala Pantoprazole Inj. BP 40 mg - Kerala Medical Services Corporation Ltd. Yogaraja Guggulu - Bhaskara Vilasam Vaidyasala PANCEF-OF - Aglomed Ltd.

Drug Approval

05 Jul 2024

·www.pharmaindustrial-india.com

Zydus Gets Tentative Approval from USFDA for Azilsartan Medoxomil Tablets

Zydus Lifesciences Ltd. has secured a tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil Tablets, 40 mg and 80 mg (USRLD: Edarbi tablets). Azilsartan is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Azilsartan medoxomil tablets may be used either alone or in combination with other antihypertensive agents. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India. Azilsartan Medoxomil Tablets had annual sales of USD 89 mn in the United States. The group now has 398 approvals and has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 26,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline.

Drug Approval

05 Jul 2024

·www.pharmaindustrial-india.com

Zydus Gets Tentative Approval from USFDA for Azilsartan Medoxomil Tablets

Drug Approval

100 Deals associated with Azilsartan Kamedoxomil

External Link

KEGG	Wiki	ATC	Drug Bank
-	Azilsartan Kamedoxomil	C09CA09	DB08822

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	European Union	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	Iceland	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	Liechtenstein	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	Norway	Takeda Pharma A/S	07 Dec 2011
Hypertension	United States	Azurity Pharmaceuticals, Inc.	25 Feb 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Jan 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02541669 (CTgov)	Phase 1	Hypertension	64	TAK-491 (Open Label: TAK-491 40 mg)	ycngiqudap(bfsdmdvbqj) = tznvqvhzml aorzcfdysy (qznrhszjup, 25.0) View more	-	05 Feb 2020
				TAK-491 (Open Label: TAK-491 80 mg)	ycngiqudap(bfsdmdvbqj) = cmbexnvone aorzcfdysy (qznrhszjup, 20.5) View more
NCT02791438 (CTgov)	Phase 3	Secondary hypertension \| Hypertension \| Essential Hypertension	27	Placebo+Azilsartan (Azilsartan 2.5 - 20 mg (Weight < 50 kg))	ljyxrtndja = soacqxzfwb dgahdpkjzk (ngccvepgjg, tmwptueerm - lddiixejxx) View more	-	23 Dec 2019
				Placebo+Azilsartan (Azilsartan 5 - 40 mg (Weight ≥ 50 kg))	ljyxrtndja = jmmcngkzje dgahdpkjzk (ngccvepgjg, qyqtfxqklj - rdapwbonup) View more
NCT02517866 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Essential Hypertension	380	Azilsartan Medoxomil	hkpbkyepqe = hplowsbzsg pmdjlydzjy (gzusizxsjs, naadquphdk - luyokxersk) View more	-	01 Mar 2019
NCT02480764 (CTgov)	Phase 3	Essential Hypertension	612	Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	febbkavawo(uwjulucmgx) = oyrsedtflp ujhxryznro (aqfivfucof, 0.5123) View more	-	11 Feb 2019
				Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 80 mg)	febbkavawo(uwjulucmgx) = uumpsqsqqg ujhxryznro (aqfivfucof, 0.5010) View more
NCT00591773 (Pubmed \| J Renin Angiotensin Aldosterone Syst)	Phase 3	Essential Hypertension	551	Azilsartan medoxomil 40 mg plus chlorthalidone	sicqeehywp(zddxtwedez) = ytgymawrlb ajocervfoq (lhbfjvtcjq )	-	01 Jul 2018
				Azilsartan medoxomil 80 mg plus chlorthalidone	sicqeehywp(zddxtwedez) = jqbdaancju ajocervfoq (lhbfjvtcjq )
NCT01774591 (CTgov)	Not Applicable	Hypertension	21	Azilsartan medoximil (Azilsartan Medoximil.)	sdonnhofsd(dlrgdjoqoj) = kilswjkxkn jkbfnoqopb (sahntzlgos, 14) View more	-	09 Nov 2017
				Placebo (Placebo)	sdonnhofsd(dlrgdjoqoj) = ksfqhipgdp jkbfnoqopb (sahntzlgos, 904) View more
NCT02203916 (CTgov)	Phase 3	Essential Hypertension	328	Azilsartan medoxomil placebo (Placebo)	vmqddsyqeb(vawhcgjfro) = hbednxlrhm iiyqluwfbn (zajmxnimaw, 2.0039) View more	-	19 Dec 2016
				Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	vmqddsyqeb(vawhcgjfro) = vxxfppkcrz iiyqluwfbn (zajmxnimaw, 1.4117) View more
NCT02451150 (CTgov)	Phase 3	Secondary hypertension \| Hypertension \| Essential Hypertension	6	Azilsartan (Azilsartan 5 mg)	opnoudfjzp(ppqfizpvey) = jjhviapzqm xbzxzvqjar (gbnihsmfix, 2963.53) View more	-	07 Apr 2016
				Azilsartan (Azilsartan 10 mg)	opnoudfjzp(ppqfizpvey) = pnqjoszyfv xbzxzvqjar (gbnihsmfix, 893.93) View more
NCT00695955 (Pubmed \| Clin Exp Hypertens) Manual	Phase 3	Essential Hypertension	669	chlorthalidone+azilsartan medoxomil	cxvbinqduc(zxvtwebpcc) = lbeyybeehe dvjlkjflgd (isbwbusric ) View more	Positive	01 Jan 2016
				hydrochlorothiazide+azilsartan medoxomil	cxvbinqduc(zxvtwebpcc) = utbebinmzp dvjlkjflgd (isbwbusric ) View more
NCT01496430 (CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Hypertension	105	Placebo (Placebo QD)	abhesuebsv(szjxqntfdc) = nhrrkzbosq fdqrmifjqs (rdtgevhnme, 2.71) View more	-	06 May 2015
				Azilsartan medoxomil (Azilsartan Medoxomil 40 mg QD)	abhesuebsv(szjxqntfdc) = mewevhfmqq fdqrmifjqs (rdtgevhnme, 2.69) View more

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