SG11201901444PA - Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods - Google Patents

Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods

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Publication number
SG11201901444PA
SG11201901444PA SG11201901444PA SG11201901444PA SG11201901444PA SG 11201901444P A SG11201901444P A SG 11201901444PA SG 11201901444P A SG11201901444P A SG 11201901444PA SG 11201901444P A SG11201901444P A SG 11201901444PA SG 11201901444P A SG11201901444P A SG 11201901444PA
Authority
SG
Singapore
Prior art keywords
international
seattle
kits
avenue
formulations
Prior art date
Application number
SG11201901444PA
Inventor
Gregory Demopulos
Kenneth Ferguson
William Lambert
John Whitaker
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Omeros Corp
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Publication date
Application filed by Omeros Corp filed Critical Omeros Corp
Publication of SG11201901444PA publication Critical patent/SG11201901444PA/en

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/26Psychostimulants, e.g. nicotine, cocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Psychiatry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Ophthalmology & Optometry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 08 March 2018 (08.03.2018) W I PO I iiiiono 1E1 oio llmonoloolo Elio° !moo im iflo °El (10) International Publication Number WO 2018/045054 Al PCT Av erag e Loa d ( lbf) 6 5 4 3 2 1 O 00 0 (51) International Patent Classification: A61K 9/08 (2006.01) A61K 47/00 (2006.01) A61K 39/395 (2006.01) (21) International Application Number: PCT/US2017/049415 (22) International Filing Date: 30 August 2017 (30.08.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/382,156 31 August 2016 (31.08.2016) US (71) Applicant: OMEROS CORPORATION [US/US]; 201 Elliott Avenue West, Seattle, WA 98119 (US). (72) Inventors; and (71) Applicants: DEMOPULOS, Gregory, A. [US/US]; 4845 Forest Avenue Se, Mercer Island, WA 98040 (US). FER- GUSON, Kenneth, M. [US/US]; 2125 First Avenue #2902, Seattle, WA 98121 (US). LAMBERT, William, Joseph [US/US]; 88 Virginia St. #23, Seattle, WA 98101 (US). WHITAKER, John, Steven [US/US]; 1510 40th Avenue, Seattle, WA 98122 (US). (74) Agent: QUINTON, Tineka; Omeros Corporation, 201 El- liott Avenue West, Seattle, WA 98119 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (54) Title: HIGHLY CONCENTRATED LOW VISCOSITY MASP-2 INHIBITORY ANTIBODY FORMULATIONS, KITS, AND METHODS Syringeability: Average Load 1 1 1 1 1 27 GA I 25 GA I 25 GA (Thin-Wall) 185 mg/mL 20 mM Citrate, 200 mM Arginine 0.01% PS-80, pH 5.8 27 GA I 25 GA I 25 GA (Thin-Wall) 185 mg/mL 20 mM Histidine, 200 mM Arginine 0.01% PS-80, pH 5.9 27 GA I 25 GA I 25 GA (Thin-Wall) 185 mg/mL 20 niM Citrate, 200 mM Arginine pH 5.8 FIG. 7A (57) : The present invention relates to stable, high-concentration low-viscosity formulations of MASP-2 inhibitory antibodies, kits comprising the formulations and therapeutic methods using the formulations and kits for inhibiting the adverse effects of MASP-2 C dependent complement activation. [Continued on next page] WO 2018/045054 Al MIDEDIMOMOIDEIREEMOMIVINIMEHIMEMOIS TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(11)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: with international search report (Art. 21(3)) with sequence listing part of description (Rule 5.2(a))
SG11201901444PA 2016-08-31 2017-08-30 Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods SG11201901444PA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662382156P 2016-08-31 2016-08-31
PCT/US2017/049415 WO2018045054A1 (en) 2016-08-31 2017-08-30 Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods

Publications (1)

Publication Number Publication Date
SG11201901444PA true SG11201901444PA (en) 2019-03-28

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US (2) US11628217B2 (en)
EP (1) EP3506886B1 (en)
JP (2) JP6864747B2 (en)
KR (2) KR20190043161A (en)
CN (3) CN109890367B (en)
AR (1) AR109494A1 (en)
AU (2) AU2017321605B2 (en)
BR (1) BR112019003479A2 (en)
CA (1) CA3035252C (en)
CL (1) CL2019000508A1 (en)
CO (1) CO2019002239A2 (en)
CR (1) CR20190150A (en)
CU (1) CU20190015A7 (en)
EA (1) EA201990598A1 (en)
EC (1) ECSP19021312A (en)
GE (1) GEP20217252B (en)
IL (1) IL265071B2 (en)
JO (1) JOP20170170B1 (en)
MA (1) MA46109A (en)
MX (2) MX2019002338A (en)
MY (1) MY189411A (en)
PE (1) PE20190469A1 (en)
PH (1) PH12019500365A1 (en)
SG (2) SG10202100697PA (en)
TW (2) TWI719245B (en)
UA (1) UA122733C2 (en)
UY (1) UY37391A (en)
WO (1) WO2018045054A1 (en)
ZA (1) ZA201901891B (en)

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IL294411A (en) * 2016-01-05 2022-08-01 Omeros Corp Masp-2 inhibitors for use in inhibiting fibrosis
JOP20170170B1 (en) * 2016-08-31 2022-09-15 Omeros Corp Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
JOP20190068A1 (en) * 2016-10-13 2019-04-01 Omeros Corp Methods for reducing proteinuria in a human subject suffering from immunoglobulin a nephropathy
BR112020003632A2 (en) * 2017-08-25 2020-10-27 Omeros Corporation method of treating an individual who suffers or is at risk of developing ahus
AU2020225202B2 (en) 2019-02-18 2023-10-26 Eli Lilly And Company Therapeutic antibody formulation
US20220273796A1 (en) * 2019-07-19 2022-09-01 Ichnos Sciences SA Lyophilized antibody formulation
CA3159159A1 (en) 2019-12-04 2021-06-10 Neil S. Cutshall Masp-2 inhibitors and methods of use
US20210179612A1 (en) 2019-12-04 2021-06-17 Omeros Corporation Masp-2 inhibitors and methods of use
IL293550A (en) 2019-12-04 2022-08-01 Omeros Corp Masp-2 inhibitor compounds, compositions comprising same and uses thereof
IL293551A (en) 2019-12-04 2022-08-01 Omeros Corp Masp-2 inhibitor compounds, compositions comprising same and uses thereof
IL300245A (en) * 2020-07-31 2023-03-01 Alamab Therapeutics Inc Anti-connexin antibody formulations
AU2021365008A1 (en) * 2020-10-22 2023-06-08 Allakos Inc. Anti-siglec-8 antibody formulations
KR20240017071A (en) * 2021-06-08 2024-02-06 상하이 제민케어 파마슈티칼 컴퍼니 리미티드 Anti-MASP-2 antibodies and uses thereof
WO2024118840A1 (en) 2022-11-30 2024-06-06 Omeros Corporation Fused pyrimidines as masp-2 inhibitors

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US20170253667A1 (en) 2016-01-05 2017-09-07 University Of Leicester Methods for inhibiting fibrosis in a subject in need thereof
IL294411A (en) 2016-01-05 2022-08-01 Omeros Corp Masp-2 inhibitors for use in inhibiting fibrosis
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JOP20170170B1 (en) * 2016-08-31 2022-09-15 Omeros Corp Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods

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EP3506886A1 (en) 2019-07-10
AR109494A1 (en) 2018-12-12
TWI730310B (en) 2021-06-11
CN109890367A (en) 2019-06-14
KR20190043161A (en) 2019-04-25
PE20190469A1 (en) 2019-04-04
NZ751988A (en) 2021-09-24
EP3506886A4 (en) 2019-10-09
US11628217B2 (en) 2023-04-18
KR102444154B1 (en) 2022-09-16
SG10202100697PA (en) 2021-02-25
MY189411A (en) 2022-02-10
CO2019002239A2 (en) 2019-03-18
US20180153988A1 (en) 2018-06-07
MX2023014120A (en) 2023-12-12
AU2020277135A1 (en) 2020-12-24
AU2017321605A1 (en) 2019-02-07
ECSP19021312A (en) 2019-04-30
IL265071B1 (en) 2023-08-01
MX2019002338A (en) 2019-08-16
CA3035252A1 (en) 2018-03-08
CU20190015A7 (en) 2019-11-04
JOP20170170A1 (en) 2019-01-30
UY37391A (en) 2018-02-28
CL2019000508A1 (en) 2019-06-28
JOP20170170B1 (en) 2022-09-15
AU2017321605B2 (en) 2020-10-08
ZA201901891B (en) 2019-12-18
EA201990598A1 (en) 2019-07-31
US20230226178A1 (en) 2023-07-20
CN116327917A (en) 2023-06-27
TW201944983A (en) 2019-12-01
TWI719245B (en) 2021-02-21
JP6864747B2 (en) 2021-04-28
CR20190150A (en) 2019-05-14
CN109890367B (en) 2022-08-30
JP2019531341A (en) 2019-10-31
JP2021105033A (en) 2021-07-26
CN116327695A (en) 2023-06-27
PH12019500365A1 (en) 2019-11-04
KR20210135618A (en) 2021-11-15
IL265071B2 (en) 2023-12-01
AU2020277135B2 (en) 2023-11-02
UA122733C2 (en) 2020-12-28
GEP20217252B (en) 2021-05-13
CA3035252C (en) 2021-08-10
WO2018045054A1 (en) 2018-03-08
JP7197623B2 (en) 2022-12-27
IL265071A (en) 2019-04-30
TW201811365A (en) 2018-04-01
EP3506886B1 (en) 2024-05-22
MA46109A (en) 2019-07-10
BR112019003479A2 (en) 2019-05-21

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