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A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy

IDENTIFIERS
Trial Protocol: TAK-994-1501
Clinicaltrials.gov: NCT04096560
JapicCTI: JapicCTI-205178
PURPOSE

The main aims of the study are: - To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. - To check what dose range provides adequate relief of narcolepsy symptoms. - To check how much TAK-994 stays in the blood of participants, over time. The study will have 4 parts. Participants can only join 1 of the parts. A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it. B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days. C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days. D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

Recruiting
US
CA
CN
9+
CZ
FI
FR
HU
IT
JP
KR
NL
ES

Trial at a glance

What medical condition is being studied?   Narcolepsy
What is the trial testing?   TAK-994, Placebo
Are placebos part of the trial?   Yes
How many participants are being enrolled?   202
When is the trial being conducted?    - 
How long is participation in the trial?   Participants will be in the study for 28 days of treatment plus about 1 week follow up or for 56 days of treatment plus about 1 week follow up, depending on which part of the study they are in.

Key requirements

Sex   
All
Age   
18 - 65 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   Phase 2
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
Part A, Cohorts A1a and Cohorts A1b and A2 (Optional), NT1 Participants: Placebo: TAK-994 placebo-matching tablets for 28 days, in participants with NT1.
Part A, Cohort A1a, NT1 Participants: TAK-994 TBD: TAK-994, tablets, dose level 1 for 28 days, in participants with NT1.
Part A, Cohort A1b, NT1 Participants: TAK-994: TAK-994 tablets, dose to be determined (TBD) based on safety, tolerability and/or efficacy in Cohort A1a participants with NT1.
Part A, Cohort A2 (Optional), NT1 Participants: TAK-994 TBD: TAK-994 tablets, TBD based on safety, tolerability and/or efficacy data of Cohort A1, for 28 days.
Part B, NT1 Participants: TAK-994 Dose 1: TAK-994 dose 1, tablets, for 56 days in participants with NT1.
Part B, NT1 Participants: TAK-994 Dose 2: TAK-994 dose 2, tablets, for 56 days in participants with NT1.
Part B, NT1 Participants: TAK-994 Dose 3: TAK-994 dose 3, tablets, 56 days in participants with NT1.
Part B, NT1 Participants: Placebo: TAK-994 placebo-matching tablets for 56 days in participants with NT1.
Part C, NT1 Participants in China: Placebo: TAK-994 placebo-matching tablets for 56 days, in participants with NT1 in China.
Part C, NT1 Participants in China: TAK-994: TAK-994 tablets, dose TBD based on safety and tolerability in Part B, for 56 days in participants with NT1 in China.
Part D, Cohort D1a, D1b and D2, NT2 Participants: Placebo: TAK-994 placebo-matching tablets for 28 days, in participants with NT2.
Part D, Cohort D1a, NT2 Participants: TAK-994: TAK-994 tablets, dose TBD based on safety, tolerability and/or efficacy in Part A , for 28 days in participants with NT2.
Part D, Cohort D1b, NT2 Participants: TAK-994: TAK-994 tablets, dose TBD based on safety and/or tolerability efficacy in Cohort D1a participants with NT2.
Part D, Cohort D2, NT2 Participants (Optional) : TAK-994 TBD: TAK-994 tablets, TBD based on safety, tolerability and/or efficacy data of Cohort D1, for 28 days.
Intervention:   TAK-994, Placebo
Primary Outcome Measure(s):   
Parts A and D: Number of Participants who Experience at least 1 Treatment Emergent Adverse Events (TEAEs) During the Study [Time Frame: First dose of study treatment to end of study follow-up (up to Day 35)]
Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Postdose During the Study [Time Frame: Baseline up to Day 35]
Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at least Once Postdose During the Study [Time Frame: Baseline up to Day 35]
Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at least Once Postdose During the Study [Time Frame: Baseline up to Day 35]
Parts B and C: Change From Baseline in Average Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT) [Time Frame: Baseline and Week 8 (Day 56)]
Secondary Outcome Measure(s):   
Parts A and D: Day 1, Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 [Time Frame: Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose]
Parts A and D: Day 1, Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 [Time Frame: Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose]
Parts A and D: Day 1, AUC(0-last): Area Under the Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration After Single Dose of TAK-994 [Time Frame: Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose]
Parts A and D: Day 28, Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 [Time Frame: Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose]
Parts A and D: Day 28, Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 [Time Frame: Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose]
Parts A and D: Day 28, AUC(0-t): Area Under the Concentration-time Curve from Time 0 to Time tau Over a Dosing Interval of TAK-994 [Time Frame: Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose]
Parts B and C: Change From Baseline in Subjective Daytime Sleepiness as Assessed by ESS Score [Time Frame: Baseline and Week 8 (Day 56)]
Parts B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) as Reported in the Patient-Reported Sleep Diary [Time Frame: Baseline and Week 8 (Day 56)]
Parts B and C: Number of Participants who Experience at least 1 Treatment Emergent Adverse Events (TEAEs) During the Study [Time Frame: First dose of study treatment to end of study follow-up (Up to Day 63)]
Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Postdose During the Study [Time Frame: Baseline up to Day 63]
Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at least Once Postdose During the Study [Time Frame: Baseline up to Day 63]
Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at least Once Postdose During the Study [Time Frame: Baseline up to Day 63]
Entry Criteria:
- Both men and women can take part. - Must be an adult from 18 to 65 years old. - Must have type 1 or type 2 narcolepsy in the last 10 years. - Must be willing to stop taking medicines for type 1 or type 2 narcolepsy. Additional entry criteria will be discussed with the study doctor.

Trial Locations

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RESULTS
Wright Clinical Research

122 1st St S, Alabaster, AL 35007, USA

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Stanford School of Medicine

450 Broadway, Redwood City, CA 94063, USA

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Pacific Research Network, Inc

3003 Fourth Ave, San Diego, CA 92103, USA

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Alpine Clinical Research Center

3434 47th St #201, Boulder, CO 80301, USA

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Delta Waves Sleep Disorders and Research Center

5835 Lehman Dr #101, Colorado Springs, CO 80918, USA

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St Francis Medical Institute

802 N Belcher Rd., Clearwater, FL 33765, USA

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Sleep Medicine Specialists of South Florida

351 NW LeJeune Rd STE 308, Miami, FL 33126, USA

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Clinical Trials of Florida, LLC

12600 SW 120th St #117, Miami, FL 33186, USA

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Florida Pulmonary Research Institute, LLC

1788 W Fairbanks Ave, Winter Park, FL 32789, USA

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NeuroTrials Research, Inc.

1100 Johnson Ferry Rd NE, Atlanta, GA 30342, USA

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iResearch Atlanta, LLC

250 E Ponce de Leon Ave #800, Decatur, GA 30030, USA

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SleepCare Research Institute, Inc. d/b/a Clinical Research Institute

1215 Eagles Landing Pkwy #209, Stockbridge, GA 30281, USA

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Fort Wayne Neurological Center

7956 W Jefferson Blvd, Fort Wayne, IN 46804, USA

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Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"

5454 Wisconsin Ave, Chevy Chase, MD 20815, USA

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Sleep Wake Disorders Center

3411 Wayne Ave, The Bronx, NY 10467, USA

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Clinical Research of Gastonia

3101 Latrobe Dr, Charlotte, NC 28211, USA

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Research Carolina Elite, LLC

Hickory, NC 28601, USA

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CTI Clinical Trial and Consulting Services

1775 Lexington Ave, Cincinnati, OH 45212, USA

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Intrepid Research

4421 Eastgate Blvd #200, Cincinnati, OH 45245, USA

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The Cleveland Clinic Foundation

9500 Euclid Ave, Cleveland, OH 44195, USA

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Ohio Sleep Medicine

4975 Bradenton Ave, Dublin, OH 43017, USA

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Respiratory Specialists

2608 Keiser Blvd, Reading, PA 19610, USA

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Bogan Sleep Consultants, LLC

1333 Taylor St #6B, Columbia, SC 29201, USA

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Sleep Therapy & Research Center

5290 Medical Dr, San Antonio, TX 78229, USA

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Comprehensive Sleep Medicine Associates

15423 Creekbend Dr, Sugar Land, TX 77478, USA

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Western Washington Medical Group

12728 19th Ave SE #200, Everett, WA 98208, USA

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Jodha Tishon Inc.

Toronto, ON M5G 1N8, Canada

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Toronto Sleep Institute

586 Eglinton Ave E #507, Toronto, ON M4P 1P2, Canada

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Hopital Gui de Chauliac

80 Avenue Augustin Fliche, 38054 Montpellier, France

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Hopital Roger Salengro - CHU Lille

Avenue du Professeur Emile Laine, 59037 Lille, France

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Kurume University Hospital

67 Asahimachi, Kurume, Fukuoka 830-0011, Japan

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SOUSEIKAI PS Clinic

812-0025, Japan

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You Ariyoshi Sleep Clinic

802-0084, Japan

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Howakai Kuwamizu Hospital

1-chōme-14-41 Kuwamizu, Chūō-ku, Kumamoto, 862-0954, Japan

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Jinyukai Kotorii Isahaya Hospital

854-0081, Japan

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Shunkaikai Inoue Hospital

6-12 Takaramachi, Nagasaki, 850-0045, Japan

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Gokeikai Osaka Kaisei Hospital

1-chōme-6-10 Miyahara, Yodogawa-ku, Osaka, 532-0003, Japan

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Koishikawa Tokyo Hospital

4-chōme-45-16 Ōtsuka, Bunkyo City, Tōkyō-to 112-0012, Japan

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Nihon University Itabashi Hospital

30-1 Ōyaguchikamichō, Itabashi City, Tōkyō-to 173-8610, Japan

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Yoyogi Sleep Disorder Center

6601 Rockhill Rd, Kansas City, MO 64131, USA

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Sleep Support Clinic

Japan, 〒140-0011 Tōkyō-to, Shinagawa City, Higashiōi, 1-chōme−18−8 ミランビーナ1階

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Sleep & Stress Clinic

Japan, 〒141-0032 Tōkyō-to, Shinagawa City, Ōsaki, 2-chōme−1−1, Thinkpark Tower, 3F

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Sumida Hospital

Japan, 〒130-0004 Tōkyō-to, Sumida City, Honjo, 1-chōme−29−1 ランダムスクウエア本所ビル

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Hospital Clinic de Barcelona

C. de Villarroel, 170, 08036 Barcelona, Spain

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Hospital Vithas Nuestra Senora de America

C. de Arturo Soria, 103, 105, 28043 Madrid, Spain

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Mayo Clinic Arizona

5701 E Mayo Blvd, Phoenix, AZ 85054, USA

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CITrials - Bellflower

17800 Woodruff Ave ste b, Bellflower, CA 90706, USA

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SDS Clinical Trials, Inc.

1535 17th St STE 101, Santa Ana, CA 92705, USA

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JSV Clinical Research Study, Inc

7345 Jackson Springs Rd A, Tampa, FL 33634, USA

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Hawaii Pacific Neuroscience

642 Ulukahiki St, Kailua, HI 96734, USA

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University of Kansas Medical Center Research Institute, Inc.

3901 Rainbow Blvd, Kansas City, KS 66160, USA

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Boston Children's Hospital

300 Longwood Ave, Boston, MA 02115, USA

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Beth Israel Deaconess Medical Center

330 Brookline Ave, Boston, MA 02215, USA

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Raleigh Neurology Associates

1520 Sunday Dr, Raleigh, NC 27607, USA

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IPS Research Company

607 N Western Ave, Oklahoma City, OK 73106, USA

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Medical University of South Carolina (MUSC)

171 Ashley Ave, Charleston, SC 29425, USA

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Lone Start Lung and Sleep Center

13325 Hargrave Rd Ste. 265, Houston, TX 77070, USA

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Beijing Xuan Wu Hospital Affiliated Capital Medical University

45 Changchun St, Xicheng Qu, Beijing Shi, China

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The First Affiliated Hospital of Jinan University

613 Huangpu W Ave, Tian He Gong Yuan, Tianhe Qu, Guangzhou Shi, Guangdong Sheng, China

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Huashan Hospital, Fudan University

12 Wulumuqi Middle Rd, Jingan Qu, Shanghai Shi, China

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Fakultni nemocnice Hradec Kralove

Sokolská 581, Nový Hradec Králové, 500 05 Hradec Králové, Czechia

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Fakultni nemocnice Ostrava

17. listopadu 1790/5, 708 00 Ostrava-Poruba, Czechia

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Vseobecna fakultni nemocnice v Praze

U Nemocnice 499/2, 128 08 Praha 2-Nové Město, Czechia

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VitalMed Oy

Helsinki, Finland

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Turku University Hospital

Kiinamyllynkatu 4-8, 20521 Turku, Finland

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SomnoCenter Budapest

Budapest, Márvány u. 17, 1012 Hungary

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IRCCS Oasi Maria SS

Via Conte Ruggero, 73, 94018 Troina EN, Italy

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Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

Via Zamboni, 33, 40126 Bologna BO, Italy

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Ospedale San Raffaele (San Raffaele Turro)

Via Stamira d'Ancona, 20, 20127 Milano MI, Italy

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Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Viale Oxford, 81, 00133 Roma RM, Italy

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Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Japan, Kanagawa, Yokohama, Kohoku Ward, 北新横浜駅

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Kyowakai Hannan Hospital

277 Handa Minaminochō, Naka Ward, Sakai, Osaka 599-8263, Japan

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The Catholic University of Korea, St. Vincent's Hospital

93 Jungbu-daero, Ji-dong, Paldal-gu, Suwon, Gyeonggi-do, South Korea

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Keimyung University Dongsan Hospital

1035 Dalgubeol-daero, Sindang-dong, Dalseo-gu, Daegu, South Korea

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Stichting Epilepsie Instelling Nederland, Heemstede

2103 SW Heemstede, Netherlands

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Kempenhaeghe, Heeze

Sterkselseweg 65, 5591 VE Heeze, Netherlands

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Hospital Universitario Araba Sede Santiago

Jose Atxotegi Kalea, s/n, 01009 Gasteiz, Araba, Spain

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Hospital General de Castellon

Avinguda de Benicàssim, 128, 12004 Castelló de la Plana, Castelló, Spain

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Hospital Universitario Clinico San Carlos

Calle del Prof Martín Lagos, s/n, 28040 Madrid, Spain

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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

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Trial Protocol ID: TAK-994-1501
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