[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643529":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":57,"studyPopulation":57,"armGroups":67,"interventions":80,"overallOfficials":92,"centralContacts":96,"locations":102,"responsibleParty":2492,"collaborators":57,"id":2494,"slug":2495,"hasResults":2496,"nctId":2497,"briefTitle":2498,"officialTitle":2499,"acronym":2500,"eligibilityCriteria":2501,"healthyVolunteers":2496,"sex":2502,"minAge":2503,"maxAge":57,"enrollmentInfo":2504,"targetDuration":57,"studyType":2507,"phases":2508,"briefSummary":2510,"conditions":2511,"keywords":57,"overallStatus":105,"whyStopped":57,"lastUpdateSubmitDate":2513,"lastUpdatePostDateStruct":2514,"startDateStruct":2517,"completionDateStruct":2519,"leadSponsor":2521,"locationsCount":2522},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants in Clinical Remission at Week 48","Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.","At Week 48",[14,17,20,23,26,30,33,37,40,43,47,49,53],{"measure":15,"description":16,"timeFrame":12},"Percentage of Participants with Endoscopic Improvement at Week 48","Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.",{"measure":18,"description":19,"timeFrame":12},"Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48","Corticosteroid-free (90 day) clinical remission is defined as clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.",{"measure":21,"description":22,"timeFrame":12},"Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48","Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Histologic remission is defined as an absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.",{"measure":24,"description":25,"timeFrame":12},"Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48","Fatigue response is defined as a greater than or equal to (\\>=) 7- point reduction in the patient-reported outcomes measurement information system (PROMIS) fatigue short form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).",{"measure":27,"description":28,"timeFrame":29},"Percentage of Participants with Sustained Mayo SF Less Than or Equal to (\u003C=) 1 and RB=0","Percentage of participants with a SF subscore of 0 or 1 and RB subscore of 0 at three assessment time points of Week 12, Week 24, and Week 48 will be reported.","At Weeks 12, 24, and 48",{"measure":31,"description":32,"timeFrame":12},"Percentage of Participants in Abdominal Pain Remission at Week 48","Percentage of participants in abdominal pain remission at week 48 will be reported.",{"measure":34,"description":35,"timeFrame":36},"Change From Baseline in Abdominal Pain Score at Week 48","Change from baseline in abdominal pain score based on abdominal pain-numerical rating scale (AP-NRS) will be reported. NRS is 11 point (0 to 10) scoring system used to evaluate abdominal pain. The score of 0 represents \"no pain\" and the score of 10 represents \"pain as bad as you can imagine\", with greater scores indicating greater pain severity and intensity.","Baseline and Week 48",{"measure":38,"description":39,"timeFrame":12},"Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48","IBDQ response is defined as improvement from baseline in the total IBDQ score of \\>= 16 points. The IBDQ is a 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).",{"measure":41,"description":42,"timeFrame":12},"Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48","PROMIS 29 MCS response is defined as a \\>= 7-point improvement from baseline in PROMIS 29 MCS response at Week 48. The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities). The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression\u002Fanxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.",{"measure":44,"description":45,"timeFrame":46},"Percentage of Participants in Clinical Remission at Week 12","Clinical remission is defined as an SF subscore of 0 or 1, RB subscore of 0, and an endoscopy subscore of 0 or 1.","At Week 12",{"measure":48,"description":16,"timeFrame":46},"Percentage of Participants with Endoscopic Improvement at Week 12",{"measure":50,"description":51,"timeFrame":52},"Percentage of Participants with Mayo SF\u002FRB Response at Week 2","Mayo SF\u002FRB response is defined as a decrease from baseline in the sum of the SF and the RB subscores by \\>=30 percent (%) and \\>= 1 point, with either a \\>= 1 point decrease from baseline in the RB subscore or an RB subscore of 0 or 1.","At Week 2",{"measure":54,"description":55,"timeFrame":56},"Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs)","An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability\u002F incapacity, is a congenital anomaly\u002Fbirth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.","Up to approximately 3 years",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":57,"primaryPurpose":61,"observationalModel":57,"timePerspective":57,"maskingInfo":62},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":63,"maskingDescription":57,"whoMasked":64},"DOUBLE",[65,66],"PARTICIPANT","INVESTIGATOR",[68,74],{"label":69,"type":70,"description":71,"interventionNames":72},"JNJ-78934804","EXPERIMENTAL","Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.",[73],"Drug: JNJ-78934804",{"label":75,"type":76,"description":77,"interventionNames":78},"Guselkumab","ACTIVE_COMPARATOR","Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.",[73,79],"Drug: Guselkumab",[81,87],{"type":82,"name":69,"description":83,"armGroupLabels":84,"otherNames":85},"DRUG","JNJ-78934804 will be administered subcutaneously.",[75,69],[86],"JNJ-4804",{"type":82,"name":75,"description":88,"armGroupLabels":89,"otherNames":90},"Guselkumab will be administered subcutaneously.",[75],[91],"TREMFYA",[93],{"name":94,"affiliation":5,"role":95},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[97],{"name":98,"role":99,"phone":100,"phoneExt":57,"email":101},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[103,117,126,135,144,154,164,173,182,192,202,212,221,231,241,250,260,270,280,290,300,310,320,329,339,345,354,363,372,381,390,399,410,419,428,437,446,449,458,467,476,487,496,505,516,525,534,540,546,555,560,569,578,589,598,607,616,622,631,640,649,655,661,670,681,690,696,702,708,714,723,735,741,751,761,771,780,789,798,808,814,825,831,837,846,855,864,873,879,885,894,903,912,921,930,939,948,957,966,975,984,993,1002,1012,1016,1025,1034,1043,1052,1058,1069,1078,1086,1097,1106,1115,1124,1133,1142,1151,1160,1169,1178,1187,1196,1205,1216,1222,1228,1237,1246,1255,1264,1273,1282,1291,1300,1309,1318,1327,1336,1347,1353,1359,1368,1379,1385,1390,1396,1402,1411,1422,1431,1440,1449,1458,1467,1476,1482,1493,1502,1508,1517,1526,1535,1544,1553,1562,1571,1582,1588,1592,1601,1607,1613,1622,1633,1642,1648,1652,1661,1670,1679,1685,1694,1703,1712,1716,1725,1731,1740,1748,1757,1763,1769,1778,1782,1786,1795,1804,1815,1824,1833,1839,1848,1859,1868,1877,1886,1897,1906,1910,1919,1928,1937,1948,1957,1963,1972,1978,1987,1996,2005,2014,2020,2029,2038,2047,2056,2062,2071,2082,2091,2097,2106,2115,2126,2132,2138,2147,2156,2167,2176,2185,2194,2203,2208,2217,2227,2236,2245,2249,2253,2262,2268,2279,2288,2297,2306,2315,2326,2337,2346,2355,2361,2370,2380,2389,2398,2404,2413,2422,2431,2442,2451,2460,2469,2477,2483],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":57},"Clinnova Research","RECRUITING","Anaheim","California","92805","United States","US",{"type":112,"coordinates":113},"Point",[114,115],-117.9145,33.83529,{"lat":115,"lon":114},{"facility":118,"status":105,"city":119,"state":107,"zip":120,"country":109,"countryCode":110,"cosmosGeoPoint":121,"geoPoint":125,"contacts":57},"Gastro SB Clinic","Chula Vista","91910",{"type":112,"coordinates":122},[123,124],-117.0842,32.64005,{"lat":124,"lon":123},{"facility":127,"status":105,"city":128,"state":107,"zip":129,"country":109,"countryCode":110,"cosmosGeoPoint":130,"geoPoint":134,"contacts":57},"United Medical Doctors","Los Alamitos","90720",{"type":112,"coordinates":131},[132,133],-118.07256,33.80307,{"lat":133,"lon":132},{"facility":136,"status":105,"city":137,"state":107,"zip":138,"country":109,"countryCode":110,"cosmosGeoPoint":139,"geoPoint":143,"contacts":57},"Medical Associates Research Group, Inc.","San Diego","92123",{"type":112,"coordinates":140},[141,142],-117.16472,32.71571,{"lat":142,"lon":141},{"facility":145,"status":105,"city":146,"state":147,"zip":148,"country":109,"countryCode":110,"cosmosGeoPoint":149,"geoPoint":153,"contacts":57},"Peak Gastroenterology Associates","Colorado Springs","Colorado","80907",{"type":112,"coordinates":150},[151,152],-104.82136,38.83388,{"lat":152,"lon":151},{"facility":155,"status":105,"city":156,"state":157,"zip":158,"country":109,"countryCode":110,"cosmosGeoPoint":159,"geoPoint":163,"contacts":57},"Florida Research Center Inc.","Lakewood Rch","Florida","34211",{"type":112,"coordinates":160},[161,162],-82.4332,27.3863,{"lat":162,"lon":161},{"facility":165,"status":105,"city":166,"state":157,"zip":167,"country":109,"countryCode":110,"cosmosGeoPoint":168,"geoPoint":172,"contacts":57},"Sanchez Clinical Research, Inc","Miami","33157-6575",{"type":112,"coordinates":169},[170,171],-80.19366,25.77427,{"lat":171,"lon":170},{"facility":174,"status":105,"city":175,"state":157,"zip":176,"country":109,"countryCode":110,"cosmosGeoPoint":177,"geoPoint":181,"contacts":57},"GCP Clinical Research","Tampa","33609",{"type":112,"coordinates":178},[179,180],-82.45843,27.94752,{"lat":180,"lon":179},{"facility":183,"status":105,"city":184,"state":185,"zip":186,"country":109,"countryCode":110,"cosmosGeoPoint":187,"geoPoint":191,"contacts":57},"Atlanta Gastroenterology Specialists","Suwanee","Georgia","30024",{"type":112,"coordinates":188},[189,190],-84.0713,34.05149,{"lat":190,"lon":189},{"facility":193,"status":105,"city":194,"state":195,"zip":196,"country":109,"countryCode":110,"cosmosGeoPoint":197,"geoPoint":201,"contacts":57},"Tri-State Gastroenterology Assoc","Crestview Hills","Kentucky","41017",{"type":112,"coordinates":198},[199,200],-84.58494,39.02728,{"lat":200,"lon":199},{"facility":203,"status":105,"city":204,"state":205,"zip":206,"country":109,"countryCode":110,"cosmosGeoPoint":207,"geoPoint":211,"contacts":57},"Gastroenterology Clinic of Acadiana","Lafayette","Louisiana","70503",{"type":112,"coordinates":208},[209,210],-92.01984,30.22409,{"lat":210,"lon":209},{"facility":213,"status":105,"city":214,"state":205,"zip":215,"country":109,"countryCode":110,"cosmosGeoPoint":216,"geoPoint":220,"contacts":57},"GIA Metairie","Metairie","70006",{"type":112,"coordinates":217},[218,219],-90.15285,29.98409,{"lat":219,"lon":218},{"facility":222,"status":105,"city":223,"state":224,"zip":225,"country":109,"countryCode":110,"cosmosGeoPoint":226,"geoPoint":230,"contacts":57},"Michigan Center of Medical Research","Farmington Hills","Michigan","48334",{"type":112,"coordinates":227},[228,229],-83.37716,42.48531,{"lat":229,"lon":228},{"facility":232,"status":105,"city":233,"state":234,"zip":235,"country":109,"countryCode":110,"cosmosGeoPoint":236,"geoPoint":240,"contacts":57},"GIA Kansas City","Lee's Summit","Missouri","64086",{"type":112,"coordinates":237},[238,239],-94.38217,38.91084,{"lat":239,"lon":238},{"facility":242,"status":105,"city":243,"state":243,"zip":244,"country":109,"countryCode":110,"cosmosGeoPoint":245,"geoPoint":249,"contacts":57},"New York Gastroenterology Associates","New York","10075",{"type":112,"coordinates":246},[247,248],-74.00597,40.71427,{"lat":248,"lon":247},{"facility":251,"status":105,"city":252,"state":253,"zip":254,"country":109,"countryCode":110,"cosmosGeoPoint":255,"geoPoint":259,"contacts":57},"University of North Carolina Hospital","Chapel Hill","North Carolina","27599-7080",{"type":112,"coordinates":256},[257,258],-79.05584,35.9132,{"lat":258,"lon":257},{"facility":261,"status":105,"city":262,"state":263,"zip":264,"country":109,"countryCode":110,"cosmosGeoPoint":265,"geoPoint":269,"contacts":57},"Great Lakes Gastroenterology Research, LLC","Mentor","Ohio","44060",{"type":112,"coordinates":266},[267,268],-81.33955,41.66616,{"lat":268,"lon":267},{"facility":271,"status":105,"city":272,"state":273,"zip":274,"country":109,"countryCode":110,"cosmosGeoPoint":275,"geoPoint":279,"contacts":57},"Digestive Disease Specialists Inc","Oklahoma City","Oklahoma","73114",{"type":112,"coordinates":276},[277,278],-97.51643,35.46756,{"lat":278,"lon":277},{"facility":281,"status":105,"city":282,"state":283,"zip":284,"country":109,"countryCode":110,"cosmosGeoPoint":285,"geoPoint":289,"contacts":57},"The Oregon Clinic","Portland","Oregon","97220",{"type":112,"coordinates":286},[287,288],-122.67621,45.52345,{"lat":288,"lon":287},{"facility":291,"status":105,"city":292,"state":293,"zip":294,"country":109,"countryCode":110,"cosmosGeoPoint":295,"geoPoint":299,"contacts":57},"Frontier Clinical Research","Uniontown","Pennsylvania","15401",{"type":112,"coordinates":296},[297,298],-79.71643,39.90008,{"lat":298,"lon":297},{"facility":301,"status":105,"city":302,"state":303,"zip":304,"country":109,"countryCode":110,"cosmosGeoPoint":305,"geoPoint":309,"contacts":57},"Gastro One","Cordova","Tennessee","38018",{"type":112,"coordinates":306},[307,308],-89.7762,35.15565,{"lat":308,"lon":307},{"facility":311,"status":105,"city":312,"state":313,"zip":314,"country":109,"countryCode":110,"cosmosGeoPoint":315,"geoPoint":319,"contacts":57},"Southern Star Research Institute, LLC","San Antonio","Texas","78229",{"type":112,"coordinates":316},[317,318],-98.49363,29.42412,{"lat":318,"lon":317},{"facility":321,"status":105,"city":322,"state":313,"zip":323,"country":109,"countryCode":110,"cosmosGeoPoint":324,"geoPoint":328,"contacts":57},"Tyler Research Institute, LLC","Tyler","75701",{"type":112,"coordinates":325},[326,327],-95.30106,32.35126,{"lat":327,"lon":326},{"facility":330,"status":105,"city":331,"state":332,"zip":333,"country":109,"countryCode":110,"cosmosGeoPoint":334,"geoPoint":338,"contacts":57},"GI Alliance Tacoma","Tacoma","Washington","98405",{"type":112,"coordinates":335},[336,337],-122.44429,47.25288,{"lat":337,"lon":336},{"facility":340,"status":105,"city":341,"state":57,"zip":342,"country":343,"countryCode":344,"cosmosGeoPoint":57,"geoPoint":57,"contacts":57},"GEDYT","AAI","C1425BGC","Argentina","AR",{"facility":346,"status":105,"city":347,"state":57,"zip":348,"country":343,"countryCode":344,"cosmosGeoPoint":349,"geoPoint":353,"contacts":57},"Instituto Medico De Alta Complejidad (IMAC)","Buenos Aires","B1643CRO",{"type":112,"coordinates":350},[351,352],-58.37723,-34.61315,{"lat":352,"lon":351},{"facility":355,"status":105,"city":356,"state":57,"zip":357,"country":343,"countryCode":344,"cosmosGeoPoint":358,"geoPoint":362,"contacts":57},"Globalpsy","La Plata","1896",{"type":112,"coordinates":359},[360,361],-57.95442,-34.92126,{"lat":361,"lon":360},{"facility":364,"status":105,"city":365,"state":57,"zip":366,"country":343,"countryCode":344,"cosmosGeoPoint":367,"geoPoint":371,"contacts":57},"HIGEA","Mendoza","M5500DPS",{"type":112,"coordinates":368},[369,370],-68.84582,-32.88946,{"lat":370,"lon":369},{"facility":373,"status":105,"city":374,"state":57,"zip":375,"country":343,"countryCode":344,"cosmosGeoPoint":376,"geoPoint":380,"contacts":57},"Instituto de Investigaciones Clinicas Quilmes","Quilmes","B1878GEG",{"type":112,"coordinates":377},[378,379],-58.25454,-34.72065,{"lat":379,"lon":378},{"facility":382,"status":105,"city":383,"state":57,"zip":384,"country":343,"countryCode":344,"cosmosGeoPoint":385,"geoPoint":389,"contacts":57},"Hospital Provincial del Centenario","Rosario","S2000KDS",{"type":112,"coordinates":386},[387,388],-60.63932,-32.94682,{"lat":388,"lon":387},{"facility":391,"status":105,"city":392,"state":57,"zip":393,"country":343,"countryCode":344,"cosmosGeoPoint":394,"geoPoint":398,"contacts":57},"MR Medicina Reumatologica","San Fernando","B1646",{"type":112,"coordinates":395},[396,397],-58.56279,-34.44104,{"lat":397,"lon":396},{"facility":400,"status":105,"city":401,"state":57,"zip":402,"country":403,"countryCode":404,"cosmosGeoPoint":405,"geoPoint":409,"contacts":57},"Banksia Trials SA","Adelaide","5000","Australia","AU",{"type":112,"coordinates":406},[407,408],138.59863,-34.92866,{"lat":408,"lon":407},{"facility":411,"status":105,"city":412,"state":57,"zip":413,"country":403,"countryCode":404,"cosmosGeoPoint":414,"geoPoint":418,"contacts":57},"Royal Prince Alfred Hospital","Camperdown","2050",{"type":112,"coordinates":415},[416,417],151.17642,-33.88965,{"lat":417,"lon":416},{"facility":420,"status":105,"city":421,"state":57,"zip":422,"country":403,"countryCode":404,"cosmosGeoPoint":423,"geoPoint":427,"contacts":57},"Monash Medical Centre","Clayton","3168",{"type":112,"coordinates":424},[425,426],145.11667,-37.91667,{"lat":426,"lon":425},{"facility":429,"status":105,"city":430,"state":57,"zip":431,"country":403,"countryCode":404,"cosmosGeoPoint":432,"geoPoint":436,"contacts":57},"The Melbourne Gut Clinic Epworth Hospital","East Melbourne","3002",{"type":112,"coordinates":433},[434,435],144.9879,-37.81667,{"lat":435,"lon":434},{"facility":438,"status":105,"city":439,"state":57,"zip":440,"country":403,"countryCode":404,"cosmosGeoPoint":441,"geoPoint":445,"contacts":57},"SA Gastrointestinal Services","Kurralta Park","5037",{"type":112,"coordinates":442},[443,444],138.56702,-34.95142,{"lat":444,"lon":443},{"facility":447,"status":105,"city":447,"state":57,"zip":448,"country":403,"countryCode":404,"cosmosGeoPoint":57,"geoPoint":57,"contacts":57},"Macquarie University","2109",{"facility":450,"status":105,"city":451,"state":57,"zip":452,"country":403,"countryCode":404,"cosmosGeoPoint":453,"geoPoint":457,"contacts":57},"Fiona Stanley Hospital","Murdoch","6150",{"type":112,"coordinates":454},[455,456],115.83757,-32.06987,{"lat":456,"lon":455},{"facility":459,"status":105,"city":460,"state":57,"zip":461,"country":403,"countryCode":404,"cosmosGeoPoint":462,"geoPoint":466,"contacts":57},"John Hunter Hospital","New Lambton Heights","2305",{"type":112,"coordinates":463},[464,465],151.69364,-32.92466,{"lat":465,"lon":464},{"facility":468,"status":105,"city":469,"state":57,"zip":470,"country":403,"countryCode":404,"cosmosGeoPoint":471,"geoPoint":475,"contacts":57},"Mater Misericordiae Hospital","South Brisbane","4101",{"type":112,"coordinates":472},[473,474],153.02049,-27.48034,{"lat":474,"lon":473},{"facility":477,"status":105,"city":478,"state":57,"zip":479,"country":480,"countryCode":481,"cosmosGeoPoint":482,"geoPoint":486,"contacts":57},"Kepler Universitatsklinikum GmbH","Linz","4021","Austria","AT",{"type":112,"coordinates":483},[484,485],14.28611,48.30639,{"lat":485,"lon":484},{"facility":488,"status":105,"city":489,"state":57,"zip":490,"country":480,"countryCode":481,"cosmosGeoPoint":491,"geoPoint":495,"contacts":57},"Krankenhaus der Barmherzigen 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