Datasets:

jinhybr

/

docvqa_donut_1200

like 0

{ "de": "Bis wann wird das Dokument fertig gestellt?", "en": "By when will the document be finalized?", "es": "¿Para cuándo se ultimará el documento?", "fr": "Quand le document sera-t-il finalisé?", "it": "Entro quando sarà ultimato il documento?" }

[ "August 26", "by August 26" ]

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{ "match_score": 1, "matched_text": "August 26", "start": 1314, "text": "August 26" }

{ "de": "Wann findet der FDA Conference Call statt?", "en": "When will the FDA Conference Call be held?", "es": "¿Cuándo se llevará a cabo la Conference Call de la FDA?", "fr": "Quand aura lieu la conférence téléphonique de la FDA?", "it": "Quando si terrà la FDA Conference Call?" }

[ "July 31, 2002" ]

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{ "match_score": 1, "matched_text": "July 31, 2002", "start": 54, "text": "July 31, 2002" }

{ "de": "Wie lautet die Überschrift des Dokuments?", "en": "What is the heading of the document?", "es": "¿Cuál es el título del documento?", "fr": "Quel est le titre du document?", "it": "Qual è il titolo del documento?" }

[ "ACTOS FDA RESPONSE TASK FORCE-TPNA" ]

[ "124-13", "px", "ACTOS", "FDA", "RESPONSE", "TASK", "FORCE-TPNA", "August", "2,", "2002", "Wendall", "Cheatham", "Alfonso", "Perez", "Koun", "Kaluguy", "Janet", "Haskins*", "Aya", "can", "this", "Mary", "Ramstack*", "Ingrid", "Hoo", "Michael", "Elisseou", "John", "Page", "Tom", "Muldom", "Claire", "Thom", "Dan", "Orlando", "David", "Baron", "(Chris", "Durak)", "Larry", "Hancock", "*Task", "Force", "Coordinators", "TASK", "FORCE", "STRATEGY", "The", "FDA", "has", "3", "key", "issues", "with", "respect", "to", "the", "non-clinical", "data", "related", "to", "bladder", "tumors.", "1.", "They", "requested", "us", "to", "propose", "a", "method", "by", "which", "to", "monitor", "bladder", "toxicity", "in", "patients", "in", "our", "long", "term", "phase", "4", "clinical", "trials", "(long", "term", "was", "defined", "as", "at", "least", "1", "year).", "a.", "TPNA", "will", "investigate", "the", "feasibility", "and", "scientific", "merit", "of", "a", "clinical", "monitoring", "plan.", "If", "deemed", "appropriate,", "TPNA", "will", "develop", "monitoring", "plan", "2.", "They", "requested", "us", "to", "give", "some", "consideration", "to", "a", "label", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "mechanism", "(dual", "PPAR", "agonist)", "instead", "of", "the", "current", "language", "(\"The", "relationship", "of", "these", "findings", "in", "male", "rats", "to", "humans", "is", "unclear.\")", "a.", "TPNA", "would", "like", "to", "challenge", "FDA", "hypothesis", "around", "tumor", "formation", "relationship", "to", "dual", "PPAR", "mechanism.", "b.", "TPNA", "goal", "is", "to", "supply", "justification", "to", "support", "maintaining", "current", "labeling.", "3.", "They", "indicated", "an", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "based", "on", "their", "concern", "about", "bladder", "tumors.", "a.", "Based", "on", "current", "verbiage", "in", "PI", "TPNA", "requests", "to", "conduct", "pediatric", "trial", "as", "scheduled.", "OR", "b.", "Request", "to", "delay", "initiation", "of", "Pediatric", "Study", "508", "pending", "506", "data", "availability", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032209", "Produced", "in", "MDL", "on", "02/21/13", "Source:", "https://www.indup5398coboots.ucsf.edu/docs/qtjf0226" ]

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{ "match_score": 1, "matched_text": "ACTOS FDA RESPONSE TASK FORCE-TPNA", "start": 10, "text": "ACTOS FDA RESPONSE TASK FORCE-TPNA" }

{ "de": "Wie viele Schlüsselprobleme hat die FDA in Bezug auf die nicht-klinischen Daten zu Blasentumoren?", "en": "How many key issues does the FDA have with respect to the non-clinical data related to bladder tumors?", "es": "¿Cuántos problemas clave tiene la FDA con respecto a los datos no clínicos relacionados con los tumores de vejiga?", "fr": "Combien de questions clés la FDA a-t-elle en ce qui concerne les données non cliniques relatives aux tumeurs de la vessie?", "it": "Quanti problemi chiave ha la FDA rispetto ai dati non clinici relativi ai tumori della vescica?" }

[ "The FDA has 3 key issues with respect to the non-clinical data related to bladder tumors.", "3" ]

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{ "match_score": 1, "matched_text": "The FDA has 3 key issues with respect to the non-clinical data related to bladder tumors.", "start": 305, "text": "The FDA has 3 key issues with respect to the non-clinical data related to bladder tumors." }

{ "de": "Welchen Plan entwickelt TPNA?", "en": "What plan is developed by TPNA?", "es": "¿Qué plan desarrolla el TPNA?", "fr": "Quel plan est élaboré par TPNA?", "it": "Qual è il piano sviluppato da TPNA?" }

[ "TPNA will develop monitoring plan.", "monitoring plan" ]

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{ "match_score": 0.9705882361591696, "matched_text": "TPNA will develop monitoring plan ", "start": 686, "text": "TPNA will develop monitoring plan." }

{ "de": "Was ist das Ziel von TPNA?", "en": "What is TPNA's goal?", "es": "¿Cuál es el objetivo del TPNA?", "fr": "Quel est l'objectif de TPNA?", "it": "Qual è l'obiettivo di TPNA?" }

[ "is to supply justification to support maintaining current labeling." ]

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{ "match_score": 1, "matched_text": "is to supply justification to support maintaining current labeling.", "start": 1104, "text": "is to supply justification to support maintaining current labeling." }

{ "de": "Wann wurde dieses Dokument zuletzt aktualisiert?", "en": "When was this document last updated?", "es": "¿Cuándo se actualizó por última vez este documento?", "fr": "Quand ce document a-t-il été mis à jour pour la dernière fois?", "it": "Quando è stato aggiornato l'ultimo documento?" }

[ "August 1, 2002" ]

[ "Task", "Notes", "Lead", "Responsibility", "Due", "Date", "8.", "COMPETITIVE", "INTELLIGENCE", "Update", "team", "on", "competitive", "Wendell", "Cheatham", "intelligence", "To", "Ongoing", "-", "update", "provided", "at", "each", "meeting", "9.", "Q&", "A", "SHEET", "Develop", "Q&A", "sheet", "to", "support", "Wendell", "Cheatham", "Draft", "-", "August", "5", "Scientific", "Communications", "Comments", "due", "-", "August", "7", "Review", "meeting", "-", "August", "7", "10.", "PATIENT", "REGISTRY", "Evaluate", "feasiblety", "of", "Pharmetric", "Database", "Rich", "Wilson", "developing", "large", "patient", "GE", "Database", "Rukmimi", "Rajagopalam", "registry", "Fred", "Murray", "notto", "be", "11", "COMMUNICATIONS", "TO", "TAKEDA", "(TCI,", "TEUR&D,", "TRNA)", "12.", "EVALUATE", "IMPACT", "ON", "TAK-559;", "Last", "Update:", "August", "1,", "2002", "Page", "7", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032216", "Produced", "in", "MDL", "on", "02/21/13", "Source:", "https://www.indups318coo0ogts.ucsf.edu/docs/qtjf0226" ]

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{ "match_score": 1, "matched_text": "August 1, 2002", "start": 579, "text": "August 1, 2002" }

{ "de": "Was ist das Fälligkeitsdatum des Entwurfs?", "en": "What is the Draft's Due Date?", "es": "¿Cuál es la fecha de vencimiento del borrador?", "fr": "Quelle est la date d'échéance de l'ébauche?", "it": "Qual è la data di scadenza del Draft?" }

[ "August 5" ]

[ "Task", "Notes", "Lead", "Responsibility", "Due", "Date", "8.", "COMPETITIVE", "INTELLIGENCE", "Update", "team", "on", "competitive", "Wendell", "Cheatham", "intelligence", "To", "Ongoing", "-", "update", "provided", "at", "each", "meeting", "9.", "Q&", "A", "SHEET", "Develop", "Q&A", "sheet", "to", "support", "Wendell", "Cheatham", "Draft", "-", "August", "5", "Scientific", "Communications", "Comments", "due", "-", "August", "7", "Review", "meeting", "-", "August", "7", "10.", "PATIENT", "REGISTRY", "Evaluate", "feasiblety", "of", "Pharmetric", "Database", "Rich", "Wilson", "developing", "large", "patient", "GE", "Database", "Rukmimi", "Rajagopalam", "registry", "Fred", "Murray", "notto", "be", "11", "COMMUNICATIONS", "TO", "TAKEDA", "(TCI,", "TEUR&D,", "TRNA)", "12.", "EVALUATE", "IMPACT", "ON", "TAK-559;", "Last", "Update:", "August", "1,", "2002", "Page", "7", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032216", "Produced", "in", "MDL", "on", "02/21/13", "Source:", "https://www.indups318coo0ogts.ucsf.edu/docs/qtjf0226" ]

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{ "match_score": 1, "matched_text": "August 5", "start": 238, "text": "August 5" }

{ "de": "Welcher Nutzen beginnt nach einem Jahr Service?", "en": "Which benefit start after 1 year of service?", "es": "¿Qué beneficio comienza después de 1 año de servicio?", "fr": "Quelles prestations commencent après 1 an de service?", "it": "Quali benefici iniziano dopo 1 anno di servizio?" }

[ "Extended Disability", "extended disability" ]

[ "Dr.", "Tan", "January", "14,", "1999", "Page", "5", "ELI", "LILLY", "AND", "COMPANY", "COMPENSATION", "AND", "BENEFITS", "PROGRAM", "(CONTINUED)", "Additional", "Company", "Benefits", "Medical", "and", "Dental", "Insurance", "Prescription", "Drug", "Benefits", "Reimbursement", "Accounts", "Illness", "Pay", "Extended", "Disability", "(Eligibility", "begins", "after", "1", "year", "of", "service)", "Credit", "Union", "Moving", "Plan", "(see", "enclosed", "brochure)", "Retirement", "Plan", "Employee", "Health", "Services", "Employee", "Activities", "Educational", "Assistance", "Program", "Savings", "Plan", "Holiday", "and", "Vacation", "Plan", "Please", "refer", "to", "the", "\"Employee", "Compensation\"", "booklet", "for", "the", "details.", "Optional", "Employee-Paid", "Benefits", "Supplemental", "Life", "Insurance", "Dependent", "Life", "Insurance", "Flexible", "CarePlus", "(life/long-term", "care", "insurance)", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-TANM-PF-00000050", "Source:", "https://www.indup6330-00005", "ts.ucsf.edu/docs/ttjf0226" ]

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{ "match_score": 1, "matched_text": "Extended Disability", "start": 219, "text": "Extended Disability" }

{ "de": "Welche Rolle spielt Frau Wakamatsu in der strategischen Entwicklung?", "en": "What is Ms Wakamatsu's role in Dept. Strategic Development?", "es": "¿Cuál es el papel de la Sra. Wakamatsu en el Departamento de Desarrollo Estratégico?", "fr": "Quel est le rôle de Mme Wakamatsu dans le ministère du Développement stratégique?", "it": "Qual è il ruolo della signora Wakamatsu nel Dipartimento dello Sviluppo Strategico?" }

[ "Assistant manager", "Assistant Manager" ]

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{ "match_score": 1, "matched_text": "Assistant manager", "start": 15, "text": "Assistant manager" }

{ "de": "Welche Ergebnisse der Toxizitätsstudie werden diskutiert?", "en": "Which drug's toxicity study results will be discussed ?", "es": "¿Se discutirán los resultados del estudio de toxicidad de qué fármaco?", "fr": "Quels sont les résultats de l'étude de toxicité du médicament qui seront discutés?", "it": "Quali risultati dello studio di tossicità del farmaco saranno discussi?" }

[ "pioglitazone" ]

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{ "match_score": 1, "matched_text": "pioglitazone", "start": 887, "text": "pioglitazone" }

{ "de": "Wie viele Seiten gibt es insgesamt als Teil dieses Dokuments?", "en": "How many pages are there in total as part of this document?", "es": "¿Cuántas páginas hay en total como parte de este documento?", "fr": "Combien de pages y a-t-il au total dans ce document?", "it": "Quante pagine ci sono in totale come parte di questo documento?" }

[ "7" ]

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{ "match_score": 1, "matched_text": "7", "start": 100, "text": "7" }

{ "de": "Wer forderte die Behörden auf, die Durchführung des Monitoringplans zu regradieren?", "en": "Who challenged authorities regrading implementing monitoring plan?", "es": "¿Quién impugnó a las autoridades que recalificaban la aplicación del plan de seguimiento?", "fr": "Qui a contesté le reclassement des autorités chargées de la mise en œuvre du plan de surveillance?", "it": "Chi ha contestato la modifica del piano di monitoraggio dell'attuazione da parte delle autorità?" }

[ "Takeda Europe" ]

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{ "match_score": 1, "matched_text": "Takeda Europe", "start": 895, "text": "Takeda Europe" }

{ "de": "Welcher Gehalt an männlichem Rattenharn ist hoch?", "en": "What content is high in male rat urine?", "es": "¿Qué contenido es alto en orina de rata macho?", "fr": "Quel est le contenu élevé dans l'urine de rat mâle?", "it": "Che contenuto c'è di alto nelle urine maschili di ratto?" }

[ "protein", "protien content" ]

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{ "match_score": 1, "matched_text": "protein", "start": 195, "text": "protein" }

{ "de": "Welche Art von Treffen wird in diesem Brief erwähnt?", "en": "What kind of meeting is mentioned in this letter?", "es": "¿Qué tipo de reunión se menciona en esta carta?", "fr": "Quel genre de réunion est mentionné dans cette lettre?", "it": "Che tipo di incontro è menzionato in questa lettera?" }

[ "ACTOS FDA RESPONSE MEETING" ]

[ "ACTOS", "FDA", "RESPONSE", "MEETING", "TPNA/TEUR&D/TCI", "AUGUST", "12-13,", "2002", "Attendees:", "TPNA", "TEUR&D", "Sam", "Hamanaka", "David", "Eckland", "Claire", "Thom", "Yasuhiko", "Wada", "Ingrid", "Hood", "Glyn", "Belcher", "Alfonso", "Perez", "Philip", "Collett", "David", "Recker", "John", "Page", "TCI", "Mary", "Ramstack", "Katsuhisa", "Saito", "Janet", "Haskins", "Masahiro", "Miyazaki", "Dan", "Orlando", "Takashi", "Kuroiwa", "David", "Baron", "Takashi", "Nonoyama", "Chris", "Durack", "Keiichiro", "Sato", "Larry", "Hancock", "Hiroyuki", "Odaka", "Bob", "Ahlbrandt", "Tom", "Muldoon", "Karen", "Kaluzny", "Summary", "of", "July", "31", "Teleconference", "with", "FDA", "(J.", "Haskins)", ">", "The", "FDA", "informed", "TPNA", "that", "they", "had", "received", "data", "from", "a", "rat", "tumor", "promoter", "study", "using", "dual", "PPAR", "agonists.", "Pioglitazone", "was", "used", "in", "this", "experiment,", "and", "the", "group", "of", "rats", "treated", "with", "pioglitazone", "experienced", "the", "same", "frequency", "of", "transitional", "cell", "tumors", "as", "the", "group", "treated", "with", "the", "dual", "PPAR", "agonist", "under", "investigation.", "The", "FDA", "clarified", "that", "due", "to", "this", "data,", "they", "had", "concerns", "with", "the", "dual", "PPAR", "mechanism,", "and", "considered", "pioglitazone", "to", "have", "a", "dual", "PPAR", "mechanism.", ">", "There", "were", "three", "key", "messages", "from", "the", "teleconference:", "The", "FDA", "asked", "TPNA", "to", "consider", "a", "label", "change,", "as", "they", "feel", "that", "the", "current", "package", "insert", "does", "not", "adequately", "inform", "patients", "of", "the", "risk", "associated", "with", "bladder", "tumors.", "The", "FDA", "asked", "TPNA", "to", "research", "and", "propose", "a", "monitoring", "plan,", "which", "would", "be", "incorporated", "into", "clinical", "trials.", "The", "FDA", "stated", "that", "they", "were", "considering", "rescinding", "their", "written", "request", "to", "TPNA", "to", "conduct", "pediatric", "studies", "with", "pioglitazone.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487173", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indup2/Thgoood", "ts.ucsf.edu/docs/myjf0226" ]

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{ "match_score": 1, "matched_text": "ACTOS FDA RESPONSE MEETING", "start": 0, "text": "ACTOS FDA RESPONSE MEETING" }

{ "de": "Was für ein Medikament wird zur Behandlung der Gruppe von Ratten verwendet?", "en": "what kind of drug is used to treat the group of rats?", "es": "¿Qué tipo de droga se usa para tratar al grupo de ratas?", "fr": "Quel genre de médicament est utilisé pour traiter le groupe de rats?", "it": "che tipo di farmaco viene usato per trattare il gruppo di ratti?" }

[ "Pioglitazone", "pioglitazone" ]

[ "ACTOS", "FDA", "RESPONSE", "MEETING", "TPNA/TEUR&D/TCI", "AUGUST", "12-13,", "2002", "Attendees:", "TPNA", "TEUR&D", "Sam", "Hamanaka", "David", "Eckland", "Claire", "Thom", "Yasuhiko", "Wada", "Ingrid", "Hood", "Glyn", "Belcher", "Alfonso", "Perez", "Philip", "Collett", "David", "Recker", "John", "Page", "TCI", "Mary", "Ramstack", "Katsuhisa", "Saito", "Janet", "Haskins", "Masahiro", "Miyazaki", "Dan", "Orlando", "Takashi", "Kuroiwa", "David", "Baron", "Takashi", "Nonoyama", "Chris", "Durack", "Keiichiro", "Sato", "Larry", "Hancock", "Hiroyuki", "Odaka", "Bob", "Ahlbrandt", "Tom", "Muldoon", "Karen", "Kaluzny", "Summary", "of", "July", "31", "Teleconference", "with", "FDA", "(J.", "Haskins)", ">", "The", "FDA", "informed", "TPNA", "that", "they", "had", "received", "data", "from", "a", "rat", "tumor", "promoter", "study", "using", "dual", "PPAR", "agonists.", "Pioglitazone", "was", "used", "in", "this", "experiment,", "and", "the", "group", "of", "rats", "treated", "with", "pioglitazone", "experienced", "the", "same", "frequency", "of", "transitional", "cell", "tumors", "as", "the", "group", "treated", "with", "the", "dual", "PPAR", "agonist", "under", "investigation.", "The", "FDA", "clarified", "that", "due", "to", "this", "data,", "they", "had", "concerns", "with", "the", "dual", "PPAR", "mechanism,", "and", "considered", "pioglitazone", "to", "have", "a", "dual", "PPAR", "mechanism.", ">", "There", "were", "three", "key", "messages", "from", "the", "teleconference:", "The", "FDA", "asked", "TPNA", "to", "consider", "a", "label", "change,", "as", "they", "feel", "that", "the", "current", "package", "insert", "does", "not", "adequately", "inform", "patients", "of", "the", "risk", "associated", "with", "bladder", "tumors.", "The", "FDA", "asked", "TPNA", "to", "research", "and", "propose", "a", "monitoring", "plan,", "which", "would", "be", "incorporated", "into", "clinical", "trials.", "The", "FDA", "stated", "that", "they", "were", "considering", "rescinding", "their", "written", "request", "to", "TPNA", "to", "conduct", "pediatric", "studies", "with", "pioglitazone.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487173", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indup2/Thgoood", "ts.ucsf.edu/docs/myjf0226" ]

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{ "match_score": 1, "matched_text": "Pioglitazone", "start": 601, "text": "Pioglitazone" }

{ "de": "Was wurde in der Onkogenitätsstudie an Ratten beobachtet?", "en": "In the rat oncogenicity study, what was observed in male rats?", "es": "En el estudio de oncogenicidad en ratas, ¿qué se observó en ratas macho?", "fr": "Dans l'étude sur l'oncogénicité chez le rat, qu'est-ce qui a été observé chez le rat mâle?", "it": "Nello studio sull'oncogenicità dei ratti, cosa è stato osservato nei ratti maschi?" }

[ "thickening of the bladder and hypertrophy of the urothelium" ]

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{ "match_score": 1, "matched_text": "thickening of the bladder and hypertrophy of the urothelium", "start": 154, "text": "thickening of the bladder and hypertrophy of the urothelium" }

{ "de": "Was ist der Fälligkeitstermin, um Überprüfungssitzungen für FDA-Pakete durchzuführen?", "en": "What is the due date to conduct review meeting for FDA package?", "es": "¿Cuál es la fecha prevista para llevar a cabo la reunión de revisión del paquete de la FDA?", "fr": "Quelle est la date prévue pour la tenue d'une réunion d'examen pour le dossier de la FDA?", "it": "Qual è la data prevista per condurre una riunione di revisione per il pacchetto FDA?" }

[ "August 22" ]

[ "Task", "Notes", "Lead", "Responsibility", "Due", "Date", "6.", "INTRODUCTORY/CONCLUSION", "STATEMENTS", "(CONTINUED)", "Send", "nonclinical", "David", "Baron", "August", "20", "rationale/justification", "section", "to", "medical", "writing", "for", "compilation", "Compile", "FDA", "package", "Larry", "Hancock", "August", "21", "Send", "package", "to", "TCI/EU", "for", "Mary", "Ramstack", "August", "21", "review", "Conduct", "review", "meeting", "for", "Janet", "Haskins/Team", "August", "22", "FDA", "package", "FDA", "Document", "to", "August", "26", "Regulatory", "Affairs", "7.", "PACKAGE", "INSERTS/INFORMED", "CONSENT", "VERBIAGE", "Request", "NN622", "literate", "Janet", "Haskins", "August", "1", "-", "DONE", "searches.", "Identify", "package", "inserts", "with", "Janet", "Haskins", "August", "12", "similar", "class-related", "issues", "(T.e.,", "ACE-inhibitors)", "Last", "Update:", "August", "1,", "2002", "Page", "6", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032215", "Produced", "in", "MDL", "on", "02/21/1", "Source:", "https://www.indup538coo097ts.ucsf.edu/docs/qtjf0226" ]

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{ "match_score": 1, "matched_text": "August 22", "start": 344, "text": "August 22" }

{ "de": "Wie lang ist die Zeitspanne, in der keine Tumore gesehen werden?", "en": "What is the time span where no tumors are seen?", "es": "¿Cuál es el lapso de tiempo en el que no se ven tumores?", "fr": "Quelle est la période pendant laquelle aucune tumeur n'est observée?", "it": "Qual è l'intervallo di tempo in cui non si vedono tumori?" }

[ "shorter term (12 month)" ]

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{ "match_score": 1, "matched_text": "shorter term (12 month)", "start": 489, "text": "shorter term (12 month)" }

{ "de": "Wer ist der federführende Verantwortliche für die Zusammenstellung des FDA-Pakets?", "en": "Who is the lead responsible person for the compilation of FDA package?", "es": "¿Quién es el responsable principal de la compilación del paquete de la FDA?", "fr": "Qui est le responsable principal de la compilation du paquet FDA?", "it": "Chi è il responsabile principale per la compilazione del pacchetto FDA?" }

[ "Larry Hancock" ]

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{ "match_score": 1, "matched_text": "Larry Hancock", "start": 216, "text": "Larry Hancock" }

{ "de": "Laut Maus-Onkogenitätsstudie, was wurde nur männliche Mäuse gesehen?", "en": "According to mouse oncogenicity study, what was seen male mice only?", "es": "Según el estudio de oncogenicidad del ratón, ¿qué se vio sólo ratones machos?", "fr": "Selon l'étude de l'oncogénicité de la souris, qu'est-ce que l'on a vu seulement des souris mâles?", "it": "Secondo lo studio sull'oncogenicità dei topi, cosa si è visto solo nei topi maschi?" }

[ "hyperplasia" ]

[ "ACTOS", "FDA", "Response", "Meeting", "August", "12-13,", "2002", "Page", "3", "of", "4", "Highlights/", "Discussion", "Points", "from", "Preclinical", "Data", "Presentation", "In", "the", "rat", "oncogenicity", "study,", "thickening", "of", "the", "bladder", "and", "hypertrophy", "of", "the", "urothelium", "was", "observed", "in", "male", "rats.", "These", "findings", "were", "not", "dose-", "dependent.", "Nearly", "all", "of", "the", "tumors", "were", "found", "at", "the", "end", "of", "the", "study", "Some", "cases", "of", "hyperplasia", "were", "seen", "in", "female", "rats", "at", "the", "highest", "dose", "level", "only,", "but", "no", "malignancies", "were", "seen.", "There", "were", "no", "tumors", "seen", "in", "the", "shorter", "term", "(12", "month)", "rat", "toxicity", "studies.", "Glyn", "Belcher", "suggested", "creating", "a", "summary", "able", "for", "all", "toxicology", "studies", "with", "durations", "between", "6", "months", "and", "less", "than", "2", "years.", "In", "the", "mouse", "oncogenicity", "study,", "hyperplasia", "was", "seen", "in", "male", "mice", "only.", "These", "findings", "were", "not", "dose-dependent,", "and", "results", "were", "not", "statistically", "significant.", "One", "case", "of", "hyperplasia", "was", "observed", "in", "the", "placebo", "group.", "Philip", "Collett", "stated", "that", "the", "European", "authorities", "did", "not", "question", "the", "mouse", "data", "for", "ACTOS,", "but", "rather", "only", "the", "rat", "data.", "A", "list", "of", "all", "mutagenicity", "studies", "conducted", "with", "pioglitazone", "was", "shown,", "and", "David", "Baron", "acknowledged", "that", "TCI", "had", "conducted", "a", "very", "robust", "program", "that", "went", "beyond", "regulatory", "requirements.", "A", "study", "observing", "the", "effects", "of", "pioglitazone", "on", "urinary", "parameters", "in", "rats", "was", "conducted,", "and", "highlights", "are", "as", "follows:", "Simple", "hyperplasia", "seen", "in", "one", "male", ">", "Increase", "in", "urine", "pH,", "urine", "volume,", "microcrystal", "count", "Slight", "decrease", "in", "magnesium,", "calcium,", "phosphorous,", "sodium,", "potassium,", "and", "chloride", "Conclusion:", "Changes", "in", "urinary", "components", "are", "considered", "to", "be", "factors", "in", "the", "etiology", "of", "proliferative", "lesions", "of", "the", "bladder:", "Pioglitazone", "ingestion", "Altered", "urinary", "physiology", "Calculus", "formation", "Urothelial", "ulceration", "an", "regeneration", "(hyperplasia)", "Benin", "papilloma", "Carcinoma", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487175", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indusp2/phg", "oooogs.ucsf.edu/docs/myjf0226" ]

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{ "match_score": 1, "matched_text": "hyperplasia", "start": 356, "text": "hyperplasia" }

{ "de": "Welche Art von Zelltumoren erlebten die gleiche Häufigkeit, wenn eine Gruppe von Ratten, die mit Pioglitazon behandelt wurden?", "en": "what kind of cell tumours experienced the same frequency when group of rats treated with pioglitazone?", "es": "¿Qué tipo de tumores celulares experimentaron la misma frecuencia cuando el grupo de ratas tratadas con pioglitazona?", "fr": "Quels types de tumeurs cellulaires ont présenté la même fréquence lorsque le groupe de rats traités par la pioglitazone?", "it": "che tipo di tumori cellulari ha sperimentato la stessa frequenza quando il gruppo di ratti trattati con pioglitazone?" }

[ "transitional", "transitional cell tumors" ]

[ "ACTOS", "FDA", "RESPONSE", "MEETING", "TPNA/TEUR&D/TCI", "AUGUST", "12-13,", "2002", "Attendees:", "TPNA", "TEUR&D", "Sam", "Hamanaka", "David", "Eckland", "Claire", "Thom", "Yasuhiko", "Wada", "Ingrid", "Hood", "Glyn", "Belcher", "Alfonso", "Perez", "Philip", "Collett", "David", "Recker", "John", "Page", "TCI", "Mary", "Ramstack", "Katsuhisa", "Saito", "Janet", "Haskins", "Masahiro", "Miyazaki", "Dan", "Orlando", "Takashi", "Kuroiwa", "David", "Baron", "Takashi", "Nonoyama", "Chris", "Durack", "Keiichiro", "Sato", "Larry", "Hancock", "Hiroyuki", "Odaka", "Bob", "Ahlbrandt", "Tom", "Muldoon", "Karen", "Kaluzny", "Summary", "of", "July", "31", "Teleconference", "with", "FDA", "(J.", "Haskins)", ">", "The", "FDA", "informed", "TPNA", "that", "they", "had", "received", "data", "from", "a", "rat", "tumor", "promoter", "study", "using", "dual", "PPAR", "agonists.", "Pioglitazone", "was", "used", "in", "this", "experiment,", "and", "the", "group", "of", "rats", "treated", "with", "pioglitazone", "experienced", "the", "same", "frequency", "of", "transitional", "cell", "tumors", "as", "the", "group", "treated", "with", "the", "dual", "PPAR", "agonist", "under", "investigation.", "The", "FDA", "clarified", "that", "due", "to", "this", "data,", "they", "had", "concerns", "with", "the", "dual", "PPAR", "mechanism,", "and", "considered", "pioglitazone", "to", "have", "a", "dual", "PPAR", "mechanism.", ">", "There", "were", "three", "key", "messages", "from", "the", "teleconference:", "The", "FDA", "asked", "TPNA", "to", "consider", "a", "label", "change,", "as", "they", "feel", "that", "the", "current", "package", "insert", "does", "not", "adequately", "inform", "patients", "of", "the", "risk", "associated", "with", "bladder", "tumors.", "The", "FDA", "asked", "TPNA", "to", "research", "and", "propose", "a", "monitoring", "plan,", "which", "would", "be", "incorporated", "into", "clinical", "trials.", "The", "FDA", "stated", "that", "they", "were", "considering", "rescinding", "their", "written", "request", "to", "TPNA", "to", "conduct", "pediatric", "studies", "with", "pioglitazone.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487173", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indup2/Thgoood", "ts.ucsf.edu/docs/myjf0226" ]

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{ "match_score": 1, "matched_text": "transitional", "start": 725, "text": "transitional" }

{ "de": "Wer hat ein robustes Programm durchgeführt?", "en": "who conducted robust program?", "es": "¿Quién llevó a cabo un programa robusto?", "fr": "qui a mené un programme robuste?", "it": "Chi ha condotto un programma robusto?" }

[ "TCI" ]

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{ "match_score": 1, "matched_text": "TCI", "start": 1117, "text": "TCI" }

{ "de": "Wer ist für den Versand des Pakets an TCI/EU zur Überprüfung verantwortlich?", "en": "Who is responsible for sending package to TCI/EU for review?", "es": "¿Quién es responsable de enviar el paquete a TCI/UE para su revisión?", "fr": "Qui est responsable de l'envoi du colis à TCI/UE pour examen?", "it": "Chi è responsabile dell'invio del pacchetto a TCI/EU per la revisione?" }

[ "Mary Ramstack" ]

[ "Task", "Notes", "Lead", "Responsibility", "Due", "Date", "6.", "INTRODUCTORY/CONCLUSION", "STATEMENTS", "(CONTINUED)", "Send", "nonclinical", "David", "Baron", "August", "20", "rationale/justification", "section", "to", "medical", "writing", "for", "compilation", "Compile", "FDA", "package", "Larry", "Hancock", "August", "21", "Send", "package", "to", "TCI/EU", "for", "Mary", "Ramstack", "August", "21", "review", "Conduct", "review", "meeting", "for", "Janet", "Haskins/Team", "August", "22", "FDA", "package", "FDA", "Document", "to", "August", "26", "Regulatory", "Affairs", "7.", "PACKAGE", "INSERTS/INFORMED", "CONSENT", "VERBIAGE", "Request", "NN622", "literate", "Janet", "Haskins", "August", "1", "-", "DONE", "searches.", "Identify", "package", "inserts", "with", "Janet", "Haskins", "August", "12", "similar", "class-related", "issues", "(T.e.,", "ACE-inhibitors)", "Last", "Update:", "August", "1,", "2002", "Page", "6", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032215", "Produced", "in", "MDL", "on", "02/21/1", "Source:", "https://www.indup538coo097ts.ucsf.edu/docs/qtjf0226" ]

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{ "match_score": 1, "matched_text": "Mary Ramstack", "start": 267, "text": "Mary Ramstack" }

{ "de": "Was ist der Fälligkeitstermin für die Übermittlung des FDA-Dokuments an Regulatory Affairs?", "en": "What is the due date for sending FDA Document to Regulatory Affairs?", "es": "¿Cuál es la fecha de vencimiento para enviar el Documento de la FDA a Asuntos Regulatorios?", "fr": "Quelle est la date d'échéance pour l'envoi du document de la FDA aux Affaires réglementaires?", "it": "Qual è la data di scadenza per l'invio del documento FDA agli affari normativi?" }

[ "August 26" ]

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{ "match_score": 1, "matched_text": "August 26", "start": 382, "text": "August 26" }

{ "de": "Was ist das letzte aktualisierte Datum, das in diesem Dokument erwähnt wird?", "en": "What is the last updated date mentioned in this document?", "es": "¿Cuál es la última fecha actualizada mencionada en este documento?", "fr": "Quelle est la dernière date mise à jour mentionnée dans ce document?", "it": "Qual è l'ultima data aggiornata menzionata in questo documento?" }

[ "August 1, 2002", "August 1, 2002" ]

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{ "match_score": 1, "matched_text": "August 1, 2002", "start": 638, "text": "August 1, 2002" }

{ "de": "Welche Haftungsansprüche werden hier beschrieben?", "en": "Which product's liability claims are described here?", "es": "¿Qué reclamaciones de responsabilidad del producto se describen aquí?", "fr": "Quelles sont les réclamations de responsabilité du produit qui sont décrites ici?", "it": "Quali crediti di responsabilità del prodotto sono descritti qui?" }

[ "ACTOS PRODUCTS", "ACTOS PRODUCTS LIABILITY CLAIMS" ]

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{ "match_score": 1, "matched_text": "ACTOS PRODUCTS", "start": 10, "text": "ACTOS PRODUCTS" }

{ "de": "Welches Datum wird in diesem Dokument unten erwähnt?", "en": "What is the date mentioned in this document at the bottom?", "es": "¿Cuál es la fecha mencionada en este documento en la parte inferior?", "fr": "Quelle est la date mentionnée dans ce document en bas?", "it": "Qual è la data indicata in basso in questo documento?" }

[ "1/11/2007" ]

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{ "match_score": 0.900000009999999, "matched_text": "1/1 1/2007", "start": 2733, "text": "1/11/2007" }

{ "de": "Nennen Sie den Vornamen in der \"Entschuldigung\"?", "en": "Mention the first name listed in the \"apologies\"?", "es": "¿Mencionar el nombre que aparece en las \"disculpas\"?", "fr": "Mentionnez le prénom mentionné dans les \"excuses\"?", "it": "Menzionando il primo nome elencato nelle \"scuse\"?" }

[ "Professor Ele Ferrannini" ]

[ "PROactive'", "Executive", "Committee", "Conference", "Call", "Minutes", "of", "Conference", "Call", "Date:", "Monday", "28\"", "November", "2005", "EXHIBIT", "NO.", "Time:", "1900", "hours", "In", "attendance:", "Professor", "Erland", "Erdmann", "(EE)", "rmandy", "(JD)", "Professor", "Bernard", "Charbonnel", "(BC)", "Professor", "Massimo", "Massi-Benedetti", "(MMB)", "Mr", "lan", "Moules", "(IM)", "Dr", "Alfonso", "Perez", "(AP)", "Mrs", "Lucy", "Bennett", "(LB)", "Dr", "Susan", "Crawford", "(SC)", "Apologies:", "Professor", "Ele", "Ferrannini", "Dr", "Allan", "Skene", "Dr", "Meng", "Tan", "Professor", "Robert", "Wilcox", "1.", "Minutes", "of", "last", "meeting/conference", "call", "(15", "October", "2005)", "Minutes", "of", "the", "last", "meeting/conference", "call", "held", "on", "15\"", "October", "2005", "were", "accepted.", "The", "EC", "stressed", "that", "it", "has", "been", "recorded", "in", "minutes", "of", "previous", "meetings", "and", "teleconferences", "that", "its", "members", "wish", "to", "review", "the", "manuscript", "for", "all", "abstracts", "for", "future", "conferences", "The", "EC", "discussed", "the", "stage", "at", "which", "each", "manuscript", "would", "be", "ready", "for", "EC", "review.", "It", "was", "confirmed", "that", "the", "EC", "require", "a", "draft", "of", "the", "manuscript", "that", "demonstrates", "the", "aims", "of", "the", "paper,", "how", "to", "interpret", "the", "data", "and", "how", "the", "manuscript", "will", "be", "discussed", "in", "the", "context", "of", "other", "data.", "This", "is", "more", "than", "simply", "an", "outline", "of", "what", "would", "be", "included", "in", "the", "manuscript", "together", "with", "supporting", "data.", "Figures", "and", "tables", "are", "required", "at", "this", "stage", "of", "review.", "The", "EC", "Lead", "will", "take", "responsibility", "for", "determining", "the", "stage", "at", "which", "the", "manuscript", "is", "ready", "for", "review.", "The", "EC", "is", "not", "interested", "in", "refining", "the", "wording", "of", "manuscripts,", "but", "all", "authors", "would", "need", "to", "agree", "on", "the", "solidity", "of", "the", "data", "and", "would", "need", "to", "agree", "to", "presentation", "of", "an", "abstract,", "in", "order", "for", "the", "EC", "to", "carry", "out", "a", "review.", "JD", "advised", "the", "EC", "that", "previous", "indications", "to", "the", "Committee", "that", "the", "EAC", "reviewed", "all", "cases", "of", "heart", "failure", "resulting", "in", "death,", "as", "discussed", "during", "the", "last", "meeting/call,", "is", "incorrect", "The", "Endpoint", "Adjudication", "Committee", "reviewed", "all", "fatal", "events,", "however,", "there", "was", "no", "classification", "regarding", "death", "due", "to", "heart", "ailure", "by", "the", "Committee/Panellists.", "This", "determination", "was", "made", "by", "the", "Investigator.", "Professor", "Ryden", "Karolinska", "Institute,", "Stockholm)", "will", "lead", "an", "independent", "commission", "into", "heart", "failure", "and", "the", "results", "of", "these", "findings", "are", "awaite", "1.1", "Revised", "membership", "of", "the", "Executive", "Committee", "Following", "EE's", "initial", "discussions", "with", "Professor", "Ferrannini", "and", "Professor", "Wilcox,", "IM", "reported", "that", "he", "had", "written", "to", "them,", "outlining", "details", "of", "the", "contract", "held", "with", "EC", "members,", "together", "with", "the", "proposed", "honorarium.", "The", "actual", "contracts", "are", "currently", "held", "up", "within", "Takeda", "but", "will", "be", "sent", "out", "within", "one", "week", "Action:", "IM", "to", "forward", "EC", "contracts", "to", "EC", "members.", "Takeda", "\"PROspective", "PioglitAzone", "Clinical", "Trial", "In", "MacroVascular", "Events", "Lilly", "Page", "1", "of", "6", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-MOULEI-00026121", "Source:", "https://www.indup6056-oooents.ucsf.edu/docs/Itjf0226" ]

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{ "match_score": 1, "matched_text": "Professor Ele Ferrannini", "start": 362, "text": "Professor Ele Ferrannini" }

{ "de": "Wie lautet die Ausstellungsnummer?", "en": "What is the exhibit number?", "es": "¿Cuál es el número de la prueba?", "fr": "Quel est le numéro de la pièce à conviction?", "it": "Qual è il numero della mostra?" }

[ "52" ]

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{ "match_score": 1, "matched_text": "52", "start": 198, "text": "52" }

{ "de": "Wann fand die letzte Sitzung/Konferenz statt?", "en": "when was the last meeting/conference call held on ?", "es": "¿Cuándo se celebró la última reunión/conferencia?", "fr": "Quand la dernière réunion/conférence a-t-elle eu lieu?", "it": "Quando è stata tenuta l'ultima riunione/conferenza?" }

[ "15th October 2005", "15 October 2005" ]

[ "PROactive'", "Executive", "Committee", "Conference", "Call", "Minutes", "of", "Conference", "Call", "Date:", "Monday", "28\"", "November", "2005", "EXHIBIT", "NO.", "Time:", "1900", "hours", "In", "attendance:", "Professor", "Erland", "Erdmann", "(EE)", "rmandy", "(JD)", "Professor", "Bernard", "Charbonnel", "(BC)", "Professor", "Massimo", "Massi-Benedetti", "(MMB)", "Mr", "lan", "Moules", "(IM)", "Dr", "Alfonso", "Perez", "(AP)", "Mrs", "Lucy", "Bennett", "(LB)", "Dr", "Susan", "Crawford", "(SC)", "Apologies:", "Professor", "Ele", "Ferrannini", "Dr", "Allan", "Skene", "Dr", "Meng", "Tan", "Professor", "Robert", "Wilcox", "1.", "Minutes", "of", "last", "meeting/conference", "call", "(15", "October", "2005)", "Minutes", "of", "the", "last", "meeting/conference", "call", "held", "on", "15\"", "October", "2005", "were", "accepted.", "The", "EC", "stressed", "that", "it", "has", "been", "recorded", "in", "minutes", "of", "previous", "meetings", "and", "teleconferences", "that", "its", "members", "wish", "to", "review", "the", "manuscript", "for", "all", "abstracts", "for", "future", "conferences", "The", "EC", "discussed", "the", "stage", "at", "which", "each", "manuscript", "would", "be", "ready", "for", "EC", "review.", "It", "was", "confirmed", "that", "the", "EC", "require", "a", "draft", "of", "the", "manuscript", "that", "demonstrates", "the", "aims", "of", "the", "paper,", "how", "to", "interpret", "the", "data", "and", "how", "the", "manuscript", "will", "be", "discussed", "in", "the", "context", "of", "other", "data.", "This", "is", "more", "than", "simply", "an", "outline", "of", "what", "would", "be", "included", "in", "the", "manuscript", "together", "with", "supporting", "data.", "Figures", "and", "tables", "are", "required", "at", "this", "stage", "of", "review.", "The", "EC", "Lead", "will", "take", "responsibility", "for", "determining", "the", "stage", "at", "which", "the", "manuscript", "is", "ready", "for", "review.", "The", "EC", "is", "not", "interested", "in", "refining", "the", "wording", "of", "manuscripts,", "but", "all", "authors", "would", "need", "to", "agree", "on", "the", "solidity", "of", "the", "data", "and", "would", "need", "to", "agree", "to", "presentation", "of", "an", "abstract,", "in", "order", "for", "the", "EC", "to", "carry", "out", "a", "review.", "JD", "advised", "the", "EC", "that", "previous", "indications", "to", "the", "Committee", "that", "the", "EAC", "reviewed", "all", "cases", "of", "heart", "failure", "resulting", "in", "death,", "as", "discussed", "during", "the", "last", "meeting/call,", "is", "incorrect", "The", "Endpoint", "Adjudication", "Committee", "reviewed", "all", "fatal", "events,", "however,", "there", "was", "no", "classification", "regarding", "death", "due", "to", "heart", "ailure", "by", "the", "Committee/Panellists.", "This", "determination", "was", "made", "by", "the", "Investigator.", "Professor", "Ryden", "Karolinska", "Institute,", "Stockholm)", "will", "lead", "an", "independent", "commission", "into", "heart", "failure", "and", "the", "results", "of", "these", "findings", "are", "awaite", "1.1", "Revised", "membership", "of", "the", "Executive", "Committee", "Following", "EE's", "initial", "discussions", "with", "Professor", "Ferrannini", "and", "Professor", "Wilcox,", "IM", "reported", "that", "he", "had", "written", "to", "them,", "outlining", "details", "of", "the", "contract", "held", "with", "EC", "members,", "together", "with", "the", "proposed", "honorarium.", "The", "actual", "contracts", "are", "currently", "held", "up", "within", "Takeda", "but", "will", "be", "sent", "out", "within", "one", "week", "Action:", "IM", "to", "forward", "EC", "contracts", "to", "EC", "members.", "Takeda", "\"PROspective", "PioglitAzone", "Clinical", "Trial", "In", "MacroVascular", "Events", "Lilly", "Page", "1", "of", "6", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-MOULEI-00026121", "Source:", "https://www.indup6056-oooents.ucsf.edu/docs/Itjf0226" ]

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{ "match_score": 0.8750000078124995, "matched_text": "15\" October 2005", "start": 551, "text": "15th October 2005" }

{ "de": "Wie lautet die Ausstellungsnummer?", "en": "What is the exhibit number?", "es": "¿Cuál es el número de la prueba?", "fr": "Quel est le numéro de la pièce à conviction?", "it": "Qual è il numero della mostra?" }

[ "107" ]

[ "107", "FDA", "Conference", "Call:", "August", "13,", "2002", "PENGAD", "800-631-698", "EXHIBIT", "FDA", "Personnel:", "Jeri", "El-Hage,", "Ph.D.,", "Toxicology", "Team", "Leader", "Jena", "Weber,", "Project", "Manager", "TPNA", "Personnel:", "David", "Baron,", "Ph.D.,", "Director,", "Nonclinical", "Safety", "and", "Efficacy", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Pat", "Frank,", "Ph.D.,", "TPNA", "Consultant", "This", "teleconference", "was", "held", "as", "a", "follow-up", "to", "a", "discussion", "between", "TPNA", "and", "the", "Agency", "on", "July", "31,", "2002.", "The", "purpose", "of", "this", "call", "was", "so", "that", "Dr.", "El-Hage", "could", "expand", "upon", "the", "nonclinical", "data", "related", "to", "dual", "PPAR", "agonists", "that", "were", "discussed", "with", "TPNA", "on", "July", "31,", "2002.", "Dr.", "El-Hage", "informed", "TPNA", "that", "in", "standard", "2-year", "rat", "and", "mouse", "bioassay", "studies,", "several", "other", "dual", "PPAR", "agonists", "were", "shown", "to", "cause", "transitional", "cell", "tumors", "in", "the", "bladder", "and", "kidneys", "of", "male", "and", "female", "rats", "and", "male", "mice.", "Therefore,", "the", "Division", "is", "considering", "the", "relevance", "of", "these", "findings", "to", "this", "pharmaceutical", "class", "of", "drugs.", "She", "also", "noted", "that", "in", "follow-up", "unspecified", "mechanistic", "studies", "of", "the", "other", "dual", "PPAR", "agonists,", "no", "evidence", "of", "irritation", "by", "crystalluria", "or", "calculi", "was", "noted.", "Dr.", "El-Hage", "then", "described", "a", "tumor", "promoter-model", "study", "that", "was", "conducted", "by", "another", "sponsor", "in", "which", "pioglitazone", "was", "administered.", "The", "study", "was", "designed", "as", "follows:", ".", "BBN", "was", "given", "to", "male", "Fisher", "rats", "in", "their", "drinking", "water", "for", "four", "weeks.", "Four", "groups", "were", "designated:", ".", "Pioglitazone", "40", "mg/kg/day", "after", "BBN", "The", "study", "compound", "plus", "BBN", "(No", "dosages", "were", "specified,", "but", "Dr.", "El-Hage", "noted", "that", "multiple", "dosages", "were", "studied", "and", "the", "high", "dose", "was", "designed", "to", "be", "\"equivalent\"", "to", "40", "mg/kg", "pioglitazone", ")", "The", "negative", "control", "group", "received", "BBN", "only.", ".", "The", "positive", "control", "group", "received", "uracil.", "Duration", "of", "daily", "dosing", "was", "32-weeks", "after", "BBN.", "Results:", ".", "85%", "of", "the", "animals", "in", "the", "pioglitazone", "and", "the", "other", "sponsor's", "compound", "groups", "had", "tumor", "formation.", "Calculi", "formation", "was", "not", "confirmed", "in", "either", "group,", "but", "was", "looked", "for", "using", "unspecified", "methodology", "15%", "of", "the", "animals", "in", "the", "negative", "control", "group", "had", "tumor", "formation,", "while", "approximately", "50%", "of", "the", "positive", "control", "group", "presented", "tumors", "in", "the", "presence", "of", "calculi", "formation", "(uracil).", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-NAUGHP-00080811", "Source:", "https://www.indup53720boots.ucsf.edu/docs/jsjf0226" ]

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{ "match_score": 1, "matched_text": "107", "start": 0, "text": "107" }

{ "de": "Wie lautet der unter dem Titel \"Protokolle der Telefonkonferenz\" genannte Termin?", "en": "what is the date mentioned under the title - \" minutes of conference call\"?", "es": "¿Cuál es la fecha mencionada bajo el título - \"minutos de conferencia telefónica\"?", "fr": "Quelle est la date mentionnée sous le titre - « procès-verbal de la conférence téléphonique »?", "it": "Qual è la data indicata sotto il titolo - \"minuti di chiamata di conferenza\"?" }

[ "Monday 28th November 2005", "monday 28th november 2005", "28th November 2005" ]

[ "PROactive'", "Executive", "Committee", "Conference", "Call", "Minutes", "of", "Conference", "Call", "Date:", "Monday", "28\"", "November", "2005", "EXHIBIT", "NO.", "Time:", "1900", "hours", "In", "attendance:", "Professor", "Erland", "Erdmann", "(EE)", "rmandy", "(JD)", "Professor", "Bernard", "Charbonnel", "(BC)", "Professor", "Massimo", "Massi-Benedetti", "(MMB)", "Mr", "lan", "Moules", "(IM)", "Dr", "Alfonso", "Perez", "(AP)", "Mrs", "Lucy", "Bennett", "(LB)", "Dr", "Susan", "Crawford", "(SC)", "Apologies:", "Professor", "Ele", "Ferrannini", "Dr", "Allan", "Skene", "Dr", "Meng", "Tan", "Professor", "Robert", "Wilcox", "1.", "Minutes", "of", "last", "meeting/conference", "call", "(15", "October", "2005)", "Minutes", "of", "the", "last", "meeting/conference", "call", "held", "on", "15\"", "October", "2005", "were", "accepted.", "The", "EC", "stressed", "that", "it", "has", "been", "recorded", "in", "minutes", "of", "previous", "meetings", "and", "teleconferences", "that", "its", "members", "wish", "to", "review", "the", "manuscript", "for", "all", "abstracts", "for", "future", "conferences", "The", "EC", "discussed", "the", "stage", "at", "which", "each", "manuscript", "would", "be", "ready", "for", "EC", "review.", "It", "was", "confirmed", "that", "the", "EC", "require", "a", "draft", "of", "the", "manuscript", "that", "demonstrates", "the", "aims", "of", "the", "paper,", "how", "to", "interpret", "the", "data", "and", "how", "the", "manuscript", "will", "be", "discussed", "in", "the", "context", "of", "other", "data.", "This", "is", "more", "than", "simply", "an", "outline", "of", "what", "would", "be", "included", "in", "the", "manuscript", "together", "with", "supporting", "data.", "Figures", "and", "tables", "are", "required", "at", "this", "stage", "of", "review.", "The", "EC", "Lead", "will", "take", "responsibility", "for", "determining", "the", "stage", "at", "which", "the", "manuscript", "is", "ready", "for", "review.", "The", "EC", "is", "not", "interested", "in", "refining", "the", "wording", "of", "manuscripts,", "but", "all", "authors", "would", "need", "to", "agree", "on", "the", "solidity", "of", "the", "data", "and", "would", "need", "to", "agree", "to", "presentation", "of", "an", "abstract,", "in", "order", "for", "the", "EC", "to", "carry", "out", "a", "review.", "JD", "advised", "the", "EC", "that", "previous", "indications", "to", "the", "Committee", "that", "the", "EAC", "reviewed", "all", "cases", "of", "heart", "failure", "resulting", "in", "death,", "as", "discussed", "during", "the", "last", "meeting/call,", "is", "incorrect", "The", "Endpoint", "Adjudication", "Committee", "reviewed", "all", "fatal", "events,", "however,", "there", "was", "no", "classification", "regarding", "death", "due", "to", "heart", "ailure", "by", "the", "Committee/Panellists.", "This", "determination", "was", "made", "by", "the", "Investigator.", "Professor", "Ryden", "Karolinska", "Institute,", "Stockholm)", "will", "lead", "an", "independent", "commission", "into", "heart", "failure", "and", "the", "results", "of", "these", "findings", "are", "awaite", "1.1", "Revised", "membership", "of", "the", "Executive", "Committee", "Following", "EE's", "initial", "discussions", "with", "Professor", "Ferrannini", "and", "Professor", "Wilcox,", "IM", "reported", "that", "he", "had", "written", "to", "them,", "outlining", "details", "of", "the", "contract", "held", "with", "EC", "members,", "together", "with", "the", "proposed", "honorarium.", "The", "actual", "contracts", "are", "currently", "held", "up", "within", "Takeda", "but", "will", "be", "sent", "out", "within", "one", "week", "Action:", "IM", "to", "forward", "EC", "contracts", "to", "EC", "members.", "Takeda", "\"PROspective", "PioglitAzone", "Clinical", "Trial", "In", "MacroVascular", "Events", "Lilly", "Page", "1", "of", "6", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-MOULEI-00026121", "Source:", "https://www.indup6056-oooents.ucsf.edu/docs/Itjf0226" ]

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{ "match_score": 0.9166666701388888, "matched_text": "Monday 28\" November 2005", "start": 80, "text": "Monday 28th November 2005" }

{ "de": "Wie lautet die Überschrift dieses Dokuments?", "en": "What is the heading of this document?", "es": "¿Cuál es el título de este documento?", "fr": "Quel est le titre de ce document?", "it": "Qual è il titolo di questo documento?" }

[ "Rationale for 3 segments", "Rationale for 3 Segments" ]

[ "Rationale", "for", "3", "Segments", "actos", "pioglitazone", "HCI", "For", "performance", "that", "benefits", "the", "body.", "Summary", "of", "Segment", "Attractiveness", "(based", "on", "current", "situation", "&", "future", "trends)", "Treatment", "Machines,", "Life", "Negotiators,", "Struggle", "for", "Control", "60", "50", "Opportunity", "40", "All", "3", "Segments", "Have", "Consistent", "Needs", "20", "10", "7:", "1101", "7/24/01", "Company", "Confidential", "File", "name/location", "Copyright", "@", "2000", "Eli", "Lilly", "and", "Company", "Source:", "https://www.indupt4608coooo2ts.ucsf.edu/docs/xqjf0226" ]

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{ "match_score": 0.9583333350694444, "matched_text": "Rationale for 3 Segments", "start": 0, "text": "Rationale for 3 segments" }

{ "de": "was ist der Titel von Kapitel 3?", "en": "what is the title of chapter 3?", "es": "¿Cuál es el título del capítulo 3?", "fr": "Quel est le titre du chapitre 3?", "it": "qual è il titolo del capitolo 3?" }

[ "Document Storage Period", "document storage period" ]

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{ "match_score": 1, "matched_text": "Document Storage Period", "start": 433, "text": "Document Storage Period" }

{ "de": "Worum geht es bei der grafischen Darstellung?", "en": "What is the graphical representation about?", "es": "¿De qué se trata la representación gráfica?", "fr": "Qu'est-ce que la représentation graphique?", "it": "Di cosa parla la rappresentazione grafica?" }

[ "Summary of Segment Attractiveness" ]

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{ "match_score": 1, "matched_text": "Summary of Segment Attractiveness", "start": 88, "text": "Summary of Segment Attractiveness" }

{ "de": "Auf welcher Grundlage erfolgt die Zusammenfassung der Segmentattraktivität?", "en": "On what basis, the Summary of Segment Attractiveness is carried out?", "es": "¿Sobre qué base se lleva a cabo el Resumen de Atractividad del Segmento?", "fr": "Sur quelle base le résumé de l'attractivité du segment est-il réalisé?", "it": "Su quali basi viene effettuata la sintesi dell'attrattività del segmento?" }

[ "based on current situation & future trends", "Based on current situation & future trends.", "current situation & future trends" ]

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{ "match_score": 1, "matched_text": "based on current situation & future trends", "start": 123, "text": "based on current situation & future trends" }

{ "de": "Was sind die drei Segmente, die in der Grafik angegeben sind?", "en": "What are the three segments indicated in the graph?", "es": "¿Cuáles son los tres segmentos indicados en el gráfico?", "fr": "Quels sont les trois segments indiqués dans le graphique?", "it": "Quali sono i tre segmenti indicati nel grafico?" }

[ "Treatment Machines, Life Negotiators, Struggle for Control" ]

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{ "match_score": 1, "matched_text": "Treatment Machines, Life Negotiators, Struggle for Control", "start": 167, "text": "Treatment Machines, Life Negotiators, Struggle for Control" }

{ "de": "Wie lautet die Artikelnummer der „Dokumentenspeicherung\"?", "en": "what is the \"document storage period \" article number?", "es": "¿Cuál es el número de artículo \"período de almacenamiento de documentos\"?", "fr": "Quel est le numéro de l'article \"période de conservation des documents \"?", "it": "che cos'è il numero dell'articolo \"periodo di conservazione dei documenti\"?" }

[ "7", "Article 7" ]

[ "(2)", "The", "person", "in", "charge", "of", "storage", "shall", "properly", "store,", "and", "dispose", "of,", "any", "stored", "documents", "assigned,", "and", "properly", "store", "any", "records", "relevant", "to", "those", "storage", "and", "disposal.", "(3)", "In", "case", "the", "document", "storage", "functions", "are", "reorganized", "or", "abolished", "due", "to", "organizational", "changes,", "etc.,", "the", "core", "organizations", "taking", "over", "the", "document-related", "operations", "shall", "continue", "to", "store", "the", "documents", "and", "retain", "the", "disposal", "records.", "Chapter", "3", "Document", "Storage", "Period", "Article", "7", "(Document", "Storage", "Period)", "The", "responsible", "person", "in", "charge", "of", "storage", "shall", "establish", "storage", "periods", "for", "different", "types", "of", "assigned", "documents,", "by", "checking", "opinions", "of", "the", "relevant", "internal", "functions,", "if", "necessary,", "and", "distinguish", "and", "designate", "the", "periods,", "in", "principle,", "as", "indicated", "below.", "However,", "if", "the", "storage", "periods", "are", "specified", "by", "laws,", "regulations", "or", "Company", "Regulations,", "they", "shall", "be", "established", "in", "compliance", "with", "those", "laws,", "regulations", "and", "Company", "Regulations.", "The", "starting", "point", "for", "determining", "a", "storage", "period", "shall", "be,", "in", "principle,", "the", "date", "on", "which", "the", "document", "is", "created.", "1.", "To", "be", "stored", "permanently", "2.", "To", "be", "stored", "for", "ten", "years", "3.", "To", "be", "stored", "for", "seven", "years", "4.", "To", "be", "stored", "for", "five", "years", "5.", "To", "be", "stored", "for", "three", "years", "6.", "To", "be", "stored", "for", "one", "year", "7.", "To", "be", "stored", "for", "less", "than", "one", "year", "(to", "be", "disposed", "of", "promptly", "after", "use)", "(2)", "If", "a", "document", "turns", "out", "not", "to", "be", "categorized", "into", "any", "document", "types", "designated", "for", "specified", "storage", "periods,", "the", "responsible", "person", "in", "charge", "of", "storage", "shall", "establish", "a", "storage", "period", "for", "the", "new", "document", "type,", "as", "stipulated", "in", "the", "preceding", "paragraph.", "(3)", "Concerning", "the", "provisions", "set", "forth", "in", "Paragraph", "I", "above,", "the", "following", "documents", "shall", "be", "stored", "permanently.", "1.", "Articles", "of", "Incorporation", "and", "Company", "Regulations", "2.", "Important", "documents", "concerning", "the", "General", "Meetings", "of", "Shareholders,", "the", "Board", "of", "Directors,", "the", "Management", "and", "Operations", "Committee,", "and", "other", "important", "conferences.", "3.", "Important", "documents", "concerning", "mid/long-range", "management", "policies", "and", "plans", "4.", "Important", "documents", "concerning", "the", "Company's", "rights", "and", "duties,", "including", "important", "contracts,", "lawsuits,", "registrations,", "etc.", "Important", "documents", "concerning", "budgets,", "account", "settlements,", "and", "other", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAKJ-TPC-00000254", "Source:", "https://www.indup2378", "0boats.ucsf.edu/docs/jpjf0226" ]

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{ "match_score": 1, "matched_text": "7", "start": 465, "text": "7" }

{ "de": "Welche Schlußfolgerung ergibt sich aus der Grafik?", "en": "What is the conclusion obtained from the graph?", "es": "¿Cuál es la conclusión obtenida del gráfico?", "fr": "Quelle est la conclusion tirée du graphique?", "it": "Qual è la conclusione ottenuta dal grafico?" }

[ "All 3 segments have consistent needs", "All 3 Segments Have Consistent Needs." ]

[ "Rationale", "for", "3", "Segments", "actos", "pioglitazone", "HCI", "For", "performance", "that", "benefits", "the", "body.", "Summary", "of", "Segment", "Attractiveness", "(based", "on", "current", "situation", "&", "future", "trends)", "Treatment", "Machines,", "Life", "Negotiators,", "Struggle", "for", "Control", "60", "50", "Opportunity", "40", "All", "3", "Segments", "Have", "Consistent", "Needs", "20", "10", "7:", "1101", "7/24/01", "Company", "Confidential", "File", "name/location", "Copyright", "@", "2000", "Eli", "Lilly", "and", "Company", "Source:", "https://www.indupt4608coooo2ts.ucsf.edu/docs/xqjf0226" ]

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{ "match_score": 0.8888888919753085, "matched_text": "All 3 Segments Have Consistent Needs", "start": 247, "text": "All 3 segments have consistent needs" }

{ "de": "Nennen Sie den zweiten Punkt, der in Artikel 7 aufgeführt ist (Zeitraum der Aufbewahrung von Dokumenten)?", "en": "mention the second point listed under the article 7(document storage period)?", "es": "mencionar el segundo punto enumerado en el artículo 7 (período de almacenamiento de documentos)?", "fr": "mentionner le deuxième point mentionné à l'article 7 (période de conservation des documents)?", "it": "indicare il secondo punto di cui all'articolo 7 (periodo di conservazione dei documenti)?" }

[ "To be stored for ten years", "to be stored for ten years" ]

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{ "match_score": 1, "matched_text": "To be stored for ten years", "start": 1095, "text": "To be stored for ten years" }

{ "de": "Semi-Exklusivrechte in wie vielen Ländern?", "en": "Semi exclusive rights in how many countries?", "es": "¿Derechos semi exclusivos en cuántos países?", "fr": "Les droits semi-exclusifs dans combien de pays?", "it": "Diritti semiesclusivi in quanti paesi?" }

[ "20", "20 countries" ]

[ "Summary", "of", "Terms", "for", "OUS", "Agreement", "License", "Exclusive", "rights", "in", "approximately", "60", "countries", "Semi", "exclusive", "rights", "in", "approximately", "20", "countries", "Upfront", "Fee", "$20", "million", "signing", "fee", "with", "$5", "million", "credible", "to", "Major", "Europe", "(Germany,", "$2.0m;", "UK,", "$1.25;", "France,", "$1:0m,", "Italy,", "$0.75m)", "Supply", "Price", "/", "Royalty", "Rate", "30%", "supply", "price", "Royalty", "schedule", "(based", "on", "half", "year", "sales)", "Royalty", "Rate", "Year", "1-3", "Tiers", "Year", "4", "onward", "Tiers", "5%", "50", "-", "$85m", "10", "-", "$170m", "8%", "$85m", "-", "$110m", "$170m", "-", "$220m", "14%", ">$110m", "220m", "Free", "Goods", "Year", "Commercial", "Free", "Goods", "Year", "1", "100%", "30%", "Year", "2", "100%", "20%", "Year", "3", "100%", "10%", "Overview", "of", "Major", "Contract", "Terms", "Product", "Liability", "0(Lilly)/20", "sharing", "of", "Serious", "Adverse", "Events", "Takeda", "Cap", "at", "$20Million", "Minimum", "Sales", "20%", "of", "Lowest", "Teir", "($68", "Million)", "or", "55%", "of", "rolling", "one", "year", "forecast", "Ability", "to", "lower", "obligation", "for", "significant", "event", "Affiliate", "Definition", "Attempting", "to", "agree", "on", "a", "proposal", "which", "prevents", "Takeda", "from", "creating", "local", "JV", "around", "ACTOS", "in", "EU", "Competing", "Product", "TZD", "or", "ISE", "which", "is", "a", "substitute", "for", "Pioglitazone", "License", "reverts", "to", "non-exclusive", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002624", "Source:", "https://www.indup5350-00002ts.ucsf.edu/docs/trjf0226" ]

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{ "match_score": 1, "matched_text": "20", "start": 129, "text": "20" }

{ "de": "Was beschreibt Artikel 5 in diesem Dokument?", "en": "What does article 5 in this document describes?", "es": "¿Qué describe el artículo 5 de este documento?", "fr": "Que décrit l'article 5 de ce document?", "it": "Cosa descrive l'articolo 5 di questo documento?" }

[ "(principles concerning document storage functions)", "principles concerning document storage functions" ]

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{ "match_score": 0.901960786236063, "matched_text": "(Principles concerning Document Storage Functions )", "start": 673, "text": "(principles concerning document storage functions)" }

{ "de": "In wie vielen Grafen wird die Lizenz für Exklusivrechte erteilt?", "en": "In how many countires, license to Exclusive rights are provided?", "es": "¿En cuántos condados se proporcionan licencias para derechos exclusivos?", "fr": "Dans combien de comtes, la licence de droits Exclusifs est-elle fournie?", "it": "In quante cotire viene fornita la licenza per i diritti esclusivi?" }

[ "in approximately 60 countries", "60 COUNTRIES", "60" ]

[ "Summary", "of", "Terms", "for", "OUS", "Agreement", "License", "Exclusive", "rights", "in", "approximately", "60", "countries", "Semi", "exclusive", "rights", "in", "approximately", "20", "countries", "Upfront", "Fee", "$20", "million", "signing", "fee", "with", "$5", "million", "credible", "to", "Major", "Europe", "(Germany,", "$2.0m;", "UK,", "$1.25;", "France,", "$1:0m,", "Italy,", "$0.75m)", "Supply", "Price", "/", "Royalty", "Rate", "30%", "supply", "price", "Royalty", "schedule", "(based", "on", "half", "year", "sales)", "Royalty", "Rate", "Year", "1-3", "Tiers", "Year", "4", "onward", "Tiers", "5%", "50", "-", "$85m", "10", "-", "$170m", "8%", "$85m", "-", "$110m", "$170m", "-", "$220m", "14%", ">$110m", "220m", "Free", "Goods", "Year", "Commercial", "Free", "Goods", "Year", "1", "100%", "30%", "Year", "2", "100%", "20%", "Year", "3", "100%", "10%", "Overview", "of", "Major", "Contract", "Terms", "Product", "Liability", "0(Lilly)/20", "sharing", "of", "Serious", "Adverse", "Events", "Takeda", "Cap", "at", "$20Million", "Minimum", "Sales", "20%", "of", "Lowest", "Teir", "($68", "Million)", "or", "55%", "of", "rolling", "one", "year", "forecast", "Ability", "to", "lower", "obligation", "for", "significant", "event", "Affiliate", "Definition", "Attempting", "to", "agree", "on", "a", "proposal", "which", "prevents", "Takeda", "from", "creating", "local", "JV", "around", "ACTOS", "in", "EU", "Competing", "Product", "TZD", "or", "ISE", "which", "is", "a", "substitute", "for", "Pioglitazone", "License", "reverts", "to", "non-exclusive", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002624", "Source:", "https://www.indup5350-00002ts.ucsf.edu/docs/trjf0226" ]

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{ "match_score": 1, "matched_text": "in approximately 60 countries", "start": 60, "text": "in approximately 60 countries" }

{ "de": "Wie lautet der Name des Kinderprogramms?", "en": "what is the name of pediatric program?", "es": "¿Cuál es el nombre del programa pediátrico?", "fr": "Quel est le nom du programme pédiatrique?", "it": "Qual è il nome del programma pediatrico?" }

[ "ACTOS", "ACTOS PEDIATRIC PROGRAM" ]

[ "ACTOS", "Pediatric", "Program", "5", "October", "2006", "TAK-TROOSA-00427563", "Source:", "https://www.industrydocu?<", "<-09001", "cuments.ucsf.edu/docs/jfkf0226" ]

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{ "match_score": 1, "matched_text": "ACTOS", "start": 0, "text": "ACTOS" }

{ "de": "Welches Datum wird auf dieser Seite erwähnt?", "en": "What is the date mentioned in this page?", "es": "¿Cuál es la fecha mencionada en esta página?", "fr": "Quelle est la date mentionnée dans cette page?", "it": "Qual è la data indicata in questa pagina?" }

[ "5 October 2006" ]

[ "ACTOS", "Pediatric", "Program", "5", "October", "2006", "TAK-TROOSA-00427563", "Source:", "https://www.industrydocu?<", "<-09001", "cuments.ucsf.edu/docs/jfkf0226" ]

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{ "match_score": 1, "matched_text": "5 October 2006", "start": 24, "text": "5 October 2006" }

{ "de": "Wie lautet der Titel dieses Dokuments?", "en": "What is the title of this document?", "es": "¿Cuál es el título de este documento?", "fr": "Quel est le titre de ce document?", "it": "Qual è il titolo di questo documento?" }

[ "Consequences of IR" ]

[ "Consequences", "of", "IR", "Damage", "to", "Eyes", "Damage", "to", "Kidneys", "HDL-C", "LDL-C", "Damage", "to", "Nerves", "Increased", "CV", "Risk", "Increased", "CV", "Risk", "Hyperglycemia", "Dyslipidemia", "Insulin", "Resistance", "Central", "Obesity", "Hypertension", "Increased", "CV", "Risk", "Increased", "CV", "Risk", "<AUTO>", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001900", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induposciscoooacts.ucsf.edu/docs/ynjf0226" ]

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{ "match_score": 1, "matched_text": "Consequences of IR", "start": 0, "text": "Consequences of IR" }

{ "de": "Was ist die Plan TZD Aktie für das Jahr 2003?", "en": "What is the Plan TZD Share for the year 2003?", "es": "¿Cuál es el Plan TZD Share para el año 2003?", "fr": "Qu'est-ce que le régime TZD Part pour l'année 2003?", "it": "Qual è il Piano TZD Share per l'anno 2003?" }

[ "19.7%" ]

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{ "match_score": 1, "matched_text": "19.7%", "start": 441, "text": "19.7%" }

{ "de": "Welches Jahr hat 13,3% Oralanteil (TZD)?", "en": "Which year has 13.3% Oral share (TZD)?", "es": "¿Qué año tiene 13,3% de participación oral (TZD)?", "fr": "Quelle année a 13,3% de part orale (TZD)?", "it": "Quale anno ha una quota orale del 13,3% (TZD)?" }

[ "2000" ]

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{ "match_score": 1, "matched_text": "2000", "start": 204, "text": "2000" }

{ "de": "die unter dem Titel \"Stärke/Chancen\" ein überlegenes Lipidprofil (v. avandia und andere) hat?", "en": "which has a superior lipid profile(v. avandia and others) under the title of \"strength/opportunities?", "es": "que tiene un perfil lipídico superior (v. avandia y otros) bajo el título de \"fuerza/oportunidades?", "fr": "qui a un profil lipidique supérieur (v. avandia et autres) sous le titre de \"force/opportunités?", "it": "che ha un profilo lipidico superiore (v. avandia e altri) sotto il titolo di \"forza/opportunità?" }

[ "ACTOS" ]

[ "Actos", "Plan", "Overview", "Issues/Uncertainties", "Competitive", "Threats", "Strategic", "Intent:", "Avandamet", "4/1000", "Establish", "Actos", "as", "the", "\"best", "oral\"", "anti-diabetic", "medication", "in", "treating", "Insulin", "Resistance", "through", "New", "Merck", "PPAR", "(05)", "sustained", "glycemic", "control", "and", "reduced", "cardiovascular", "risk.", "Other", "Lilly", "Drugs", "Critical", "Success", "Factors", ">", "TZD's", "are", "prescribed", "earlier", "in", "the", "treatment", "of", "Type", "2", "Contract", "negotiations", "in", "progress", "Diabetes", ">Actos", "is", "the", "first", "TZD", "prescribed", "(vs.", "Avandia)", "for", "patients", "with", "Type", "2", "Diabetes.", "Strengths/Opportunities", "Key", "Priorities", "TL's", "believe", "TZDs", "will", "provide", "improved", "durability", "&", "Drive", "a", "thoughtful,", "robust,", "and", "coherent", "set", "of", "medical", "b-cell", "preservation", "and", "reduced", "CV", "risk", "studies", "to", "document", "the", "full", "benefits", "of", "ACTOS", "Supporting", "studies", "on", "TZDs", "are", "underway", "Keep", "opinion", "leaders", "at", "the", "cutting", "edge", "ACTOS", "has", "a", "superior", "lipid", "profile", "(v.", "Avandia", "and", "Fund", "CME", "and", "other", "initiatives", "that", "allow", "the", "opinion", "others)", "leaders", "to", "\"spread", "the", "word\"", "ahead", "of", "our", "evolving", "label", "New", "lipid", "standards", "place", "more", "importance", "on", "lipid", "claims", "management", "in", "diabetes", "Drive", "behavior", "change", "with", "physicians", "via", "our", "sales", "force.", "Pre-diabetes", "and", "DPP", "Results", "Keep", "managed", "care", "from", "being", "a", "barrier.", "Window", "of", "opportunity", "exists", "-", "no", "new", "TZD", "entrants", "to", "market", "until", "2005.", "<AUTO>", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001911", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induposescoots.ucsf.edu/docs/ynjf0226" ]

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{ "match_score": 1, "matched_text": "ACTOS", "start": 732, "text": "ACTOS" }

{ "de": "Welche Studiesynopsis ist das?", "en": "Which study's synopsis is this?", "es": "¿Qué sinopsis de estudio es ésta?", "fr": "C'est le synopsis de quelle étude?", "it": "Qual e' la sinossi dello studio?" }

[ "Clinical Study", "clinical" ]

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{ "match_score": 1, "matched_text": "Clinical Study", "start": 0, "text": "Clinical Study" }

{ "de": "welcher Code wird unter dem Titel der klinischen Studien-Synopsis erwähnt?", "en": "what is the code mentioned under the title of clinical study synopsis?", "es": "¿Cuál es el código mencionado bajo el título de la sinopsis del estudio clínico?", "fr": "Quel est le code mentionné sous le titre de synopsis de l'étude clinique?", "it": "Qual è il codice menzionato sotto il titolo di sinossi di studio clinico?" }

[ "01-06-TL-OPI-527" ]

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{ "match_score": 1, "matched_text": "01-06-TL-OPI-527", "start": 24, "text": "01-06-TL-OPI-527" }

{ "de": "Welche Studie wird in der Tabelle beschrieben?", "en": "What study is described in the table given?", "es": "¿Qué estudio se describe en la tabla dada?", "fr": "Quelle étude est décrite dans le tableau donné?", "it": "Quale studio è descritto nella tabella riportata?" }

[ "Glycemic Parameters in a 26-Week Placebo-Controlled Dose-Ranging Study.", "PLACEBO- CONTROLLED DOSE RANGING STUDY" ]

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{ "match_score": 0.9859154931561198, "matched_text": "Glycemic Parameters in a 26-Week Placebo-Controlled Dose-Ranging Study ", "start": 100, "text": "Glycemic Parameters in a 26-Week Placebo-Controlled Dose-Ranging Study." }

{ "de": "Welche Parameter werden für die Studie berücksichtigt (siehe Überschrift der Tabelle 2)?", "en": "Which parameters are considered for the study(see heading of table 2)?", "es": "¿Qué parámetros se consideran para el estudio (véase el encabezamiento del cuadro 2)?", "fr": "Quels paramètres sont pris en considération pour l'étude (voir rubrique du tableau 2)?", "it": "Quali parametri sono presi in considerazione per lo studio (cfr. rubrica della tabella 2)?" }

[ "Glycemic Parameters", "GLYCEMIC" ]

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{ "match_score": 1, "matched_text": "Glycemic Parameters", "start": 100, "text": "Glycemic Parameters" }

{ "de": "Vor welcher Behandlung traten die Patienten in einer 8-wöchigen Auswaschphase/Run-in-Periode ein?", "en": "Prior to what, the patients entered an 8 week washout/run-in-period?", "es": "¿Antes de qué, los pacientes entraron en un periodo de lavado de 8 semanas?", "fr": "Avant quoi, les patients sont-ils entrés dans une période de lavage/de rinçage de 8 semaines?", "it": "Prima di cosa, i pazienti sono entrati in un washout/run-in-period di 8 settimane?" }

[ "double-blind treatment" ]

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{ "match_score": 1, "matched_text": "double-blind treatment", "start": 1083, "text": "double-blind treatment" }

{ "de": "Was ist der Grundversorgungspreis?", "en": "What is the floor supply price?", "es": "¿Cuál es el precio del suelo?", "fr": "Quel est le prix de l'approvisionnement en plancher?", "it": "Qual è il prezzo di fornitura del pavimento?" }

[ "$0.17 / 30 mg or Takeda's cost from site of lowest cost" ]

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{ "match_score": 0.944444445473251, "matched_text": "50.17 / 30mg or Takeda's Cost from site of lowest cost", "start": 466, "text": "$0.17 / 30 mg or Takeda's cost from site of lowest cost" }

{ "de": "Was ist die Lizenzanpassung, wenn Generika auf den Markt kommt?", "en": "What is the royalty adjustment if generic enters the market ?", "es": "¿Cuál es el ajuste de los cánones si los genéricos entran en el mercado?", "fr": "Quel est l'ajustement des redevances si générique entre sur le marché?", "it": "Qual è l'adeguamento dei canoni se il generico entra nel mercato?" }

[ "50%", "50% royalty adjustment" ]

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{ "match_score": 1, "matched_text": "50%", "start": 658, "text": "50%" }

{ "de": "Wofür sind die Werbepfade Datennutzung(Lilly in exklusiv)?", "en": "what is the promotional trails data usage for( Lilly in exclusive) ?", "es": "¿Cuál es el uso de datos de rutas promocionales para (Lilly en exclusiva)?", "fr": "Quelle est l'utilisation des données des sentiers promotionnels pour( Lilly en exclusivité)?", "it": "Qual è l'utilizzo dei dati dei percorsi promozionali per (Lilly in esclusiva)?" }

[ "Split of 70/30 (Lilly in Exclusive)", "split of 70/30 (Lilly in exclusive)", "Split of 70/30" ]

[ "Overview", "of", "Major", "Contract", "Terms", "Promotional", "Samples", "At", "Cost", "New", "Indications/Line", "Extension", "Takeda", "must", "offer", "to", "Lilly", "If", "Lilly", "agrees,", "then", "cost", "sharing", "based", "on", "expected", "benefit\"", "If", "Lilly", "disagrees,", "Takeda", "/", "Lilly", "agree", "on", "any", "damages", "due", "Lilly", "Promotional", "Trials", "Data", "Usage", "Both", "parties", "can", "gain", "access", "to", "each", "others", "trial", "data", "Split", "of", "70/30", "(Lilly", "in", "Exclusive)", "50/50", "in", "Semi-exclusive", "Sub-license", "Right", "to", "sub-license", "with", "Takeda's", "consent", "Floor", "Supply", "Price", "50.17", "/", "30mg", "or", "Takeda's", "Cost", "from", "site", "of", "lowest", "cost", "Overview", "of", "Major", "Contract", "Terms", "Termination", "Right", "to", "terminate", "in", "specific", "markets", "if", "significant", "events", "occur", "Generic", "Entry", "Adjustment", "50%", "royalty", "adjustment", "if", "generic", "enters", "the", "market", "and", "causes", "sales", "decline", "of", "25%", "Intellectual", "Property", "Fakeda", "owns", "all", "5", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002627", "Source:", "https://www.indup5350-00005", "ts.ucsf.edu/docs/trjf0226" ]

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{ "match_score": 1, "matched_text": "Split of 70/30 (Lilly in Exclusive)", "start": 332, "text": "Split of 70/30 (Lilly in Exclusive)" }

{ "de": "Wofür nutzen die Promotion-Tests Daten (semi exclusive)?", "en": "What is the promotional trials data usage for (semi exclusive)?", "es": "¿Para qué se utilizan los datos de ensayos promocionales (semi exclusivos)?", "fr": "Quelle est l'utilisation des données d'essais promotionnels pour (semi exclusive)?", "it": "A cosa servono i dati di prova promozionali (semiesclusivi)?" }

[ "50/50 in Semi-exclusive" ]

[ "Overview", "of", "Major", "Contract", "Terms", "Promotional", "Samples", "At", "Cost", "New", "Indications/Line", "Extension", "Takeda", "must", "offer", "to", "Lilly", "If", "Lilly", "agrees,", "then", "cost", "sharing", "based", "on", "expected", "benefit\"", "If", "Lilly", "disagrees,", "Takeda", "/", "Lilly", "agree", "on", "any", "damages", "due", "Lilly", "Promotional", "Trials", "Data", "Usage", "Both", "parties", "can", "gain", "access", "to", "each", "others", "trial", "data", "Split", "of", "70/30", "(Lilly", "in", "Exclusive)", "50/50", "in", "Semi-exclusive", "Sub-license", "Right", "to", "sub-license", "with", "Takeda's", "consent", "Floor", "Supply", "Price", "50.17", "/", "30mg", "or", "Takeda's", "Cost", "from", "site", "of", "lowest", "cost", "Overview", "of", "Major", "Contract", "Terms", "Termination", "Right", "to", "terminate", "in", "specific", "markets", "if", "significant", "events", "occur", "Generic", "Entry", "Adjustment", "50%", "royalty", "adjustment", "if", "generic", "enters", "the", "market", "and", "causes", "sales", "decline", "of", "25%", "Intellectual", "Property", "Fakeda", "owns", "all", "5", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002627", "Source:", "https://www.indup5350-00005", "ts.ucsf.edu/docs/trjf0226" ]

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{ "match_score": 1, "matched_text": "50/50 in Semi-exclusive", "start": 368, "text": "50/50 in Semi-exclusive" }

{ "de": "Was ist das letzte Revisionsdatum, das in diesem Dokument erwähnt wird?", "en": "What is the last revision date mentioned in this document?", "es": "¿Cuál es la última fecha de revisión mencionada en este documento?", "fr": "Quelle est la dernière date de révision mentionnée dans ce document?", "it": "Qual è l'ultima data di revisione menzionata in questo documento?" }

[ "August 7, 2002" ]

[ "ACTOS", "FDA", "Response", "Strategy", "TASK", "FORCE", "-TPNA", "Alfonso", "Perez", "Janet", "Haskins*", "Mary", "Ramstack*", "Ingrid", "Hoos", "Michael", "Elisseou", "John", "Page", "(Rich", "Wilson)", "Claire", "Thom", "Dan", "Orlando", "David", "Baron", "(Chris", "Durack)", "Larry", "Hancock", "Karen", "Kaluzny", "Masatake", "Kashiyae", "Chuck", "Burant", "*Task", "Force", "Coordinators", "TASK", "FORCE", "STRATEGIES:", "The", "FDA", "has", "3", "key", "issues", "with", "respect", "to", "the", "non-clinical", "data", "related", "to", "bladder", "tumors.", "1.", "They", "requested", "us", "to", "propose", "a", "method", "by", "which", "to", "monitor", "bladder", "toxicity", "in", "patients", "in", "our", "long", "term", "phase", "4", "clinical", "trials", "(long", "term", "was", "defined", "as", "at", "least", "1", "year).", "a,", "TPNA", "will", "challenge", "the", "FDA", "request", "to", "conduct", "clinical", "monitoring", "in", "long-term", "studies", "2.", "They", "requested", "us", "to", "give", "some", "consideration", "to", "a", "label", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "mechanism", "(dual", "PPAR", "agonist)", "instead", "of", "the", "current", "language", "(\"", "The", "relationship", "of", "these", "findings", "in", "male", "rats", "to", "humans", "is", "unclear.\")", "a", "TPNA", "would", "like", "to", "challenge", "FDA", "hypothesis", "around", "tumor", "formation", "relationship", "to", "dual", "PPAR", "mechanism.", "b.", "TPNA", "goal", "is", "to", "supply", "justification", "to", "support", "maintaining", "current", "labeling.", "3.", "They", "indicated", "an", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "based", "on", "their", "concern", "about", "bladder", "tumors.", "a.", "Based", "on", "current", "verbiage", "in", "PI", "TPNA", "requests", "to", "conduct", "pediatric", "trial", "as", "scheduled.", "Last", "revision;", "August", "7,", "2002", "EXHIBIT", "Confidential", "-", "Subject", "to", "Protective", "Order", "DATE:", "3", "Juliana", "Zajicek", "CSA", "TAK-RAMSTM-00236225", "Produced", "in", "MDL", "on", "09/18/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/yljf0226" ]

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{ "match_score": 1, "matched_text": "August 7, 2002", "start": 1348, "text": "August 7, 2002" }

{ "de": "Was ist das Ziel von TPNA?", "en": "What is the goal of TPNA?", "es": "¿Cuál es el objetivo del TPNA?", "fr": "Quel est l'objectif de TPNA?", "it": "Qual è l'obiettivo di TPNA?" }

[ "to supply justification to support maintaining current labeling." ]

[ "ACTOS", "FDA", "Response", "Strategy", "TASK", "FORCE", "-TPNA", "Alfonso", "Perez", "Janet", "Haskins*", "Mary", "Ramstack*", "Ingrid", "Hoos", "Michael", "Elisseou", "John", "Page", "(Rich", "Wilson)", "Claire", "Thom", "Dan", "Orlando", "David", "Baron", "(Chris", "Durack)", "Larry", "Hancock", "Karen", "Kaluzny", "Masatake", "Kashiyae", "Chuck", "Burant", "*Task", "Force", "Coordinators", "TASK", "FORCE", "STRATEGIES:", "The", "FDA", "has", "3", "key", "issues", "with", "respect", "to", "the", "non-clinical", "data", "related", "to", "bladder", "tumors.", "1.", "They", "requested", "us", "to", "propose", "a", "method", "by", "which", "to", "monitor", "bladder", "toxicity", "in", "patients", "in", "our", "long", "term", "phase", "4", "clinical", "trials", "(long", "term", "was", "defined", "as", "at", "least", "1", "year).", "a,", "TPNA", "will", "challenge", "the", "FDA", "request", "to", "conduct", "clinical", "monitoring", "in", "long-term", "studies", "2.", "They", "requested", "us", "to", "give", "some", "consideration", "to", "a", "label", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "mechanism", "(dual", "PPAR", "agonist)", "instead", "of", "the", "current", "language", "(\"", "The", "relationship", "of", "these", "findings", "in", "male", "rats", "to", "humans", "is", "unclear.\")", "a", "TPNA", "would", "like", "to", "challenge", "FDA", "hypothesis", "around", "tumor", "formation", "relationship", "to", "dual", "PPAR", "mechanism.", "b.", "TPNA", "goal", "is", "to", "supply", "justification", "to", "support", "maintaining", "current", "labeling.", "3.", "They", "indicated", "an", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "based", "on", "their", "concern", "about", "bladder", "tumors.", "a.", "Based", "on", "current", "verbiage", "in", "PI", "TPNA", "requests", "to", "conduct", "pediatric", "trial", "as", "scheduled.", "Last", "revision;", "August", "7,", "2002", "EXHIBIT", "Confidential", "-", "Subject", "to", "Protective", "Order", "DATE:", "3", "Juliana", "Zajicek", "CSA", "TAK-RAMSTM-00236225", "Produced", "in", "MDL", "on", "09/18/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/yljf0226" ]

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{ "match_score": 1, "matched_text": "to supply justification to support maintaining current labeling.", "start": 1043, "text": "to supply justification to support maintaining current labeling." }

{ "de": "Nennen Sie das Jahr für Actos gegeben?", "en": "Mention the year given for Actos?", "es": "¿Mencionar el año dado a Actos?", "fr": "Mention de l'année donnée pour Actos?", "it": "Menziona l'anno dato per Actos?" }

[ "2004", "Actos 2004" ]

[ "Actos", "2004", "Marketing", "Plan", "Review", "DALY", "12", "Lilly", "Answers", "That", "Matter.", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001895", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induposescooouts.ucsf.edu/docs/ynjf0226" ]

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{ "match_score": 1, "matched_text": "2004", "start": 6, "text": "2004" }

{ "de": "Wie hoch ist der Prozentsatz der TZD-Aktie im Jahr 2000?", "en": "what is the percentage of TZD share in the year 2000 ?", "es": "¿Cuál es el porcentaje de participación de TZD en el año 2000?", "fr": "Quel est le pourcentage de la part de TZD en l'an 2000?", "it": "Qual è la percentuale della quota di TZD nell'anno 2000?" }

[ "40.3%" ]

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{ "match_score": 1, "matched_text": "40.3%", "start": 492, "text": "40.3%" }

{ "de": "Was ist Actos TRx (000s) im Jahr 2003?", "en": "what is Actos TRx (000s) in the year 2003 ?", "es": "¿Qué es Actos TRx (000s) en el año 2003?", "fr": "Qu'est-ce qu'Actos TRx (en milliers) en 2003?", "it": "che cos'è Actos TRx (000s) nel 2003?" }

[ "9,497" ]

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{ "match_score": 1, "matched_text": "9,497", "start": 461, "text": "9,497" }

{ "de": "Wie hoch ist der Anteil des Plans an der TZD-Aktie im Jahr 2004?", "en": "what is the percentage of plan TZD share in the year 2004 ?", "es": "¿Cuál es el porcentaje de participación del plan TZD en el año 2004?", "fr": "Quel est le pourcentage de la part du régime TZD en 2004?", "it": "Qual è la percentuale della quota TZD del piano nell'anno 2004?" }

[ "42.9%" ]

[ "Actos", "Share", "of", "TZDs", "Retail", "TRX", "SOM,", "IMS", "Health", "60.00%", "Actual", "Forecast", "50.00%", "40.00%", "Launch", "of", "Launch", "of", "30.00%", "Merck's", "BMS'", "PPAR's", "PPAR's", "Q3", "2005", "20.00%", "Feb", "2005", "10.00%", "0.00%", "n-00", "Apr-00", "1-00", "t-00", "Jan", "Apr-01", "Jul-01", "Apr-02", "11-02", "t-02", "Jul-03", "Jan-04", "Apr-04", "Jul-04", "Jan-05", "Apr-05", "Jul-05", "Oct", "Jan-01", "Oct", "Jan-02", "Jan-03", "Apr-03", "Oct-03", "Oct-04", "Oct-05", "2000", "2001", "200", "200", "2004", "2005", "TZDs", "TRx", "(000s", "10,577", "14,681", "17,", "101", "19,", "407", "21,479", "22,902", "Actos", "TRx", "(000s)", "4,261", "6,872", "8,582", "9,497", "10,", "149", "10,472", "TZD", "Share", "40.3%", "46.8%", "50.2%", "49.0%", "47.3%", "45.7%", "Plan", "TZD", "Share", "n/a", "n/a", "7/a", "46.", "1%", "42.9%", "Forecast", "as", "a", "%", "of", "Plan", "n/a", "n/a", "na", "106.3%", "110.1%", "AUTO>", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001898", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induposciscoooo4ts.ucsf.edu/docs/ynjf0226" ]

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{ "match_score": 1, "matched_text": "42.9%", "start": 562, "text": "42.9%" }

{ "de": "wie viel Prozent des Placebos in Avandia neben den klinischen Befunden vorhanden?", "en": "how much percent of placebo present in avandia alongside of the clinical findings?", "es": "¿Cuánto porcentaje de placebo presente en avandia junto con los hallazgos clínicos?", "fr": "Combien de pour cent du placebo présent dans l'avandie en plus des résultats cliniques?", "it": "quanto percentuale di placebo presente in Avandia insieme ai risultati clinici?" }

[ "0.20%", "0.20" ]

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{ "match_score": 1, "matched_text": "0.20%", "start": 241, "text": "0.20%" }

{ "de": "was ist die TRx (000s) des TZD im Jahr 2005?", "en": "what is the TZD's TRx (000s) in the year 2005 ?", "es": "¿Cuál es el TRx del TZD (en miles) en el año 2005?", "fr": "qu'est-ce que le TRx (000s) du TZD en 2005?", "it": "che cos'è il TRx del TZD (000s) nel 2005?" }

[ "22,902" ]

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{ "match_score": 1, "matched_text": "22,902", "start": 419, "text": "22,902" }

{ "de": "Wie hoch ist die Gesamtzahl aller Ansprüche unter dem Titel \"Zusammenfassung des Rechtsstreitrisikos in den Hoheitsgebieten\"?", "en": "what is the total number of all claims under the title of \"summary of litigation risk in the ous territories\"?", "es": "¿cuál es el número total de reclamaciones bajo el título de \"resumen del riesgo de litigio en los territorios\"?", "fr": "Quel est le nombre total de réclamations sous le titre de «résumé du risque de litige dans les territoires concernés»?", "it": "Qual è il numero totale di tutti i crediti sotto il titolo di \"sommario del rischio di contenzioso nei territori\"?" }

[ "10" ]

[ "Most", "Significant", "Adverse", "Events", "Risks", "for", "Pioglitazone", "Risk", "Onset", "Reversibility", "Clinical", "Findings", "Occurrence", "of", "ALT", "Elevation", "Within", "2", "months", "Only", "through", "Drug", "Placebo", "Liver", "Failure", "Transplant", "Rezulln", "1.1", "70", "0.120.", "ACTOS", "0.26%", "0.25%", "Avandia", "0.20%", "0.20%", "Cardiac", "Hypertrophy", "Unknown", "Unknown", "Observed", "during", "Preclinical", "Studies", "in", "Rats", ".", "No", "cases", "in", "Humans", "Unknown", "Unknown", "Observed", "during", "Bladder", "Cancer", "Preclinical", "Studies", "in", "Rats", ".", "No", "cases", "in", "Humans", "Edema", "Within", "Yes", "Occurrence", "of", "Edema", "12", "months", "Drug", "Placebo", "ACTOS", "15.3%", "7.0%", "Summary", "of", "Litigation", "Risk", "in", "the", "OUS", "Territories", "Out", "of", "10,359", "claims", "on", "the", "Litigation", "Support", "System", "database,", "only", "10", "claims", "have", "arose", "from", "the", "Territory", "in", "this", "Agreement", "Country", "All", "Claims", "Drug", "Claims", "Australia", "Saudi", "Arabia", "South", "Africa", "Spain", "Sweden", "Total", "U", "-", "OO", "-", "W", "4", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002626", "Source:", "https://www.indup5350", "0oo04ts.ucsf.edu/docs/trjf0226" ]

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{ "match_score": 1, "matched_text": "10", "start": 584, "text": "10" }

{ "de": "Für welche Art von Diabetes wird das TZD früher in der Behandlung verschrieben?", "en": "For which type of diabetes the TZD's prescribed earlier in treatment?", "es": "¿Para qué tipo de diabetes se prescribe la TZD antes en el tratamiento?", "fr": "Pour quel type de diabète le TZD prescrit plus tôt dans le traitement?", "it": "Per quale tipo di diabete il TZD's prescritto in precedenza nel trattamento?" }

[ "Type 2 diabetes" ]

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{ "match_score": 1, "matched_text": "Type 2 diabetes", "start": 254, "text": "Type 2 diabetes" }

{ "de": "Welches spezifische Beispiel wird gegeben?", "en": "What is the Specific example given?", "es": "¿Qué es el ejemplo específico dado?", "fr": "Quel est l'exemple spécifique donné?", "it": "Qual è l'esempio specifico fornito?" }

[ "pioglitazone: need to commit to studies to investigate certain signals", "Pioglitazone: Need to commit to studies to investigate certain signals" ]

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{ "match_score": 0.9714285718367347, "matched_text": "Pioglitazone: Need to commit to studies to investigate certain signals", "start": 255, "text": "pioglitazone: need to commit to studies to investigate certain signals" }

{ "de": "Was ist in der Zusammenfassung enthalten?", "en": "what is included in the summary document ?", "es": "¿Qué se incluye en el documento de síntesis?", "fr": "Qu'est-ce qui est inclus dans le document sommaire?", "it": "cosa è incluso nel documento di sintesi?" }

[ "includes benefit-risk assessment", "benefit risk assessment", "(includes benefit-risk assessment)" ]

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{ "match_score": 0.9393939412304866, "matched_text": "Includes benefit- risk assessment", "start": 105, "text": "includes benefit-risk assessment" }

{ "de": "Was ist die Zusammenfassung der Blasenkrebs-Fälle?", "en": "what is the executive summary of bladder cancer cases ?", "es": "¿Cuál es el resumen ejecutivo de los casos de cáncer de vejiga?", "fr": "Quel est le résumé des cas de cancer de la vessie?", "it": "Qual è il riassunto esecutivo dei casi di cancro alla vescica?" }

[ "CONFIRM" ]

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{ "match_score": 1, "matched_text": "CONFIRM", "start": 279, "text": "CONFIRM" }

{ "de": "Volle Form von PEM?", "en": "Full form of PEM?", "es": "¿Forma completa de PEM?", "fr": "Une forme complète de PEM?", "it": "Una forma completa di PEM?" }

[ "prescription event monitoring" ]

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{ "match_score": 1, "matched_text": "prescription event monitoring", "start": 1102, "text": "prescription event monitoring" }

{ "de": "Wie viele Themen sollten im Rahmen der Telekonferenz diskutiert werden?", "en": "On the purpose of teleconference, how many topics were to be discussed?", "es": "A propósito de la teleconferencia, ¿cuántos temas se debatirían?", "fr": "Dans le but de la téléconférence, combien de sujets devaient être discutés?", "it": "Per quanto riguarda la teleconferenza, quanti argomenti dovevano essere discussi?" }

[ "3", "3 topics" ]

[ "PENGAD", "BOO-631-698", "EXHIBIT", "102", "FDA", "Conference", "Call", "on", "July", "31,", "2002", "TPNA", "Personnel:", "Wendell", "Cheatham,", "M.D.", "Vice", "President,", "of", "Medial", "and", "Scientific", "Affairs", "Michael", "Elisseou,", "Ph.D.,", "Director,", "Product", "Development", "and", "Planning", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Ingrid", "Hoos,", "Director,", "Regulatory", "Affairs", "John", "Page,", "M.D.,", "Director.", "Product", "Safety", "Alfonso", "Perez,", "M.D.,", "Sr.", "Director", "of", "Clinical", "Development", "Mary", "Ramstack,", "Sr.", "Manager,", "Product", "Development", "and", "Planning", "Claire", "Thom,", "Pharm.D.,", "Vice", "President,", "Research", "and", "Development", "FDA", "Personnel:", "David", "Orloff,", "M.D.,", "Division", "Director", "Bob", "Misbin,", "M.D.,", "Medical", "Review", "Jena", "Weber,", "Project", "Manager", "Jeri", "El-Hage,", "Toxicology", "Team", "Leader", "Dr.", "Orloff", "stated", "that", "the", "purpose", "of", "the", "teleconference", "was", "to", "discuss", "three", "topics", "related", "to", "additional", "nonclinical", "data", "recently", "received", "by", "the", "Division", "1.", "a", "proposal", "to", "monitor", "bladder", "toxicily", "in", "long", "term", "clinical", "trials", "2.", "the", "Division's", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "3.", "a", "labeling", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "drug", "mechanism", "of", "action.", "Dr.", "Orloff", "stated_that", "the", "Division", "is", "considering", "additional", "data", "that", "indicates", "that", "the", "bladder", "tumors", "seen", "in", "the", "rat", "carcinogenicity", "study", "maybe", "a", "mixed", "PPAR", "class", "effect.", "He", "further", "noted", "that", "when", "proglitazone", "was", "approved", "by", "the", "Division,", "the", "significance", "of", "these", "findings", "was", "tempered", "by", "the", "data", "presented", "by", "Takeda", "relating", "the", "tumor", "formation", "to", "the", "presence", "of", "calculi.", "He", "further", "indicated", "that", "However", ",", "as", "the", "Division", "has", "recently", "reviewed", "data", "for", "similar", "compounds.", "the", "additional.", "Additional", "data", "suggests", "that", "those", "tumors", "may", "have", "beenbe-", "drug", "related.", "Dr.", "Perez", "inquired", "about", "the", "Division's", "definition", "of", "long", "term", "trials", "and", "stated", "that", "urine", "cytology", "was", "preformed", "in", "two", "trials", "that", "were", "over", "one", "year", "in", "duration.", "Dr.", "Misbin", "noted", "that", "the", "Division", "considers", "long-term", "as", "a", "trial", "longer", "than", "one-year", "and", "inquired", "about", "what", "type", "of", "testing", "was", "conducted", "in", "the", "trials", "mentioned", "by", "Dr.", "Perez.", "Dr.", "Perez", "noted", "that", "urine", "cytology", "was", "performed", "for", "any", "subject", "presenting", "hematuria", "at", "any", "time", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00235775", "Produced", "in", "MDL", "on", "09/18/12", "Source:", "https://www.indup53670boots.ucsf.edu/docs/fsjf0226" ]

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{ "match_score": 1, "matched_text": "3", "start": 12, "text": "3" }

{ "de": "von wem der derzeitige Aktionsplan angenommen wurde?", "en": "basically by whom the current action plan was approved ?", "es": "¿Quién aprobó, básicamente, el plan de acción actual?", "fr": "par qui le plan d'action actuel a-t-il été approuvé?", "it": "fondamentalmente da chi è stato approvato l'attuale piano d'azione?" }

[ "CEO" ]

[ "Saito", "/2low", "Takeda", "Basic", "Policy", "on", "Actos", "Issue", ".", "Reported", "to", "CEO", "on", "August", "6", ".", "Basically", "the", "current", "action", "plan", "was", "approved", "by", "CEO", ".", "Mr.", "Saito", "was", "appointed", "as", "the", "responsible", "person", "on", "this", "issue", ".", "An", "outline", "of", "the", "FDA", "response", "has", "to", "be", "reported", "to", "CEO", "on", "August", "20", "(Japan", "time)", "for", "approval", "before", "submission.", "August", "12", "-", "13,", "2002", "1", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019735", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.induspo452-ooo01s.ucsf.edu/docs/ymjf0226" ]

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{ "match_score": 1, "matched_text": "CEO", "start": 61, "text": "CEO" }

{ "de": "Welches Datum wird unten erwähnt?", "en": "What is the date mentioned at the bottom?", "es": "¿Cuál es la fecha mencionada en la parte inferior?", "fr": "Quelle est la date mentionnée en bas?", "it": "Qual è la data indicata in basso?" }

[ "09/18/12" ]

[ "PENGAD", "BOO-631-698", "EXHIBIT", "102", "FDA", "Conference", "Call", "on", "July", "31,", "2002", "TPNA", "Personnel:", "Wendell", "Cheatham,", "M.D.", "Vice", "President,", "of", "Medial", "and", "Scientific", "Affairs", "Michael", "Elisseou,", "Ph.D.,", "Director,", "Product", "Development", "and", "Planning", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Ingrid", "Hoos,", "Director,", "Regulatory", "Affairs", "John", "Page,", "M.D.,", "Director.", "Product", "Safety", "Alfonso", "Perez,", "M.D.,", "Sr.", "Director", "of", "Clinical", "Development", "Mary", "Ramstack,", "Sr.", "Manager,", "Product", "Development", "and", "Planning", "Claire", "Thom,", "Pharm.D.,", "Vice", "President,", "Research", "and", "Development", "FDA", "Personnel:", "David", "Orloff,", "M.D.,", "Division", "Director", "Bob", "Misbin,", "M.D.,", "Medical", "Review", "Jena", "Weber,", "Project", "Manager", "Jeri", "El-Hage,", "Toxicology", "Team", "Leader", "Dr.", "Orloff", "stated", "that", "the", "purpose", "of", "the", "teleconference", "was", "to", "discuss", "three", "topics", "related", "to", "additional", "nonclinical", "data", "recently", "received", "by", "the", "Division", "1.", "a", "proposal", "to", "monitor", "bladder", "toxicily", "in", "long", "term", "clinical", "trials", "2.", "the", "Division's", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "3.", "a", "labeling", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "drug", "mechanism", "of", "action.", "Dr.", "Orloff", "stated_that", "the", "Division", "is", "considering", "additional", "data", "that", "indicates", "that", "the", "bladder", "tumors", "seen", "in", "the", "rat", "carcinogenicity", "study", "maybe", "a", "mixed", "PPAR", "class", "effect.", "He", "further", "noted", "that", "when", "proglitazone", "was", "approved", "by", "the", "Division,", "the", "significance", "of", "these", "findings", "was", "tempered", "by", "the", "data", "presented", "by", "Takeda", "relating", "the", "tumor", "formation", "to", "the", "presence", "of", "calculi.", "He", "further", "indicated", "that", "However", ",", "as", "the", "Division", "has", "recently", "reviewed", "data", "for", "similar", "compounds.", "the", "additional.", "Additional", "data", "suggests", "that", "those", "tumors", "may", "have", "beenbe-", "drug", "related.", "Dr.", "Perez", "inquired", "about", "the", "Division's", "definition", "of", "long", "term", "trials", "and", "stated", "that", "urine", "cytology", "was", "preformed", "in", "two", "trials", "that", "were", "over", "one", "year", "in", "duration.", "Dr.", "Misbin", "noted", "that", "the", "Division", "considers", "long-term", "as", "a", "trial", "longer", "than", "one-year", "and", "inquired", "about", "what", "type", "of", "testing", "was", "conducted", "in", "the", "trials", "mentioned", "by", "Dr.", "Perez.", "Dr.", "Perez", "noted", "that", "urine", "cytology", "was", "performed", "for", "any", "subject", "presenting", "hematuria", "at", "any", "time", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00235775", "Produced", "in", "MDL", "on", "09/18/12", "Source:", "https://www.indup53670boots.ucsf.edu/docs/fsjf0226" ]

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{ "match_score": 1, "matched_text": "09/18/12", "start": 2213, "text": "09/18/12" }

{ "de": "Wie lautet die Überschrift dieses Dokuments oben?", "en": "What is the heading of this document, given at the top?", "es": "¿Cuál es el título de este documento, dado en la parte superior?", "fr": "Quel est le titre de ce document, en haut?", "it": "Qual è l'intestazione di questo documento, riportata in alto?" }

[ "Avandamet Uptake" ]

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{ "match_score": 1, "matched_text": "Avandamet Uptake", "start": 0, "text": "Avandamet Uptake" }

{ "de": "Wie hoch ist der Prozentsatz der Avandamet-Skripte von Actos?", "en": "What is the percentage of Avandamet scripts from Actos mentioned?", "es": "¿Cuál es el porcentaje de escrituras de Avandamet de Actos mencionado?", "fr": "Quel est le pourcentage de scripts Avandamet d'Actos mentionné?", "it": "Qual è la percentuale di Avandamet script da Actos menzionato?" }

[ "36%", "36" ]

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{ "match_score": 1, "matched_text": "36%", "start": 66, "text": "36%" }

{ "de": "Was ist auf der Horizontachse des Graphen?", "en": "What is on the horizonal axis of the graph?", "es": "¿Qué hay en el eje horizonte del gráfico?", "fr": "Qu'est-ce qui se trouve sur l'axe horizonal du graphique?", "it": "Che cosa c'è sull'asse orizzontale del grafico?" }

[ "Full Months Post Launch" ]

[ "Avandamet", "Uptake", "Retail", "TRx", "(000s),", "IMS", "Health", "TRX", "(000s)", "Assumes", "36%", "of", "Avandamet", "scripts", "from", "Actos", "500", "Glucovance", "450", "400", "*", "350", "Avandamet", "300", "Forecast", "250", "200", "150", "100", "Avandamet", "at", "31%", "of", "original", "X", "forecast.", "50", "Avandamet", "2", "3", "4", "5", "6", "7", "8", "9", "10", "11", "12", "13", "15", "Full", "Months", "Post", "Launch", "<AUTO>", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001899", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induposescoooosts.ucsf.edu/docs/ynjf0226" ]

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{ "match_score": 1, "matched_text": "Full Months Post Launch", "start": 255, "text": "Full Months Post Launch" }

{ "de": "Wer ist die verantwortliche Person für TPNA?", "en": "who is the responsible person for TPNA ?", "es": "¿Quién es la persona responsable del TPNA?", "fr": "qui est la personne responsable de l'ARNPT?", "it": "Chi è la persona responsabile della TPNA?" }

[ "Dr. C Thom" ]

[ "Actos", "Issue", "Organization", "Chief", "leader", ":", "Mr.", "K", "Saito", ".", "Responsible", "persons", "-", "TPNA", ":", "Dr.", "C", "Thom", "-", "EuR", "&D", ":", "Dr.", "D", "Eckland", "-", "TCI", ":", "Mr.", "K", "Saito", ".", "First", "contact", "persons", "-", "TPNA", ":", "Ms.", "M", "Ramstack,", "Ms.", "J", "Haskins", "-", "EuR", "&D", ":", "Dr.", "P", "Collett", "TCI", ":", "Mr.", "M", "Miyazaki", "August", "12", "-", "13,", "2002", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019736", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupp45200002s.ucsf.edu/docs/ymjf0226" ]

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{ "match_score": 1, "matched_text": "Dr. C Thom", "start": 83, "text": "Dr. C Thom" }

{ "de": "Wie lautet das Datum der Randomisierung?", "en": "What is the date of randomisation?", "es": "¿Cuál es la fecha de la aleatorización?", "fr": "Quelle est la date de la randomisation?", "it": "Qual è la data di randomizzazione?" }

[ "05-11-01", "05/11/01" ]

[ "04/05/2004", "11:05", "22434/2084", "12:0", "49-931-20136759", "NORL", "*", "9004993123136283", "DIABETESAMBULANZ", "S.", "02/03", "NO.", "938", "PROactive", "Urgent", "Data", "Enquiry", "Form", "Centre", "number", "Patient", "number", "Patient", "initials", "Date", "of", "randomisation", "49012", "014", "05-11-0", ".Reference", "Date", "issue", "35037-hrt-11", "92-04-04", "Date", "resolved", "Alert", "Report", "Booklet", "A15778", "(page", "001)", "...-06.", "Benton", "turnor", "of", "the", "urinary", "ble", "ITEM", "07:", "Medical", "event", "(diagnosis)", "For", "all", "serlove", "episodes", "of", "Bladder", "cancer,", "Takeda", "Drug", "Safety", "require", "additional", "information", "and", "would", "appreci-", "ate", "At", "A", "you", "could", "complete", "the", "attached", "questionnaire", "and", "return", "it", "to", "is", "with", "this", "enquiry", "form", "signed", "and", "card", "as", "soon", "as", "possible.", "Reply:", "was", "no", "it", "was", "a", "benign", "turnor", "see", "the", "diagnosis", "of", "the", "afoot", "report", "Signature:", "C", "Beds", "Date:", "4/5/04", "Please", "write", "your", "reply", "in", "the", "space", "provided", "and", "ensure", "that", "the", "reply", "is", "signed", "as", "this", "sheet", "will", "become", "part", "of", "the", "patient's", "record", "form.", "Once", "completed,", "please", "fax", "the", "form", "back", "to", "the", "Study", "Coordinating", "Centre", "(++", "44", "115", "956", "77", "22)", "and", "retain", "the", "original", "In", "the", "patient's", "Case", "Report", "Form.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-00456053", "Produced", "in", "MDL", "on", "09/12/12", "Source:", "https://www.indupoo26-ooocats.ucsf.edu/docs/rljf0226" ]

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{ "match_score": 0.8750000156249981, "matched_text": "05-11-0 ", "start": 220, "text": "05-11-01" }

{ "de": "Wie lautet die Patientennummer?", "en": "What is the patient number?", "es": "¿Cuál es el número de paciente?", "fr": "Quel est le numéro du patient?", "it": "Qual è il numero del paziente?" }

[ "014" ]

[ "04/05/2004", "11:05", "22434/2084", "12:0", "49-931-20136759", "NORL", "*", "9004993123136283", "DIABETESAMBULANZ", "S.", "02/03", "NO.", "938", "PROactive", "Urgent", "Data", "Enquiry", "Form", "Centre", "number", "Patient", "number", "Patient", "initials", "Date", "of", "randomisation", "49012", "014", "05-11-0", ".Reference", "Date", "issue", "35037-hrt-11", "92-04-04", "Date", "resolved", "Alert", "Report", "Booklet", "A15778", "(page", "001)", "...-06.", "Benton", "turnor", "of", "the", "urinary", "ble", "ITEM", "07:", "Medical", "event", "(diagnosis)", "For", "all", "serlove", "episodes", "of", "Bladder", "cancer,", "Takeda", "Drug", "Safety", "require", "additional", "information", "and", "would", "appreci-", "ate", "At", "A", "you", "could", "complete", "the", "attached", "questionnaire", "and", "return", "it", "to", "is", "with", "this", "enquiry", "form", "signed", "and", "card", "as", "soon", "as", "possible.", "Reply:", "was", "no", "it", "was", "a", "benign", "turnor", "see", "the", "diagnosis", "of", "the", "afoot", "report", "Signature:", "C", "Beds", "Date:", "4/5/04", "Please", "write", "your", "reply", "in", "the", "space", "provided", "and", "ensure", "that", "the", "reply", "is", "signed", "as", "this", "sheet", "will", "become", "part", "of", "the", "patient's", "record", "form.", "Once", "completed,", "please", "fax", "the", "form", "back", "to", "the", "Study", "Coordinating", "Centre", "(++", "44", "115", "956", "77", "22)", "and", "retain", "the", "original", "In", "the", "patient's", "Case", "Report", "Form.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-00456053", "Produced", "in", "MDL", "on", "09/12/12", "Source:", "https://www.indupoo26-ooocats.ucsf.edu/docs/rljf0226" ]

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{ "match_score": 1, "matched_text": "014", "start": 216, "text": "014" }

{ "de": "Was ist die Überschrift des Tisches?", "en": "What is the heading of the table?", "es": "¿Cuál es el título de la mesa?", "fr": "Quel est le titre de la table?", "it": "Qual è la direzione del tavolo?" }

[ "Weight Changes (kg) from Baseline during Double-Blind Clinical Trials with ACTOS" ]

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{ "match_score": 1, "matched_text": "Weight Changes (kg) from Baseline during Double-Blind Clinical Trials with ACTOS", "start": 1170, "text": "Weight Changes (kg) from Baseline during Double-Blind Clinical Trials with ACTOS" }

{ "de": "Wie hoch ist die Gesamtzahl der Drogenansprüche unter dem Titel \"Zusammenfassung des Streitrisikos in den Hoheitsgebieten\"?", "en": "what is the total number of drug claims under the title of \"summary of litigation risk in the ous territories\"?", "es": "¿cuál es el número total de reclamaciones de drogas bajo el título de \"resumen del riesgo de litigio en los territorios\"?", "fr": "Quel est le nombre total de demandes de remboursement de médicaments sous le titre de «résumé du risque de litige dans les territoires concernés»?", "it": "Qual è il numero totale di richieste di droga sotto il titolo di \"sommario del rischio di contenzioso nei territori\"?" }

[ "5" ]

[ "Most", "Significant", "Adverse", "Events", "Risks", "for", "Pioglitazone", "Risk", "Onset", "Reversibility", "Clinical", "Findings", "Occurrence", "of", "ALT", "Elevation", "Within", "2", "months", "Only", "through", "Drug", "Placebo", "Liver", "Failure", "Transplant", "Rezulln", "1.1", "70", "0.120.", "ACTOS", "0.26%", "0.25%", "Avandia", "0.20%", "0.20%", "Cardiac", "Hypertrophy", "Unknown", "Unknown", "Observed", "during", "Preclinical", "Studies", "in", "Rats", ".", "No", "cases", "in", "Humans", "Unknown", "Unknown", "Observed", "during", "Bladder", "Cancer", "Preclinical", "Studies", "in", "Rats", ".", "No", "cases", "in", "Humans", "Edema", "Within", "Yes", "Occurrence", "of", "Edema", "12", "months", "Drug", "Placebo", "ACTOS", "15.3%", "7.0%", "Summary", "of", "Litigation", "Risk", "in", "the", "OUS", "Territories", "Out", "of", "10,359", "claims", "on", "the", "Litigation", "Support", "System", "database,", "only", "10", "claims", "have", "arose", "from", "the", "Territory", "in", "this", "Agreement", "Country", "All", "Claims", "Drug", "Claims", "Australia", "Saudi", "Arabia", "South", "Africa", "Spain", "Sweden", "Total", "U", "-", "OO", "-", "W", "4", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002626", "Source:", "https://www.indup5350", "0oo04ts.ucsf.edu/docs/trjf0226" ]

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{ "match_score": 1, "matched_text": "5", "start": 230, "text": "5" }

{ "de": "Wie hoch ist die Anzahl der Patienten?", "en": "What is the number of patients ?", "es": "¿Cuál es el número de pacientes?", "fr": "Quel est le nombre de patients?", "it": "Qual è il numero di pazienti?" }

[ "5,000" ]

[ "PROactive", "Objective:", "Demonstrate", "that", "pioglitazone", "reduces", "total", "mortality", "and", "macrovascular", "morbidity", "in", "high-risk", "patients", "with", "type", "2", "diabetes", "mellitus", "Number", "of", "patients:", "5,000", "Countries:", "Austria,", "Belgium,", "Czech", "Republic,", "Denmark,", "Estonia,", "Finland,", "France,", "Germany,", "Hungary,", "Italy,", "Latvia,", "Lithuania,", "Netherlands,", "Norway,", "Poland,", "Sweden,", "Switzerland,", "UK", "FPV:", "June", "2001", "LPV:", "Q2", "2005", "Primary", "Endpoints:", "All-cause", "mortality,", "non-fatal", "MI,", "acute", "coronary", "syndrome,", "cardiac", "intervention,", "stroke,", "major", "leg", "amputation,", "bypass", "surgery,", "or", "revascularisation", "in", "the", "leg", "Secondary", "Endpoints:", "Cardiovascular", "mortality", "9/18/2013", "Company", "Confidential", "Copyright", "@", "2000", "Eli", "Lilly", "and", "Company", "PLA-TAK-00053926", "Source:", "https://www.indup634orooorts.ucsf.edu/docs/fzjf0226" ]

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{ "match_score": 1, "matched_text": "5,000", "start": 175, "text": "5,000" }

{ "de": "Wie lautet das erwähnte Datum?", "en": "What is the date mentioned?", "es": "¿Cuál es la fecha mencionada?", "fr": "Quelle est la date mentionnée?", "it": "Qual è la data indicata?" }

[ "August 12-13, 2002" ]

[ "TPNA/TEUR&D/TCI", "ACTOS", "RESPONSE", "MEETING", "August", "12-13,", "2002", "TAK-THOMCL-00017303", "Produced", "in", "MDL", "on", "09/14/12", "Action", "Item", "List/Document", "Timelines", "Item", "Person", "Responsible", "Create", "table", "summarizing", "medium", "term", "toxicology", "studies", "|", "Nonoyama", "Historical", "data", "on", "incidence", "of", "bladder", "hyperplasia", "in", "Toxicology", "mouse", "Exposure", "Toxicology", "|Mouse", "versus", "rat", "Male", "rat", "versus", "female", "rat", "Get", "literature", "on", "transient", "nature", "of", "stones", "in", "rat", "Michael", "Elisseou", "will", "ask", "Sam", "Cohen", "Add", "troglitazone", "to", "PPAR", "activation", "table", "Dr.", "Odaka", "In", "carcinogenecity", "studies,", "did", "rosiglitazone", "exposure", "lead", "|", "Through", "FOI,", "to", "PPAR", "alpha", "activation", "Max", "Run", "NN622", "through", "liver", "homogenetic/GCMS/identify", "TCI", "will", "conduct", "metabolites/SAR", "assay", "Literature", "to", "support", "role", "of", "urinary", "ph", "and", "microcrystals", "Michael", "Elisseou", "will", "in", "promoter", "model", "Fuckishim", "ask", "Sam", "Cohen", "Summary", "of", "US/EU", "bladder", "cancer", "for", "NDA/MAA", "Glyn", "Belcher", "Add", "renal", "colic", "to", "clinical", "AE", "search", "Bob", "Ahlbrandt", "will", "send", "to", "John", "Search", "POR", "for", "label", "wording", "based", "on", "results", "from", "tumor", "Janet", "Haskins", "model", "study", "and", "for", "class", "tox", "label", "wording", "Send", "non-serious", "bladder", "cancer", "AE", "to", "John", "Page", "Glyn", "Belcher", "Confidential", "-", "Subject", "to", "Protective", "Order", "Source:", "https://www.induporky-oocops.ucsf.edu/docs/mnjf0226" ]

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{ "match_score": 1, "matched_text": "August 12-13, 2002", "start": 39, "text": "August 12-13, 2002" }

{ "de": "Wie lautet das in der Form angegebene Datum?", "en": "what is the date issued mentioned in the form ?", "es": "¿Cuál es la fecha de emisión mencionada en el formulario?", "fr": "Quelle est la date de délivrance mentionnée dans le formulaire?", "it": "qual è la data di rilascio indicata nel modulo?" }

[ "22-04-04" ]

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{ "match_score": 0.8750000156249981, "matched_text": "32-04-04", "start": 267, "text": "22-04-04" }

{ "de": "Was ist der Artikel, der den Verantwortlichen Bob Ahlbrandt an John schickt?", "en": "What is the Item that shows Person Responsible Bob Ahlbrandt will send to John?", "es": "¿Qué es el artículo que muestra a la persona responsable que Bob Ahlbrandt enviará a John?", "fr": "Quel est l'élément qui montre la personne responsable Bob Ahlbrandt enverra à John?", "it": "Qual è l'articolo che mostra la persona responsabile Bob Ahlbrandt invierà a John?" }

[ "Add renal colic to clinical AE search" ]

[ "TPNA/TEUR&D/TCI", "ACTOS", "RESPONSE", "MEETING", "August", "12-13,", "2002", "TAK-THOMCL-00017303", "Produced", "in", "MDL", "on", "09/14/12", "Action", "Item", "List/Document", "Timelines", "Item", "Person", "Responsible", "Create", "table", "summarizing", "medium", "term", "toxicology", "studies", "|", "Nonoyama", "Historical", "data", "on", "incidence", "of", "bladder", "hyperplasia", "in", "Toxicology", "mouse", "Exposure", "Toxicology", "|Mouse", "versus", "rat", "Male", "rat", "versus", "female", "rat", "Get", "literature", "on", "transient", "nature", "of", "stones", "in", "rat", "Michael", "Elisseou", "will", "ask", "Sam", "Cohen", "Add", "troglitazone", "to", "PPAR", "activation", "table", "Dr.", "Odaka", "In", "carcinogenecity", "studies,", "did", "rosiglitazone", "exposure", "lead", "|", "Through", "FOI,", "to", "PPAR", "alpha", "activation", "Max", "Run", "NN622", "through", "liver", "homogenetic/GCMS/identify", "TCI", "will", "conduct", "metabolites/SAR", "assay", "Literature", "to", "support", "role", "of", "urinary", "ph", "and", "microcrystals", "Michael", "Elisseou", "will", "in", "promoter", "model", "Fuckishim", "ask", "Sam", "Cohen", "Summary", "of", "US/EU", "bladder", "cancer", "for", "NDA/MAA", "Glyn", "Belcher", "Add", "renal", "colic", "to", "clinical", "AE", "search", "Bob", "Ahlbrandt", "will", "send", "to", "John", "Search", "POR", "for", "label", "wording", "based", "on", "results", "from", "tumor", "Janet", "Haskins", "model", "study", "and", "for", "class", "tox", "label", "wording", "Send", "non-serious", "bladder", "cancer", "AE", "to", "John", "Page", "Glyn", "Belcher", "Confidential", "-", "Subject", "to", "Protective", "Order", "Source:", "https://www.induporky-oocops.ucsf.edu/docs/mnjf0226" ]

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{ "match_score": 1, "matched_text": "Add renal colic to clinical AE search", "start": 883, "text": "Add renal colic to clinical AE search" }

{ "de": "Wie lautet die Überschrift des Dokuments?", "en": "What is the heading of the document?", "es": "¿Cuál es el título del documento?", "fr": "Quel est le titre du document?", "it": "Qual è il titolo del documento?" }

[ "TPNA/TEUR&D/TCI ACTOS RESPONSE MEETING" ]

[ "TPNA/TEUR&D/TCI", "ACTOS", "RESPONSE", "MEETING", "August", "12-13,", "2002", "TAK-THOMCL-00017303", "Produced", "in", "MDL", "on", "09/14/12", "Action", "Item", "List/Document", "Timelines", "Item", "Person", "Responsible", "Create", "table", "summarizing", "medium", "term", "toxicology", "studies", "|", "Nonoyama", "Historical", "data", "on", "incidence", "of", "bladder", "hyperplasia", "in", "Toxicology", "mouse", "Exposure", "Toxicology", "|Mouse", "versus", "rat", "Male", "rat", "versus", "female", "rat", "Get", "literature", "on", "transient", "nature", "of", "stones", "in", "rat", "Michael", "Elisseou", "will", "ask", "Sam", "Cohen", "Add", "troglitazone", "to", "PPAR", "activation", "table", "Dr.", "Odaka", "In", "carcinogenecity", "studies,", "did", "rosiglitazone", "exposure", "lead", "|", "Through", "FOI,", "to", "PPAR", "alpha", "activation", "Max", "Run", "NN622", "through", "liver", "homogenetic/GCMS/identify", "TCI", "will", "conduct", "metabolites/SAR", "assay", "Literature", "to", "support", "role", "of", "urinary", "ph", "and", "microcrystals", "Michael", "Elisseou", "will", "in", "promoter", "model", "Fuckishim", "ask", "Sam", "Cohen", "Summary", "of", "US/EU", "bladder", "cancer", "for", "NDA/MAA", "Glyn", "Belcher", "Add", "renal", "colic", "to", "clinical", "AE", "search", "Bob", "Ahlbrandt", "will", "send", "to", "John", "Search", "POR", "for", "label", "wording", "based", "on", "results", "from", "tumor", "Janet", "Haskins", "model", "study", "and", "for", "class", "tox", "label", "wording", "Send", "non-serious", "bladder", "cancer", "AE", "to", "John", "Page", "Glyn", "Belcher", "Confidential", "-", "Subject", "to", "Protective", "Order", "Source:", "https://www.induporky-oocops.ucsf.edu/docs/mnjf0226" ]

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{ "match_score": 1, "matched_text": "TPNA/TEUR&D/TCI ACTOS RESPONSE MEETING", "start": 0, "text": "TPNA/TEUR&D/TCI ACTOS RESPONSE MEETING" }

{ "de": "Was steht knapp unter dem Datum geschrieben?", "en": "What is written just below the date?", "es": "¿Qué está escrito justo debajo de la fecha?", "fr": "Qu'est-ce qui est écrit juste en dessous de la date?", "it": "Che cosa è scritto appena sotto la data?" }

[ "Action Item List/Document Timelines" ]

[ "TPNA/TEUR&D/TCI", "ACTOS", "RESPONSE", "MEETING", "August", "12-13,", "2002", "TAK-THOMCL-00017303", "Produced", "in", "MDL", "on", "09/14/12", "Action", "Item", "List/Document", "Timelines", "Item", "Person", "Responsible", "Create", "table", "summarizing", "medium", "term", "toxicology", "studies", "|", "Nonoyama", "Historical", "data", "on", "incidence", "of", "bladder", "hyperplasia", "in", "Toxicology", "mouse", "Exposure", "Toxicology", "|Mouse", "versus", "rat", "Male", "rat", "versus", "female", "rat", "Get", "literature", "on", "transient", "nature", "of", "stones", "in", "rat", "Michael", "Elisseou", "will", "ask", "Sam", "Cohen", "Add", "troglitazone", "to", "PPAR", "activation", "table", "Dr.", "Odaka", "In", "carcinogenecity", "studies,", "did", "rosiglitazone", "exposure", "lead", "|", "Through", "FOI,", "to", "PPAR", "alpha", "activation", "Max", "Run", "NN622", "through", "liver", "homogenetic/GCMS/identify", "TCI", "will", "conduct", "metabolites/SAR", "assay", "Literature", "to", "support", "role", "of", "urinary", "ph", "and", "microcrystals", "Michael", "Elisseou", "will", "in", "promoter", "model", "Fuckishim", "ask", "Sam", "Cohen", "Summary", "of", "US/EU", "bladder", "cancer", "for", "NDA/MAA", "Glyn", "Belcher", "Add", "renal", "colic", "to", "clinical", "AE", "search", "Bob", "Ahlbrandt", "will", "send", "to", "John", "Search", "POR", "for", "label", "wording", "based", "on", "results", "from", "tumor", "Janet", "Haskins", "model", "study", "and", "for", "class", "tox", "label", "wording", "Send", "non-serious", "bladder", "cancer", "AE", "to", "John", "Page", "Glyn", "Belcher", "Confidential", "-", "Subject", "to", "Protective", "Order", "Source:", "https://www.induporky-oocops.ucsf.edu/docs/mnjf0226" ]

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{ "match_score": 1, "matched_text": "Action Item List/Document Timelines", "start": 106, "text": "Action Item List/Document Timelines" }

{ "de": "Was ist die BOP-Nummer?", "en": "What is the BOP Number?", "es": "¿Qué es el número BOP?", "fr": "Qu'est-ce que le numéro BOP?", "it": "Che cos'è il numero BOP?" }

[ "CORP-B-019" ]

[ "EXHIBIT", "Takeda", "R", "-", "12", "Function", "Corporate", "Effective", "Date:", "CORP-B-019", "05/01/2006", "BOP", "Number;", "Supersedes:", "NA", "BOP", "Name:", "E-mail", "Management", "and", "Retention", "Name/", "Title", "Signature", "Date", "Originator", "Amolo", "D'Angelo,", "Associate", "General", "Counsel", "Signature", "on", "File", "1/21/06", "Approver", "Nancy", "Loeb,", "General", "Counsel", "Signature", "on", "File", "1/21/06", "Approver", "Jeanine", "Jiganti,", "VP.", "Chief", "Compliance", "Officer", "Signature", "on", "File", "1/21/06", "Approver", "Lee", "Voight,", "VP.", "Information", "Technology", "Signature", "on", "File", "4/27/06", "Approver", "Claire", "Thom,", "SVP,", "QA", "and", "Compliance", "Signature", "on", "File", "/25/06", "Approver", "John", "Yates,", "President,", "TGRD", "Signature", "on", "File", "4/24/06", "Approver", "Mark", "Booth,", "President,", "TPNA", "Signature", "on", "File", "4/21/06", "1.0", "Purpose", "The", "purpose", "of", "this", "Operating", "Procedure", "is", "to", "describe", "the", "requirements", "for", "personnel", "of", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.,", "Takeda", "Global", "Research", "and", "Development", "Center,", "Inc,", "and", "their", "U.S.", "subsidiaries", "(collectively", "Takeda)", "to", "fulfill", "our", "legal,", "financial,", "regulatory,", "and", "organizational", "obligations", "as", "they", "relate", "to", "E-Mail", "Management", "and", "Retention.", "2.0", "Scope", "2.1", "This", "BOP", "is", "applicable", "to", "all", "functional", "areas", "and", "all", "Takeda", "employees", "2.2", "This", "BOP", "is", "applicable", "to", "all", "Takeda", "corporate", "e-mail", "messages.", "2.3", "This", "BOP", "is", "not", "applicable", "to", "electronic", "records", "that", "are", "required", "to", "be", "maintained", "under", "records", "requirements", "set", "by", "the", "Food", "and", "Drug", "Administration,", "Electronic", "records", "required", "to", "be", "maintained", "under", "any", "FDA", "regulation", "shall", "be", "maintained", "in", "alternate", "systems", "provided", "by", "Takeda,", "and", "shall", "not", "be", "stored", "or", "maintained", "in", "the", "e-mail", "system", "in", "any", "folder", "other", "than", "a", "\"Reference\"", "folder.", "2.4", "This", "BOP", "does", "not", "apply", "to", "e-mail,", "e-mail", "messages,", "e-mail", "records,", "documents,", "materials", "information,", "or", "things", "that", "are", "hosted", "on", "any", "system", "that", "is", "not", "the", "Takeda", "e-mail", "system.", "3.0", "Responsibility", "3.", "1", "Takeda", "employees", "are", "responsible", "for", "management", "and", "retention", "of", "corporate", "e-mall", "records", "and", "the", "proper", "disposition", "of", "e-mail", "non-records.", "3.2", "Takeda", "functional", "managers", "are", "responsible", "for", "facilitating", "adherence", "to", "this", "Operating", "Procedure", "for", "all", "current", "employees", "and", "terminating", "employees.", "3.3", "The", "responsible", "party(ies)", "cited", "may", "delegate", "activities,", "but", "retains", "the", "responsibility", "for", "the", "outcome.", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "and", "Affiliates", "Page", "1", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00000083", "Source:", "https://www.indup", "23*", "sooooats.ucsf.edu/docs/gpjf0226" ]

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{ "match_score": 1, "matched_text": "CORP-B-019", "start": 57, "text": "CORP-B-019" }

{ "de": "Was ist das wirksame Datum?", "en": "What is the Effective Date?", "es": "¿Cuál es la fecha efectiva?", "fr": "Quelle est la date d'entrée en vigueur?", "it": "Qual è la data di entrata in vigore?" }

[ "05/01/2006" ]

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{ "match_score": 1, "matched_text": "05/01/2006", "start": 68, "text": "05/01/2006" }

{ "de": "Wie lautet die Überschrift des Dokuments?", "en": "What is the heading of the document?", "es": "¿Cuál es el título del documento?", "fr": "Quel est le titre du document?", "it": "Qual è il titolo del documento?" }

[ "TPNA/TEUR&D/TCI ACTOS RESPONSE MEETING" ]

[ "TPNA/TEUR&D/TCI", "ACTOS", "RESPONSE", "MEETING", "August", "12-13,", "2002", "FDA", "Response", "Outline", "LABEL", "CHANGE", "CLINICAL", "PEDIATRIC", "INDICATION", "Current", "label", "adequately", "reflects", "General", "epidemiology", "of", "bladder", "We", "believe", "that", "there", "is", "no", "Information", "that", "we", "have", "cancer", "Increased", "risk", "for", "bladder", "cancer", "Not", "genotoxic", "*", "Incidence", "associated", "with", "Actos", "Two", "year", "studies,", "one", "sex", "one", ">", "Latency", ".We", "would", "like", "to", "proceed", "with", "the", "species", ">", "Risk", "factors", "Actos", "508", "study", ">", "No", "data", "to", "correlate", "those", ">Observations", "with", "pic", ">", "Propose", "delay", "until", "resolved", "findings", "to", "man", ">", "Post-marketing", "surveillance", "No", "new", "date", "OCT020", ">", "Critique", "presumed", "promoter", "model", "Findings", "to", "be", "expected", ">", "Mkrocrystals", "known", "to", "increase", "tumors", "in", "those", "models", "appendly:", ">Any", "findings", "found", "require", "MONITORING", "Expert", "opinion", "confirmation", "with", "a", "2", "year", "Restate", "that", "there", "are", "no", "findings", "carcinogenicity", "study", "which", "suggest", "a", "need", "to", "monitor", "Unvalidated", "We", "have", "already", "presented", "in", "the", "NDA", "the", "standard", "of", "care", "(-001,", "-", ".", "Possible", ">", "Question", "definition", "of", "dual", "agonist", "Evidence", "in", "literature", "that", "pio", "011,", "-031),", "and", "no", "tumors", "were", "suppresses", "urothellal", "cells", "as", "well", "found", "as", "other", "cell", "types", "Talked", "to", "experts,", "evaluated", "Reinforce", "Cohen", "hypothesis", "existing", "methods", ">", "Reiterate", "that", "current", "label", "is", ">", "Latency", "adequate", ">", "Markers", "not", "approved", "We", "don't", "believe", "we", "should", "monitor", "We", "will", "watch", "current", "clinical", "trials", "carefully", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00017302", "Produced", "in", "MDL", "on", "09/14/12", "EXHIBIT", "2", "2", "Source:", "https://www.indupornoboots.ucsf.edu/docs/mnjf0226" ]

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{ "match_score": 1, "matched_text": "TPNA/TEUR&D/TCI ACTOS RESPONSE MEETING", "start": 0, "text": "TPNA/TEUR&D/TCI ACTOS RESPONSE MEETING" }

{ "de": "Wie lautet das erwähnte Datum?", "en": "What is the date mentioned?", "es": "¿Cuál es la fecha mencionada?", "fr": "Quelle est la date mentionnée?", "it": "Qual è la data indicata?" }

[ "August 12-13, 2002" ]

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{ "match_score": 1, "matched_text": "August 12-13, 2002", "start": 39, "text": "August 12-13, 2002" }

{ "de": "Welche Verfahren wird hier nicht beschrieben?", "en": "Which Procedures No is being decribed here?", "es": "¿Qué Procedimientos No se está describiendo aquí?", "fr": "Quelles procédures Non est décribée ici?", "it": "Quali procedure viene descritto qui?" }

[ "Procedures No. 19" ]

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{ "match_score": 1, "matched_text": "Procedures No. 19", "start": 86, "text": "Procedures No. 19" }

{ "de": "Wie viele gezielte primäre Pflegeärzte sind in diesen Sitzungen enthalten?", "en": "how many targeted primary care physicians are included in these meetings ?", "es": "¿Cuántos médicos de atención primaria están incluidos en estas reuniones?", "fr": "combien de médecins de soins primaires ciblés sont inclus dans ces réunions?", "it": "Quanti medici di assistenza primaria mirati sono inclusi in queste riunioni?" }

[ "350" ]

[ "Top-Line", "Summary", "Eight", "Regional", "Market", "Research", "Consultants", "Meetings", "were", "held", "in", "October", "and", "November", "2001.", "Each", "location", "featured", "the", "same", "program:", "1)", "A", "3-hour", "plenary", "session", "featuring", "speakers", "and", "Q&A;", "and", "2)", "90-minute", "breakout", "discussion", "sessions", "in", "which", "High", "Potential", "TZD", "users", "were", "separated", "from", "TZD", "Splitters.", "These", "meetings", "included", "350", "targeted", "primary", "care", "physicians-", "181", "High", "Potentials", "and", "169", "TZD", "Splitters.", "The", "presentations", "strengthened", "already-positive", "perceptions", "of", "TZDs.", "Participants", "in", "all", "groups", "agree", "that", "insulin", "resistance", "is", "the", "primary", "or", "foundational", "defect", "in", "Type", "2", "diabetes.", "Most", "believe", "intuitively", "that", "TZDs", "preserve", "beta", "cell", "function.", "If", "convinced", "by", "clinical", "data", "that", "TZDs", "do,", "in", "fact,", "preserve", "beta", "cells,", "many", "participants", "would", "feel", "compelled", "to", "use", "TZDs", "as", "1\"-line", "therapy.", "There", "is", "broad", "and", "substantial", "recognition", "of", "the", "relationship", "of", "diabetic", "dyslipidemia", "and", "cardiovascular", "disease.", "TZDs", "are", "currently", "perceived", "to", "be", "better", "than", "other", "OADs", "on", "most", "concepts", "related", "to", "IR", "and", "vascular", "health.", "Most", "believe", "that", "TZDs", "have", "the", "best", "potential", "for", "a", "positive", "cardiovascular", "profile.", "Participants", "accept", "ACTOS", "as", "an", "effective", "and", "liver-safe", "agent.", "ACTOS", "is", "currently", "perceived", "to", "be", "better", "than", "or", "equal", "to", "Avandia", "on", "all", "key", "attributes,", "including", "lipid", "effects.", "While", "participants", "accept", "the", "head-to-head", "lipid", "studies", "as", "validly-", "conducted", "research", "(with", "some", "reservations),", "most", "are", "reluctant", "to", "attach", "a", "great", "deal", "of", "clinical", "value", "to", "the", "data.", "Head-to-head", "data", "from", "clinical", "studies", "(TZDs", "vs.", "other", "OADs,", "AND", "ACTOS", "vs.", "Avandia)", "is", "needed", "to", "significantly", "alter", "prescribing", "habits.", "Splitters", "and", "High", "Potentials", "responded", "similarly", "with", "regard", "to", "most", "of", "the", "observed", "core", "issues,", "although", "Splitters", "are", "clearly", "more", "likely", "than", "High", "Potentials", "to", "use", "TZDs", "as", "first-line", "therapy.", "All", "groups", "believe", "that", "ACTOS", "can", "be", "shown", "to", "be", "valid", "foundation", "therapy,", "assuming", "the", "accumulation", "of", "clinical", "outcomes", "data.", "Metformin", "is", "an", "effective", "and", "trusted", "agent.", "Doctors", "caution", "against", "fighting", "against", "it", "-", "instead,", "promote", "combo", "use", "with", "metformin.", "The", "most", "commonly", "mentioned", "reasons", "NOT", "to", "prescribe", "TZDs", "are", "1)", "Cost,", "2)", "Edema/weight", "gain,", "and", "3)", "Reimbursement.", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-DALYRI-00058798", "Produced", "in", "MDL", "on", "09/17/12", "Source:", "https://www.induptygacoo093ts.ucsf.edu/docs/rnjf0226" ]

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{ "match_score": 1, "matched_text": "350", "start": 345, "text": "350" }

{ "de": "Worum geht es in diesem Dokument bei Artikel 4?", "en": "What is Article 4 in this document referred to?", "es": "¿A qué se refiere el artículo 4 en este documento?", "fr": "Qu'est-ce que l'article 4 du présent document?", "it": "A che cosa si riferisce l'articolo 4 del presente documento?" }

[ "Disposal Record Ledger" ]

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{ "match_score": 1, "matched_text": "Disposal Record Ledger", "start": 1801, "text": "Disposal Record Ledger" }

{ "de": "In welchem Monat und Jahr fanden acht Sitzungen regionaler Marktforschungsberater statt?", "en": "in which month and year eight regional market research consultants meetings were held ?", "es": "¿En qué mes y año se celebraron ocho reuniones regionales de consultores de investigación de mercado?", "fr": "Au cours de quel mois et de l'année huit réunions régionales de consultants en études de marché ont-elles eu lieu?", "it": "In quale mese e in quale anno si sono svolte otto riunioni di consulenti regionali di ricerca di mercato?" }

[ "October and November 2001", "october and november 2001" ]

[ "Top-Line", "Summary", "Eight", "Regional", "Market", "Research", "Consultants", "Meetings", "were", "held", "in", "October", "and", "November", "2001.", "Each", "location", "featured", "the", "same", "program:", "1)", "A", "3-hour", "plenary", "session", "featuring", "speakers", "and", "Q&A;", "and", "2)", "90-minute", "breakout", "discussion", "sessions", "in", "which", "High", "Potential", "TZD", "users", "were", "separated", "from", "TZD", "Splitters.", "These", "meetings", "included", "350", "targeted", "primary", "care", "physicians-", "181", "High", "Potentials", "and", "169", "TZD", "Splitters.", "The", "presentations", "strengthened", "already-positive", "perceptions", "of", "TZDs.", "Participants", "in", "all", "groups", "agree", "that", "insulin", "resistance", "is", "the", "primary", "or", "foundational", "defect", "in", "Type", "2", "diabetes.", "Most", "believe", "intuitively", "that", "TZDs", "preserve", "beta", "cell", "function.", "If", "convinced", "by", "clinical", "data", "that", "TZDs", "do,", "in", "fact,", "preserve", "beta", "cells,", "many", "participants", "would", "feel", "compelled", "to", "use", "TZDs", "as", "1\"-line", "therapy.", "There", "is", "broad", "and", "substantial", "recognition", "of", "the", "relationship", "of", "diabetic", "dyslipidemia", "and", "cardiovascular", "disease.", "TZDs", "are", "currently", "perceived", "to", "be", "better", "than", "other", "OADs", "on", "most", "concepts", "related", "to", "IR", "and", "vascular", "health.", "Most", "believe", "that", "TZDs", "have", "the", "best", "potential", "for", "a", "positive", "cardiovascular", "profile.", "Participants", "accept", "ACTOS", "as", "an", "effective", "and", "liver-safe", "agent.", "ACTOS", "is", "currently", "perceived", "to", "be", "better", "than", "or", "equal", "to", "Avandia", "on", "all", "key", "attributes,", "including", "lipid", "effects.", "While", "participants", "accept", "the", "head-to-head", "lipid", "studies", "as", "validly-", "conducted", "research", "(with", "some", "reservations),", "most", "are", "reluctant", "to", "attach", "a", "great", "deal", "of", "clinical", "value", "to", "the", "data.", "Head-to-head", "data", "from", "clinical", "studies", "(TZDs", "vs.", "other", "OADs,", "AND", "ACTOS", "vs.", "Avandia)", "is", "needed", "to", "significantly", "alter", "prescribing", "habits.", "Splitters", "and", "High", "Potentials", "responded", "similarly", "with", "regard", "to", "most", "of", "the", "observed", "core", "issues,", "although", "Splitters", "are", "clearly", "more", "likely", "than", "High", "Potentials", "to", "use", "TZDs", "as", "first-line", "therapy.", "All", "groups", "believe", "that", "ACTOS", "can", "be", "shown", "to", "be", "valid", "foundation", "therapy,", "assuming", "the", "accumulation", "of", "clinical", "outcomes", "data.", "Metformin", "is", "an", "effective", "and", "trusted", "agent.", "Doctors", "caution", "against", "fighting", "against", "it", "-", "instead,", "promote", "combo", "use", "with", "metformin.", "The", "most", "commonly", "mentioned", "reasons", "NOT", "to", "prescribe", "TZDs", "are", "1)", "Cost,", "2)", "Edema/weight", "gain,", "and", "3)", "Reimbursement.", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-DALYRI-00058798", "Produced", "in", "MDL", "on", "09/17/12", "Source:", "https://www.induptygacoo093ts.ucsf.edu/docs/rnjf0226" ]

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{ "match_score": 1, "matched_text": "October and November 2001", "start": 82, "text": "October and November 2001" }

{ "de": "In welchem Artikel werden Personen beschrieben, die für die Vorratshaltung verantwortlich sind?", "en": "In which Article, Persons In Charge of Retention is described?", "es": "¿En qué artículo se describe a las personas a cargo de la retención?", "fr": "Dans quel article les personnes chargées de la rétention sont-elles décrites?", "it": "In quale articolo sono descritte le persone incaricate della detenzione?" }

[ "Article 2" ]

[ "Translation", "of", "TAKJ-TPC-00000431", "Procedures", "Regarding", "Document", "Control", "Research.", "Div.", "Procedures", "No.", "19", "Article", "1", "(Purpose)", "These", "procedures", "make", "stipulations", "about", "the", "retention", "and", "disposal", "of", "documents", "that", "the", "Pharmaceutical", "Research", "Division", "(hereinafter", "referred", "to", "as", "\"this", "Division\")", "handles", "and", "other", "handling", "details,", "based", "on", "the", "Policy", "on", "Document", "Control", "(Policy", "#8)", "(hereinafter", "referred", "to", "as", "\"the", "Policy\").", "Article", "2", "(Persons", "In", "Charge", "of", "Retention)", "The", "Persons", "In", "Charge", "of", "Retention", "in", "Article", "3", "of", "the", "Policy", "within", "this", "Division", "shall", "be", "as", "it", "is", "below", "for", "work", "subdivision", "units.", "Existing", "Location", "of", "Work", "Subdivision", "Unit", "Person", "In", "Charge", "of", "Retention", "Pharmaceutical", "Research", "Division", "(Shonan", "Region)", "|", "Senior", "Manager", "of", "Research", "Work", "Article", "3", "(Retention)", "For", "the", "retention", "format", "of", "documents", "this", "Division", "retains,", "we", "shall", "retain", "them", "in", "the", "format", "of", "the", "document", "(for", "electromagnetic", "records,", "after", "printing).", "However,", "whenever", "necessary", "in", "work", "duties,", "they", "can", "be", "retained", "in", "electromagnetic", "records.", "Further,", "if", "having", "received", "a", "request", "stipulated", "in", "Article", "12", "Section", "1", "of", "the", "Policy,", "the", "Person", "In", "Charge", "of", "Retention", "shall", "immediately", "take", "necessary", "measures.", "For", "documents", "this", "Division", "retains,", "we", "shall", "have", "it", "made", "at", "each", "control", "unit", "in", "accordance", "with", "the", "format", "of", "Attachment", "1,", "and", "shall", "stipulate", "the", "retention", "time", "period", "and", "retention", "location", "by", "specific", "type", "of", "such", "document.", "Further,", "regardless", "of", "the", "retention", "time", "period", "that", "has", "been", "stipulated,", "when", "it", "is", "recognized", "to", "be", "necessary", "in", "work", "duties,", "based", "on", "the", "determination", "of", "the", "Person", "Responsible", "for", "Retention", "(the", "Head", "of", "the", "Pharmaceutical", "Research", "Division),", "for", "a", "portion", "of", "the", "retained", "documents.", "the", "retention", "can", "be", "continued", "by", "stipulating", "an", "extended", "period", "of", "time.", "Article", "4", "(Disposal", "Record", "Ledger)", "The", "Person", "Responsible", "of", "each", "control", "unit,", "for", "retained", "documents", "it", "keeps,", "shall", "create", "a", "Disposal", "Record", "Ledger", "in", "accordance", "with", "the", "form", "of", "Attachment", "2.", ")", "When", "the", "members", "affiliated", "in", "this", "Division", "dispose", "of", "documents", "for", "which", "the", "retention", "period", "has", "elapsed.", "they", "shall", "carry", "it", "out", "obtaining", "the", "approval", "of", "the", "Person", "Responsible", "of", "each", "control", "unit,", "and", "when", "disposed", "of,", "shall", "enter", "it", "that", "into", "the", "Disposal", "Record", "Ledger.", "3)", "The", "Person", "Responsible", "of", "each", "control", "unit", "shall", "properly", "control", "the", "Disposal", "Record", "Ledger,", "and", "the", "Persons", "In", "Charge", "of", "Retention", "shall", "inspect", "them", "after", "having", "periodically", "gathered", "each", "Disposal", "Record", "Ledger", "within", "this", "Division,", "and", "when", "necessary", "shall", "report", "those", "results", "to", "the", "Person", "Responsible", "for", "Retention.", "Article", "5", "(Items", "to", "Confirm", "At", "the", "Time", "of", "Retained", "Document", "Disposal)", "EXHIBIT", "$762823", "v2", "5402825", "v2", "PENGAD", "200-631-5989", "Confidential", ",", "Briniant", "in", "Dratentina", "Andar", "TAK_DiManhe.nonnon??", "Source:", "https://www.indupt2377coooats.ucsf.edu/docs/xpjf0226" ]

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{ "match_score": 1, "matched_text": "Article 2", "start": 423, "text": "Article 2" }

{ "de": "Was sind die Herausforderungen von ACTOS-positiven Daten?", "en": "what are the challenges of ACTOS positive data?", "es": "¿Cuáles son los desafíos de los datos positivos de ACTOS?", "fr": "Quels sont les défis des données positives d'ACTOS?", "it": "Quali sono le sfide dei dati positivi dell'ACTOS?" }

[ "small numbers in the studies, non-randomized, company-sponsored." ]

[ "There", "is", "generally", "broad", "acceptance", "of", "the", "lipid", "distinctions", "between", "ACTOS", "and", "Avandia,", "Participants", "are", "seeking", "clinical", "endpoint", "data", "comparing", "ACTOS", "to", "Avandia.", "There", "is", "broad", "general", "acceptance", "of", "the", "lipid", "distinctions", "between", "ACTOS", "and", "Avandia,", "although", "some", "groups", "thought", "the", "presentation", "might", "have", "been", "slanted", "toward", "ACTOS-positive", "data.", "Overall,", "there", "were", "few", "challenges", "to", "the", "data", "as", "presented.", "Challenges", "included:", "small", "numbers", "in", "the", "studies,", "non-randomized,", "company-", "sponsored.", "While", "participants", "accept", "the", "head-to-head", "lipid", "studies", "as", "validly", "conducted", "research", "(with", "the", "caveats", "mentioned", "above),", "they", "are", "reluctant", "to", "attach", "a", "great", "deal", "of", "clinical", "value", "to", "the", "data.", "Most", "are", "not", "willing", "to", "base", "their", "decision", "of", "ACTOS", "or", "Avandia", "on", "these", "data.", ".", "In", "certain", "cities", "a", "slide", "was", "presented", "showing", "differences", "in", "PPAR-alpha", "activation", "by", "ACTOS", "and", "Avandia.", "This", "data", "provided", "an", "important", "\"hook\"", "for", "participants", "that", "helped", "them", "accept", "the", "lipid", "effect", "differences.", "Multiple", "groups", "noted", "that", "standard", "territory", "reps", "may", "not", "be", "trusted", "to", "present", "and", "discuss", "detailed", "information", "on", "PPAR", "activation.", "There", "is", "a", "real", "desire", "for", "clinical", "endpoint", "data", "that", "compares", "CVD", "endpoints", "of", "ACTOS", "vs.", "Avandia.", "In", "lieu", "of", "those", "clinical", "endpoint", "data,", "surrogates", "would", "include", "those", "listed", "in", "the", "previous", "section.", "D.", "Reaction", "to", "ACTOS", "Foundation", "Therapy", "Strategy", "All", "groups", "believe", "ACTOS", "can", "eventually", "capture", "the", "position", "of", "\"Foundation", "Therapy\"", "Participants", "caution", "against", "promoting", "against", "metformin.", "Instead,", "promote", "combination", "therapy.", "All", "groups", "believe", "that", "ACTOS", "can", "be", "shown", "to", "be", "valid", "foundation", "therapy,", "with", "clinical", "outcomes", "data", "Alternative", "terms", "include:", "core", "therapy;", "cornerstone", "therapy;", "first-line.", ".", "Several", "impediments", "to", "broad", "first-line", "use", "were", "mentioned:", "edema,", "cost,", "reimbursement,", "potential", "liver", "toxicity.", "Several", "groups", "noted", "the", "need", "for", "patient", "education", "efforts,", "although", "specific", "programs", "were", "not", "defined.", "10", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-DALYRI-00058806", "Produced", "in", "MDL", "on", "09/17/12", "Source:", "https://www.industrygacoooquits.ucsf.edu/docs/rnjf0226" ]

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