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Safety update on dapagliflozin (DAPA) across the phase 2b/3 clinical trial program

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1/3/2017 cOASIS, The Online Abstract Submission System http://www.abstractsonline.com/cSubmit/SubmitPrinterFriendlyVersion.asp?ControlKey=%7B26BE13D1%2DEDF6%2D46A3%2D9149%2D4AA354BEC… 1/3 Přįňț țħįș Pǻģě fǿř Ỳǿųř Řěčǿřđș Čŀǿșě Ẅįňđǿẅ Čǿňțřǿŀ/Țřǻčķįňģ Ňųmběř: 2017-Ǻ-4681-Đįǻběțěș Ǻčțįvįțỳ: Ǻbșțřǻčț Čųřřěňț Đǻțě/Țįmě: 1/3/2017 11:12:10 ǺM Șǻfěțỳ Ųpđǻțě ǿň Đǻpǻģŀįfŀǿżįň (ĐǺPǺ) Ǻčřǿșș țħě Pħǻșě 2b/3 Čŀįňįčǻŀ Țřįǻŀ Přǿģřǻm Ǻųțħǿř Bŀǿčķ: ȘĚŘĢĚ Ǻ. JǺBBǾŲŘ, JǾČĦĚŇ ȘĚŲFĚŘȚ, ǺŇĐŘÉ J. ȘČĦĚĚŇ, ČĿİFFǾŘĐ J. BǺİĿĚỲ, ČǺȚĦŘİŇǺ ĶǺŘŲP, ǺŇŇǺ MǺŘİǺ ĿǺŇĢĶİĿĐĚ, Pħįŀǻđěŀpħįǻ, PǺ, Fřěįbųřģ, Ģěřmǻňỳ, Ŀįèģě, Běŀģįųm, Bįřmįňģħǻm, Ųňįțěđ Ķįňģđǿm, Möŀňđǻŀ, Șẅěđěň Ǻbșțřǻčț: Șǻfěțỳ/țǿŀěřǻbįŀįțỳ ǿf șǿđįųm-ģŀųčǿșě čǿțřǻňșpǿřțěř-2 įňħįbįțǿřș (ȘĢĿȚ2į) ǻřě ǿf įňțěřěșț. ĐǺPǺ įș ǻ ħįģħŀỳ șěŀěčțįvě ȘĢĿȚ2į fǿř țħě țřěǻțměňț ǿf țỳpě 2 đįǻběțěș. Đǻțǻ ẅěřě pǿǿŀěđ fřǿm 13 pŀǻčěbǿ (PBǾ)-čǿňțřǿŀŀěđ țřįǻŀș (Țǻbŀě). Țǿ đěțěčț řǻřě ǻđvěřșě ěvěňțș (ǺĚș), ŀǻřģěř PBǾ/čǿmpǻřǻțǿř-čǿňțřǿŀŀěđ pǿǿŀș ǿf 21 țřįǻŀș (≤208 ẅěěķ [ẅķ]; ĐǺPǺ, ň=5936; Čǿňțřǿŀ, ň=3403) ǻňđ 30 țřįǻŀș (≥12 ẅķ; ĐǺPǺ, ň=9195; Čǿňțřǿŀ, ň=4629) ǻșșěșșěđ đįǻběțįč ķěțǿǻčįđǿșįș (ĐĶǺ) ǻňđ ŀǿẅěř-ŀįmb ǻmpųțǻțįǿňș, řěșpěčțįvěŀỳ. Ǿvěř 24 ẅķș, ǺĚ ǻňđ șěřįǿųș ǺĚ řǻțěș ẅěřě șįmįŀǻř fǿř ĐǺPǺ vș PBǾ; 60 vș 56% ǻňđ 5 vș 5%, řěșpěčțįvěŀỳ. Řǻțěș ǿf ħỳpǿģŀỳčěmįǻ, vǿŀųmě đěpŀěțįǿň ǺĚș ǻňđ ųřįňǻřỳ țřǻčț įňfěčțįǿň ẅěřě bǻŀǻňčěđ běțẅěěň ģřǿųpș (Țǻbŀě). Ģěňįțǻŀ įňfěčțįǿňș ẅěřě mǿřě fřěqųěňț ẅįțħ ĐǺPǺ vș PBǾ (6 vș 1%), fřǻčțųřěș ẅěřě bǻŀǻňčěđ běțẅěěň ģřǿųpș (0.3 vș 0.7%) ǻňđ řěňǻŀ fųňčțįǿň ǺĚș ǿččųřřěđ įň 3 vș 2% ǿf pǻțįěňțș (mǿșț čǿmmǿň ẅǻș đěčřěǻșěđ čřěǻțįňįňě čŀěǻřǻňčě; 1.1 vș 0.7%). İň țħě 21-șțųđỳ pǿǿŀ, 1 șěřįǿųș ěvěňț ǿf ĐĶǺ ǻňđ 3 ěvěňțș ǿf ķěțǿňųřįǻ/měțǻbǿŀįč ǻčįđǿșįș ǿččųřřěđ ẅįțħ ĐǺPǺ; ěșțįmǻțěđ įňčįđěňčě fǿř ǻňỳ ǿf țħěșě ěvěňțș ẅǻș 0.03 (95% Čİ: 0.010, 0.089). İň țħě 30-șțųđỳ pǿǿŀ, ŀǿẅěř-ŀįmb ǻmpųțǻțįǿň ǿččųřřěđ įň 8 (0.1%) ĐǺPǺ vș 7 (0.2%) Čǿňțřǿŀ pǻțįěňțș. İň șųmmǻřỳ, ĐǺPǺ ẅǻș ẅěŀŀ țǿŀěřǻțěđ ǻčřǿșș țħě čŀįňįčǻŀ țřįǻŀ přǿģřǻm. ǺĚ řǻțěș ẅěřě ģěňěřǻŀŀỳ bǻŀǻňčěđ fǿř ĐǺPǺ vș PBǾ/Čǿňțřǿŀ, įňčŀųđįňģ șpěčįǻŀ įňțěřěșț ǺĚș șųčħ ǻș ħỳpǿģŀỳčěmįǻ, fřǻčțųřěș, ǻmpųțǻțįǿňș ǻňđ ĐĶǺ. Ǻđvěřșě ěvěňțș ǿf șpěčįǻŀ įňțěřěșț įň țħě đǻpǻģŀįfŀǿżįň Pħǻșě 2b/3 čŀįňįčǻŀ țřįǻŀ přǿģřǻm PBǾ/čǿmpǻřǻțǿř-čǿňțřǿŀŀěđ 30-șțųđỳ pǿǿŀ PBǾ/čǿmpǻřǻțǿř-čǿňțřǿŀŀěđ 21-șțųđỳ pǿǿŀ Ǻmpųțǻțįǿň ĐǺPǺțǿțǻŀ (Ň=9195) Čǿňțřǿŀ (Ň=4629) ĐĶǺ ĐǺPǺțǿțǻŀ (Ň=5936) Čǿňțřǿŀ (Ň=3403) Pțș ẅįțħ ŀǿẅěř-ŀįmb ǻmpųțǻțįǿň, ň (%) 8 (0.1) 7 (0.2) ȘǺĚ ǿf ĐĶǺ, ň ǺĚ ķěțǿňųřįǻ, ň ǺĚ měțǻbǿŀįč ǻčįđǿșįș, ň İňčįđěňčě ĐĶǺ* % (95% Čİ) . İňčįđěňčě ĐĶǺ/měțǻbǿŀįč ǻčįđǿșįș*, % (95% Čİ) . 1 2 1 0.02 (0.004, 0.059) 0.03 (0.010, 0.089) 0 0 0 0 . . 0 . . Pǻțįěňțș ẅįțħ ěvěňțș, ň (%) ȘȚ PBǾ-čǿňțřǿŀŀěđ 13-șțųđỳ pǿǿŀ ĐǺPǺ 10 mģ (Ň=2360) 998 p-ỳ PBǾ (Ň=2295) 958 p-ỳ Fřǻčțųřěș 8 (0.3) 17 (0.7)

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1/3/2017 cOASIS, The Online Abstract Submission System http://www.abstractsonline.com/cSubmit/SubmitPrinterFriendlyVersion.asp?ControlKey=%7B26BE13D1%2DEDF6%2D46A3%2D9149%2D4AA354BEC… 2/3 Ǻměřįčǻň Đįǻběțěș Ǻșșǿčįǻțįǿň 2451 Čřỳșțǻŀ Đřįvě, Șųįțě 900 Ǻřŀįňģțǿň, VǺ 22202 Qųěșțįǿňș ǻbǿųț ǻbșțřǻčțș? Čǿňțǻčț țħě ǺĐǺ ǻț ǻbșțřǻčțș@đįǻběțěș.ǿřģ Fřǻčțųřěș Ħỳpǿģŀỳčěmįǻ Mǻjǿř ěvěňț ǺĚ → đįșčǿň. Řěňǻŀ fųňčțįǿň† Vǿŀųmě đěpŀěțįǿň§ ŲȚİ Fěmǻŀěș Ģěňįțǻŀ įňfěčțįǿň Fěmǻŀěș 8 (0.3) 324 (14) 3 (0.1) 1 (<0.1) 76 (3) 27 (1) 110 (5) 85 (4) 130 (6) 84 (4) 17 (0.7) 284 (12) 2 (0.1) 0 42 (2) 17 (1) 81 (4) 64 (3) 14 (1) 11 (<1) Ǻđvěřșě ěvěňțș ǻřě bǻșěđ ǿň ǻ přěđěfįňěđ ŀįșț ǿf přěfěřřěđ țěřmș; İňčŀųđěș đǻțǻ ǻfțěř řěșčųě; *Ěșțįmǻțěđ įňčįđěňčě; †İňčŀųđěș řěňǻŀ fǻįŀųřě ǿř įmpǻįřměňț, čřěǻțįňįňě řěňǻŀ čŀěǻřǻňčě đěčřěǻșěđ/įňčřěǻșěđ/ǻbňǿřmǻŀ, bŀǿǿđ čřěǻțįňįňě įňčřěǻșěđ/đěčřěǻșěđ, ģŀǿměřųŀǻř fįŀțřǻțįǿň řǻțě đěčřěǻșěđ/įňčřěǻșěđ/ǻbňǿřmǻŀ, čỳșțǻțįň Č įňčřěǻșěđ, řěňǻŀ fųňčțįǿň țěșț ǻbňǿřmǻŀ, ųřįňě fŀǿẅ ǿř ǿųțpųț đěčřěǻșěđ/įňčřěǻșěđ/ǻbňǿřmǻŀ, ǻňųřįǻ. §Ħỳpǿțěňșįǿň/ħỳpǿvǿŀěmįǻ/đěħỳđřǻțįǿň. ĐǺPǺ țǿțǻŀ įňčŀųđěș ĐǺPǺ 2.5, 5, 10, 20 ǻňđ 50 mģ ģřǿųpș čǿmbįňěđ. Čǿňțřǿŀ įňčŀųđěș pŀǻčěbǿ ẅįțħ/ẅįțħǿųț bǻčķģřǿųňđ měđįčǻțįǿňș ǿř ǻčțįvě čǿňțřǿŀ įňčŀųđįňģ běňčħmǻřķ țřěǻțměňțș. ǺĚ=ǻđvěřșě ěvěňț; ĐǺPǺ=đǻpǻģŀįfŀǿżįň; đįșčǿň.=đįșčǿňțįňųǻțįǿň; ĿȚ=ŀǿňģ țěřm; PBǾ=pŀǻčěbǿ; p-ỳ=pǻțįěňț-ỳěǻřș; ȘǺĚ=șěřįǿųș ǻđvěřșě ěvěňț; ȘȚ=șħǿřț țěřm; ŲȚİ=ųřįňǻřỳ țřǻčț įňfěčțįǿň; ẅķș=ẅěěķș : Ǻųțħǿř Đįșčŀǿșųřě İňfǿřmǻțįǿň: Ș.Ǻ. Jǻbbǿųř: Ǻđvįșǿřỳ Pǻňěŀ; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Ěŀį Ŀįŀŀỳ ǻňđ Čǿmpǻňỳ. Čǿňșųŀțǻňț; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Ěŀį Ŀįŀŀỳ ǻňđ Čǿmpǻňỳ. J. Șěųfěřț: Ǻđvįșǿřỳ Pǻňěŀ; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Bǿěħřįňģěř İňģěŀħěįm ĢmbĦ, Ģİ Đỳňǻmįčș, İňč., ĢŀǻxǿȘmįțħĶŀįňě, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Șǻňǿfį, Ỳpșǿměđ. Čǿňșųŀțǻňț; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Bǿěħřįňģěř İňģěŀħěįm ĢmbĦ, Ģİ Đỳňǻmįčș, İňč., ĢŀǻxǿȘmįțħĶŀįňě, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Șǻňǿfį, Ỳpșǿměđ. Řěșěǻřčħ Șųppǿřț; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Bǿěħřįňģěř İňģěŀħěįm ĢmbĦ, Břįșțǿŀ-Mỳěřș Șqųįbb Čǿmpǻňỳ, Ģİ Đỳňǻmįčș, İňč., ĢŀǻxǿȘmįțħĶŀįňě, İňțǻřčįǻ Țħěřǻpěųțįčș, İňč., Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Řǿčħě Pħǻřmǻ, Șǻňǿfį-Ǻvěňțįș, Șěřvįěř, Țǻķěđǻ Pħǻřmǻčěųțįčǻŀ Čǿmpǻňỳ Ŀįmįțěđ, Ỳpșǿměđ. Șpěǻķěř'ș Bųřěǻų; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Běřŀįň-Čħěmįě ǺĢ, Bǿěħřįňģěř İňģěŀħěįm ĢmbĦ, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Ěŀį Ŀįŀŀỳ ǻňđ Čǿmpǻňỳ, Měřčķ Șħǻřp & Đǿħmě Čǿřp., Ňǿvǻřțįș ǺĢ, Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Șǻňǿfį-Ǻvěňțįș. Ǻ.J. Șčħěěň: Ǻđvįșǿřỳ Pǻňěŀ; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Ěŀį Ŀįŀŀỳ ǻňđ Čǿmpǻňỳ, Șǻňǿfį, Měřčķ Șħǻřp & Đǿħmě Čǿřp., Bǿěħřįňģěř İňģěŀħěįm ĢmbĦ. Řěșěǻřčħ Șųppǿřț; Ǻųțħǿř; Ňǿvǿ Ňǿřđįșķ Ǻ/Ș. Șpěǻķěř'ș Bųřěǻų; Ǻųțħǿř; ǺșțřǻŻěňěčǻ, Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Ěŀį Ŀįŀŀỳ ǻňđ Čǿmpǻňỳ, Șǻňǿfį, Měřčķ Șħǻřp & Đǿħmě Čǿřp., Bǿěħřįňģěř İňģěŀħěįm ĢmbĦ, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč. Č.J. Bǻįŀěỳ: Ǻđvįșǿřỳ Pǻňěŀ; Ǻųțħǿř; Ǻbbǿțț, ǺșțřǻŻěňěčǻ, Bǿěħřįňģěř İňģěŀħěįm Pħǻřmǻčěųțįčǻŀș, İňč., Ěŀčěŀỳx Țħěřǻpěųțįčș, İňč., Ěŀį Ŀįŀŀỳ ǻňđ Čǿmpǻňỳ, Jǻňșșěň Pħǻřmǻčěųțįčǻŀș, İňč., Měřčķ Șħǻřp & Đǿħmě Čǿřp., Ňǿvǿ Ňǿřđįșķ Ǻ/Ș, Șǻňǿfį. Č. Ķǻřųp: Ěmpŀǿỳěě; Ǻųțħǿř; ǺșțřǻŻěňěčǻ. Ǻ. Ŀǻňģķįŀđě: Ěmpŀǿỳěě; Ǻųțħǿř; ǺșțřǻŻěňěčǻ. Čǻțěģǿřỳ (Čǿmpŀěțě): 12-Ě Čŀįňįčǻŀ Țħěřǻpěųțįčș/Ňěẅ Țěčħňǿŀǿģỳ–Ǿřǻŀ Ǻģěňțș Přěșěňțǻțįǿň Přěfěřěňčě (Čǿmpŀěțě): Ǿřǻŀ Přěfěřřěđ Fįňǻňčįǻŀ Șųppǿřț (Čǿmpŀěțě): * ǺĐǺ Șųppǿřț: Ňǿ Șųppǿřțěđ bỳ: : ǺșțřǻŻěňěčǻ Ķěỳẅǿřđ (Čǿmpŀěțě): ȘĢĿȚ-2 įňħįbįțǿřș ; Șǻfěțỳ ǻňđ țǿŀěřǻbįŀįțỳ Pǻỳměňț (Čǿmpŀěțě): Ỳǿųř čřěđįț čǻřđ ǿřđěř ħǻș běěň přǿčěșșěđ ǿň Țųěșđǻỳ 3 Jǻňųǻřỳ 2017 ǻț 10:02 ǺM. Șțǻțųș: Čǿmpŀěțě

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ǻț

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běțẅěěň țħě ħǿųřș ǿf 7:00 ǻ.m. ǻňđ 6:00 p.m. (ČȘȚ) Mǿňđǻỳ țħřǿųģħ Fřįđǻỳ.

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Pour le moment, l’ACORP compte présenter l’épreuve A de la composante clinique (initialement prévue pour juin 2020) le 15 novembre 2020, conformément à notre calendrier révisé,

À l' aide de deux tâches projectives et d'un questionnaire sur la perception des figures parentales, le fonctionnement intrapsychique et l' intériorisation

With careful syntactic constraints, it ensures the use of history and prophecy variables would not affect the behaviors of the original program, which justifies the verification

To our knowledge, Bilhvax (rSh28GST adjuvanted with Alhydrogel) is the first schistosomiasis candidate vaccine to reach a phase 3 clinical trial, aiming a significant delay in