Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy
Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure pres...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Watanabe, Satoru [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2016transfer abstract |
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| Schlagwörter: |
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| Umfang: |
10 |
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| Übergeordnetes Werk: |
Enthalten in: Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN - Hanief, M. ELSEVIER, 2015transfer abstract, a multidisciplinary journal of antiviral agents, natural host defence mechanisms, interferons and antiviral vaccines : an official publication of the International Society for Antiviral Research, Amsterdam [u.a.] |
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| Übergeordnetes Werk: |
volume:127 ; year:2016 ; pages:10-19 ; extent:10 |
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| DOI / URN: |
10.1016/j.antiviral.2015.12.008 |
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| 520 | |a Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). | ||
| 520 | |a Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). | ||
| 650 | 7 | |a AG129 mouse model |2 Elsevier | |
| 650 | 7 | |a Viremia reduction |2 Elsevier | |
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| 700 | 1 | |a Low, Jenny G. |4 oth | |
| 700 | 1 | |a Vasudevan, Subhash G. |4 oth | |
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10.1016/j.antiviral.2015.12.008 doi GBVA2016005000005.pica (DE-627)ELV029542065 (ELSEVIER)S0166-3542(15)30047-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 670 VZ 530 VZ 660 VZ 000 150 VZ 54.74 bkl Watanabe, Satoru verfasserin aut Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy 2016transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). AG129 mouse model Elsevier Viremia reduction Elsevier Antiviral Elsevier Dengue virus Elsevier Celgosivir Elsevier Chan, Kitti Wing-Ki oth Dow, Geoffrey oth Ooi, Eng Eong oth Low, Jenny G. oth Vasudevan, Subhash G. oth Enthalten in Elsevier Science Hanief, M. ELSEVIER Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN 2015transfer abstract a multidisciplinary journal of antiviral agents, natural host defence mechanisms, interferons and antiviral vaccines : an official publication of the International Society for Antiviral Research Amsterdam [u.a.] (DE-627)ELV012905879 volume:127 year:2016 pages:10-19 extent:10 https://doi.org/10.1016/j.antiviral.2015.12.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 54.74 Maschinelles Sehen VZ AR 127 2016 10-19 10 045F 610 |
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10.1016/j.antiviral.2015.12.008 doi GBVA2016005000005.pica (DE-627)ELV029542065 (ELSEVIER)S0166-3542(15)30047-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 670 VZ 530 VZ 660 VZ 000 150 VZ 54.74 bkl Watanabe, Satoru verfasserin aut Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy 2016transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). AG129 mouse model Elsevier Viremia reduction Elsevier Antiviral Elsevier Dengue virus Elsevier Celgosivir Elsevier Chan, Kitti Wing-Ki oth Dow, Geoffrey oth Ooi, Eng Eong oth Low, Jenny G. oth Vasudevan, Subhash G. oth Enthalten in Elsevier Science Hanief, M. ELSEVIER Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN 2015transfer abstract a multidisciplinary journal of antiviral agents, natural host defence mechanisms, interferons and antiviral vaccines : an official publication of the International Society for Antiviral Research Amsterdam [u.a.] (DE-627)ELV012905879 volume:127 year:2016 pages:10-19 extent:10 https://doi.org/10.1016/j.antiviral.2015.12.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 54.74 Maschinelles Sehen VZ AR 127 2016 10-19 10 045F 610 |
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10.1016/j.antiviral.2015.12.008 doi GBVA2016005000005.pica (DE-627)ELV029542065 (ELSEVIER)S0166-3542(15)30047-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 670 VZ 530 VZ 660 VZ 000 150 VZ 54.74 bkl Watanabe, Satoru verfasserin aut Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy 2016transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). AG129 mouse model Elsevier Viremia reduction Elsevier Antiviral Elsevier Dengue virus Elsevier Celgosivir Elsevier Chan, Kitti Wing-Ki oth Dow, Geoffrey oth Ooi, Eng Eong oth Low, Jenny G. oth Vasudevan, Subhash G. oth Enthalten in Elsevier Science Hanief, M. ELSEVIER Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN 2015transfer abstract a multidisciplinary journal of antiviral agents, natural host defence mechanisms, interferons and antiviral vaccines : an official publication of the International Society for Antiviral Research Amsterdam [u.a.] (DE-627)ELV012905879 volume:127 year:2016 pages:10-19 extent:10 https://doi.org/10.1016/j.antiviral.2015.12.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 54.74 Maschinelles Sehen VZ AR 127 2016 10-19 10 045F 610 |
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10.1016/j.antiviral.2015.12.008 doi GBVA2016005000005.pica (DE-627)ELV029542065 (ELSEVIER)S0166-3542(15)30047-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 670 VZ 530 VZ 660 VZ 000 150 VZ 54.74 bkl Watanabe, Satoru verfasserin aut Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy 2016transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). AG129 mouse model Elsevier Viremia reduction Elsevier Antiviral Elsevier Dengue virus Elsevier Celgosivir Elsevier Chan, Kitti Wing-Ki oth Dow, Geoffrey oth Ooi, Eng Eong oth Low, Jenny G. oth Vasudevan, Subhash G. oth Enthalten in Elsevier Science Hanief, M. ELSEVIER Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN 2015transfer abstract a multidisciplinary journal of antiviral agents, natural host defence mechanisms, interferons and antiviral vaccines : an official publication of the International Society for Antiviral Research Amsterdam [u.a.] (DE-627)ELV012905879 volume:127 year:2016 pages:10-19 extent:10 https://doi.org/10.1016/j.antiviral.2015.12.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 54.74 Maschinelles Sehen VZ AR 127 2016 10-19 10 045F 610 |
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10.1016/j.antiviral.2015.12.008 doi GBVA2016005000005.pica (DE-627)ELV029542065 (ELSEVIER)S0166-3542(15)30047-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 670 VZ 530 VZ 660 VZ 000 150 VZ 54.74 bkl Watanabe, Satoru verfasserin aut Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy 2016transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). AG129 mouse model Elsevier Viremia reduction Elsevier Antiviral Elsevier Dengue virus Elsevier Celgosivir Elsevier Chan, Kitti Wing-Ki oth Dow, Geoffrey oth Ooi, Eng Eong oth Low, Jenny G. oth Vasudevan, Subhash G. oth Enthalten in Elsevier Science Hanief, M. ELSEVIER Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN 2015transfer abstract a multidisciplinary journal of antiviral agents, natural host defence mechanisms, interferons and antiviral vaccines : an official publication of the International Society for Antiviral Research Amsterdam [u.a.] (DE-627)ELV012905879 volume:127 year:2016 pages:10-19 extent:10 https://doi.org/10.1016/j.antiviral.2015.12.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 54.74 Maschinelles Sehen VZ AR 127 2016 10-19 10 045F 610 |
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Enthalten in Modeling and prediction of surface roughness for running-in wear using Gauss-Newton algorithm and ANN Amsterdam [u.a.] volume:127 year:2016 pages:10-19 extent:10 |
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Watanabe, Satoru @@aut@@ Chan, Kitti Wing-Ki @@oth@@ Dow, Geoffrey @@oth@@ Ooi, Eng Eong @@oth@@ Low, Jenny G. @@oth@@ Vasudevan, Subhash G. @@oth@@ |
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Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy |
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Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). |
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Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). |
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Although the antiviral drug celgosivir, an α-glucosidase I inhibitor, is highly protective when given twice daily to AG129 mice infected with dengue virus, a similar regimen of twice daily dosing did not significantly reduce serum viral loads in patients in a recent clinical trial. This failure presumably might reflect the initiation of treatment when patients were already viremic. To better mimic the clinical setting, we used viruses isolated from patients to develop new mouse models of DENV1 and DENV2 infection and employed the models to test the twice daily treatment, begun either on the day of infection or on the third day post-infection, when the mice had peak of viremia. We found that, although the treatment started on day 0 was effective on viral load reduction, it provided no benefit when begun on day 3, indicating that in vivo antiviral efficacy becomes less prominent once viremia reaches the peak level. To determine if the therapeutic regimen in humans could be improved, we tested regimen of four-times daily treatment and found that the treatment significantly reduced viremia, suggesting that a similar regimen may be effective in a human clinical trial. A new clinical trial to investigate an altered dosing regimen has been approved (NCT02569827). |
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