chapter seven
Below is a detailed chart showing when the testing and safety measurements were taken beginning with Day 1 that includes IPSS , URF , Prostate Volume and PSA . After taking UMOOZE ® twice daily , IPSS and URF tests were done as a safety measurement . Day 42 involved an IPSS followed by a complete lab test for vital signs that included the same tests from Day 1 : IPSS , URF , Prostate Volume and PSA .
Results The results of the study were recorded as follows :
• Improved the mean change from baseline in IPSS at Day 28 ( visit 4 , all patients ).
• Improved the mean change from baseline in IPSS at Day 28 ( visit 4 , patients who fit Qmax≤15mL / sec criteria ).
• Improved the mean change from baseline in IPSS at Day 28 ( visit 4 , patients took BPH drug less than 6 months , p≤0.05 ).
• Improved the mean change from baseline in IPSS at Day 28 ( visit 4 , patients took Harnalidge 0.4mg once daily for up to 6 months , p≤0.05 ).
• Improved the mean change from baseline in IPSS at Day 28 ( visit 4 , patients with non-Harnalidge 0.4mg treatment ).
• Improved nocturia in patients with Qmax≤15mL / sec at any stages of the study .
• Improved the mean change from baseline in QoL at Day 56 ( visit 6 , patients who fit IPSS criteria ).
• Improved the mean change from baseline in QoL at Day 56 ( visit 6 , patients took Harnalidge 0.4mg once daily , p≤0.05 ).
• Improved the mean change from baseline in QoL at Day 56 ( visit 6 , patients took Harnalidge 0.4mg once daily and fit IPSS criteria , p≤0.05 ).
• Improved the mean change from baseline in QoL at Day 56 ( visit 6 , patients took Harnalidge 0.4mg once daily and fit Qmax criteria ).
• Improved the mean change from baseline in QoL at Day 42 ( visit 5 , patients took Harnalidge 0.4mg once daily ).
• Improved the mean change from baseline in QoL at Day 42 ( visit 6 , patients took Harnalidge 0.4mg once daily and fit both Qmax≤15mL / sec and IPSS criteria ).
• Improved the mean change from baseline in PVR at Day 56 ( visit 6 , all patients , p≤0.05 ).
• Improved the mean change from baseline in PVR at Day 56
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