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Re: dr_lowenstein post# 152177

Friday, 04/24/2015 12:22:21 PM

Friday, April 24, 2015 12:22:21 PM

Post# of 399506
Secondary Outcome Measures:

Number of Subjects with Changes in Blood Chemistry Analytes from baseline to end of study [ Time Frame: Screening, 48 hours post-dose and Day 8 ] [ Designated as safety issue: Yes ]
Changes in Blood Chemistry values at 48 hours post-dose and end of study will be evaluated/analyzed from baseline (screening) values. Descriptive statistics will be used (number and percent of occurrences).


•Number of Subjects with Changes in Hematology Analytes from baseline to end of study [ Time Frame: Screening, 48 hours post-dose and Day 8 ] [ Designated as safety issue: Yes ]
Changes in Hematology values at 48 hours post-dose and end of study will be evaluated/analyzed. Descriptive statistics will be used (number and percent of occurrences).


•Number of Subjects with Changes in Urinalysis from baseline to end of study [ Time Frame: Screening, 48 hours post-dose and Day 8 ] [ Designated as safety issue: Yes ]
Changes in Urinalysis at 48 hours post-dose and end of study will be evaluated/analyzed. Descriptive statistics will be used (number and percent of occurrences)




https://clinicaltrials.gov/ct2/show/NCT02401750?term=%22Elite+Laboratories%2C+Inc%22&rank=2
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