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Message: Re: Buy, sell or fold
2
Dec 04, 2019 06:39PM
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Dec 04, 2019 07:10PM
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Dec 04, 2019 09:12PM

 "In FDA test, RVX Phase 3, after patient has MACE, how does test adjust for personal behavioral changes......Is any change in life style incorporated into the results or is it all science?"

Of course there is going to be lifestyle/behavior differences amongst patients. Just like there are genetic differences amongst the patients. Lots of environmental and genetic differences in human studies. This is not unique to BETonMACE, cardiovascular trials, or any clinical trial. Certain inclusion/exclusion criteria are set, and based on patient recruitment and treatment protocol, one has a good idea of the standard of care treatments. But variability in lifestyle/behavior/genetics/etc is just inherent to human clinical trials. 

 

"Seems control group may have changed life styles better and faster.  jimo, will leave this to our experts."

On what basis are you making this conclusion?

 

"Do we have blood work on both sides to compare 208 patients with control group?"

Yes, lots of blood samples from all patients, both placebo and apabetalone treated. From the rationale and design paper "Follow-up visits occur every 2 weeks until Week 12, then every 4 weeks until Week 28, then every 12 weeks until the common study end date. Four weeks after last visit on treatment, a final follow-up visit is conducted. At randomization and at multiple time points after randomization patients are assessed for study end points and adverse events, and blood and urine samples are collected for measurements of hematology and chemistry studies"

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Dec 05, 2019 08:54AM
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