他第一个trial没有包括safety, 是efficacy study:
Study Design:     
Endpoint Classification: Efficacy Study

Primary Outcome Measures:

* Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients. [ time frame: evaluated at 6 months and 1 year ][ designated as safety issue: no ]

他第一个已完成的efficacy trial是在没有proper safety data的情况下完成的！！

而现在的试验含safety评估的成分， 说明老肖作了2000多例了，此手术安全性不明， 要再做16例！！！老肖就差16例？ 2000例和2016例的差别！ 你们都明白我再说什么！！

Study Design:     
Endpoint Classification: Safety/Efficacy Study
Primary Outcome Measures:

* Reproducible bladder contraction [ time frame: 6 to 24 months post procedure ] [ designated as safety issue: yes ]