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Significantly elevated homocysteine has been observed in people suffering with cardiovascular disease, stroke, neurodegeneration (Nelson et al, 2016) and frailty in old age (Guaita et al, 2021) and elevated homocysteine is associated with a reduced blood flow to the small vessels in the brain (reduced microcirculation) (Hassan et al, 2004) which is an important connection because a reduced microcirculation may increase the risk of developing Alzheimers disease, amyotrophic lateral sclerosis (ALS) or Parkinsons disease (Erdener and Dalkara, 2019)

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Overall, approximately 50% of all episodes of GI adverse events associated with Orlistat treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks

Comment: The applicant noted that, after FDA authorization, it changed the devices' names from aprevo Cervical ACDF system and aprevo Cervical ACDF-X system to aprevo Cervical ACDF interbody and aprevo Cervical ACDF-X interbody, respectively