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SAEs relatedness to the administration of vitamin B 12 or placebo will be judged by the investigator/designee, the Ethics Committee and the DSMB who will have access to all relevant investigations, clinical assessments and if require unblinding allocated interventions

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Secretagogues are constrained by the body's own regulatory mechanisms the pituitary cannot produce more GH than its capacity allows, and somatostatin provides a natural ceiling

Transdermal estrogen tends to have less impact