Cluster 7: comprehend informed consent able sign document written willing subjects form Cluster 52: written informed consent given provides obtained able participate patient study Cluster 241: irb approved sign document informed understand consent willing written able Cluster 668: specific study entry consent informed provide prior patient sign patients Cluster 688: understand able sign consent informed document willing patients read patient Cluster 793: sign consent informed patients able willing written refusal document patient Cluster 861: legally authorized representative consent informed written provide patient sign understand Cluster 1008: document sign understand written consent willing informed able patient patients Cluster 1045: unwillingness inability consent informed supplementation written transfused vitamin individual folic Cluster 1058: guardians parents legal sign consent written informed patients benefits indicating Cluster 1554: able consent informed willing patients patient subjects study participants eligible Cluster 1583: pertinent aspects informed dated indicating signed document consent legally trial Cluster 1591: comply able protocol informed consent sign requirements signed willing icf Cluster 1602: inability consent informed provide understand written obtain assent document sign Cluster 2334: legal representative consent informed able written provide patient understand sign Cluster 2397: unwilling unable consent informed sign form document written patients icd