Created at Source Raw Value Validated value
Oct. 26, 2020, 11:31 p.m. usa

- inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes; - any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial; - any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study; - any ecg examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial; - known hypersensitivity to the components of the drugs used during the study; - women in pregnancy or breastfeeding; - body weight less than 15kg; - estimated glomerular filtration rate (ckd-epidemiology collaboration, ckd-epi) <30 ml / min; - aspartate aminotransaminase (ast) or alanine aminotransaminase (alt)> 5 times the upper limit of normality; - refusal to participate; - refusal to sign the informed consent form.

- inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes; - any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial; - any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study; - any ecg examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial; - known hypersensitivity to the components of the drugs used during the study; - women in pregnancy or breastfeeding; - body weight less than 15kg; - estimated glomerular filtration rate (ckd-epidemiology collaboration, ckd-epi) <30 ml / min; - aspartate aminotransaminase (ast) or alanine aminotransaminase (alt)> 5 times the upper limit of normality; - refusal to participate; - refusal to sign the informed consent form.