National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Effect of Fenofibrate on thioacetamide-induced hepatic encephalopathy in rats

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

NO

Comment to the Committee

Regarding Sample Size Justification:
The protocol states 32 rats (8/group) but cites a calculation requiring 12/group (90% power, effect size 3.1). Later, it mentions 80% power without clarification. Please clarify the rationale for using 8/group instead of 12 and power (80% vs. 90%) and Provide updated justification.

Regarding Euthanasia:
Midazolam Use: Midazolam (15 mg/kg ) is a sedative, not an anesthetic. Cervical dislocation under sedation alone may not comply with the 3 Rs guidelines.

Informed consent form:

N/A

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