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Table 1 Criteria of inclusion and exclusion of patients.

From: PORTAL: Pilot study on the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection: a double-blind randomized placebo-controlled trial

Inclusion criteria

Exclusion criteria

patients meeting all of the following criteria are considered for inclusion in the study:

patients with any of the following will not be included in the trial:

- scheduled for elective major partial liver resection of ≥3 liver segments for liver neoplasms

- patients <18 and >90 years

- written informed consent

- patients <50 and >120 kg

- adequate contraception is required for women with childbearing potential

- patients with severe, organ-specific disorders (e.g., liver or renal failure, acute pancreatitis)

 

- patients undergoing emergency procedures

 

- patients with expected intubation problems

 

- pregnancy and/or lactation

 

- history of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any compound present in the pharmaceutical form of the investigational product

 

- simultaneous participation in another clinical trial

 

- mental condition rendering the subject incapable of understanding the nature, scope, and consequences of the trial

 

No subject will be enrolled in this study more than once.