Per the protocol, participants' blood creatinine level must be no greater than 2.

To calculate the maximum allowable creatinine level, multiply the upper limit of normal (1.2 mg/dL) by 2.5.

1.2 x 2.5 = 3.0 mg/dL

Therefore, the maximum creatinine level that a participant can have to remain eligible for the trial is 3.0 mg/dL.

GCP guidelines specify that eligibility criteria, including lab values, must be strictly followed to maintain protocol compliance.

"The protocol specifies that laboratory values must not exceed the defined limits to ensure participant safety and data integrity."

Objectives:

Maintain accurate interpretation of laboratory criteria.

Ensure compliance with protocol-defined inclusion/exclusion criteria.