- If it appears that Cmax may exceed the stopping criteria, the daily dose for that cohort will be divided into to two halves given 6-12 hours apart with the exception of Day 10 on which a single morning half dose will be given. The changes will be made on the basis of pharmacokinetic predictions using data obtained from previous cohorts. In that case, blood and urine sampling times will be adjusted accordingly and documented in a note to file. The number of blood samples drawn for pharmacokinetics will not exceed 68 without approval of the relevant ethics committee.