ICH notes that it should be included, but does not specify how the information should be presented.
Explanation: There is no definitive answer to this question as it depends on a number of factors, including the specific design of the clinical trial, the number of arms in the trial, and the number of participants enrolled. However, in general, it is typically true that the probability of being assigned to a particular trial arm is equal for all participants. This means that, if a trial has two arms, each participant has a 50% chance of being assigned to either arm. If a trial has three arms, each participant has a 33% chance of being assigned to each arm, and so on.