A randomized controlled trial was conducted to evaluate the effectiveness of a self-management program on the physical function of patients living with osteoarthritis. Which of the following statements is/are TRUE? Justify your answers.

A.Trial participants who DO NOT START their randomized treatment should be excludedfrom the intention to treat analysis

B.Intention-to-Treat Analysis maintains the original treatment group assignmentsachieved by randomization

C. Intention-to-Treat Analysis provides a valid estimate of the benefit of intervention

D.Per Protocol Analysis includes the data from only those participants who complete the protocol for their originally randomized treatment.

E.Decide whether or not you would include data from each of the following subsets of subjects in an Intention-to-Treat analysis

1.Subjects who die

2.Subjects who withdrew voluntarily from the Trial

3.Subjects who did not adhere to the treatment protocol

4.Subjects who received the alternate treatment (not the treatment indicated by

randomization)

5.Subjects lost to follow-up

F. What is the principal benefit of Intention-to-Treat analysis?