A Randomized, Double-Blind, Placebo-Controlled Clinical Study of a Novel Medication

A randomized, double-blind, placebo-controlled clinical study of a novel medication for the treatment of peripheral neuropathy in adults with multiple myeloma is being conducted by an investigator (MM) . The trial includes 150 individuals with MM who are randomly assigned to receive either the new medicine (n = 75) or a placebo (n = 75) . According to the trial design, participants in both groups must take one medication every day and keep a pain diary. After three months of therapy, each patient is interviewed and their pain diaries are examined; nine patients on the new medicine and three patients on the placebo did not take the tablets as directed. The investigator decides to analyze the trial data using the intention-to-treat principle.  Which of the following best describes how the data pertaining to all patients who did not adhere to protocol should be treated?

A) Conduct separate analyses of the 12 nonadherent patients and the 138 adherent patients
B) Exclude all 12 nonadherent patients from analysis
C) Exclude the 3 nonadherent patients in the group taking placebo from analysis
D) Exclude the 9 nonadherent patients in the group taking the new drug from analysis
E) Keep all 12 nonadherent patients in their respective groups for analysis