In the placebo group, the patients with serious TEAEs were: one patient with increased alanine aminotransferase and gamma‐glutamyl transferase (both assessed as unrelated to study treatment); one patient with vomiting (assessed as related to study treatment and resulting in discontinuation from the study); one patient with gastrointestinal obstruction (assessed as unrelated to study treatment); and one patient with abdominal pain (assessed as related to study treatment and resulting in discontinuation from the study). This evidence concerns the gene GPT and Gastrointestinal obstruction.