^aAdverse events were collected at each visit via inquiry and clinical laboratory tests. The safety population included all patients who were randomised and received at least 1 dose of study drug. If a patient had multiple types of adverse events, he/she was counted once for each type. One patient randomised to receive placebo inadvertently received 1 dose of AJOVY®, 225mg. Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

^bOne death occurred in the AJOVY® quarterly group as a result of diphenhydramine overdose (suicide); assessment by the investigator determined that the death was unrelated to treatment.

^cLocal injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

^dAspartate aminotransferase or alanine aminotransferase ≥3 x ULN.

^eTotal bilirubin ≥2 x ULN.

^fPresence of 3 components: aspartate aminotransferase or alanine aminotransferase ≥3 x ULN; total bilirubin ≥2 x ULN; and no other reason to explain these increases (eg, viral hepatitis A, B, or C; liver disease; or drug capable of causing injury).

^gOne patient in the placebo group had a serious adverse event of drug hypersensitivity that was assessed as severe; the event was considered to be a generalised allergic reaction to ceftriaxone.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

 

 

^*Shown are data collected during the double-blind, placebo-controlled intervention period. The safety population included all the patients who underwent randomisation and received at least one dose of a trial regimen. Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

^†One serious adverse event led to discontinuation of the trial; an event of suicidal ideation (assessed by the investigator as being moderate in severity and unrelated to the trial regimen) was reported in a patient in the AJOVY® monthly group who had a history of depression.

^‡One death occurred in the AJOVY® quarterly group as a result of chronic obstructive pulmonary disease; this was determined by the investigator and sponsor to be unrelated to the trial regimen.

^§Local injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

^¶Patients could have more than one type of possible trial-agent–induced liver injury.

^**An event was reported in one additional patient but was inadvertently omitted as an adverse event of special interest.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

 

*Local injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

 

*Local injection sites were systematically assessed for erythema, induration, ecchymosis, and pain both immediately and 1 hour after dosing.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.

 

Patients with certain major cardiovascular diseases were excluded from the study. No safety data are available in these patients.