Table 5.

List of serious adverse events (SAE) exclusive of congenital anomalies

C31G (N=10; 1.2%)	Conceptrol® (N=12; 2.1%)
Anemia Crohn’s disease Food poisoning Viral gastroenteritis Cholelithiasis Joint dislocation Ruptured ovarian cyst Ectopic pregnancy Acute stress disorder Stress incontinence Menorrhagia	Cardiac palpitations Diabetic ketoacidosis E. coli gastroenteritis Gastrointestinal pain Nausea Bile duct stone Hypersensitivity to product Pelvic inflammatory disease Laceration (unspecified) Hypoglycemia Dermoid cyst Viral meningitis Depression Kidney infection Infection (unspecified)

N refers to number of subjects in each group with SAEs; some subjects reported more than one SAE.

Each of the specific SAEs listed was reported by one and only one participant.