Safety
psychic alterations, Headache, oedema
ADVERSE EVENTS, ADVERSE EVENT, OEDEMA
The study medication was well tolerated and no severe adverse events occurred. A list of the adverse events occurring during the study is given in Safety.All adverse events resolved spontaneously without sequel.AE = Adverse event; AESI = Adverse event of special interest: Headache, abdominal symptoms, sleep related problems, oedema, psychic alterations; SAE = Serious adverse events.