As a result of requests made by the Ethics Committee during the initial evaluation, some changes to protocol version no. 1 have been introduced. This has resulted in a new version of the protocol (version no. 2) and related documents. The present Amendment is intended to harmonize the documents submitted to AIFA with those requested and approved by the Ethics Committee. The requests for changes / additions made by the Ethics Committee have resulted in a new version of the following documents:1) Study Protocol; 2) Synopsis 3) CTA Form 4) Information sheet and Informed Consent Form. The main changes made to the concerned protocol were as follows: 1) In the eligibility criteria, the differential diagnosis of vertigo was better specified; 2) A new exclusion criterion was introduced: patients with hypertension; 3) In the study design an additional visit during the treatment phase (on day 14) was added, in order to better monitor the patients’ safety. We finally took the opportunity to make some "Errata Corrige” to the initial text.

The current exclusion criterion n. 1 provides for patients not be included in the study if affected by cerebellopontine lesions, multiple sclerosis, vascular dementia, migraine associated vertigo, phobic vertigo, motion sickness, acoustic neuroma or other CNS tumor, as documented by CT or MRI performed within 3 months of the screening visit. However, since patients who will be included in the study are already being treated for a long time at the center and their health conditions are well known to the Investigator and are periodically re-checked, it is considered sufficient that the exclusion criterion is verified by the Investigator on the basis of a previous instrumental examination (brain CT or MRI) and of the patient's medical history and any changes in the patient’s health over time, since he/she is being treated at the center. The eligibility of the patient will be assessed by the Investigator, based also on a previous brain CT or MRI, although not necessarily carried out in the 3 months prior to the start of the study. For these reasons it is considered appropriate to remove the time limit of 3 months for the acceptability of cerebral CT or MRI, from the first exclusion criterion. We finally took the opportunity to update the period of the study, as communicated to the Ethical Committee with letter dated 23/07/2014, and to correct the investigator phone number indicated in the Information sheet and Informed Consent Form.