Clarified the main objective of this study, the previous secondary objective “To collect long-term data on serious adverse events and adverse events of special interest” was elevated to primary objective. In addition, the protocol was amended to clarify the safety monitoring guidance and to include the collection of all AEs (including non-serious AEs) and an investigator attestation of continued clinical benefit.

 Included language on the trial end date to meet the regulatory guidelines of the Medicine and Health Research Authority, in the United Kingdom (UK).  Clarified that this trial was deemed to be a voluntary PASS by Novartis Regulatory Affairs in 2016. An interim analysis was to be performed in 2017, and every 2 years thereafter, until the final database lock.  Clarified the visit schedules for patients taking pasireotide s.c. and those taking pasireotide LAR, and further highlighted the required timelines for using highly effective methods of contraception after last dose of study medication

The main purpose of this amendment is to: • Update the trial selection criteria to allow patients from Novartis-sponsored trials, being treated with pasireotide alone or in combination with another treatment for Cushing’s Disease and Acromegaly, to participate in this study. Several of the participating parent protocols permit for pasireotide to be administered in combination with another medical therapy. Revising the selection criteria would ensure those patients receiving clinical benefit would have continued access to the combination treatment. Combination treatment through this rollover would only be available for patients with Cushing’s Disease or Acromegaly.

Since Novartis had signed an agreement to transfer the worldwide rights of Signifor® and Signifor® LAR to Recordati, all applicable sections of the protocol updated to substitute the name of the current sponsor Novartis with the name of the new sponsor Recordati or of IQVIA on behalf of Recordati, as applicable.

It is anticipated that pasireotide will not be commercially available and reimbursed in all participating countries at study end. In order to ensure that patients deriving clinical benefit from pasireotide will continue receiving treatment with this drug outside the frame of the clinical trial, they will be allowed to obtain pasireotide through country-specific programmes as soon as they become available – even prior to the end of the study. This will ensure treatment continuity (applicable to Brazil, France, Germany, India, Italy, Malaysia, Mexico, Peru and Thailand)