Early termination of the study

The Sponsor may terminate the study prematurely in certain circumstances; for example, ethical concerns, insufficient recruitment, when the safety of the participants is at risk, alterations in accepted clinical practice making continuation unwise and early evidence of benefit or harm of the experimental intervention. All patients will be free to withdraw from participation at any time, for any reason, and without prejudice. The reason for withdrawal should be documented wherever possible. The withdrawal will not affect the actual medical assistance or future treatments. On rare occasions, the investigators may terminate a patient’s participation to protect their best interest. After study termination, the evaluations required at the next scheduled clinical visits will remain.