1) Change in safety information: Due to the global harmonization of the Company Core Safety Information (CCSI) which is included as RSI within the investigator's brochure (IB) new safety information have been included for the indication blepharospasm. Common AEs related to NT 201 in the indication BEB were updated. 2) Updates in the current approval status and external responsibilities implemented.

1) Addition of a new safety assessment to prospectively monitor suicidality in order to comply with FDA guidance on suicidality testing in all clinical trials investigating neurological indications: Columbia Suicide Severity Rating Scale (C-SSRS). 2) Addition of a new safety variable (classified as other safety variable) based on the results of the C-SSRS. 3) Addition of an exclusion criterion specifying that subjects with significant risk of suicidality at the baseline assessment were to be excluded. 4) Addition of a new eligibility criterion for injection in the OLEX period: no significant risk of suicidality since last injection based on the investigator's judgement, or if appropriate, as indicated of "no" to questions 4 or 5 in the suicidal ideation section of the C-SSRS, or no non suicidal self-injurious behavior, or no suicidal behavior. 5) Addition of a new discontinuation criterion: subjects were to be discontinued if there was a positive report on suicidality based on the C-SSRS. 6) Modification of data management procedures clarifying documentation of the C-SSRS results. 7) Modification of the definition of SAEs further specifying suicidal ideation (a response of “yes” to questions 4 or 5) or any suicidal behavior as “medically important condition”. 8) Description of the analysis of C-SSRS data. 9) New data added to the risk-benefit assessment.