ANALYSIS SETS 5.1. ENROLLED POPULATION The enrolled population will include all patients who have signed the Informed Consent Form (ICF). This population will be used only for the presentation of patient disposition. 5.2. INTENT TO TREAT AND MODIFIED INTENT TO TREAT ANALYSIS POPULATIONS The ITT Population will include all enrolled patients who received at least 1 dose of SL-701. The mITT population will include all enrolled patients who had a measurable disease at baseline, received at least 1 dose of study drug and had at least one post-baseline tumor assessment ≥8 weeks from first drug administration confirmed by the modified RANO criteria (Wen 2010, Appendix 2), unless they had progressive disease prior to the first efficacy assessment at week 8 (patients wit h progressive disease prior to week 8 will be included in the mITT population). The ITT Population will be used to analyze all safety data (will be referred to as ‘safety population’) and both the mITT and ITT Populations will be used to analyze all efficacy data. In addition, efficacy data will also be analyzed based on a Per Protocol Population (PPP) that w ill include all mITT patients who completed the initial dosing period (12 doses for Stage 1 and 16 doses for Stage 2). 5.3. PROTOCOL DEVIATIONS A protocol deviation is an unintended and/or unanticipated departure from the procedures and/or processes, whether approved or not approved by the Sponsor and/or the IRB/IEC. A major deviation is non-adherence to the protocol that results in a significant, additional risk to the patient, when the patient or Investigator or sub-investigator has failed to adhere to sig nificant protocol requirements or when there is nonadherence to FDA or other applicable regulations and guidelines. The clinical monitor will document protocol violations and deviations throughout the course of monitoring visits. Protocol deviations and violations will be presented in a listing. No patients w ill be excluded from analyse s of efficacy and safety data due to a protocol deviation or violation. DocuSign Envelope ID: B3F56764-C440-4885-BA44-7578C4A73DB3 Stemline Therapeutics, Inc. Protocol: STML- 701-0114 Version 3.0, 10-JUL-2015 (Amendment 2) Statistical Analysis Plan Page 22 of 63 6.