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Statistical Analysis Plan Statistical Analysis Plan Sponsor Name: Urovant Sciences GmbH Protocol Number and Title: RVT-901-3003 An International Phase 3, Randomized, Double- Blind, Placebo- and Active (Tolterodine)- Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder Protocol Version and Date: RVT-901-3003 <Protocol Amendment numbers v3.0, 15NOV2018 and dates> v2.1, 12FEB2018 v2.0, 30JAN2018 v1.2, 01NOV2017 v1.1, 05OCT2017 v1.0, 29SEP2017 Author(s): , , Biostats, Programming & Data Management, Urovant Sciences SAP Version: 3.1 SAP Version Date: 06-MAR-2019 Notice of Confidential and Proprietary Information: The information contained in this document is confidential belonging to Urovant Sciences Acceptance of this document constitutes agreement by the recipient that no information contained herein will be published or disclosed without prior written authorization from an official of Urovant Sciences. However, this document may be disclosed to appropriate Institutional Review Board and Ethics Committees or duly authorized representatives of a national regulatory authority under the condition that they are requested to keep it confidential. In the event of an actual or suspected breach of this obligation, should be notified promptly. Page 1 of 88 1 NCT Number: NCT03492281 This NCT number has been applied to the document for purposes of posting on clinicaltrials.gov Statistical Analysis Plan Urovant Protocol #3003 Version 3.1 Revision History Version # Date Document Owner Revision Summary (dd-mmm-yyyy) 1.0 30APR2018 Initial Release Version Additions to the efficacy section to include Multiple imputation instead of LOCF 2.0 20NOV2018 Minor changes to content to be in line with protocol version 2.1 Updates to shells per Sponsor comments; 3.0 05MAR2019 Addition of section on deviations from Protocol; Minor changes to content to be in line with Protocol version 3.0. Minor update to allow for the possibility to transform 3.1 06MAR2019 data prior to modeling for primary analyses if assumptions for the model are grossly violated. Page 2 of 88 2 Statistical Analysis Plan Urovant Protocol #3003 Version 3.1 1 confirm that T have reviewed this document and agree with the content. 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GLOSSARY OF ABBREVIATIONS Abbreviation Description AE Adverse Event AIC Akaike’s Information Criteria ANCOVA Analysis of Covariance AR Autoregressive ATC Anatomical Therapeutic Chemical AUC Area Under the Curve BMI Body Mass index BP Blood Pressure BPH Benign Prostatic Hyperplasia BPM Beats Per Minute CI Confidence Interval CFB Change from Baseline CS Compound Symmetry ECDF Empirical Cumulative Distribution Function eCRF Electronic Case Report Form C24 24h Concentration CV Coefficient of Variation DBL Database Lock DBP Diastolic Blood Pressure DRM Data Review Meeting ECG Electrocardiogram EQ-5D EuroQual 5 Dimension Questionnaire FAS Full Analysis Set FAS-I Full Analysis Set for Incontinence GPP Good Pharmacoepidemiology Practice HRQL Health-Related Quality of Life ICF Informed Consent Form ICH International Conference on Harmonization IP Investigational Product IxRS Interactive Voice/Web Response System LOCF Last Observation Carried Forward LF Long Form MAR Missing at Random Max Maximum MedDRA Medical Dictionary for Regulatory Activities MI Multiple Imputation Min Minimum Page 9 of 88 9 Statistical Analysis Plan Urovant Protocol #3003 Version 3.1 Abbreviation Description MMRM Mixed Model for Repeated Measures MNAR Missing Not At Random N/A Not Applicable NA Not Applicable NVU Night Time Voids Associated with Urgency OAB Overactive Bladder OAB Dry OAB in the absence of Incontinence OAB Type Investigator-Defined Baseline OAB Categorization OAB Wet OAB with Incontinence OAB-d Type eCRF Derived Baseline OAB Categorization OAB-q Overactive Bladder Questionnaire PGI Patient Global Impression PK Pharmacokinetic(s) PRO Patient Reported Outcomes PPS Per-Protocol Set PPS-I Per-Protocol Set for Incontinence PT Preferred Term PVR Post-Void Residual (Volume) QC Quality Control QTc Corrected QT Interval REML Restricted (or Residual) Maximum Likelihood RVT-901 Vibegron (Urovant Code Number) SAE Serious Adverse Event SAF Safety Set SAP Statistical Analysis Plan SBP Systolic Blood Pressure SD Standard Deviation SE Standard Error SOC System Organ Class SOP Standard Operating Procedure SUI Stress Urinary Incontinence TEAE Treatment Emergent Adverse Event TLF Table, Listing and Figure Urovant Urovant Sciences GmbH US United States UUI Urge Urinary Incontinence WHO World Health Organization WPAI-US Work Productivity and Activity Impairment Questionnaire-Urinary Symptoms Page 10 of 88 10 6WDWLVWLFDO$QDO\VLV3ODQ 8URYDQW3URWRFRO 9HUVLRQ 385326( 7KH SXUSRVH RI WKLV VWDWLVWLFDO DQDO\VLV SODQ 6$3 LV WR HQVXUH WKDW WKH GDWD OLVWLQJV VXPPDU\WDEOHVDQGILJXUHVZKLFKZLOOEHSURGXFHGDQGWKHVWDWLVWLFDOPHWKRGRORJLHVWKDW ZLOOEHXVHGDUHFRPSOHWHDQGDSSURSULDWHWRDOORZYDOLGFRQFOXVLRQVUHJDUGLQJWKHVWXG\ REMHFWLYHV 5HVSRQVLELOLWLHV ZLOOSHUIRUPWKHVWDWLVWLFDODQDO\VHVDQGDUHUHVSRQVLEOHIRUWKHSURGXFWLRQ DQG TXDOLW\ FRQWURO 4& RI DOO WDEOHV ILJXUHV DQG OLVWLQJV 7KH SRSXODWLRQ SKDUPDFRNLQHWLFV 3. 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