Sap 001

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File: Sap 001

Clinical Study Report 547-PPD-202B 16.1 Study Information 9. DOCUMENTATION OF STATISTICAL METHODS Statistical Analysis Plan 1 Statistical Analysis Plan (Methods) Sage Therapeutics, Inc. Study 547-PPD-202B CONFIDENTIAL SAGE THERAPEUTICS INCORPORATED ...

Filetype PDF | Posted on 02 Mar 2023 | 2 years ago

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...Clinical study report ppd b information documentation of statistical methods analysis plan sage therapeutics inc confidential incorporated protocol number nct a multicenter randomized double blind parallel group placebo controlled evaluating the efficacy safety and pharmacokinetics injection in treatment adult female subjects with severe postpartum depression moderate author sap version date october sponsor representative phd first street cambridge massachusetts this document contains any use distribution or disclosure without prior written consent is strictly prohibited except to extent required under applicable laws regulations persons whom disclosed must be informed that may not further by them table contents list abbreviations introduction objectives primary objective secondary other pharmacokinetic endpoints endpoint key design overall sample size power randomization blinding unblinding modifications from approved dmc charter sets all enrolled set per general considerations day de...

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Posted on: 02 Mar 2023 | 2 years ago
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Filetype: PDF
File size: 1.24 MB
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