The following changes were made in Amendment 1: The first of the 7 defined relapse criteria was revised.- Increase in Positive and Negative Syndrome Scale (PANSS) total score by ≥ 30% for participants who had a total score of ≥ 50 at Randomization or a ≥ 10-point increase in PANSS total score for participants who had a PANSS total score < 50 at Randomization. The fifth of the 7 defined relapse criteria was revised.- Initiation of treatment with a mood stabilizer, antidepressant, antipsychotic agent, or with a benzodiazepine that exceeds the protocol-specified allowance or duration (ie, more than 2 mg/d of lorazepam or equivalent or for more than 3 consecutive days) to treat worsening symptoms of schizophrenia or any other psychiatric disorder as judged by the clinical impression of the investigator. Columbia-Suicide Severity Rating Scale (C-SSRS) was revised.- The C-SSRS was completed,. A new analysis population was added.- The open-label safety-follow-up (OL SFU) population consisted of participants in the OL safety population who were not randomized. Pharmacogenetic Sampling was revised.- Pharmacogenetic consent may be obtained at any time between Screening and Week 8. Ophthalmological Examination was revised.- Participants with a finding of cataracts at any time during the study must be discontinued. New text added for summarization of ocular events of special interest.- The number and percentage of participants reporting treatment emergent adverse events (TEAEs) of ocular events of special interest will be summarized overall for the OL treatment period in the open-label safety population and the OL SFU period in the OL SFU population, and by treatment for the DB treatment period and the DB SFU period in the double-blind safety population. The listing of all reported ocular events of special interest was provided.

The following changes were made in Amendment 2: Updated PANSS to SCI-PANSS. Changed “Threshold Symptoms” to “response criteria”. Exclusion Criteria was revised.- Exclusion around urine drug screen was clarified. Replaced SCI-PANSS Scoring Sheet. Schedule of visits and procedures was revised.- Replaced the scale used to make the diagnostic assessment from MINI to Structured Clinical Interview for DSM-5 (SCID-5). Removed extrapyramidal symptoms (EPS) assessment from Visit 1. Ophthalmological Examination was revised.- Added: anterior chamber and iris to slit-lamp examination. Personal and social performance (PSP) Scale was revised.- Updated with full copy of scale.

The following changes were made in Amendment 3: Protocol Summary, Screening/Washout period was revised.- Added text to clarify that psychotropic medications, not listed as rescue medications, may not be newly initiated or reinstated. Screening/Washout Period was revised.- Added text to clarify that psychotropic medications, not listed as rescue medications, may not be newly initiated or reinstated. Exclusion Criteria was revised.- Added text to exclude moderate CYP3A4 inhibitors. Added: Absolute neutrophil count < 1000 per mm^3 at screening. Hemoglobin A1c (HbA1c) > 7% at screening. Blood alcohol concentration > 0.02 gram per deciliter (g/dL) at Visit 1 as measured by breathalyzer. Added Suvorexant (maximum of 20 milligram per day [mg/d]) to the list of allowed medications for insomnia. Added Biperiden to permissible rescue medications for EPS or akathisia and removed dosing guidance. Treatment Compliance was revised.- Added text to state that any participant who misses ≥ 4 consecutive doses of IP must be discontinued from the study. Clinical Global Impressions-Severity was revised.- Changed text to state that the rating scale must be performed by a trained rater. Clinical Global Impressions-Improvement was revised.- Changed text to state that the rating scale must be performed by a trained rater. Adverse Events was revised.- Replaced all text to define how AEs and TEAEs will be coded and summarized. Withdrawal Criteria was revised.- Added text to number 7 to clarify that a participant with a positive urine drug screen (UDS) after enrollment should only be withdrawn if the positive test is confirmed at the next scheduled visit.

The following changes were made in Amendment 4: Phrase ocular events of special interest changed to ocular adverse event of special interests (AESIs). There is no longer a distinct serious adverse event (SAE) reporting form and AESI reporting form. It is a combined SAE/AESI form. Serious Adverse Event was revised. Text revised to clarify which pregnancy outcomes or genetic abnormalities are considered SAEs.